Nogapendekin alfa inbakicept - Altor BioScience Corporation
Alternative Names: ALT 803; ANKTIVA; IL-15N72D/IL-15Ra-Fc - Altor BioScience Corporation; IL-15N72D:IL-15RαSu/Fc fusion protein complex; IL-15sa - Altor BioScience Corporation; Interleukin 15 superagonist - Altor BioScience Corporation; N-803; Nogapendekin alfa inbakicept - ImmunityBio; Nogapendekin alfa inbakicept-pmln - Altor BioScience Corporation; Superagonist Interleukin-15:Interleukin-15 receptor alphaSu/Fc Fusion complex - Altor BioScience Corporation; VesAnktiva™Latest Information Update: 06 May 2024
At a glance
- Originator Altor BioScience Corporation
- Developer Altor BioScience Corporation; ImmunityBio
- Class Antineoplastics; Antiretrovirals; Immunoglobulin Fc fragments; Immunotherapies; Interleukins; Recombinant fusion proteins
- Mechanism of Action Interleukin-15 receptor agonists
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Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Registered Bladder cancer
- Phase III Non-small cell lung cancer
- Phase II Acute myeloid leukaemia; Cervical cancer; Colorectal cancer; Fallopian tube cancer; Gastric cancer; Hereditary nonpolyposis colorectal cancer; HIV infections; Liver cancer; Malignant melanoma; Merkel cell carcinoma; Myelodysplastic syndromes; Oesophageal cancer; Ovarian cancer; Pancreatic cancer; Peritoneal cancer; Renal cell carcinoma; Small cell lung cancer; Solid tumours; Squamous cell cancer; Urogenital cancer
- Phase I/II Multiple myeloma; Non-Hodgkin's lymphoma; Triple negative breast cancer
- Phase I HIV-1 infections
Most Recent Events
- 02 May 2024 ImmunityBio has patent protection for development and commercialization of N-803
- 02 May 2024 The validity of one of European patents, EP Patent is being challenged in an opposition proceeding
- 25 Apr 2024 ImmunityBio plans a meeting with the FDA in June to discuss the company’s overall survival results in PD-L1 negative and positive patients and registration plans for 2nd-line and 3rd-line NSCLC patients whose cancer did not respond or continue to respond to checkpoint therapy and for whom few alternative therapies are available
Development Overview
Introduction
Nogapendekin alfa inbakicept (ALT 803) is a recombinant interleukin-15 (IL-15) super agonist protein complex, being developed by Altor BioScience Corporation (an indirect wholly-owned subsidiary of ImmunityBio) for the treatment of multiple cancer types including bladder cancer, breast cancer, non-small cell lung cancer, small cell lung cancer, acute myeloid leukaemia, myelodysplastic syndromes, cervical cancer, colorectal cancer, ovarian cancer, liver cancer, malignant melanoma, urogenital cancer, renal cell carcinoma, pancreatic cancer, advanced solid tumours, non-Hodgkin's lymphoma, Lynch syndrome [hereditary nonpolyposis colorectal cancer in the development table], head and neck squamous cell carcinoma [squamous cell cancer in the development table], and HIV infections. Nogapendekin alfa inbakicept is a novel IL-15 superagonist complex consisting of an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor alpha-IgG1 Fc (IL-15Rα-IgG1 Fc) fusion protein. The cytokine IL-15 is a critical factor for the development, proliferation and activation of cellular immune responses that are involved in killing cancer cells. Binding of nogapendekin alfa inbakicept to its receptor results in proliferation and activation of NK, CD4, CD8+ and memory T cells without proliferation of immuno-suppressive Treg cells, leading to durable complete responses. It shows improved pharmacokinetic properties, longer persistence in lymphoid tissues and enhanced anti-tumour activity compared to native, non-complexed IL-15 in vivo. The candidate is approved for bladder cancer in the US. Clinical development for multiple cancer indications is underway in the US. Clinical development for HIV infections is underway in the US and Thailand.
As at August 2023, no recent reports of development had been identified for phase-I development in Solid tumours (Inoperable/Unresectable, Late-stage disease, Metastatic disease) and HIV-infections (Adjunctive treatment) in USA (SC, Injection).
In March 2021, NantKwest merged with ImmunityBio to form ImmunityBio [1] .
Company Agreements
In August 2020, ImmunityBio & NantKwest signed a definitive research and development agreement to jointly develop, manufacture, market, and commercialise therapeutics and vaccines for COVID-2019 infections. Under the terms of the definitive agreement, both the companies will share equally the costs incurred after 21 August 2020 relating to development, manufacturing, marketing, and commercialisation of the candidates that each is developing related to COVID-19. Should a product be commercialized successfully, the net global profits would be split 60-40%, with the larger share going to the company that developed the product. The agreement also detailed the structure of shared governance of the joint collaboration. Earlier in May 2020, the companies signed a binding term sheet for the joint development, manufacture and marketing of vaccines and therapeutics. Both the companies would jointly develop haNK, mesenchymal stem cells (MSC), adenovirus constructs (Ad5), and N 803 for the prevention and treatment of SAR-CoV-2 viral infections and associated conditions, including COVID-19. NantKwest would contribute the haNK, MSC, and certain of its manufacturing capabilities, and ImmunityBio will contribute Ad5, IL-15, and certain manufacturing equipment. Under the terms of the agreement, All net profits from sales of combined collaboration products will be shared equally. This collaboration will be supervised by joint committees, comprised of an equal number of representatives from both companies. In October 2016, Altor Bioscience signed an exclusive co-development agreement with NantKwest for the development of immunotherapies using latter's natural killer cell therapy and Altor BioScience's ALT 801 and nogapendekin alfa inbakicept for the treatment of cancer. Financial terms of the co-development agreement were not disclosed. [2] [3] [4]
In April 2016, Altor BioScience entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), an Institute of the National Institutes of Health (NIH). Under the CRADA, Altor will work with NCI to further develop its proprietary single-chain T-cell-receptor/Interleukin-2 (IL-2) fusion protein ALT-801 and interleukin-15 (IL-15) superagonist, nogapendekin alfa inbakicept [5]
In September 2014, Altor BioScience Corporation and Shenzhen Beike Biotechnology Co Ltd entered into a license agreement to develop and commercialise nogapendekin alfa inbakicept in China. Under the terms of the agreement, Altor has granted Beike an exclusive license for the research, development, manufacture and commercialisation of nogapendekin alfa inbakicept for therapeutic uses in all human disease indications in China. Altor will receive an upfront fee of $US4 million and could potentially receive over $US200 million in development and sales milestones and tiered double-digit royalties based on sales of licensed products. Beike has also made a strategic equity investment of approximately $US5 million into Altor. Beike will have marketing rights for licensed products in China and Altor will retain marketing rights in all other countries. Nogapendekin alfa inbakicept is an immunotherapeutic agent against hematologic and solid tumors and virally infected cells. [6]
In June 2011, Florida Biologix agreed to manufacture nogapendekin alfa inbakicept for clinical testing [7] .
Key Development Milestones
Bladder cancer: In April 2024, the US FDA approved nogapendekin alfa inbakicept-pmln (ANKTIVA®) with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours. The approval is based on the safety and efficacy data from the phase II/III QUILT-3.032 trial [see below]. ImmunityBio intends to launch the candidate in the US by mid-May 2024. Earlier, in October 2023, ImmunityBio announced that the US FDA accepted its resubmission of Biologics License Application (BLA) for review. The FDA had set a user fee goal PDUFA date as of April 23, 2024. Also, this was considered as a complete response to the FDA’s May 9, 2023 complete response letter. Earlier in the same month, ImmunityBio had submitted the application. In July 2023, US FDA accepted BLA with PDUFA date as May 23, 2023 which was previously submitted in May 2022 [8] [9] [10] [11] [12] [13] [14] .
In May 2024, ImmunityBio announced the drug substance (DS) has been completed and successfully qualified for “fill finish” (filling vials and finishing packaging), sufficient for 170,000 doses of 400mcg nogapendekin alfa inbakicept [15]
In December 2019, the US FDA granted breakthrough therapy designation to nogapendekin alfa inbakicept for the treatment of patients with BCG-unresponsive non-muscle invasive bladder carcinoma in situ (CIS). The breakthrough therapy designation applies for the development of nogapendekin alfa inbakicept, in combination with Bacillus Calmette-Guerin (BCG) [16] .
In May 2017, the US FDA granted Fast Track designation to nogapendekin alfa inbakicept for the treatment of patients with non-muscle invasive bladder cancer (NMIBC). The Fast Track designation will apply to clinical development of nogapendekin alfa inbakicept in combination with BCG for the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder, as well as for the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR) in patients with NMIBC [17] .
In December 2020, ImmunityBio announced that the phase II/III QUILT-3.032 trial met its primary end point in the first cohort for BCG unresponsive non-muscle invasive bladder cancer carcinoma in situ (CIS) with 72% complete response rate. In October 2021, ImmunityBio announced that that Papillary disease (Cohort B) in the phase II/III QUILT-3.032 trial met its primary endpoints with disease-free survival of 57% of patients at 12 months. In June 2017, Altor Bioscience Corporation initiated the phase II/III QUILT-3.032 trial to assess the safety and efficacy of nogapendekin alfa inbakicept combination with intravesical Bacillus Calmette-Guerin (BCG), administered by intravesical instillation, in patients with BCG unresponsive high grade non-muscle invasive bladder cancer (CA-ALT-803-01-16; QUILT 3.032; NCT03022825). The open-label, single-group trial, enrolled 190 patients in the US. In November 2018, early clinical efficacy results demonstrated that 100% of patients with papillary NMIBC remained disease free for 3 to 15 months following fusion protein activation of NK and T cells. In May 2019, Nantkwest presented safety and efficacy data at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO-2019). In December 2020, enrolment of BCG unresponsive non-muscle invasive bladder cancer CIS cohort is completed in the trial. In December 2020, positive efficacy and safety data from the first cohort of a phase II/III QUILT-3.032 trial was released by ImmunityBio. In September 2021, Immunity Bio announced that, 81 participants are fully enrolled in cohort A and evaluable with median follow-up of over 20 months. In September 2021, ImmunityBio released updated results from the Cohort A of the trial and also presented at 116th Annual Meeting of the American Urological Association (AUA-2021). In October 2021, ImmunityBio released updated results from the Cohort B of the trial (ImmunityBio pipeline, January 2022) [18] [19] [20] [21] [22] [23] [17] [24] . In February 2022, data from the trial was released by the company [25] . In April 2022, ImmunityBio reported that it has achieved a major milestone with over 80 patients in the trial completing at least 12 months of follow-up as of January 14, 2022. The company has compiled BLA and, following final quality review, is expected to be submitted to the US FDA in April 2022 [26] . In June 2022, results from the trial were presented at the 58th Annual Meeting of the American Society of Clinical Oncology (ASCO-2022) [27] . In November 2022, company released updated data from the trial [28] .
In July 2014, Altor BioScience initiated a phase Ib/IIb QUILT-2.005 trial to assess the safety and efficacy of intravesical nogapendekin alfa inbakicept in combination with Bacillus Calmette-Guerin (BCG), administered by intravesical instillation in BCG-naive patients with non-muscle invasive bladder cancer (CA-ALT-803-01-14; QUILT 2.005; NCT02138734). The open-label, parallel, randomised trial, intends to enroll 596 patients in the US. In May 2017, safety and efficacy results from the trial were presented at the 112th Annual Meeting of the American Urological Association (AUA-2017) [29] [7] [30] .
Breast cancer
In May 2019, NantKwest withdrew the phase II QUILT-3.057 trial prior to enrolment. The trial was designed to evaluate the efficacy and safety (as assessed by pCR) of the NANT neoadjuvant triple negative breast cancer vaccine regimen (experimental arm) compared with the SoC dose-dense regimen of doxorubicin/cyclophosphamide followed by paclitaxel (control arm) (NCT03554109). The randomised, open-label trial intended to enrol patients in the US [31] .
As of June 2020, ImmunityBio is planning to file an IND application with the US FDA, for the phase II QUILT 3.069 study, that is designed to evaluate PD-L1 t-haNK, N 803, aldoxorubicin and a checkpoint inhibitor in combination with standard of care therapy, versus standard of care alone, for the first- and second line treatment of advanced or metastatic triple-negative breast cancer [32] .
In March 2023, ImmunityBio terminated phase I/II trial as trial did not meet recruiting goals that intends to evaluate the safety and preliminary efficacy of nogapendekin alfa inbakicept and PD-L1 t-hank in combination with standard chemo and sacituzumab govitecan in patients with advanced triple-negative breast cancer (TNBC) (QUILT-3.058; NCT04927884). The open-label trial intends to recruit approximately 3 patients in the US [33] . In October 2021, first two patients enrolled in the trial [34] . Earlier in In June 2021, ImmunityBio received the US FDA authorisation to conduct the QUILT 3.058 phase Ib/II trial in patients with advanced triple-negative breast cancer (TNBC) [35] .
In March 2018, NantKwest initiated a phase I/II QUILT-3.067 trial to evaluate the safety and efficacy of metronomic combination therapy containing Aldoxorubicin, nogapendekin alfa inbakicept, ETBX 011, ETBX 051, ETBX 061, GI 4000, GI 6207, GI 6301, haNK, avelumab, bevacizumab, capecitabine, cisplatin, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, SBRT [See ADIS Insight Drug Profile 800025015 800020658 800032624 800051647 800051649 800030043 800035600 800050206 800037592 800008086 800006401] in patients with triple negative breast cancer who have progressed on or after previous SoC chemotherapy (NCT03387085). The open-label trial will enrol approximately 79 patients in the US. The preliminary results from the trial were released by NantKwest in June 2019 [36] [37] .
Colorectal cancer
In March 2023, National Cancer Institute initiated a phase IIb trial to evaluate whether Tri-Ad5 in combination with N 803 works to prevent colon and other cancers in participants with Lynch syndrome [Hereditary nonpolyposis colorectal cancer in the development table] (NCI-2021-14234; NCT05419011). This randomized trial enrolled 186 patients in the US and may expand to Puerto Rico [38] . In February 2024, company announced the completion of enrollment in the trial [39] .
In September 2020, ImmunityBio in collaboration with National Cancer Institute initiated a phase II trial to evaluate a combination immunotherapy of modified vaccinia Ankara (MVA)-BN-CV301, Fowlpox (FPV)-CV301), M7824 (MSB0011359C), and N-803 (Anktiva) in patients with locally advanced or metastatic small bowel or colorectal adenocarcinomas (NCT04491955; 200138; 20-C-0138). The open-label trial intends to enrol 32 patients in the US [40] .
In March 2024, ImmunityBio in collaboration with National Cancer Institute initiates a phase I/II trial to evaluate the combination of anti-cancer drugs including nogapendekin alfa inbakicept, retifanlimab, TriAdeno vaccine, and SX 682 for the treatment of colorectal cancer (NCT06149481; 10001563; 01563-C). The open-label trial intends to enrol 60 patients in the US [41]
In August 2019, NantKwest withdrew the phase Ib/II QUILT-3.050 trial prior to enrolment as the trial was not initiated, that was designed to evaluate the safety and efficacy of metronomic combination therapy in participants with recurrent and metastatic colorectal cancer (NCT03169777). The open-label trial intended to enrol approximately 79 patients [42] .
In May 2018, NantKwest initiated the QUILT-3.071 phase Ib/II study to evaluate NANT CRC vaccine regimen (Aldoxorubicin, nogapendekin alfa inbakicept, ETBX 011, ETBX 051, ETBX 061, GI 4000, GI 6207, GI 6301, haNK, avelumab, capecitabine, cetuximab, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, oxaliplatin, regorafenib, SBRT, trastuzumab, [see AdisInsight drug profiles 800025015, 800050206, 800032624, 800051647, 800051649, 800030043, 800035600, 800020658, 800037592, 800008086, 800006401]) versus regorafenib, in previously treated patients with relapsed or refractory colorectal cancer (NCT03563157). The primary endpoint for the phase Ib portion of the trial is safety and the primary endpoint for the phase II portion of the trial is progression-free survival and objective response rate, both by RECIST. The open-label, randomised study intends to enrol approximately 332 patients in the US [43] . In January 2019, the first patient had been dosed in the phase Ib portion of trial [44] . In December 2019, efficacy and safety data from the trial was presented at the 42nd Annual San Antonio Breast Cancer Symposium (SABCS-2019) [45] .
HIV infections
In March 2021, Thai Red Cross AIDS Research Centre and the Walter Reed Army Institute of Research initiated a phase II trial to evaluate the safety, tolerability and immunomodulation effect of combining nogapendekin alfa inbakicept with antiretroviral therapy (ART) during acute HIV infection (RV550; NCT04505501). The trial is designed to compare levels of HIV RNA and DNA in lymph node samples pre- and post-treatment and evaluate the therapy’s effects on CD8+ T and natural killer (NK) immune cells. The patients in the trial are recruited through the U.S. Military HIV Research Program's (MHRP at Walter Reed Army Institute of Research) acute HIV infection cohort, which identifies individuals in the earliest post-infection stages. The open-label trial intends to enrol approximately 15 patients in Thailand [46] [47] .
In December 2022, Rockefeller University initiated a phase I trial to evaluate evaluate the safety and antiretroviral activity of the combination of two long-acting broadly neutralizing antibodies, 3BNC117-LS dosed once at 30 mg/kg and 10-1074-LS dosed once at 10 mg/kg, plus nogapendekin alfa inbakicept in HIV infection (NCT05245292; MCA-1031 (ES38918); 1U01AI145921-U.S. NIH Grant/Contract). The open label single arm, trial intends to enrol approximately 36 participants in the US [48] .
In May 2021, the AIDS Clinical Trials Group initiated the phase I trial to evaluate the safety, tolerability, and efficacy of subcutaneously administered nogapendekin alfa inbakicept alone or in combination with broadly neutralising antibodies (bNABs); 10 1074 and VRC07 523LS to control HIV-1 infections after participants stop their antiretroviral therapy (ART) (38639; A5386; ACTG A5386; NCT04340596). After receiving mono- and combination therapy treatment, participants will stop taking ART and will be followed for approximately for approximately 100 weeks to monitor for signs that they need to restart ART. The open-label, randomised trial intends to enrol approximately 46 patients in the US. The trial is funded by the National Institute of Allergy and Infectious Diseases (NIAID) [49] [50] .
In January 2023, University of Minnesota and National Institute of Allergy and Infectious Diseases completed a phase I trial which was designed to evaluate the effect of subcutaneously administered nogapendekin alfa inbakicept on B cells follicles and frequency of CD8+ T cells in HIV infected patients who were treated with antiretroviral therapy (ART) (IDIM-2019-27395; NCT04808908). The open-label, single-group trial, initiated in April 2021, enrolled 10 patients in the US [51] .
In April 2021, University of Minnesota in collaboration with Altor BioScience Corporation completed a phase I trial which was designed to evaluate adoptive transfer of haploidentical natural killer cells and nogapendekin alfa inbakicept in HIV infections (NCT03899480; IDIM-2018-26587).The open-label trial, initiated in May 2019, enrolled nine patients in the US.
In September 2019, University of Minnesota completed a phase I proof of principle trial that evaluated the safety, efficacy and tolerability of nogapendekin alfa inbakicept in patients with HIV (ALT-803; NCT02191098). The open-label, single-arm intra-patient dose escalating pilot trial was initiated in June 2015 and enrolled 10 patients in the US. Results from the trial showed that the drug was safe and reduced the viral reservoir in peripheral blood mononuclear cells [46] [52] . In April 2018, Altor Bioscience presented results for seven patients from the trial at the 25th Conference on Retroviruses and Opportunistic Infections [53] . In February 2022, Altor Bioscience released results from the trial [54] .
In March 2020, ImmunityBio initiated two clinical trial evaluating nogapendekin alfa inbakicept in patients with HIV infections [55] .
In March 2024, pharmacodynamics data from the preclinical study in HIV infections were released by ImmunityBio [56] .
In June 2021, ImmunityBio reported that nogapendekin alfa inbakicept reversed HIV latency by activating HIV replication within long-lived cells in the immune system thus allowing the infected cells to be recognised and cleared by the immune system [49] .
In April 2021, results from preclinical studies in HIV infections were released by ImmunityBio [46] .
Results from preclinical studies for nogapendekin alfa inbakicept, conducted in SIV-infected ART-treated rhesus macaques were presented at the 26th Conference on Retroviruses and Opportunistic Infections (ROI-2019) [57] . Additional results were released by the company in March 2020 [55] .
In March 2020, preclinical pharmacodynamics data for nogapendekin alfa inbakicept HIV infections was presented at the 27th Conference on Retroviruses and Opportunistic Infections (CROI-2020) [58] .
Merkel cell carcinoma
In October 2021, ImmunityBio terminated a phase II trial designed to assess the triple combination therapy comprising nogapendekin alfa inbakicept, high-affinity CD16-expressing natural killer cell therapy [see Adis Insight Drug profile 800050206] and avelumab [see Adis Insight Drug profile800037592], for the treatment of merkel cell carcinoma as it was not meeting recruitment goal (NCT03853317; QUILT 3.063). The open-label trial was initiated in February 2020 and enrolled 9 patients in the US [59] [60] . The first patient was dosed in March 2020. Preliminary results presented at the Society for Immunotherapy of Cancer conference (SITC-2019) showed complete response with high-affinity CD16-expressing natural killer cell therapy as third-line treatment in patients with merkel cell carcinoma. The study is being conducted under a Cost Allocation Agreement between ImmunityBio and NantKwest [61] [62] .
In August 2015, NantKwest initiated the non-randomised, open-label, phase II QUILT-3.009 trial to evaluate the effect of aNK cell infusion [see Adis Insight Drug profile 800019483] in approximately 24 patients with unresectable stage III (IIIB) or distant metastatic (stage IV) Merkel cell carcinoma (MCC) (MCC-001; NCT02465957). Results from three patients demonstrated indication-specific safety and favourable biological activity as a monotherapy, with radiological complete response in one patient and a mixed response in another patient. Later, in order to enhance the activity of the aNK cell infusion, the protocol of the trial was amended to include administration of nogapendekin alfa inbakicept, in combination with the aNK cell infusion. In February 2017, the first patient was dosed with the combination therapy, following enrolment of the patient in January 2017. The combination therapy was well tolerated, without any dose limiting adverse events. Enrolment of the second patient for the combination therapy occurred in February 2017, and dosing was expected to occur by the end of March 2017. Results from the trial were released by the company in November 2019 [63] [64] [65] [65] [66] .
In March 2021, ImmunityBio withdrew a phase I/II trial which was designed to evaluate the safety and efficacy of metronomic combination therapy in patients with merkel cell carcinoma who have progressed on or after anti-PD-L1 therapy prior to enrolment (NCT03167164; QUILT-3.045). The open-label trial intended to enrol patients in the US [67] .
Multiple myeloma
In October 2014, Altor BioScience initiated an open-label phase Ib/II, dose escalation trial in the US to evaluate the safety and efficacy of nogapendekin alfa inbakicept patients with relapsed or refractory multiple myeloma (NCT02099539). Approximately 50 patients will be administered intravenous infusion of nogapendekin alfa inbakicept two 6 week treatment cycles. The study will assess the number and severity of adverse events assessed over 24 months, and determine the maximum tolerated dose or minimum efficacious dose assessed over 9 months [68] . This trial is supported by a $US1.5 million Small Business Innovation Research phase II grant from the National Cancer Institute (NCI). Altor reported in November 2014 that it has enrolled patients into the trial [69] .
Non-small cell lung cancer
In April 2024, ImmunityBio announced that the company plans to have a meeting with the US FDA in June 2024, to discuss about the registration of nogapendekin alfa inbakicept in the US for the treatment of non-small cell lung cancer [70] .
In March 2022, ImmunityBio in collaboration with Southwest Oncology Group and National Cancer Institute (NCI) initiated a phase II/III Lung-MAP Treatment trial (800-site master protocol trial) to study N-803 plus pembrolizumab versus investigator choice of standard-of-care chemotherapy in patients with non-small cell lung cancer (NSCLC) (NCT05096663; S1800D; NCI-2021-09852; U10CA180888) [71] . This Lung-MAP study will look at how N-803 could potentially bolster the effectiveness of Keytruda for patients with non-targetable cancer cell mutations. The open-label, randomised trial intends to enrol approximately 478 patients in the US. The patient was enrolled in the trial [72] [73] .
In May 2018, Altor BioScience in collaboration with ImmunityBio (formerlyNantCell) initiated the phase II/III QUILT-2.023 trial to evaluate the safety and efficacy of combination therapy of nogapendekin alfa inbakicept and with standard of care including pembrolizumab versus standard of care including pembrolizumab alone (control arm), as first-line treatment for patients with metastatic NSCLC in which pembrolizumab is indicated for first-line treatment (NCT03520686; QUILT-2.023). The open-label, randomised trial intends to enrol approximately 1538 patients in the US. In June 2020, QUILT-2.023 trial progressed to phase III [74] [75] .
As of June 2020, ImmunityBio is planning to file an IND application with the US FDA, for the phase III QUILT 59 study, to evaluate standard of care therapy in combination with PD-L1 t-haNK, nogapendekin alfa inbakicept and a checkpoint antibody, versus standard of care chemotherapy alone, for the first and second line treatment of advanced or metastatic non-small cell lung cancer [32] .
In November 2021, Washington University School of Medicine in collaboration with Eli Lilly and Company and ImmunityBio withdrew a phase II trial prior to enrolment to evaluate ramucirumab in combination with atezolizumab and N 803 after progression on any immune checkpoint blocker in non-small cell lung cancer, due to lose in funding (NCT05007769; 21-x234) [76] .
In April 2024, ImmunityBio in collaboration with National Cancer Institute initiated a phase I/II trial to evaluate cancer lysate vaccine and montanide(R) ISA-51 VG with or without the nogapendekin alfa inbakicept as adjuvant therapy for PD-L1 negative non-small cell lung cancer (NCT05642195; 000520-C; 10000520). The open-label trial intends to enrol 30 patients in the US [77] .
In August 2019, NantCell withdrew the phase Ib/II QUILT-3.044 trial prior to enrolment that was designed to evaluate the safety and efficacy of metronomic combination therapy in participants with NSCLC who had progressed on or after treatment with PD-1/PD-L1 inhibitors (NCT03169738; QUILT-3.044). The open-label trial intended to enrol approximately 85 patients [78] .
In February 2023, Medical University of South Carolina, in collaboration with Altor BioScience completed a phase Ib/II trial which was designed to evaluate nogapendekin alfa inbakicept, in combination with nivolumab [see Adis Insight Drug profile 800022442], in previously-treated patients with advanced or metastatic non-small cell lung cancer (NCT02523469; 102323). The open-label trial, initiated in January 2016, enrolled 58 patients in the US [79] . In June 2018, data from the trial were presented at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO-2018) [80] .
Pancreatic cancer
In January 2020, NantKwest (now ImmunityBio) reported initiation of a compassionate use expanded access programme for the PDL1 t-haNK cell therapy in combination with nogapendekin alfa inbakicept (N 803) [see Adis Insight Drug profile 800039285] for the treatment of a patient with metastatic pancreatic cancer who had inadequate response on standard of care. The programme was initiated based on results of the safety and efficacy data of a phase I trial in 11 patients with metastatic pancreatic cancer who had received haNK [see Adis Insight Drug profile 800050206] and nogapendekin alfa inbakicept (N 803). In preliminary evaluation, the patient’s tumor metastasis resolved completely per CT/Pet scan and the complete response has been confirmed by a repeat CT/Pet scan after five infusions of PD-L1.t-haNK and nogapendekin alfa inbakicept. Earlier, the US FDA granted approval to a Investigational New Drug application (IND) for a compassionate use expanded access programme for evaluation of the combination therapy in a patient with metastatic pancreatic cancer who had inadequate response on standard of care [62] [81] .
In July 2020, ImmunityBio and NantKwest initiated a phase II trial to evaluate the efficacy and overall safety of standard-of-care chemotherapy in combination with aldoxorubicin HCl [see Adis Insight Drug profile800025015] , nogapendekin alfa inbakicept, and PD-L1 t hank [see Adis Insight Drug profile 800055675] versus standard-of-care chemotherapy for patients with locally advanced or metastatic pancreatic cancer (QUILT88; NCT04390399). Each treatment setting (ie, first line maintenance, or second or later line) will be evaluated independently as a separate cohort. The randomised, open-label, trial intends to enrol approximately 328 patients in the US. The US FDA approved the IND application for this trial earlier [82] [83] . In October 2020, NantKwest announced the addition of third cohort to this ongoing phase II trial. The third cohort enables pancreatic cancer patients who have failed all approved standards of care to participate in the trial [84] . In January 2021, NantKwest and ImmunityBio announced the interim results from cohort C [85] . In April 2021, ImmunityBio announced that it has dosed 100th patient in the QUILT 88 trial [86] . In October 2021, Immunity Bio announced completion of enrollment in the trial. Efficacy data from a trial in pancreatic cancer released by ImmunityBio [87] . In January 2022, ImmunityBio released data from the trial which demonstrated no treatment-related (TR) deaths or adverse events [88] . In June 2022, the company released adverse events data from the trial at the 58th Annual Meeting of the American Society of Clinical Oncology (ASCO-2022) [89] . In January 2023, the company released efficacy data from the trial [90] .
In August 2019, NantKwest withdrew the phase II QUILT-3.088 trial prior to enrolment, that was designed to evaluate the safety and efficacy (as assessed by PFS) of the NANT Pancreatic Cancer Vaccine regimen (experimental arms) vs SoC therapy (control arms) as first-line treatment for participants with metastatic pancreatic cancer (NCT03563144; QUILT-3.088). The open-label, randomised trial intended to enrol approximately 1 064 participants in the US [91] .
In July 2018, NantKwest initiated the QUILT-3.080 phase I/II trial to assess the safety and efficacy of its metronomic combination therapy in patients with pancreatic cancer who have progressed on or after standard of care treatment (NCT03586869). The combination therapy consists of NANT pancreatic cancer vaccine regimen (Aldoxorubicin, nogapendekin alfa inbakicept , ETBX 011, ETBX 021, ETBX 051, ETBX 061, GI 4000, GI 6207, GI 6301, haNK, bevacizumab, avelumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, oxaliplatin, nab-paclitaxel).The open-label trial will enrol 173 patients in the US. In June 2019, results from the study were presented at 55th Annual Meeting of the American Society of Clinical Oncology (ASCO-2019) [92] [36] [93] .
In January 2018, NantKwest initiated the phase I/II QUILT3-070 to evaluate the safety and efficacy of metronomic combination therapy (avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-Paclitaxel, lovaza, oxaliplatin, nogapendekin alfa inbakicept, ETBX 011, haNK for infusion, GI 4000, aldoxorubicin, GI 6207 [see Adis Insight Drug Profile 800019483, 800020658, 800025015, 800030043, 800032624, 800035600, 800050206] in subjects with pancreatic cancer who have progressed on or after previous SoC chemotherapy (NCT03387098). The open-label trial intends to enrol approximately 173 patients in the US [94] . In the same month, first patient was dosed in the trial [95] .
In November 2017, NantKwest initiated the phase I/II QUILT-3.060 trial to evaluate the safety and efficacy of metronomic combination therapy containing nogapendekin alfa inbakicept, GI 4000 [see Adis Insight Drug profile 800020658], ETBX 011 [See ADIS Insight Drug Profile 800032624] and haNK [see Adis Insight Drug profile 800050206] in subjects with pancreatic cancer who have progressed on or after previous SoC chemotherapy (NCT03329248). The open-label trial is enrolling approximately 80 patients in the US [96] .
In February 2018, Altor Bioscience completed a phase I/II trial that evaluated the safety and tolerability of escalating doses, to identify the maximum tolerated dose and designate a dose level for phase II study of nogapendekin alfa inbakicept, administered in combination with gemcitabine and nab-paclitaxel, in patients with advanced pancreatic cancer (NCT02559674; CA-ALT803-01-15). The open-label trial was initiated in July 2016 and enrolled eight patients in the US [97] .
In August 2017, NantCell initiated phase Ib/II trial to evaluate the safety and efficacy of metronomic combination therapy (cyclophosphamide, oxaliplatin, capecitabine, fluorouracil, leucovorin, nab-paclitaxel, bevacizumab, avelumab, nogapendekin alfa inbakicept, aNK, GI 4000 and ETBX 011 [see Adis Insight Drug profiles 800020658, 800032624 and 800019483]), in patients with pancreatic cancer who have progressed on or after previous standard of care first line therapy and chemotherapy (QUILT-3.039; NCT03136406). The open label trial enrolled 3 patients in the US. In May 2017, NantCell and NantKwest announced that the US FDA authorised an Investigational New Drug Application for the trial [98] [99] .
Squamous cell carcinoma
In February 2024, ImmunityBio initiated the phase II QUILT-505 trial to evaluate the safety and efficacy of the combination of PD-L1 t-haNK (modified immune cells), N 803 and cetuximab for immunotherapy-treated patients with recurrent, metastatic head and neck squamous cell carcinoma (HNSCC) (NCT06239220; 23-583). The open-label trial intends to enrol approximately 25 patients in the US [100] .
In August 2019, NantCell withdrew the phase Ib/II QUILT-3.047 trial prior to enrolment that was designed to evaluate the safety and efficacy of metronomic combination therapy in participants with HNSCC who have progressed on or after previous chemotherapy and anti-PD-1/PD-L1 therapy (NCT03169764). The open-label trial intended to enrol approximately 113 patients [101] .
In January 2018, NantCell dosed first patient in the phase Ib part of a phase Ib/II QUILT-3.090 trial evaluating the efficacy of its high-affinity natural killer (haNK) cell therapy in combination with anti-cancer agents (avelumab, bevacizumab, capecitabine, cetuximab, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, lovaza, cisplatin, nogapendekin alfa inbakicept, ETBX 011, ETBX 021, ETBX 051, ETBX 061, GI 4000, GI 6207, GI 6301), including aldoxorubicin, for the treatment of patients with squamous cell carcinoma (QUILT-3.090; NCT03387111). The trial intends to enrol 65 patients in the US [102] [103] .
In July 2020, Bristol-Myers Squibb in collaboration with Altor BioScience and Miltenyi Biotec initiated the phase I trial to evaluate safety and efficacy of a combination of nogapendekin alfa inbakicept and Ipilimumab and biologic therapy (CIML NK cell infusion) in patients with squamous cell carcinoma of head and neck (19-505; NCT04290546). The primary endpoint of the trial is to determine rate of dose limiting toxicity. Non randomized, open label trial is designed to enroll approximately 12 participants in the US [104] . In April 2022, the company presented efficacy and safety data from the trial at the 113th Annual Meeting of the American Association for Cancer Research (AACR-2022) [105] . In July 2023, efficacy data from the trial was released by ImmunityBio [106] .
COVID-2019 infections
In July 2020, ImmunityBio initiated a phase Ib trial to assess the safety and immunostimulatory activity of nogapendekin alfa inbakicept in adult patients with COVID-19. The randomised, blinded, placebo-controlled trial enrolled 1 patient in the US [107] . In May 2020, ImmunityBio and NantKwest announced that the US FDA has approved the IND application for a phase I trial for COVID-2019 infections [3] .
Other cancers
In April 2024, Altor BioScience in collaboration with National Cancer Institute withdrew a phase II trial prior to enrollment which was designed to evaluate nogapendekin alfa inbakicept alone or in combination With BN-Brachyury vaccine or bintrafusp alfa (M7824) for patients with castration resistant prostate cancer (NCT05445882; 000309-C; 10000309). The open-label trial intended to enrol 10 patients in the US [108] .
In April 2024, ImmunityBio completed the phase II QUILT-3.055 trial of nogapendekin alfa inbakicept in combination with other immunotherapies in patients with multiple tumour types who have previously received treatment with PD-1/PD-L1 immunecheckpoint inhibitor therapy (CA-ALT-803-02-17; NCT03228667). The open-label study was initiated in December 2018 and enrolled 147 patients in the US [109] . The US FDA, as at December 2019, had cleared NantKwest's IND amendment, seeking approval to conduct the study to assess PD-L1 t-haNK,nogapendekin alfa inbakicept and a checkpoint inhibitor, in patients with non-small cell lung cancer that has progressed on initial checkpoint inhibitor therapy [32] . In January 2021, the company released safety and efficacy data from the NSCLC patients in cohort 1 of the trial [110] . In May 2021, ImmunityBio released preliminary data from the trial [75] . In June 2021, additional preliminary results were presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [111] . In April 2024, updated results from the phase II trials were released by ImmunityBio [70] .
In February 2022, Altor BioScience in collaboration with Masonic Cancer Center completed a phase II trial which was designed to investigate single dose of intraperitoneal nogapendekin alfa inbakicept followed by maintenance therapy with SC nogapendekin alfa inbakicept compared with SC nogapendekin alfa inbakicept alone, in patients with advanced ovarian, fallopian tube, and primary peritoneal cancer who have received first line therapy (2016LS034; NCT03054909). The randomised, open-label trial, initiated in September 2017, enrolled 7 patients in the US [112] .
In December 2021, National Cancer Institute initiated a phase II trial to evaluate the efficacy of nogapendekin alfa inbakicept in combination with irradiated PD-L1 CAR-NK cells [see RDI profile 500055675] and pembrolizumab in people with advanced forms of gastric or head and neck squamous cell cancer (NCT04847466; 000096-C; 10000096). The open-label trial intends to enrol 55 patients in the US [113] .
In August 2022, Masonic Cancer Center, University of Minnesota completed a phase II trial which was designed to prevent relapse using nogapendekin alfa inbakicept 6 mcg/kg SC maintenance after allogeneic haematopoietic cell transplantation in acute myelogenous leukaemia and myelodysplastic syndrome (2016LS058; MT2016-07; NCT02989844). The open-label, single-group trial, initiated in April 2017, enrolled 20 patients in the US [114] .
In December 2019, Altor BioScience in collaboration with Masonic Cancer Center, University of Minnesota completed a phase II trial which was designed to assess the efficacy and safety of subcutaneous formulation of nogapendekin alfa inbakicept 10 mcg/kg, given in combination with CD3/CD19 depleted, nogapendekin alfa inbakicept activated, haploidentical donor natural killer cells infusion, in patients with refractory or released acute myelogenous leukaemia (2016LS056; NCT03050216). The primary endpoint is to determine the rate of complete remission with incomplete platelet recovery, by day 42 after the infusion. The open-label, Simon's optimal two-stage, single-group study, initiated in May 2017, enrolled 8 adult and elderly patients in the US [115] .
In November 2018, Altor BioScience in collaboration with University of Minnesota withdrew a phase II trial which was designed to evaluate nogapendekin alfa inbakicept in non-myeloablative T cell receptor (TCR) alpha/beta depleted haploidentical transplantation with post-transplant immune reconstitution using nogapendekin alfa inbakicept for the treatment of high-risk myeloid leukemia (AML), treatment-related/secondary AML, and myelodysplastic syndrome (MDS) (NCT03365661; 2016LS057; MT2016-06). The open-label trial intended to enrol patients in the US [116] .
In January 2017, Immunity Bio in collaboration with National Institutes of Health initiated a phase II trial to evaluate cytokine induced memory-like NK cell adoptive therapy with nogapendekin alfa inbakicept after haploidentical donor haematopoietic cell transplantation in patients with acute myeloid leukemia (NCT02782546; 201610088). The open-label trial intends to enrol 60 patients in the US.
In April 2022, Altor BioScience Corporation in collaboration with Washington University School of Medicine terminated a phase I/II trial which was designed to evaluate activated natural killer cells with ALT 803 in treating patients with relapsed or refractory acute myeloid leukemia and myelodysplastic syndromes, due to insufficient funding/staff (NCT01898793; 201401085). The open-label trial, initiated in August 2014, enrolled 89 patients in the US [117] .
In July 2020, Altor BioScience in collaboration with University of Minnesota completed a first-in-human phase I/II trial that investigated the efficacy and tolerability of nogapendekin alfa inbakicept in patients with haematological malignancies (including acute myelogenous leukaemia, acute lymphoblastic leukaemia, myelodysplastic syndromes, lymphoma, myeloma, chronic lymphocytic leukaemia and chronic myelogenous leukaemia) who have relapsed 60 days after allogeneic stem cell transplantation (2012LS023; HM2013-12; NCT01885897). The open-label, dose finding, dose escalation trial was initiated in November 2013 and enrolled 33 patients in the US [118] . Thirty-three haematologic malignancy patients who relapsed >60 days after allogeneic haematopoietic cell transplantation with no active graft versus host disease (GVHD), off immune-suppression, and with at least 10% donor chimerism, were administered nogapendekin alfa inbakicept in 4 weekly doses via two routes, intravenous (IV) and subcutaneous. In December 2017, the results of the study were presented at the 59th Annual Meeting and Exposition of the American Society of Hematology (ASH-Hem-2017) [119] .
In May 2018, National Cancer Institute initiated the QuEST1 phase I/II study to evaluate immunotherapy combination BN-brachyury vaccine [see Adis Insight Drug profile800041043], MSB 0011359C [see Adis Insight Drug profile800041043] nogapendekin alfa inbakicept and epacadostat in patients with solid tumours and prostate cancer (18-C-0078; NCT03493945). The open-label randomised study intends to enrol approximately 113 patients in the US [120] . In September 2020, interim data from the trial in castration-resistant prostate cancer was presented at the 45th European Society for Medical Oncology Congress (ESMO-2020) [121] .
In June 2021, ImmunityBio initiated a phase I study to evaluate the safety and preliminary efficacy of intravenously infused memory cytokine enriched natural killer cell therapy (M-ceNK) [see Adis Insight Drug profile 800063803] and nogapendekin alfa inbakicept for subcutaneous administration, cryopreserved in patients with locally advanced or metastatic solid tumours (QUILT-3.076; NCT04898543). The study consists of two cohorts: cohort 1 includes subjects with newly diagnosed high-risk solid tumors who have not received prior treatment for high-risk tumors; and cohort 2 includes subjects with relapsed/refractory (r/r) solid tumors who have progressive disease after receiving ≥ 2 prior therapies. The non-randomised, open-label trial is enrolling approximately 30 patients in the US [122] . In May 2021, ImmunityBio received FDA authorisation to conduct a phase I study to evaluate the safety and preliminary efficacy of its memory cytokine enriched natural killer cell therapy [see Adis Insight Drug profile800063803] combined with nogapendekin alfa inbakicept in participants with locally advanced or metastatic solid tumours [123] .
In December 2020, Altor Bioscience terminated a phase I/II QUILT-3.002 trial of nogapendekin alfa inbakicept infusion, in combination with rituximab, in patients with indolent B cell Non-Hodgkin lymphoma, due to the change in drug product development strategy (CA-ALT-803-02-14; NCT02384954). The open-label, dose-escalation study, initiated in April 2015, to evaluate the safety, tolerability, immunogenicity and pharmacokinetics of the combination therapy, enrolled 43 patients, in the US [124] . In May 2021, ImmunityBio published safety and efficacy results from the phase I part of the study [125] .
In December 2017, NantCell, completed a phase I/II QUILT-3.040 trial that evaluated the safety, tolerability, and efficacy of ETBX 011 vaccine [see AdisInsight drug profile800032624], in combination with nogapendekin alfa inbakicept, in patients with locally advanced or metastatic CEA-expressing cancers whose tumour has recurred after standard-of-care treatment (QUILT3-040; NCT03127098). This open-label trial was initiated in June 2017 and enrolled three patients in the US [126] .
In August 2019, NantKwest withdrew the phase I/II QUILT-3.072 trial prior to enrolment as the trial was not initiated, that was designed to evaluate the safety and efficacy of metronomic combination therapy in participants with advanced, unresectable, and untransplantable hepatocellular carcinoma (NCT03563170; QUILT-3.072). The combination therapy consisted of NANT CRC vaccine regimen (Aldoxorubicin, nogapendekin alfa inbakicept, ETBX 011, ETBX 051, ETBX 061, GI 4000, GI 6207, GI 6301, haNK, avelumab, capecitabine, cetuximab, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, sorafenib, SBRT [See ADIS Insight Drug Profile 800025015800039285800050206800051647800051649800030043800035600800020658800037592800008086800006401) The open label trial was initiated in May 2018 and intended to enrol approximately 382 patients in the US [127] .
In August 2019, NantCell withdrew the phase Ib/II QUILT-3.051 trial prior to enrolment, that was designed to evaluate the safety and efficacy of metronomic combination therapy in participants with epithelial ovarian cancer who have progressed on or after SoC therapy (NCT03197584; QUILT-3.051). The open-label trial intended to enrol approximately 67 patients [128] .
In August 2019, NantCell withdrew the phase Ib/II QUILT-3.048 trial prior to enrolment that was designed to evaluate the safety and efficacy of metronomic combination therapy in participants with urothelial cancer who have progressed on or after chemotherapy and anti- PD-1/PD-L1 therapy (NCT03197571; QUILT-3.048). The open-label trial intended to enrol approximately 113 patients [129] .
In August 2019, NantCell withdrew the phase Ib/II QUILT-3.046 trial prior to enrolment that was designed to evaluate the safety and efficacy of metronomic combination therapy in participants with melanoma who have progressed on or after chemotherapy and anti-PD-1/PD-L1 therapy (NCT03167177; QUILT-3.046). The open-label trial intended to enrol approximately 67 patients [130] .
In August 2019, NantCell withdrew the phase Ib/II QUILT-3.052 trial prior to enrolment as the trial was not initiated, that was designed to evaluate the safety and efficacy of metronomic combination therapy containing nogapendekin alfa inbakicept in participants with with CD20-positive NHL who have progressed on or after rituximab therapy (NCT03169790; QUILT-3.052). The open-label trial intended to enrol approximately 67 patients [131] .
In October 2023, ImmunityBio initiated a phase I QUILT-105 trial to demonstrate the effect of nogapendekin alfa inbakicept stimulation on the expansion, enrichment, and proliferation of natural killer cells collected by apheresis (QUILT – 105; NCT06040918). This open label trial intends to enrol approximately 10 healthy participants in the US [132] .
In February 2023, Altor BioScience in collaboration with The Case Comprehensive Cancer Center completed a phase I trial which was designed to assess the combination of universal donor natural killer (NK) cell therapy with nogapendekin alfa inbakicept, in cancer patients (CASE2Z16; NCT02890758). The open-label, non-randomised trial, initiated in May 2018, enrolled 14 patients in the US [133] .
In December 2017, Altor BioScience, in collaboration with the National Cancer Institute, Melanoma Research Alliance (MRA) and Cancer Immunotherapeutic Trial Network, completed a phase I trial, that assessed the safety, immunogenicity and efficacy of nogapendekin alfa inbakicept in patients with advanced solid tumours (NCT01946789; CITN06-ALT-803). The study was initiated in May 2014, and enrolled 26 patients, in the US. The collaborative project was funded under the MRA's Academic-Industry Partnership grant programme [134] [135] . The IND for this trial was accepted by the US FDA in August 2013 [136]
In March 2018, Altor BioScience completed the phase I QUILT-1.004 pharmacokinetic study of nogapendekin alfa inbakicept subcutaneous injection in healthy volunteers (CA-ALT-803-03-17; NCT03381586). The single center, open-label, randomised, parallel study was initiated in January 2018 and enrolled 20 participants in the US. Later, in May 2020, data was presented at the 56th Annual Meeting of the American Society of Clinical Oncology (ASCO-2020) [137] [138] .
In November 2020, ImmunityBio released pharmacodynamics data from a preclinical study in cancer [139] .
In May 2018, Precision Biologics reported that nogapendekin alfa inbakicept enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) mediated by NEO 201 against human carcinoma cells [140] .
In preclinical studies, conducted in collaboration with Washington University, nogapendekin alfa inbakicept demonstrated simultaneous mobilisation of both innate and adaptive immune systems to elicit rapid, robust, and long-lasting responses against cancer and virally-infected cells. In various other tumour models, nogapendekin alfa inbakicept was found to potently activate natural killer cells and also enhance the antibody dependent cell-mediated cytotoxicity of rituximab against human B cell lymphoma cell lines and primary follicular lymphoma cells [141] .
Financing info
In December 2023, ImmunityBio announced an up to $US320 million royalty financing and equity investment from private investors , with $US210 million of gross proceeds received at closing. The financing will be used to accelerate company's commercialisation efforts in anticipation of a potential regulatory approval, as well as to expand its pipeline within the broader urological cancer space, including nogapendekin alfa inbakicept (Anktiva®) indications into multiple solid tumours [142] .
In September 2023, ImmunityBio announced $US 470 million equity and debt financing from private investors to fund its ongoing business operations and pre-commercialisation efforts for a potential regulatory approval of nogapendekin alfa inbakicept plus BCG for BCG-unresponsive non-muscle invasive bladder cancer [143] .
In March 2019, NantKwest raised aggregate proceeds of $US39.2 million by exercise of warrants and options. The proceeds are intended to support IND-funding of PD-L1 targeted haNK programme [see Adis Insight Drug profile 800052891], CD19-targeted haNK programme [see Adis Insight Drug profile 800052913] and funding of a phase II trial [see above] exploring the combination of nogapendekin alfa inbakicept, high-affinity CD16-expressing natural killer cell therapy [see Adis Insight Drug profile 800050206] and avelumab [see Adis Insight Drug profile 800037592], for the treatment of relapsed Merkel cell carcinoma [144] .
In September 2015, Altor was awarded a $US2 million SBIR direct-to-phase II grant by the NCI to support the ongoing phase I/II trial of nogapendekin alfa inbakicept combination with rituximab in patients with relapsed or refractory indolent B cell non-Hodgkin lymphoma [141] .
In August 2014, the National Cancer Institute (NCI) awarded a Small Business Innovation Research (SBIR) phase II grant worth $US1.2 million to Altor BioScience, to support the phase I/II trial of nogapendekin alfa inbakicept for the treatment of non-muscle invasive bladder cancer [145] .
In June 2014, Altor was awarded a $US1.5 million SBIR phase II grant by the NCI to support a phase Ib/II trial of nogapendekin alfa inbakicept patients with relapsed or refractory multiple myeloma [69] .
Patent Information
As of May 2024, ImmunityBio own patents and patent applications related to the development and commercialization of N-803 [146] .
As of May 2024, the validity of one of European patents, EP Patent No. 3601363, is being challenged in an opposition proceeding. This patent is directed to methods of using N-803-based combination therapy with anti-CD38 antibodies to treat cancer, which does not directly relate to any of current programs. intend to defend patent and believed meritorious defenses against this opposition.
As of December 31, 2023, ImmunityBio owned patent portfolio directed to N-803, methods of use of N-803, and combinations with additional therapeutics consists of approximately 27 issued U.S. patents and 14 pending U.S. patent applications, as well as approximately 82 patents issued in jurisdictions outside of the U.S., including Europe, China, Japan, Canada, and Australia. Excluding any patent term adjustment and patent term extension, the issued U.S. patents directed to N-803, methods of use of N-803, and combinations with additional therapeutics are expected to expire from 2028 to 2040. Excluding any applicable extensions, the issued foreign patents are expected to expire from 2028 to 2039. If patents are issued from pending U.S. patent applications, excluding any patent term adjustment and patent term extension, such patents will be expected to expire from 2031 to 2043 [146] .
As of October 2021, the US Patent & Trademark Office (USPTO) has allowed ImmunityBio’s patent application for a method of treating cancer, including non-muscle invasive bladder cancer, using nogapendekin alfa inbakicept in combination with Bacillus Calmette-Guerin (BCG). Patent also covers intravesical administration of candidates. The new patent will extend patent life on the nogapendekin alfa inbakicept/BCG combination therapy for bladder cancer to at least 2035 [18] .
Altor BioScience has been issued by the US Patent and Trademark Office, a composition-of-matter patent covering nogapendekin alfa inbakicept (US Patent No 8 507 222) entitled “multimeric IL-15 Soluble Fusion Molecules and Methods of Making and Using Same”). As of August 2013, Altor has five issued and allowed patents covering the composition, production and uses of nogapendekin alfa inbakicept and IL-15 derivatives [136] .
Drug Properties & Chemical Synopsis
- Route of administration Intraperitoneal, Intravesicular, IV, Parenteral, SC
- Formulation Infusion, Injection, Liquid, unspecified
- Class Antineoplastics, Antiretrovirals, Immunoglobulin Fc fragments, Immunotherapies, Interleukins, Recombinant fusion proteins
- Target Interleukin-15 receptor
- Mechanism of Action Interleukin-15 receptor agonists
-
WHO ATC code
J05A-X (Other antivirals)
L01X-X (Other antineoplastic agents)
L03A (Immunostimulants)
-
EPhMRA code
J5 (Antivirals for Systemic Use)
L1X (All Other Antineoplastics)
L1X9 (All other antineoplastics)
L3A (Immunostimulating Agents Excluding Interferons)
- CAS Registry Number 1622189-43-8
Biomarkers Sourced From Trials
| Indication | Biomarker Function | Biomarker Name | Number of Trials |
|---|---|---|---|
|
acute myeloid leukaemia |
Brief Title |
Interleukin-15 (IL-15) |
|
|
acute myeloid leukaemia |
Eligibility Criteria |
Tyrosine-protein kinase ABL1 (JTK7) Thyroid stimulating hormone beta (TSH) RUNX1 p53 (tumor protein p53) MHC class I antigen HLA-A heavy chain (HLA-A) major histocompatibility complex, class II, DR beta 1 major histocompatibility complex, class I, C Interleukin-15 (IL-15) HLA-B HLA-A FLT3 DNMT3A complement component (3b/4b) receptor 1 (Knops blood group) C-C motif chemokine ligand 28 Breakpoint cluster region protein (BCR/NY-REN-26) ASXL1 |
|
|
acute myeloid leukaemia |
Official Title |
Interleukin-15 (IL-15) |
|
|
acute myeloid leukaemia |
Outcome Measure |
Tyrosine-protein kinase ABL1 (JTK7) T-cell receptor T3 delta chain (CD3d) T-cell receptor CD3-epsilon (CD3e) CD56 CD3 gamma chain (CD3G) BCR-ABL / Philadelphia Chromosome |
|
|
adenocarcinoma |
Arm Group Description |
T-box 1 PD-L1/CD274 Microsatellite Instable (MSI) HER2/ERBB2 CEA CA 15-3 |
|
|
adenocarcinoma |
Eligibility Criteria |
T-cell surface antigen CD4 PD-L1/CD274 PD-1/CD279 neuralized E3 ubiquitin protein ligase 1 mitogen-activated protein kinase kinase 7 HER2/ERBB2 Epidermal growth factor receptor (EGFR) Cytokeratin 18 Butanone BRAF Anaplastic lymphoma receptor tyrosine kinase (ALP) Alkaline phosphatase (ALPL) |
|
|
adenocarcinoma |
Official Title |
PD-L1/CD274 |
|
|
adenocarcinoma |
Outcome Measure |
Tumor necrosis factor alpha (TNF-alpha) Monocyte chemoattractant protein-1 (MCP-1/CCL2) Interleukin-6 (IL-6) Interleukin-4 (IL-4) Interleukin-2 (IL-2) Interleukin-10 (IL-10) Interferon Gamma (IFNg) |
|
|
Adenoid cystic carcinoma |
Arm Group Description |
Interleukin-15 (IL-15) |
|
|
Adenoid cystic carcinoma |
Official Title |
cytotoxic T-lymphocyte-associated protein 4 |
|
|
advanced breast cancer |
Eligibility Criteria |
Uridine 5'-diphosphate UGT1A1 UDP glucuronosyltransferase family 1 member A8 UDP glucuronosyltransferase family 1 member A4 UDP glucuronosyltransferase family 1 member A10 UDP glucuronosyltransferase 1 family, polypeptide A7 UDP glucuronosyltransferase 1 family, polypeptide A6 solute carrier family 45, member 2 PSA PGR HER2/ERBB2 Estrogen receptor alpha (ER alpha) Alkaline phosphatase (ALPL) |
|
|
bladder cancer |
Detailed Description |
cytokine inducible SH2-containing protein |
|
|
bladder cancer |
Eligibility Criteria |
cytokine inducible SH2-containing protein |
|
|
carcinoma |
Brief Title |
PD-L1/CD274 |
|
|
carcinoma |
Arm GroupDescription |
Interleukin-15 (IL-15) |
|
|
carcinoma |
Arm Group Description |
PD-L1/CD274 |
|
|
carcinoma |
Detailed Description |
PD-L1/CD274 HER2/ERBB2 cytokine inducible SH2-containing protein |
|
|
carcinoma |
Eligibility Criteria |
HER2/ERBB2 cytokine inducible SH2-containing protein |
|
|
carcinoma |
Official Title |
PD-L1/CD274 cytotoxic T-lymphocyte-associated protein 4 |
|
|
cervical cancer |
Arm Group Description |
PD-L1/CD274 Microsatellite Instable (MSI) |
|
|
cervical cancer |
Eligibility Criteria |
PD-L1/CD274 PD-1/CD279 neuralized E3 ubiquitin protein ligase 1 mitogen-activated protein kinase kinase 7 HER2/ERBB2 Epidermal growth factor receptor (EGFR) Cytokeratin 18 Butanone BRAF Anaplastic lymphoma receptor tyrosine kinase (ALP) |
|
|
cervical cancer |
Official Title |
PD-L1/CD274 |
|
|
Chordoma |
Arm Group Label |
Chordoma |
|
|
Chordoma |
Brief Title |
Chordoma |
|
|
Chordoma |
Eligibility Criteria |
p53 (tumor protein p53) Nuclear protein Ki67 Alkaline phosphatase (ALPL) |
|
|
Chordoma |
Official Title |
Chordoma |
|
|
chronic lymphocytic leukaemia |
Brief Title |
Interleukin-15 (IL-15) |
|
|
chronic lymphocytic leukaemia |
Eligibility Criteria |
Tyrosine-protein kinase ABL1 (JTK7) Thyroid stimulating hormone beta (TSH) Interleukin-15 (IL-15) Cytokeratin 20 Breakpoint cluster region protein (BCR/NY-REN-26) B-lymphocyte antigen CD20 |
|
|
chronic lymphocytic leukaemia |
Official Title |
Interleukin-15 (IL-15) |
|
|
chronic lymphocytic leukaemia |
Outcome Measure |
Tyrosine-protein kinase ABL1 (JTK7) Tumor necrosis factor alpha (TNF-alpha) T-cell receptor T3 delta chain (CD3d) T-cell receptor CD3-epsilon (CD3e) Monocyte chemoattractant protein-1 (MCP-1/CCL2) Interleukin-6 (IL-6) Interleukin-4 (IL-4) Interleukin-2 (IL-2) Interleukin-10 (IL-10) Interferon Gamma (IFNg) CD56 CD3 gamma chain (CD3G) BCR-ABL / Philadelphia Chromosome |
|
|
chronic myeloid leukaemia |
Brief Title |
Interleukin-15 (IL-15) |
|
|
chronic myeloid leukaemia |
Eligibility Criteria |
Tyrosine-protein kinase ABL1 (JTK7) Thyroid stimulating hormone beta (TSH) Interleukin-15 (IL-15) Breakpoint cluster region protein (BCR/NY-REN-26) |
|
|
chronic myeloid leukaemia |
Official Title |
Interleukin-15 (IL-15) |
|
|
chronic myeloid leukaemia |
Outcome Measure |
Tyrosine-protein kinase ABL1 (JTK7) T-cell receptor T3 delta chain (CD3d) T-cell receptor CD3-epsilon (CD3e) CD56 CD3 gamma chain (CD3G) BCR-ABL / Philadelphia Chromosome |
|
|
colon cancer |
Outcome Measure |
Tyrosine-protein kinase ABL1 (JTK7) T-cell receptor T3 delta chain (CD3d) T-cell receptor CD3-epsilon (CD3e) CD56 CD3 gamma chain (CD3G) BCR-ABL / Philadelphia Chromosome |
|
|
colon cancer |
Brief Title |
Interleukin-15 (IL-15) |
|
|
colon cancer |
Arm Group Description |
CA 15-3 |
|
|
colon cancer |
Eligibility Criteria |
T-cell surface antigen CD4 pregnancy specific beta-1-glycoprotein 2 CEA carcinoembryonic antigen related cell adhesion molecule 3 |
|
|
colon cancer |
Official Title |
Interleukin-15 (IL-15) |
|
|
colon cancer |
Brief Summary |
pregnancy specific beta-1-glycoprotein 2 CEA carcinoembryonic antigen related cell adhesion molecule 3 |
|
|
colorectal cancer |
Arm Group Description |
PD-L1/CD274 Microsatellite Instable (MSI) CA 15-3 |
|
|
colorectal cancer |
Eligibility Criteria |
Vascular endothelial growth factor A (VEGF) T-cell surface antigen CD4 RAS PSA PD-L1/CD274 PD-1/CD279 neuralized E3 ubiquitin protein ligase 1 mitogen-activated protein kinase kinase 7 HER2/ERBB2 Epidermal growth factor receptor (EGFR) Cytokeratin 18 Butanone BRAF Anaplastic lymphoma receptor tyrosine kinase (ALP) |
|
|
colorectal cancer |
Official Title |
PD-L1/CD274 |
|
|
COVID 2019 infections |
Arm Group Description |
Interleukin-15 (IL-15) |
|
|
COVID 2019 infections |
Eligibility Criteria |
Lactate dehydrogenase (LDH) Interleukin-6 (IL-6) Ferritin D-dimer C-reactive protein (CRP) |
|
|
early breast cancer |
Eligibility Criteria |
PGR HER2/ERBB2 Estrogen receptor alpha (ER alpha) |
|
|
follicular lymphoma |
Eligibility Criteria |
Cytokeratin 20 B-lymphocyte antigen CD20 |
|
|
follicular lymphoma |
Outcome Measure |
Tumor necrosis factor alpha (TNF-alpha) Monocyte chemoattractant protein-1 (MCP-1/CCL2) Interleukin-6 (IL-6) Interleukin-4 (IL-4) Interleukin-2 (IL-2) Interleukin-10 (IL-10) Interferon Gamma (IFNg) |
|
|
gastric cancer |
Brief Title |
PD-L1/CD274 |
|
|
gastric cancer |
Arm Group Description |
PD-L1/CD274 Microsatellite Instable (MSI) |
|
|
gastric cancer |
Detailed Description |
PD-L1/CD274 HER2/ERBB2 |
|
|
gastric cancer |
Eligibility Criteria |
PD-L1/CD274 PD-1/CD279 neuralized E3 ubiquitin protein ligase 1 mitogen-activated protein kinase kinase 7 HER2/ERBB2 Epidermal growth factor receptor (EGFR) Cytokeratin 18 Butanone BRAF Anaplastic lymphoma receptor tyrosine kinase (ALP) |
|
|
gastric cancer |
Official Title |
PD-L1/CD274 |
|
|
haematological malignancies |
Brief Title |
Interleukin-15 (IL-15) |
|
|
haematological malignancies |
Eligibility Criteria |
Tyrosine-protein kinase ABL1 (JTK7) Thyroid stimulating hormone beta (TSH) Interleukin-15 (IL-15) Breakpoint cluster region protein (BCR/NY-REN-26) |
|
|
haematological malignancies |
Official Title |
Interleukin-15 (IL-15) |
|
|
head and neck cancer |
Outcome Measure |
Interferon Gamma (IFNg) |
|
|
head and neck cancer |
Brief Title |
PD-L1/CD274 PD-1/CD279 |
|
|
head and neck cancer |
Arm Group Description |
PD-L1/CD274 Microsatellite Instable (MSI) Interleukin-15 (IL-15) |
|
|
head and neck cancer |
Detailed Description |
PD-L1/CD274 p16 HER2/ERBB2 H3P10 |
|
|
head and neck cancer |
Eligibility Criteria |
T-cell surface antigen CD4 PD-L1/CD274 PD-1/CD279 p16 neuralized E3 ubiquitin protein ligase 1 mitogen-activated protein kinase kinase 7 HER2/ERBB2 H3P10 Epidermal growth factor receptor (EGFR) Cytokeratin 18 Butanone BRAF Anaplastic lymphoma receptor tyrosine kinase (ALP) Alkaline phosphatase (ALPL) |
|
|
head and neck cancer |
Official Title |
PD-L1/CD274 PD-1/CD279 Interleukin-15 (IL-15) cytotoxic T-lymphocyte-associated protein 4 |
|
|
HIV infections |
Outcome Measure |
vault RNA 1-1 T-Cell differentiation antigen CD8 |
|
|
HIV infections |
Brief Title |
Interleukin-15 (IL-15) |
|
|
HIV infections |
Detailed Description |
vault RNA 1-1 |
|
|
HIV infections |
Eligibility Criteria |
tubulin polymerization promoting protein transmembrane p24 trafficking protein 2 proteasome 26S subunit, non-ATPase 8 neurensin 1 H3P19 CHP1 |
|
|
HIV infections |
Official Title |
Interleukin-15 (IL-15) |
|
|
HIV-1 infections |
Outcome Measure |
vault RNA 1-1 T-cell surface antigen CD4 T-Cell differentiation antigen CD8 |
|
|
HIV-1 infections |
Brief Title |
Interleukin-15 (IL-15) |
|
|
HIV-1 infections |
Detailed Description |
vault RNA 1-1 |
|
|
HIV-1 infections |
Eligibility Criteria |
tubulin polymerization promoting protein transmembrane p24 trafficking protein 2 T-cell surface antigen CD4 proteasome 26S subunit, non-ATPase 8 neurensin 1 H3P19 CHP1 |
|
|
HIV-1 infections |
Official Title |
Interleukin-15 (IL-15) |
|
|
HIV-1 infections |
Brief Summary |
T-Cell differentiation antigen CD8 |
|
|
Hodgkin's disease |
Outcome Measure |
Tyrosine-protein kinase ABL1 (JTK7) T-cell receptor T3 delta chain (CD3d) T-cell receptor CD3-epsilon (CD3e) CD56 CD3 gamma chain (CD3G) BCR-ABL / Philadelphia Chromosome |
|
|
Hypopharyngeal cancer |
Arm Group Description |
Interleukin-15 (IL-15) |
|
|
Hypopharyngeal cancer |
Official Title |
cytotoxic T-lymphocyte-associated protein 4 |
|
|
laryngeal cancer |
Arm Group Description |
Interleukin-15 (IL-15) |
|
|
laryngeal cancer |
Official Title |
cytotoxic T-lymphocyte-associated protein 4 |
|
|
liver cancer |
Arm Group Description |
PD-L1/CD274 Microsatellite Instable (MSI) |
|
|
liver cancer |
Eligibility Criteria |
PD-L1/CD274 PD-1/CD279 neuralized E3 ubiquitin protein ligase 1 mitogen-activated protein kinase kinase 7 HER2/ERBB2 Epidermal growth factor receptor (EGFR) Cytokeratin 18 Butanone BRAF Anaplastic lymphoma receptor tyrosine kinase (ALP) Alkaline phosphatase (ALPL) |
|
|
liver cancer |
Official Title |
PD-L1/CD274 |
|
|
lymphoma |
Brief Title |
Interleukin-15 (IL-15) |
|
|
lymphoma |
Eligibility Criteria |
Tyrosine-protein kinase ABL1 (JTK7) Thyroid stimulating hormone beta (TSH) Interleukin-15 (IL-15) Breakpoint cluster region protein (BCR/NY-REN-26) |
|
|
lymphoma |
Official Title |
Interleukin-15 (IL-15) |
|
|
male breast cancer |
Eligibility Criteria |
Uridine 5'-diphosphate UGT1A1 UDP glucuronosyltransferase family 1 member A8 UDP glucuronosyltransferase family 1 member A4 UDP glucuronosyltransferase family 1 member A10 UDP glucuronosyltransferase 1 family, polypeptide A7 UDP glucuronosyltransferase 1 family, polypeptide A6 solute carrier family 45, member 2 PSA PGR HER2/ERBB2 Estrogen receptor alpha (ER alpha) Alkaline phosphatase (ALPL) |
|
|
malignant melanoma |
Outcome Measure |
Interferon Gamma (IFNg) |
|
|
malignant melanoma |
Brief Title |
PD-L1/CD274 PD-1/CD279 |
|
|
malignant melanoma |
Arm Group Description |
PD-L1/CD274 Microsatellite Instable (MSI) |
|
|
malignant melanoma |
Eligibility Criteria |
PSA PD-L1/CD274 PD-1/CD279 neuralized E3 ubiquitin protein ligase 1 mitogen-activated protein kinase kinase 7 HER2/ERBB2 Epidermal growth factor receptor (EGFR) Cytokeratin 18 Butanone BRAF Anaplastic lymphoma receptor tyrosine kinase (ALP) Alkaline phosphatase (ALPL) |
|
|
malignant melanoma |
Official Title |
PD-L1/CD274 PD-1/CD279 Interleukin-15 (IL-15) |
|
|
marginal zone B-cell lymphoma |
Eligibility Criteria |
Cytokeratin 20 B-lymphocyte antigen CD20 |
|
|
marginal zone B-cell lymphoma |
Outcome Measure |
Tumor necrosis factor alpha (TNF-alpha) Monocyte chemoattractant protein-1 (MCP-1/CCL2) Interleukin-6 (IL-6) Interleukin-4 (IL-4) Interleukin-2 (IL-2) Interleukin-10 (IL-10) Interferon Gamma (IFNg) |
|
|
Merkel cell carcinoma |
Arm Group Description |
PD-L1/CD274 Microsatellite Instable (MSI) |
|
|
Merkel cell carcinoma |
Brief Title |
PD-L1/CD274 |
|
|
Merkel cell carcinoma |
Eligibility Criteria |
PSA PD-L1/CD274 PD-1/CD279 neuralized E3 ubiquitin protein ligase 1 mitogen-activated protein kinase kinase 7 HER2/ERBB2 Epidermal growth factor receptor (EGFR) Cytokeratin 18 Butanone BRAF Anaplastic lymphoma receptor tyrosine kinase (ALP) Alkaline phosphatase (ALPL) |
|
|
Merkel cell carcinoma |
Official Title |
PD-L1/CD274 Interleukin-15 (IL-15) Fc gamma RIIIa Fc fragment of IgG, low affinity IIIb, receptor (CD16b) |
|
|
mouth neoplasm |
Arm Group Description |
Interleukin-15 (IL-15) |
|
|
mouth neoplasm |
Official Title |
cytotoxic T-lymphocyte-associated protein 4 |
|
|
multiple myeloma |
Outcome Measure |
Tyrosine-protein kinase ABL1 (JTK7) Tumor necrosis factor alpha (TNF-alpha) T-cell receptor T3 delta chain (CD3d) T-cell receptor CD3-epsilon (CD3e) Monocyte chemoattractant protein-1 (MCP-1/CCL2) Interleukin-6 (IL-6) Interleukin-4 (IL-4) Interleukin-2 (IL-2) Interleukin-10 (IL-10) Interferon Gamma (IFNg) CD56 CD3 gamma chain (CD3G) BCR-ABL / Philadelphia Chromosome |
|
|
myelodysplastic syndromes |
Brief Title |
Interleukin-15 (IL-15) |
|
|
myelodysplastic syndromes |
Eligibility Criteria |
Tyrosine-protein kinase ABL1 (JTK7) Thyroid stimulating hormone beta (TSH) RUNX1 p53 (tumor protein p53) MHC class I antigen HLA-A heavy chain (HLA-A) major histocompatibility complex, class II, DR beta 1 major histocompatibility complex, class I, C Interleukin-15 (IL-15) HLA-B HLA-A FLT3 DNMT3A complement component (3b/4b) receptor 1 (Knops blood group) C-C motif chemokine ligand 28 Breakpoint cluster region protein (BCR/NY-REN-26) ASXL1 |
|
|
myelodysplastic syndromes |
Official Title |
Interleukin-15 (IL-15) |
|
|
myelodysplastic syndromes |
Outcome Measure |
Tyrosine-protein kinase ABL1 (JTK7) T-cell receptor T3 delta chain (CD3d) T-cell receptor CD3-epsilon (CD3e) CD56 CD3 gamma chain (CD3G) BCR-ABL / Philadelphia Chromosome |
|
|
myeloma |
Brief Title |
Interleukin-15 (IL-15) |
|
|
myeloma |
Eligibility Criteria |
Tyrosine-protein kinase ABL1 (JTK7) Thyroid stimulating hormone beta (TSH) Interleukin-15 (IL-15) Breakpoint cluster region protein (BCR/NY-REN-26) |
|
|
myeloma |
Official Title |
Interleukin-15 (IL-15) |
|
|
myeloproliferative disorders |
Outcome Measure |
Tyrosine-protein kinase ABL1 (JTK7) T-cell receptor T3 delta chain (CD3d) T-cell receptor CD3-epsilon (CD3e) CD56 CD3 gamma chain (CD3G) BCR-ABL / Philadelphia Chromosome |
|
|
non-Hodgkin's lymphoma |
Outcome Measure |
Tyrosine-protein kinase ABL1 (JTK7) Tumor necrosis factor alpha (TNF-alpha) T-cell receptor T3 delta chain (CD3d) T-cell receptor CD3-epsilon (CD3e) Monocyte chemoattractant protein-1 (MCP-1/CCL2) Interleukin-6 (IL-6) Interleukin-4 (IL-4) Interleukin-2 (IL-2) Interleukin-10 (IL-10) Interferon Gamma (IFNg) CD56 CD3 gamma chain (CD3G) BCR-ABL / Philadelphia Chromosome |
|
|
non-Hodgkin's lymphoma |
Brief Title |
Cytokeratin 20 B-lymphocyte antigen CD20 |
|
|
non-Hodgkin's lymphoma |
Eligibility Criteria |
PSA Cytokeratin 20 B-lymphocyte antigen CD20 Alkaline phosphatase (ALPL) |
|
|
non-Hodgkin's lymphoma |
Official Title |
Cytokeratin 20 B-lymphocyte antigen CD20 |
|
|
non-Hodgkin's lymphoma |
Brief Summary |
Cytokeratin 20 B-lymphocyte antigen CD20 |
|
|
non-small cell lung cancer |
Outcome Measure |
Interleukin-15 (IL-15) Interferon Gamma (IFNg) |
|
|
non-small cell lung cancer |
Brief Title |
PD-L1/CD274 PD-1/CD279 |
|
|
non-small cell lung cancer |
Arm Group Description |
PIK3CA PD-L1/CD274 Microsatellite Instable (MSI) Fibroblast growth factor receptor 3 (FGFR3) Fibroblast growth factor receptor 2 (FGFR2) Fibroblast growth factor receptor 1 (FGFR1) Cyclin-dependent kinase 4 (CDK4) Cyclin D3 Cyclin D2 Cyclin D1 c-Met |
|
|
non-small cell lung cancer |
Detailed Description |
PIK3CA Phosphatidylinositols GUCY2EP glutaryl-CoA dehydrogenase Fibroblast growth factor receptor 3 (FGFR3) Fibroblast growth factor receptor 2 (FGFR2) Fibroblast growth factor receptor 1 (FGFR1) Fibroblast Growth Factor (FGF2) Cyclin-dependent kinase 4 (CDK4) Cyclin D3 Cyclin D2 Cyclin D1 |
|
|
non-small cell lung cancer |
Eligibility Criteria |
TTF1 ROS1 RET PSA PD-L1/CD274 PD-1/CD279 p63 neuralized E3 ubiquitin protein ligase 1 mitogen-activated protein kinase kinase 7 HER2/ERBB2 Epidermal growth factor receptor (EGFR) EML4 Cytokeratin18 Butanone BRAF Anaplastic lymphoma receptor tyrosine kinase (ALP) Alkaline phosphatase (ALPL) |
|
|
non-small cell lung cancer |
Official Title |
PD-L1/CD274 PD-1/CD279 Interleukin-15 (IL-15) |
|
|
oesophageal cancer |
Brief Title |
PD-L1/CD274 |
|
|
oesophageal cancer |
Arm Group Description |
PD-L1/CD274 Microsatellite Instable (MSI) |
|
|
oesophageal cancer |
Detailed Description |
PD-L1/CD274 HER2/ERBB2 |
|
|
oesophageal cancer |
Eligibility Criteria |
PD-L1/CD274 PD-1/CD279 neuralized E3 ubiquitin protein ligase 1 mitogen-activated protein kinase kinase 7 HER2/ERBB2 Epidermal growth factor receptor (EGFR) Cytokeratin 18 Butanone BRAF Anaplastic lymphoma receptor tyrosine kinase (ALP) |
|
|
oesophageal cancer |
Official Title |
PD-L1/CD274 |
|
|
oropharyngeal cancer |
Arm Group Description |
Interleukin-15 (IL-15) |
|
|
oropharyngeal cancer |
Official Title |
cytotoxic T-lymphocyte-associated protein 4 |
|
|
pancreatic cancer |
Arm Group Description |
T-box 1 HER2/ERBB2 CEA CA 15-3 |
|
|
pancreatic cancer |
Eligibility Criteria |
T-cell surface antigen CD4 PSA BRCA2 Alkaline phosphatase (ALPL) |
|
|
pancreatic cancer |
Outcome Measure |
Tumor necrosis factor alpha (TNF-alpha) Monocyte chemoattractant protein-1 (MCP-1/CCL2) Interleukin-6 (IL-6) Interleukin-4 (IL-4) Interleukin-2 (IL-2) Interleukin-10 (IL-10) Interferon Gamma (IFNg) |
|
|
paranasal sinus diseases |
Arm Group Description |
Interleukin-15 (IL-15) |
|
|
paranasal sinus diseases |
Official Title |
cytotoxic T-lymphocyte-associated protein 4 |
|
|
precursor cell lymphoblastic leukaemia-lymphoma |
Brief Title |
Interleukin-15 (IL-15) |
|
|
precursor cell lymphoblastic leukaemia-lymphoma |
Eligibility Criteria |
Tyrosine-protein kinase ABL1 (JTK7) Thyroid stimulating hormone beta (TSH) Interleukin-15 (IL-15) Breakpoint cluster region protein (BCR/NY-REN-26) |
|
|
precursor cell lymphoblastic leukaemia-lymphoma |
Official Title |
Interleukin-15 (IL-15) |
|
|
precursor cell lymphoblastic leukaemia-lymphoma |
Outcome Measure |
Tyrosine-protein kinase ABL1 (JTK7) T-cell receptor T3 delta chain (CD3d) T-cell receptor CD3-epsilon (CD3e) CD56 CD3 gamma chain (CD3G) BCR-ABL / Philadelphia Chromosome |
|
|
prostate cancer |
Detailed Description |
PSA |
|
|
prostate cancer |
Eligibility Criteria |
Tumor Mutational Burden Testosterone solute carrier organic anion transporter family member 1B3 RAD54L RAD51 paralog D RAD51 paralog C RAD51 paralog B PSA partner and localizer of BRCA2 Microsatellite Instable (MSI) Fanconi anemia, complementation group L cyclin-dependent kinase 12 CHK2 CHK1 BRCA2 BRCA1 interacting protein C-terminal helicase 1 BRCA1 associated RING domain 1 BRCA1 Ataxia telangiectasia mutated |
|
|
rectal cancer |
Outcome Measure |
Tyrosine-protein kinase ABL1 (JTK7) T-cell receptor T3 delta chain (CD3d) T-cell receptor CD3-epsilon (CD3e) CD56 CD3 gamma chain (CD3G) BCR-ABL / Philadelphia Chromosome |
|
|
rectal cancer |
Brief Title |
Interleukin-15 (IL-15) |
|
|
rectal cancer |
Arm Group Description |
CA 15-3 |
|
|
rectal cancer |
Eligibility Criteria |
T-cell surface antigen CD4 pregnancy specific beta-1-glycoprotein 2 CEA carcinoembryonic antigen related cell adhesion molecule 3 |
|
|
rectal cancer |
Official Title |
Interleukin-15 (IL-15) |
|
|
rectal cancer |
Brief Summary |
pregnancy specific beta-1-glycoprotein 2 CEA carcinoembryonic antigen related cell adhesion molecule 3 |
|
|
renal cell carcinoma |
Arm Group Description |
PD-L1/CD274 Microsatellite Instable (MSI) |
|
|
renal cell carcinoma |
Eligibility Criteria |
PD-L1/CD274 PD-1/CD279 neuralized E3 ubiquitin protein ligase 1 mitogen-activated protein kinase kinase 7 HER2/ERBB2 Epidermal growth factor receptor (EGFR) Cytokeratin 18 Butanone BRAF Anaplastic lymphoma receptor tyrosine kinase (ALP) |
|
|
renal cell carcinoma |
Official Title |
PD-L1/CD274 Interleukin-15 (IL-15) |
|
|
renal cell carcinoma |
Outcome Measure |
Interferon Gamma (IFNg) |
|
|
salivary gland cancer |
Arm Group Description |
Interleukin-15 (IL-15) |
|
|
salivary gland cancer |
Official Title |
cytotoxic T-lymphocyte-associated protein 4 |
|
|
small cell lung cancer |
Arm Group Description |
PD-L1/CD274 Microsatellite Instable (MSI) |
|
|
small cell lung cancer |
Eligibility Criteria |
PD-L1/CD274 PD-1/CD279 neuralized E3 ubiquitin protein ligase 1 mitogen-activated protein kinase kinase 7 HER2/ERBB2 Epidermal growth factor receptor (EGFR) Cytokeratin 18 Butanone BRAF Anaplastic lymphoma receptor tyrosine kinase (ALP) |
|
|
small cell lung cancer |
Official Title |
PD-L1/CD274 |
|
|
soft tissue sarcoma |
Outcome Measure |
Tyrosine-protein kinase ABL1 (JTK7) T-cell receptor T3 delta chain (CD3d) T-cell receptor CD3-epsilon (CD3e) CD56 CD3 gamma chain (CD3G) BCR-ABL / Philadelphia Chromosome |
|
|
solid tumours |
Outcome Measure |
T-cell receptor T3 delta chain (CD3d) T-cell receptor CD3-epsilon (CD3e) Interferon Gamma (IFNg) Fc gamma RIIIa Fc fragment of IgG, low affinity IIIb, receptor (CD16b) CD56 CD3 gamma chain (CD3G) |
|
|
solid tumours |
Arm Group Description |
PD-L1/CD274 Microsatellite Instable (MSI) |
|
|
solid tumours |
Detailed Description |
PSA |
|
|
solid tumours |
Eligibility Criteria |
Tumor Mutational Burden Testosterone T-cell surface antigen CD4 solute carrier organic anion transporter family member 1B3 RAD54L RAD51 paralog D RAD51 paralog C RAD51 paralog B PSA PD-L1/CD274 PD-1/CD279 partner and localizer of BRCA2 neuralized E3 ubiquitin protein ligase 1 mitogen-activated protein kinase kinase 7 Microsatellite Instable (MSI) HER2/ERBB2 Fanconi anemia, complementation group L Epidermal growth factor receptor (EGFR) Cytokeratin 18 cyclin-dependent kinase 12 CHK2 CHK1 Butanone BRCA2 BRCA1 interacting protein C-terminal helicase 1 BRCA1 associated RING domain 1 BRCA1 BRAF Ataxia telangiectasia mutated Anaplastic lymphoma receptor tyrosine kinase (ALP) |
|
|
solid tumours |
Official Title |
PD-L1/CD274 Interleukin-15 (IL-15) |
|
|
squamous cell cancer |
Outcome Measure |
Interferon Gamma (IFNg) |
|
|
squamous cell cancer |
Brief Title |
PD-L1/CD274 PD-1/CD279 |
|
|
squamous cell cancer |
Arm Group Description |
PIK3CA PD-L1/CD274 Microsatellite Instable (MSI) Interleukin-15 (IL-15) Fibroblast growth factor receptor 3 (FGFR3) Fibroblast growth factor receptor 2 (FGFR2) Fibroblast growth factor receptor 1 (FGFR1) Cyclin-dependent kinase 4 (CDK4) Cyclin D3 Cyclin D2 Cyclin D1 c-Met |
|
|
squamous cell cancer |
Detailed Description |
PIK3CA Phosphatidylinositols PD-L1/CD274 p16 HER2/ERBB2 H3P10 GUCY2EP glutaryl-CoA dehydrogenase Fibroblast growth factor receptor 3 (FGFR3) Fibroblast growth factor receptor 2 (FGFR2) Fibroblast growth factor receptor 1 (FGFR1) Fibroblast Growth Factor (FGF2) Cyclin-dependent kinase 4 (CDK4) Cyclin D3 Cyclin D2 Cyclin D1 |
|
|
squamous cell cancer |
Eligibility Criteria |
TTF1 T-cell surface antigen CD4 PD-1/CD279 p63 p16 neuralized E3 ubiquitin protein ligase 1 mitogen-activated protein kinase kinase 7 HER2/ERBB2 H3P10 Epidermal growth factor receptor (EGFR) EML4 Cytokeratin 18 Butanone BRAF Anaplastic lymphoma receptor tyrosine kinase (ALP) Alkaline phosphatase (ALPL) |
|
|
squamous cell cancer |
Official Title |
PD-L1/CD274 PD-1/CD279 Interleukin-15 (IL-15) cytotoxic T-lymphocyte-associated protein 4 |
|
|
squamouscell cancer |
Eligibility Criteria |
PD-L1/CD274 |
|
|
triple negative breast cancer |
Eligibility Criteria |
Uridine 5'-diphosphate UGT1A1 UDP glucuronosyltransferase family 1 member A8 UDP glucuronosyltransferase family 1 member A4 UDP glucuronosyltransferase family 1 member A10 UDP glucuronosyltransferase 1 family, polypeptide A7 UDP glucuronosyltransferase 1 family, polypeptide A6 solute carrier family 45, member 2 PSA PGR HER2/ERBB2 Estrogen receptor alpha (ER alpha) Alkaline phosphatase (ALPL) |
|
|
triple negative breast cancer |
Official Title |
PD-L1/CD274 PD-1/CD279 |
|
|
urogenital cancer |
Arm Group Description |
PD-L1/CD274 Microsatellite Instable (MSI) |
|
|
urogenital cancer |
Brief Title |
PD-L1/CD274 PD-1/CD279 |
|
|
urogenital cancer |
Eligibility Criteria |
PSA PD-L1/CD274 PD-1/CD279 neuralized E3 ubiquitin protein ligase 1 mitogen-activated protein kinase kinase 7 HER2/ERBB2 Epidermal growth factor receptor (EGFR) Cytokeratin 18 Butanone BRAF Anaplastic lymphoma receptor tyrosine kinase (ALP) |
|
|
urogenital cancer |
Official Title |
PD-L1/CD274 PD-1/CD279 |
|
|
Waldenstrom's macroglobulinaemia |
Eligibility Criteria |
Cytokeratin 20 B-lymphocyte antigen CD20 |
|
|
Waldenstrom's macroglobulinaemia |
Outcome Measure |
Tumor necrosis factor alpha (TNF-alpha) Monocyte chemoattractant protein-1 (MCP-1/CCL2) Interleukin-6 (IL-6) Interleukin-4 (IL-4) Interleukin-2 (IL-2) Interleukin-10 (IL-10) Interferon Gamma (IFNg) |
Biomarker
| Drug Name | Biomarker Name | Biomarker Function |
|---|---|---|
| Nogapendekin alfa inbakicept - Altor BioScience Corporation | Alkaline phosphatase (ALPL) | Eligibility Criteria, Outcome Measure |
| ALT | Outcome Measure | |
| Anaplastic lymphoma receptor tyrosine kinase (ALP) | Eligibility Criteria | |
| ASXL1 | Eligibility Criteria | |
| Ataxia telangiectasia mutated | Eligibility Criteria | |
| B-lymphocyte antigen CD20 | Brief Summary, Brief Title, Eligibility Criteria, Official Title | |
| BCR-ABL / Philadelphia Chromosome | Outcome Measure | |
| Bilirubin | Outcome Measure | |
| BRAF | Eligibility Criteria | |
| BRCA1 | Eligibility Criteria | |
| BRCA1 associated RING domain 1 | Eligibility Criteria | |
| BRCA1 interacting protein C-terminal helicase 1 | Eligibility Criteria | |
| BRCA2 | Eligibility Criteria | |
| Breakpoint cluster region protein (BCR/NY-REN-26) | Eligibility Criteria | |
| Butanone | Eligibility Criteria | |
| C-C motif chemokine ligand 28 | Eligibility Criteria | |
| C-reactive protein (CRP) | Eligibility Criteria | |
| CA 15-3 | Arm Group Description | |
| carcinoembryonic antigen related cell adhesion molecule 3 | Brief Summary, Eligibility Criteria | |
| CCAAT/enhancer binding protein zeta | Eligibility Criteria | |
| CD3 gamma chain (CD3G) | Outcome Measure | |
| CD56 | Outcome Measure | |
| CEA | Arm Group Description, Brief Summary, Eligibility Criteria | |
| CHK1 | Eligibility Criteria | |
| CHK2 | Eligibility Criteria | |
| Chordoma | Arm Group Label, Brief Title, Official Title | |
| CHP1 | Eligibility Criteria | |
| complement component (3b/4b) receptor 1 (Knops blood group) | Eligibility Criteria | |
| Creatinine | Outcome Measure | |
| cyclin-dependent kinase 12 | Eligibility Criteria | |
| Cytidine monophosphate | Outcome Measure | |
| Cytokeratin 18 | Eligibility Criteria | |
| Cytokeratin 20 | Brief Summary, Brief Title, Eligibility Criteria, Official Title | |
| cytokine inducible SH2-containing protein | Detailed Description, Eligibility Criteria | |
| cytotoxic T-lymphocyte-associated protein 4 | Official Title | |
| D-dimer | Eligibility Criteria | |
| DNMT3A | Eligibility Criteria | |
| ELN | Eligibility Criteria | |
| Epidermal growth factor receptor (EGFR) | Eligibility Criteria | |
| Estrogen receptor alpha (ER alpha) | Eligibility Criteria | |
| Fanconi anemia, complementation group L | Eligibility Criteria | |
| Fc fragment of IgG receptor Ib | Arm Group Description, Eligibility Criteria | |
| Fc fragment of IgG, low affinity IIIb, receptor (CD16b) | Official Title | |
| Fc gamma RIIIa | Official Title | |
| Ferritin | Eligibility Criteria | |
| FLT3 | Eligibility Criteria | |
| G-CSF | Arm Group Description | |
| H3P10 | Detailed Description, Eligibility Criteria | |
| H3P19 | Eligibility Criteria | |
| Hematopoietic progenitor cell antigen CD34 | Arm Group Description, Eligibility Criteria | |
| HER2/ERBB2 | Arm Group Description, Detailed Description, Eligibility Criteria | |
| HLA-A | Eligibility Criteria | |
| HLA-B | Eligibility Criteria | |
| Interferon Gamma (IFNg) | Outcome Measure | |
| Interleukin-10 (IL-10) | Outcome Measure | |
| Interleukin-15 (IL-15) | Arm Group Description, Brief Title, Eligibility Criteria, Official Title, Outcome Measure | |
| Interleukin-2 (IL-2) | Arm Group Description, Arm Group Label, Outcome Measure | |
| Interleukin-4 (IL-4) | Outcome Measure | |
| Interleukin-6 (IL-6) | Eligibility Criteria, Outcome Measure | |
| L-Aspartic acid | Outcome Measure | |
| Lactate dehydrogenase (LDH) | Eligibility Criteria | |
| major histocompatibility complex, class I, C | Eligibility Criteria | |
| major histocompatibility complex, class II, DR beta 1 | Eligibility Criteria | |
| matrilin 1, cartilage matrix protein | Outcome Measure | |
| MHC class I antigen HLA-A heavy chain (HLA-A) | Eligibility Criteria | |
| Microsatellite Instable (MSI) | Arm Group Description, Eligibility Criteria | |
| mitogen-activated protein kinase kinase 7 | Eligibility Criteria | |
| Monocyte chemoattractant protein-1 (MCP-1/CCL2) | Outcome Measure | |
| neuralized E3 ubiquitin protein ligase 1 | Eligibility Criteria | |
| neurensin 1 | Eligibility Criteria | |
| Nuclear protein Ki67 | Eligibility Criteria | |
| p16 | Detailed Description, Eligibility Criteria | |
| p53 (tumor protein p53) | Eligibility Criteria | |
| partner and localizer of BRCA2 | Eligibility Criteria | |
| PD-1/CD279 | Brief Title, Eligibility Criteria, Official Title | |
| PD-L1/CD274 | Arm Group Description, Brief Title, Detailed Description, Eligibility Criteria, Official Title | |
| PGR | Eligibility Criteria | |
| pregnancy specific beta-1-glycoprotein 2 | Brief Summary, Eligibility Criteria | |
| pro-melanin concentrating hormone | Outcome Measure | |
| proteasome 26S subunit, non-ATPase 8 | Eligibility Criteria | |
| PSA | Detailed Description, Eligibility Criteria | |
| RAD51 paralog B | Eligibility Criteria | |
| RAD51 paralog C | Eligibility Criteria | |
| RAD51 paralog D | Eligibility Criteria | |
| RAD54L | Eligibility Criteria | |
| RAS | Eligibility Criteria | |
| RET | Eligibility Criteria | |
| ROS1 | Eligibility Criteria | |
| RUNX1 | Eligibility Criteria | |
| small integral membrane protein 6 | Eligibility Criteria | |
| solute carrier family 45, member 2 | Eligibility Criteria | |
| solute carrier organic anion transporter family member 1B3 | Eligibility Criteria | |
| T-box 1 | Arm Group Description | |
| T-Cell differentiation antigen CD8 | Brief Summary, Outcome Measure | |
| T-cell receptor CD3-epsilon (CD3e) | Outcome Measure | |
| T-cell receptor T3 delta chain (CD3d) | Outcome Measure | |
| T-cell surface antigen CD4 | Eligibility Criteria, Outcome Measure | |
| Testosterone | Eligibility Criteria | |
| Thyroid stimulating hormone beta (TSH) | Eligibility Criteria | |
| transmembrane p24 trafficking protein 2 | Eligibility Criteria | |
| tubulin polymerization promoting protein | Eligibility Criteria | |
| Tumor Mutational Burden | Eligibility Criteria | |
| Tumor necrosis factor alpha (TNF-alpha) | Outcome Measure | |
| Tyrosine-protein kinase ABL1 (JTK7) | Eligibility Criteria, Outcome Measure | |
| UDP glucuronosyltransferase 1 family, polypeptide A6 | Eligibility Criteria | |
| UDP glucuronosyltransferase 1 family, polypeptide A7 | Eligibility Criteria | |
| UDP glucuronosyltransferase family 1 member A10 | Eligibility Criteria | |
| UDP glucuronosyltransferase family 1 member A4 | Eligibility Criteria | |
| UDP glucuronosyltransferase family 1 member A8 | Eligibility Criteria | |
| UGT1A1 | Eligibility Criteria | |
| Uridine 5'-diphosphate | Eligibility Criteria | |
| Vascular endothelial growth factor A (VEGF) | Eligibility Criteria | |
| vault RNA 1-1 | Detailed Description, Outcome Measure |
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| Acute myeloid leukaemia | - | Second-line therapy or greater | Phase II | USA | SC / unspecified | Altor BioScience Corporation | 16 May 2017 |
| Bladder cancer | in combination with BCG for patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumours | Combination therapy, Second-line therapy or greater | Registered | USA | Intravesicular / Liquid | Altor BioScience Corporation | 22 Apr 2024 |
| Cervical cancer | - | Combination therapy, Metastatic disease, Second-line therapy or greater | Phase II | USA | SC / Injection | ImmunityBio | 11 Dec 2018 |
| Colorectal cancer | - | Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater | Phase II | USA | SC / Injection | ImmunityBio | 22 Sep 2020 |
| Colorectal cancer | - | Combination therapy, Second-line therapy or greater | Phase II | USA | SC / Injection | ImmunityBio | 11 Dec 2018 |
| Fallopian tube cancer | - | Late-stage disease, Second-line therapy or greater | Phase II | USA | SC / Injection | Altor BioScience Corporation | 19 Sep 2017 |
| Fallopian tube cancer | - | Late-stage disease, Second-line therapy or greater | Phase II | USA | Intraperitoneal / Injection | Altor BioScience Corporation | 19 Sep 2017 |
| Gastric cancer | - | Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease, Second-line therapy or greater | Phase II | USA | SC / Injection | ImmunityBio | 11 Dec 2018 |
| HIV infections | N-803 with antiretroviral therapy (ART) | Adjunctive treatment | Phase II | Thailand | SC / Injection | Altor BioScience Corporation | 01 Mar 2021 |
| HIV infections | - | Adjunctive treatment | No development reported (I) | USA | SC / Injection | Altor BioScience Corporation | 28 Aug 2022 |
| HIV-1 infections | - | Monotherapy, Treatment-experienced | Phase I | USA | SC / Injection | ImmunityBio | 21 May 2021 |
| HIV-1 infections | - | Combination therapy, Treatment-experienced | Phase I | USA | SC / Injection | ImmunityBio | 21 May 2021 |
| Hereditary nonpolyposis colorectal cancer | in combination with TRI AD5 | Combination therapy, Prevention | Phase II | USA | SC / Injection | Altor BioScience Corporation | 22 Mar 2023 |
| Liver cancer | - | Combination therapy, Second-line therapy or greater | Phase II | USA | SC / Injection | ImmunityBio | 11 Dec 2018 |
| Liver cancer | - | Combination therapy, Inoperable/Unresectable, Late-stage disease, Second-line therapy or greater | Phase I/II | USA | SC / unspecified | ImmunityBio | 25 May 2018 |
| Malignant melanoma | - | Combination therapy, Metastatic disease, Second-line therapy or greater | Phase II | USA | SC / Injection | ImmunityBio | 11 Dec 2018 |
| Merkel cell carcinoma | - | Combination therapy, Metastatic disease, Second-line therapy or greater | Phase II | USA | SC / Injection | ImmunityBio | 11 Dec 2018 |
| Merkel cell carcinoma | - | Combination therapy, Late-stage disease, Second-line therapy or greater | Phase II | USA | IV / Infusion | ImmunityBio | 31 Jan 2017 |
| Multiple myeloma | - | Second-line therapy or greater | Phase I/II | USA | IV / Infusion | Altor BioScience Corporation | 01 Sep 2014 |
| Multiple myeloma | - | Second-line therapy or greater | Phase I/II | USA | SC / unspecified | Altor BioScience Corporation | 01 Sep 2014 |
| Myelodysplastic syndromes | - | - | Phase II | USA | SC / unspecified | ImmunityBio | 12 Apr 2017 |
| Non-Hodgkin's lymphoma | Indolent B Cell Non-Hodgkin Lymphoma | Combination therapy, Second-line therapy or greater | Phase I/II | USA | SC / unspecified | Altor BioScience Corporation | 01 Apr 2015 |
| Non-Hodgkin's lymphoma | Indolent B Cell Non-Hodgkin Lymphoma | Combination therapy, Second-line therapy or greater | Phase I/II | USA | IV / unspecified | Altor BioScience Corporation | 01 Mar 2015 |
| Non-small cell lung cancer | - | Combination therapy, First-line therapy, Late-stage disease, Metastatic disease | Phase III | USA | SC / unspecified | Altor BioScience Corporation, ImmunityBio | 29 Jul 2020 |
| Non-small cell lung cancer | - | Combination therapy, In adults, In children, In the elderly, Second-line therapy or greater | Phase II/III | USA | SC / unspecified | Altor BioScience Corporation | 26 Apr 2022 |
| Non-small cell lung cancer | - | Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater | Phase II | USA | IV / Infusion | Altor BioScience Corporation | 01 May 2018 |
| Non-small cell lung cancer | - | Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease, Recurrent, Second-line therapy or greater | Phase II | USA | Parenteral / unspecified | Altor BioScience Corporation | 01 Jun 2018 |
| Non-small cell lung cancer | - | Adjuvant therapy | Phase I/II | USA | SC / unspecified | ImmunityBio | 26 Apr 2024 |
| Oesophageal cancer | - | Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater | Phase II | USA | SC / Injection | ImmunityBio | 11 Dec 2018 |
| Ovarian cancer | - | Late-stage disease, Second-line therapy or greater | Phase II | USA | Intraperitoneal / Injection | Altor BioScience Corporation | 19 Sep 2017 |
| Ovarian cancer | - | Late-stage disease, Second-line therapy or greater | Phase II | USA | SC / Injection | Altor BioScience Corporation | 19 Sep 2017 |
| Pancreatic cancer | first line maintenance in combination with aldoxorubicin HCl and PD-L1 t haNK | Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease | Phase II | USA | SC / Injection | ImmunityBio | 22 Jun 2020 |
| Pancreatic cancer | in combination with aldoxorubicin HCl and PD-L1 t haNK | Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease, Second-line therapy or greater | Phase II | USA | SC / Injection | ImmunityBio | 22 Jun 2020 |
| Peritoneal cancer | - | Late-stage disease, Second-line therapy or greater | Phase II | USA | SC / Injection | Altor BioScience Corporation | 19 Sep 2017 |
| Peritoneal cancer | - | Late-stage disease, Second-line therapy or greater | Phase II | USA | Intraperitoneal / Injection | Altor BioScience Corporation | 19 Sep 2017 |
| Renal cell carcinoma | - | Combination therapy, Late-stage disease, Second-line therapy or greater | Phase II | USA | SC / Injection | ImmunityBio | 11 Dec 2018 |
| Small cell lung cancer | - | Combination therapy, Metastatic disease, Second-line therapy or greater | Phase II | USA | SC / Injection | ImmunityBio | 11 Dec 2018 |
| Solid tumours | - | Combination therapy, Inoperable/Unresectable, Metastatic disease, Second-line therapy or greater | Phase II | USA | SC / Injection | ImmunityBio | 11 Dec 2018 |
| Solid tumours | - | Inoperable/Unresectable, Late-stage disease, Metastatic disease | No development reported (I) | USA | SC / Injection | Altor BioScience Corporation | 28 Apr 2019 |
| Solid tumours | - | Inoperable/Unresectable, Late-stage disease, Metastatic disease | No development reported (I) | USA | IV / Infusion | Altor BioScience Corporation | 28 Apr 2019 |
| Squamous cell cancer | head and neck squamous cell carcinoma; in combination with PD-L1 t-hank (modified immune cells) and cetuximabno | Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease, Recurrent, Second-line therapy or greater | Phase II | USA | SC / Injection | ImmunityBio | 16 Feb 2024 |
| Triple negative breast cancer | Triple negative breast cancer | Combination therapy, Inoperable/Unresectable, Metastatic disease, Second-line therapy or greater | Phase I/II | USA | SC / Injection | ImmunityBio | 16 Mar 2018 |
| Triple negative breast cancer | In combination with sacituzumab govitecan; Advanced Triple Negative Breast Cancer | Combination therapy, Late-stage disease, Second-line therapy or greater | Phase I/II | USA | SC / Injection | ImmunityBio | 27 Sep 2021 |
| Urogenital cancer | - | Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater | Phase II | USA | SC / Injection | ImmunityBio | 11 Dec 2018 |
Priority Development Status
| Type | Region | Indication |
|---|---|---|
| Breakthrough Therapy | USA | Bladder cancer |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Altor BioScience Corporation | Originator | USA |
| Altor BioScience Corporation | Owner | USA |
| Beike Biotechnology | Licensee | China |
| National Cancer Institute (USA) | Funder | USA |
| National Cancer Institute (USA) | Collaborator | USA |
| ImmunityBio | Collaborator | USA |
Brand Names
| Brand Name | Organisations | Indications | Countries |
|---|---|---|---|
| ANKTIVA | Altor BioScience Corporation | Bladder cancer | USA |
Scientific Summary
Pharmacokinetics
Haematological malignancies
Phase I/II
Results of the first-in-human, open-label, dose escalation, phase I/II trial in patients (n = 33) with haematological malignancies, who have relapsed 60 days after allogeneic haematopoietic stem cell transplantation demonstrated distinct pharmacokinetic profiles following nogapendekin alfa inbakicept (ALT 803) intravenous (IV) versus subcutaneous (SC) administration, and a longer half-life in SC (10 mcg/kg: T1/2 29.3+10.3 hours) versus IV (10 mcg/kg: T-1/2 mean 4.87+3.46 hours) [119] [118] [151] .
Phase I
Treatment with nogapendekin alfa inbakicept subcutaneous injection, showed good pharmacokinetics, in healthy volunteers (n=20), in the phase I QUILT-1.004 trial. Serum nogapendekin alfa inbakicept concentrations peaked 10.3-15.4 hours after administration and declined with a half-life of 20.0-20.7 hours. Peak nogapendekin alfa inbakicept serum concentrations were dose-dependent, with a 1.5-fold increase in Cmax after administration of 20 µg/kg vs 10 µg/kg. In the peripheral blood, nogapendekin alfa inbakicept induced a transient decline. nogapendekin alfa inbakicept administration also increased serum levels of interferon gamma, IL-10, and IL-6 [137] [138] .
Adverse Events
Bladder cancer:
Phase II/III
In phase II/III QUILT-3.032 trial, safety profile was comparable to BCG alone. Most adverse events for patients receiving BCG plus NAI were grade 1 to 2 (86%) and comparable to adverse events associated with BCG alone [28] . Updated results from the phase II/III QUILT-3.032 trial, indicated Excellent safety and tolerability profile. Low grade treatment related AEs (grade 1-2) include dysuria (22%), pollakiurua (19%), hematuria (18%), fatigue (16%), and urgency (12%), all other AEs were seen at 7% or less. No treatment related grade 4 or 5 AE were seen. No serious adverse events (SAEs) were considered treatment related. No immune related SAEs were observed [27] . Previously, 0% treatment-related SAEs, immune-related AE and grade 4 and 5 AE were observed in Cohort A and B [25] . The safety profile of nogapendekin alfa inbakicept in Cohort B was consistent with that seen in Cohort A, in which 0% SAEs, including 0% immune-related SAEs, were detected. In a phase II/III QUILT-3.032 trial, treatment with nogapendekin alfa inbakicept was safe and well tolerated. No patients reported treatment emergent serious adverse events, immune-related AEs or grade 4 or 5 treatment-related AEs. In earlier results, three serious adverse events (AEs) were reported (E. coli infection, anemia, and bacteraemia). In cohort A, Low grade treatment related AEs include dysuria, hematuria, and pollakiurua (all 16%), urgency (14%), and bladder spasm (8%), all other AEs were seen at 6% or less. A total of 9 subjects experienced at least 1 treatment emergent SAE (Severe Adverse event), the SAE rate is 1% for any given AE [150] [150] [18] [23] [21] [20] [24] .
Pancreatic cancer
Phase II
Updated results from the follow up study of the phase II QUILT-88 trial showed that aldoxorubicin was well tolerated with mainly low grade AEs [fatigue, chills, injection site reaction ( > 50%)]. Treatment related grade ≥3 mainly associated with chemotherapy without prophylactic growth factors, anemia 46%, neutropenia 23%, thrombocytopenia 12%, all others < 10%. Patients with at least 1 treatment related SAE were 6%; edema, pyrexia, anemia, atrial flutter. No treatment related deaths [89] . In interim results (N=63) from the trial in pancreatic cancer studying Nant Cancer Vaccine, comprising anktiva, PD-L1 t-haNK, and aldoxorubicin showed that treatment-related serious adverse events were uncommon (8%) and no treatment-related deaths were reported [88] [83] .
Merkel cell carcinoma
Phase II
Administration of ALT 803 in combination with aNK cell infusion in the phase II QUILT-3.009 trial was found to be generally safe and well tolerated, with no treatment-related serious adverse events or grade =3 adverse events reported. There were no reports of immune related adverse events [63] [66]
Cancer
Phase II
In preliminary data from the QUILT 3.055 phase II trial in 121 patients with checkpoint relapse multiple tumour types - non-small cell lung cancer, small cell lung cancer, urothelial carcinoma, head and neck squamous cell carcinoma, melanoma, renal, gastric, and cervical cancer- nogapendekin alfa inbakicept in combination with checkpoint therapy was well tolerated with grade 1-2 common treatment related adverse events (TRAE) were injection site reaction (68%), chills (32%) fatigue (26%), flu-like illness (14%); pyrexia and nausea ere reported similar to previous results. No other individual AE > 10%. Grade 3 N-803 TRAE were 12% but no individual grade 3 AEs were greater than 5%. Previous preliminary results showed that nogapendekin alfa inbakicept in combination with checkpoint therapy exhibited a favorable toxicity profile in combination with several different checkpoint inhibitors in second-line or greater settings, across a variety of tumor types. Adverse events, 12% of which were grade 3 or above, that were related to the chemotherapy-free combination regimen were favourable to the historical standard of care comprising combination therapies that include chemotherapy. Treatment-related serious adverse events (SAEs) were seen in 8% of study participants. In the phase II QUILT-3.055 trial in non-small cell lung cancer (NSCLC) patients, the combination regimen of nogapendekin alfa nogapendekin alfa inbakicept was combined with the pembrolizumab or nivolumab was well tolerated, with low incidence of treatment-related severe adverse events in second- and third-line NSCLC patients who had progressed on checkpoint inhibitor therapy at the time of study enrolment. Among 78 participants, nine (12%) exhibited grade 3 or higher treatment-emergent adverse events (AEs). Common low-grade AEs observed included injection site reactions (72%), chills (30%), fatigue (27%), fever (26%) and nausea (12%) [111] [110] [75] [109] .
Triple negative breast cancer
Phase I/II
The results from the QUILT-3.067 phase I/II trial for combination chemoradiation, cytokine fusion protein, NK cell therapy, and a checkpoint inhibitor showed that all nine treated patients had at least 1 grade ≥3 TRAE, primarily chemotherapy-related neutropenia or anemia. Grade ≥3 haNK-related AEs (fever and fatigue) were observed in 2 subjects. No SAEs were attributed to investigational agents. No cytokine release syndrome was observed [45] . The results from the QUILT-3.067 phase I/II trial showed that the metronomic combinationation therapy exhibits a manageable safety profile. All the patients in the trial experienced at least 1 grade 3 treatment related adverse event. Neutropenia was the primary chemotherapy related AE. Two patients experienced grade 3 haNK related AEs like fever and fatigue. Serious adverse events (SAEs) were observed in 2 patients, 7 patients survived, 6 patients are undergoing the study treatment [36] [37] .
Non-Hodgkin's lymphoma:
Phase I/II
In a phase I/II study nogapendekin alfa inbakicept in combination with rituxan was reported to be well tolerated in patients with NHL with a single reported grade 4 adverse event (AEs) and no reported grade 5 AEs [125] [124] .
Pancreatic cancer
Phase I/II
The results from the QUILT-3.080 phase I/II trial showed that the primarily observed haematologic adverse events could be managed by the planned chemotherapy dose reduction. Among the 12 patients, 9 experienced grade 3 treatment related adverse events (TRAEs), predominately chemotherapy-related neutropenia [92] [36] [93] .
Haematological malignancies
Phase I/II
Results of the first-in-human, open-label, dose escalation, phase I/II trial in patients (n = 33) with haematological malignancies, who have relapsed 60 days after allogeneic haematopoietic stem cell transplantation demonstrated that nogapendekin alfa inbakicept (ALT 803) was well tolerated in both the intravenous (IV) (n = 16), and subcutaneous (SC) (n = 17) cohorts, with no dose-limiting toxicities (DLTs) observed. The most common adverse events (AEs) were constitutional symptoms. In the ALT 803 SC cohort, injection site rash occurred frequently, which were self-limiting and showed a variable degree of CD8+, CD4+ T cells and NK cells on biopsies. None of the patients developed cytokine release or capillary leak syndromes. No new onset of severe graft versus host disease (GVHD) or clinical progression of prior GVHD was reported. Grade 4 or 5 severe AEs reported in three patients were sepsis (n = 2) and an intracranial haemorrhage [119] [118] [151] .
Bladder cancer
Phase I/II
In a phase Ib/II trial, adverse events (AEs) consistent with standard-of-care BCG treatment such as haematuria and urinary tract pain, were reported across all cohorts, with 9, 4 and 1 AEs observed in the 100µg, 200µg and 400µg dosage cohorts, respectively. In the 400μg cohort, a urinary tract infection that required a delay of intravesical treatment by one week, was developed by one patient. No grade III/IV toxicities and dose-limiting toxicities were observed in the patients [29] [30] .
Non-small cell lung cancer
Phase I/II
In a phase Ib/II trial, nogapendekin alfa inbakicept (ALT 803), in combination with nivolumab, was found to be safe in patients (n = 38) with NSCLC. Dose-limiting toxicities were not observed. Injection site reactions and flu-like symptoms were common adverse events. The most common grade 3 adverse event, occurring in two patients each, was lymphocytopenia and fatigue. A grade 3 myocardial infarction occurred in one patient. Grade 4 or 5 toxicity was not observed. Recommended phase II dose of ALT 803 was weekly subcutaneous 20 mcg/kg in combination with intravenous nivolumab 240mg every two weeks. The open-label trial is designed to enrol approximately 91 patients [79] [80] .
Prostate cancer
Phase I/II
Preliminary results of a phase I/II QuEST1 study in castration-resistant prostate cancer (CRPC) demonstrated that combination of nogapendekin alfa inbakicept (N 803), BN-brachyury (BNVax) and bintrafusp alfa (BA) was safe and well-tolerated. There were no dose limiting toxicities or grade >3 treatment-related adverse events (TRAEs). Grade 3 TRAEs included one pancreatitis in Arm 2.1 (BNVax plus BA), one secondary adrenal insufficiency (Arm 2.1), and one hyperglycemia due to new onset diabetes mellitus in Arm 2.2 (BNVax plus BA plus N 803). The data is from 22 CRPC patients with 3 to 17 months follow up [121] [120] .
HIV-1 infections
Phase I
In a proof-of-principle, dose-escalating phase I trial, nogapendekin alfa inbakicept was safe and well-tolerated, in patients with HIV-1 infection. First two participants received 0.3 mcg/kg IV and the remaining five received 1.0 mcg/kg SQ of ALT 803. SQ dosing was associated with an injection site rash and adenopathy. Eight of the first 13 doses were associated with transient low-level plasma viraemia [53] [52] . The primary clinical adverse events (AEs) reported were an injection site rash and adenopathy and four participants experienced a grade 1 or 2 QTc prolongation, which was deemed unrelated to the N 803 administration. There were no significant laboratory AEs attributable to N 803 [54] .
Squamous cell carcinoma of head and neck
Phase I
In a phase I trial, treatment with combination of ipilimumab and nogapendekin alfa inbakicept demonstrated one dose limiting toxicity at dose level 0, in patients with squamous cell carcinoma. Patients reported grade 3-4 haematologic adverse events (6/6, 100%). One patient died of G5 febrile neutropenia and infection. Median days hospitalized: 14 (range: 9-37). Mild cytokine release syndrome was observed in 5/6 (83%) (median peak ferritin: 2248, CRP: 168); 3/5 required anti-IL6 therapy; no neurotoxicity was noted. There were no dose adjustments or discontinuation of therapy [105] [104] .
Phase I
Treatment with nogapendekin alfa inbakicept subcutaneous injection, was safe and generally well tolerated in healthy volunteers (n=20), in the phase I QUILT-1.004 trial. Nogapendekin alfa inbakicept resulted in no grade ≥3 or serious adverse events (AEs). Mild injection site reactions, chills, and pyrexia were the most common AEs [137] [138] .
Pharmacodynamics
Summary
Haematological malignancies
Phase I/II
Results of the first-in-human, open-label, dose escalation, phase I/II trial of nogapendekin alfa inbakicept (ALT 803) in patients (n = 33) with haematological malignancies, who have relapsed 60 days after allogeneic haematopoietic stem cell transplantation demonstrated a marked induction of Ki67+ NK cells peaking at day 5 post-injection, with significantly longer persistence of Ki67+ via the subcutaneous (SC) route (10 mcg/kg, IV: 32%, SQ 70%, p = 0.002). Increased NK cell percentages and absolute numbers were observed. Ki67 was induced within CD8+ T cells, but to a lesser degree than in the NK cells. Minimal induction of Ki67 was observed within CD4+ T cells. Mass cytometry of the NK cell compartment demonstrated viSNE clustering of 37 different NK cell markers showed marked alteration of the NK cell compartment after ALT 803 dosing (n = 4; 10 mcg/kg SC). There were minimal changes in KIR and NKG2A expression on NK cells, but consistent upregulation of the receptors NKG2D, NKp30, and TIM-3 in vivo. There was more inter-patient variability with other receptors, with LAG-3 and DNAM-1 each markedly upregulated in one out of four patients evaluated [119] [118] [151] .
Triple negative breast cancer
Phase I/II
The results from the QUILT-3.067 phase I/II trial that assessed the utility of cell-free circulating RNA (cfRNA) as a predictor of treatment response showed that increasing and decreasing cfRNA levels are correlated with increasing and decreasing tumor size, respectively. The average PD-L1 expression and variability of the 18 genes exhibited a correlation with tumor size change from baseline (p-values = 0.08 and 0.03, respectively). Only trace levels of PD-L1 expression were observed in all 6 patients at baseline, prior to the initiation of the combination immunotherapy. Among the 5 patients that showed a reduction in tumor size of at least 10%, 4 also showed an associated increase in cfRNA PD-L1 expression from nearly 0 to normalized values between 2.1 and 6.8 [36] [37] .
Treatment with nogapendekin alfa inbakicept subcutaneous injection caused a significant proliferation of NK (22-fold increase in Ki-67+ cells), CD8+ (27-fold) and CD4+ T (11-fold) cells, in healthy volunteers (n=20), in the phase I QUILT-1.004 trial. It significantly increased (3-fold) NK cell number that persisted for ≥24 days. However, increased cell number occurred only in NK cells [137] [138] .
In preclinical study, nogapendekin alfa inbakicept induced HPC-NK cell proliferation in a dose-dependent manner, increased IFN production in CD34+ hematopoietic progenitor-derived NK cells (HPC-NK) stimulated with leukemia cells lines and improved the killing of primary AML samples from patients. Nogapendekin alfa inbakicept demonstrated improvement in tumour killing Further an increase in the CXCL10 production and improvement in long-term HPC-NK cell-mediated killing was reported in ovarian cancer model [139] .
In a proof-of-principle, dose-escalating phase I trial, in patients with HIV-1 infection, nogapendekin alfa inbakicept (ALT 803) led to a 7.6-fold increase in NK cell activation, a 23-fold increase in CD4 activation and a 10-fold increase in CD8 T cell activation in LN 48 hours after dosing. EDITS assay (Envelope Detection by Induced Transcription-based Sequencing) was used to measure inducible cell-associated HIV RNA. Prior to Con A stimulation a significant increase in HIV transcription was seen after the first 2 ALT-803 doses but after dose 3 there were fewer transcription events. With ConA stimulation there was a trend towards decreasing transcription events. The results indicated that drug caused activation and proliferation of CD4, CD8 T cells and NK cells and induced transcription of HIV. These studies suggested that ALT 803 reactivated virus from latency and activated NK and T cells. Results were drawn from seven patients enrolled in the trial [53] [52] .
Preclinical pharmacodynamics data for nogapendekin alfa inbakicept (ALT 803) in HIV infections in studies with rhesus macaques (RM) showed that in both studies, blood NK cells showed peak activation at 48h post ALT 803 administration throughout the dosing period. Memory T cells were preferentially activated by ALT 803, and CD8+ T cells demonstrated more robust expansion during the dosing period. No immune activation of PBMC was associated with bNAb treatment. We observed no change in integrated SHIV DNA between pre- and post- treatment timepoints in either PBMC or LN tissues. Plasma viral rebound kinetics in RMs treated with either ALT 803 alone, or in combination, were comparable to the control group after ART discontinuation. However, 3 of 5 combination treated RMs showed durable control of viremia after initial low-level rebound. Combination-treated (ALT 803 /bNAbs) RMs exhibited durable control of viremia beyond week 25 following initial low-level rebound. Nogapendekin alfa inbakicept plus one or two anti-HIV broadly neutralizing antibodies, suppressed simian/human immunodeficiency virus replication in 9 of 13 animals evaluated [46] [58] .
The results from the preclinical study in HIV infections demonstrated that the combined use of nogapendekin alfa inbakicept and broadly neutralizing antibodies (bNAbs) resulted in sustained control of viral replication after the cessation of antiretroviral therapy (ART) in rhesus macaques infected with simian-human immunodeficiency virus AD8 (SHIV-AD8). While treatment with nogapendekin alfa inbakicept and bNAbs triggered immune activation and temporary presence of the virus in the bloodstream, there were only minor reductions observed in the SHIV reservoir. Following the discontinuation of ART, all animals experienced a resurgence of the virus, but around 70% of those treated with nogapendekin alfa inbakicept and bNAbs exhibited long-term control of the infection for up to 10 months [56] .
Results from preclinical studies conducted in SIV-infected ART-treated rhesus macaques, for nogapendekin alfa inbakicept alone did not reactivate virus production. However, when given to CD8-depleted rhesus macaques, it resulted in loss of virus suppression (>60 copies/ml) in 14/14 animals (100%) in 41/56 samples (73.2%) collected 1 week after each dose. In addition, viremia >1,000 copies/ml was observed in 6/14 animals (42.9%) and 13/56 (23.2%) time points, with a maximum of 21,000 SIVgag copies/mL. Preliminary virus sequence analysis indicated a diverse range of circulating virus after CD8 depletion and ALT 803 treatment [57] .
Therapeutic Trials
Merkel cell carcinoma
Phase II
: In the phase II QUILT-3.009 trial, administration of ALT 803 in combination with aNK cell infusion demonstrated an overall response rate of 29%(2/7). An increase in levels of tumour-infiltrating lymphocytes and increased immune response-related gene expression within tumour tissue was observed when treated with aNK cell therapy [63] [66] .
Pancreatic cancer:
Phase II
Updated results from the phase II QUILT-88 trial in pancreatic cancer the median overall survival (OS) in this highly advanced group of patients, up to seven lines (N=83) of treatment, was 5.8 months (95% CI: 4.9, 6.4 months), exceeding the approximately 2- to 3-month historical median OS. In the third-line setting (N=41), the median OS in this group was 6.3 months (95% CI: 5.0, 7.2 months), more than doubling the historical OS. The baseline median CA 19-9 level (a marker of metastatic pancreatic disease) of the enrolled subjects (N=83) was very high at 4120 IU/ml, a significant increase from normal levels of 40 IU/ml. In subjects with CA 19-9 levels less than 4120 IU/ml (N=40), the median OS was 6.9 months (95% CI: 5.7,10.9) [90] In interim results (N=63) from the phase II QUILT-88 trial in pancreatic cancer studying Nant Cancer Vaccine, comprising anktiva, PD-L1 t-haNK, and aldoxorubicin, overall survival rate for patients doubled compared to historical survival rate of three months after two prior lines of therapy. To date, 27% of third-line or greater patients (17/63) remain on study. The median overall survival in this highly advanced group of patients, who failed two to six prior lines of treatment, is 5.8 months (95% CI: 3.9, 6.9 months) exceeding the approximately three-month historical median overall survival. Of the 63 patients, 30 (48%) had progressed after two prior lines of therapy. Median overall survival in this group was 6.3 months (95% CI: 5.0, 9.8 months), more than doubling the historical overall survival [88] . In pivotal QUILT 88 phase II trial, majority of participants in the study to date remained on therapy and 90% (43/48) of the evaluable patients have exceeded the approximately two-month historical survival rate. Of the 48 evaluable patients, 23 (48%) had extremely advanced disease upon enrollment (i.e. had progressed after three to six prior lines of therapy) and, of these patients, 20 out of 23 (87%) have exceeded historical survival rates. Interim results from cohort C of pivotal QUILT 88 phase II trial based on combination immunotherapy in which 15 out of 18 (83%) patients enrolled with second-line or greater pancreatic cancer remained alive to date [85] [87] [83]
Cancer
Phase II
Updated data from the QUILT 3.055 phase II trial of nogapendekin alfa inbakicept in combination with checkpoint therapy in 147 patients with checkpoint relapse multiple tumour types, non-small cell lung cancer, small cell lung cancer, urothelial carcinoma, head and neck squamous cell carcinoma, melanoma, renal, gastric, and cervical cancer demonstrated that addition of nogapendekin alfa inbakicept resulted in the rescue of the checkpoint therapy efficacy, with significant prolongation of overall survival [70] . Previously, preliminary data showed CR 0%, PR 8%, Stable Disease 51%, Progression 29%, response unevaluable 12% to date. A PR or SD was seen in all subgroups. Median PFS 3.9 months (95% CI: 2.6,5.0). Median OS 13.8 months (95% CI: 11.8, 16.3). Previous preliminary results from 121 patients showed 68% (82 out of 121) disease control (partial response and stable disease >6 weeks). Combination regimens that included nogapendekin alfa inbakicept demonstrated clinical benefit in the majority of subjects, with cessation of progression, prolonged stable disease, and occasional partial responses per RECIST were observed in different tumor types. In the phase II QUILT-3.055 trial, clinical benefit was demonstrated in a majority of the non-small cell lung cancer (NSCLC) patients, as measured by reduction of target lesion size and cessation of progression in the target lesion over time (with follow-up of up to 13 months). Clinical benefit was observed in patients with immediate prior progression on checkpoint inhibitors when nogapendekin alfa inbakicept was combined with the pembrolizumab or nivolumab, regardless of PD-L1 status or use of chemotherapy with checkpoint inhibitors [111] [110] [75] [109] .
Bladder cancer
Phase I/II
In a phase Ib/II trial, 100% patients (9/9) were disease-free and showed a complete response (CR) at week 12, six, nine and 12 months, respectively at dosages of 100µg, 200µg and 400µg [29] [30] .
Triple negative breast cancer
Phase I/II
In the phase Ib/II QUILT-3.067 trial, 78% disease control rate, 56% overall response rate (ORR) and 22% (2/9) complete response (CR) in patients with metastatic TNBC was observed for combination chemoradiation, cytokine fusion protein, NK cell therapy, and a checkpoint inhibitor. Disease control rate (CR+PR+SD) of 78% (7/9 pts); ORR (PR+CR) of 56% (5/9 pts). Two patients (22%; 2/9) achieved a complete response (CR). Also, seven patients were alive, and the duration of response ranged from 2 -12 months. For CR or PR, peripheral blood (PB) analysis showed >13x increase in TCR diversity at 2 months after initial treatment with increasing overall diversity thereafter; conversely, in patients with SD, PB TCR diversity increased <2x or decreased. Four patients remain on study [45] . The earlier results showed that one patient experienced complete response, two patients experienced partial response and 78% disease control rate were observed after the study treatment [149] [36] [37] .
Non-Hodgkin's lymphoma:
Phase I/II
Results from phase I part of a phase I/II study showed that nogapendekin alfa inbakicept demonstrated an overall response rate (ORR) of 78% (7 out of 9 patients) in the SQ cohort, along with a 100% complete remissions (CR) in patients (7 out of 7) with anti-CD20 mAb sensitive NHL. Prolonged stable disease (SD) and conversion of SD and/or partial response (PR) to CRs with a prolonged duration without progression were observed, in 8 of 12 patients without progression at 18-24 months. For the patients (n=5) with anti-CD20 mAb refractory disease in both IV and SQ cohorts, the ORR was 40% (2 out of 5) with 1 CR, 1 PR, 1 SD, and 2 progressive disease (PD), with the PR and SD are ongoing at over 18 months. In correlative immunology experiments, nogapendekin alfa inbakicept in combination with rituxan induced the expansion, activation and modulation of NK cells and CD8+ T cells, with minimal impact on CD4+ T cells and Tregs. Multi-dimensional mass cytometry studies demonstrated remodeling of iNHL patient immune landscapes by promotion of an activation signature approximately in all immune cell lineages including NK cells, CD8+ TEM, gd T cells, and CD14 and CD16 monocytes [125] [124] .
Pancreatic cancer
Phase I/II
The results from the QUILT-3.080 phase I/II trial showed that among 12 patients, 9 (75 %) experienced stable disease in a span of 8 weeks. The median progression free survival was 7.1 months (4.4 - 8.8) and the median overall survival was 8.2 months (5.7 - 9.7), with 1 patient continuing the treatment [92] [36] [93] .
Prostate cancer:
Phase I/II
Preliminary results of a phase I/II QuEST1 study in castration-resistant prostate cancer (CRPC) demonstrated that addition of N 803 to BN-brachyury (BNVax) plus bintrafusp alfa (BA) was associated with more activity. In BNVax plus BA (Arm 2.1), 1/13 (7.8%) patients had a PSA response sustained for 13 months. Out of three patients with measurable disease by RECIST, zero patients had complete response and partial response (PR), one had stable disease and two had progressive disease. In BNVax plus BA plus N 803 (Arm 2.2) 4/9 (44%) patients had sustained PSA responses; two of these patients had confirmed PR, including one patient who progressed on abiraterone and enzalutamide. Out of three patients with measurable disease by RECIST, zero patients had complete response, one patient had stable disease and zero patients had progressive disease. Arm 2.2 met the predetermined threshold for efficacy. The data is from 22 CRPC patients with 3 to 17 months follow up [121] [120] .
Squamous cell carcinoma of head and neck
Phase I
In a phase I trial, treatment with allogeneic cytokine-induced memory-like natural killer cells with nogapendekin alfa inbakicept demonstrated that it may induce tumor regression in advanced head-and-neck cancer patients. The results showed tumor regression associated with the expansion of CD56dimCD16+ NK cells, which have cytolytic activity and can target and kill tumor cells. Notably, some patients showed tumor regression despite being heavily pre-treated, indicating the potential of this live cell therapy approach [106] . In a phase I trial, treatment with the combination therapy of ipilimumab and nogapendekin alfa inbakicept showed one (17%) partial response (PR) lasting 6.5 months; four (67%) pts had stable disease (SD), and one (17%) had progression. Tumour regression was reported in 3/6 (50%) pts at day +30. At a median follow-up of 9.5 months, median PFS was 3.4 months (95% CI 2.6-6.5), median OS was 4.7 months (95%CI 3.4-11.8). CIML NK cells showed large expansion in the peripheral blood (PB) at day +7 in all pts mean increase was reported to be 66% (6-fold; standard deviation [SD] 10.5), to constitute 80% (SD 12.1) of PB lymphocytes. In pts with tumour regression at day +30 compared to those without, the % of PB NK cells remained high at day +28 (mean: 78 vs. 11%). PB NK cells remained >50% at day +42 in the pt with a PR [105] [104] .
Bladder cancer
Phase II/III
In phase II/III QUILT-3.032 trial, BCG plus nogapendekin alfa inbakicept met its primary endpoint in high-risk carcinoma in situ (CIS) cohort and in papillary non-muscle invasive bladder cancer (NMIBC) cohort. BCG plus nogapendekin alfa inbakicept (referred to as NAI) demonstrated complete responses (CRs) with a persistence of effect with 90% probability of avoiding cystectomies in responders, a life-changing procedure of removing the bladder, and 100% bladder cancer-specific survival at 24 months. The combination of nogapendekin alfa inbakicept plus BCG produced both a higher CR rate and more durable responses. In patients who received intravesical nogapendekin alfa inbakicept plus BCG (cohort A), a CR was achieved in 58 (71%) of 82 patients (95% confidence interval [CI]=59.6 to 80.3; median follow-up, 23.9 months), with a median duration of 26.6 months 95% CI 59.9 months to [upper bound not reached]). At 24 months in patients with CR, the Kaplan–Meier–estimated probability of avoiding cystectomy and of disease-specific survival was 89.2% and 100%, respectively. In patients with BCG-unresponsive high-grade Ta/T1 papillary NMIBC who received nogapendekin alfa inbakicept plus BCG (cohort B), the Kaplan–Meier–estimated disease-free survival (DFS) rate was 55.4% (95% CI=42.0% to 66.8%) at 12 months, with median DFS of 19.3 months (95% CI=7.4 months to [upper bound not reached]) [28] . In updated results from a phase II/III QUILT-3.032 trial demonstrated that carcinoma in situ (CIS) patients had a complete response (CR) rate of 71% (59/83), with a mediation duration of CR of 24.1 months in responders, 91% avoided cystectomy and 96% 24 month bladder cancer specific progression free survival. Papillary patients had a 57% 12 month DFS rate, 48% 24 month disease-free rate (DFS) rate and 95% avoided cystectomy. Median time to cystectomy in responders (N = 4) is 12.9 months versus 7.8 in non-responders (N = 8) for a 5.1 month delay in cystectomy [27] . Previously, complete response rates in patients with BCG-unresponsive non-muscle invasive carcinoma in situ (NMIBC CIS) bladder cancer (Cohort A) and with papillary disease (Cohort B) was observed. Of the 83 patients with BCG-unresponsive NMIBC CIS, 59 (71%) had a complete response with a median duration of response of 26.6 months—exceeding historical complete response rates of 41% and 18% for FDA-approved therapies pembrolizumab and valrubicin, respectively. In the papillary disease arm of the study (Cohort B), 57% of patients are disease free at 12 months and 53% at 18 months. In Cohort A nogapendekin alfa inbakicept demonstrated 1 Months median durable complete remission. 96% Avoidance of bladder cancer progression at 24 months in responders .91% Avoidance of cystectomy at 24 months in responders. 100% Bladder cancer specific overall survival at 24 months . In Cohort B 57% Disease free survival rate at 12 months was observed. 99% Overall bladder cancer specific survival and 95% Cystectomy avoidance rate was demonstrated [25] . The second indication of its study of intravesical BCG plus nogapendekin alfa inbakicept in patients with BCG-unresponsive high-grade NMIBC, met its primary endpoints with disease-free survival of 57% of patients at 12 months. The primary endpoint was met with a disease-free rate at 12-months of 57% (95% CI: 43.7%, 68.5%) and at 18-months, 53% (95% CI: 38.8%, 64.6%) by Kaplan-Meier analysis. Durable responses were noted in both cohorts and the therapy resulted in significant avoidance of cystectomy. In previous results from a phase II/III QUILT-3.032 trial, Fifty-eight percent (58%) of patients with CR had a DOR ≥ 12 months and 40% had a DOR ≥ 24 months. The CR rate for the 77 evaluable patients was 62% with the upper end of the confidence interval being 73%. The duration of complete response at cut-off was more than 47 months. Treatment with nogapendekin alfa inbakicept met its primary end point in the first cohort (Cohort A) for BCG unresponsive non-muscle invasive bladder cancer carcinoma in situ (CIS) with 72% complete response rate. The data showed 58 out of 81 evaluable patients (72%) had a complete response at any time (three to six months) to intravesical BCG plus nogapendekin alfa inbakicept (Anktiva). A median duration of complete response of 19.9 months. The probability to maintain a CR for more than 12 months in the responding patients were 59% (95% confidence interval; 43.1%, 71.2%). For the patients who had a CR within the first three months, the CR rate was 77%, and with probability of remaining disease free at 18 months of 61% [150] [18] [23] [20] [21] [24] .
Non-small cell lung cancer
Phase I/II
In the phase Ib part of a phase Ib/II trial, treatment with ALT 803, in combination with nivolumab, resulted in the disease control rate of 91% (10 of 11 patients), with 27% (3 patients) partial responses and 64% (7 patients) stable disease was observed in PD1 immunotherapy relapsed or refractory NSCLC. Among 10 patients with PD-L1 negative tumours, the disease control rate was 70% and partial response rate was 30%. The open-label trial is designed to enrol approximately 91 patients [79] [80] .
HIV-1 infections
Phase I
Results from phase I trial demonstrated the activation of CD4+ and CD8+ T cells and natural killer (NK) cells in people living with HIV by ImmunityBio’s IL-15 superagonist N 803. It stimulates latent HIV replication (the “kick”) in CD4 memory cells allowing the previously hidden infected cells to be revealed and eliminated (the “kill”) by CD8 and NK cells. IFN, IP10, MCP-1, and IL-15 increased during treatment. HIV transcription in memory CD4 T cells and intact proviral DNA initially increased after N-803 treatment and there was a small but significant decrease in the frequency of PBMCs with an inducible HIV provirus that persisted for up to six months post therapy [54] [52]
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Dec 2024 | Regulatory Status | Immunity announces intention to submit NDA to the US FDA for Non-small cell lung cancer (Second-line therapy or greater) in 2024 [70] | 30 Apr 2024 |
| 30 Jun 2024 | Regulatory Status | ImmunityBio plans a meeting with the FDA in June to discuss the company’s overall survival results in PD-L1 negative and positive patients and registration plans for 2nd-line and 3rd-line NSCLC patients whose cancer did not respond or continue to respond to checkpoint therapy and for whom few alternative therapies are available [147] | 01 May 2024 |
| 24 May 2024 | Trial Update | Dana-Farber Cancer Institute and ImmunityBio plans a phase I trial for Ovarian cancer (Recurrent, Combination therapy, Second-line therapy or greater, In adults, In elderly) in USA (NCT06321484) (700372087) | 27 Mar 2024 |
| 15 May 2024 | Regulatory Status | ImmunityBio intends to launch nogapendekin alfa inbakicept in Bladder cancer (Combination therapy, Second-line therapy or greater) in the US (Intravesicular) by mid-May 2024 [8] | 30 Apr 2024 |
| 30 Apr 2024 | Trial Update | Dana-Farber Cancer Institute in collaboration with ImmunityBio plans a phase 0 trial in Urogenital cancer/Renal Cell Carcinoma (Late-stage disease, Metastatic disease, Second-line therapy or greater, Combination therapy) in USA (SC) in April 2024 (NCT06318871) (700372083) | 30 Apr 2024 |
| 23 Apr 2024 | Regulatory Status | The US FDA sets PDUFA date of 23 April 2024 for BLA review for Bladder cancer (Combination therapy) [11] | 30 Apr 2024 |
| 01 Mar 2024 | Trial Update | ImmunityBio plans the phase II QUILT-505 trial for Squamous cell cancer (Combination therapy, Recurrent, Metastatic disease, Inoperable/Unresectable, Late-stage disease, Second-line therapy or greater) in the US, in March 2024 (700370840) (NCT06239220) | 29 Mar 2024 |
| 20 Feb 2024 | Trial Update | National Cancer Institute plans a phase I/II trial for Endometrial Cancer (Combination therapy, Metastatic disease, Late-stage disease, Second-line therapy or greater, In adults, In the elderly) in the US (IV, Infusion) (NCT06253494) | 30 Apr 2024 |
| 16 Nov 2023 | Trial Update | ImmunityBio plans a phase II trial for Glioblastoma(Recurrent, Second-line therapy or greater, Combination therapy) in November 2023 (SC) (NCT06061809) | 04 Oct 2023 |
| 30 Sep 2023 | Trial Update | ImmunityBio plans a phase I Stimulation trial on NK cells in Healthy volunteers (NCT06040918) | 11 Oct 2023 |
| 23 May 2023 | Regulatory Status | FDA assigns PDUFA action date of (23/05/2023) for nogapendekin alfa inbakicept for Bladder cancer (Combination therapy) [28] | 01 May 2024 |
| 31 Dec 2022 | Regulatory Status | ImmunityBio announces intention to meet with the US FDA to discuss the path for the approval of nogapendekin alfa inbakicept for Pancreatic cancer in the 2022 [87] | 01 May 2024 |
| 15 Dec 2022 | Trial Update | National Cancer Institute plans a phase I/II trial in Non-small cell lung cancer (Adjuvant therapy, Second-line therapy or greater) in USA (SC, Injection) in December 2022 (NCT05642195) | 30 Apr 2024 |
| 13 Jul 2022 | Trial Update | National Cancer Institute plans a phase II trial for Castration resistant prostate cancer (Monotherapy, Combination therapy, Metastatic disease, Hormone refractory) in USA (SC) (NCT05445882) | 30 Apr 2024 |
| 30 Apr 2022 | Regulatory Status | ImmunityBio announces intention to submit BLA to the US FDA for Bladder cancer, in April 2022 (9353810)(9345585) | 25 May 2022 |
| 31 Mar 2022 | Trial Update | Rockefeller University plans a phase I trial for HIV infections (Combination therapy, Treatment-experienced) in USA (IV) (NCT05245292) | 07 Mar 2024 |
| 31 Dec 2021 | Trial Update | The National Cancer Institute plans to begin enrolment in the Lung-MAP trial for Non-small cell lung cancer (Combination therapy, Second-line therapy or greater) in fourth quarter of 2021 [73] | 27 Apr 2022 |
| 31 Oct 2021 | Trial Update | Washington University School of Medicine in collaboration with Eli Lilly and ImmunityBio plans a phase II trial for Non-small Cell Lung Cancer in the USA (NCT05007769) | 30 Apr 2024 |
| 30 Sep 2021 | Trial Update | ImmunityBio plans the QUILT 3.058 phase Ib/II trial for Breast cancer (Late-stage disease, Second-line therapy or greater, Combination therapy, Metastatic disease) in Q3 2021 (9327415) | 30 Apr 2024 |
| 01 Jul 2021 | Trial Update | ImmunityBio plans a phase I/II trial for Breast Cancer (Combination therapy, Second-line therapy or greater, Late-stage disease) [SC, Injection], in July 2021 (NCT04927884) (700338590) | 18 Oct 2021 |
| 30 Jun 2021 | Trial Update | ImmunityBio plans phase I QUILT 3.076 trial in Solid tumours (Combination therapy, Late-stage disease, Metastatic disease) in USA (Parenteral) in second quarter of 2021 (700337334) [123] | 30 Apr 2024 |
| 31 May 2021 | Trial Update | University of Minnesota and National Institute of Allergy and Infectious Diseases plans a phase I trial for HIV infections (Adjunctive treatment) in USA in May 2021 (SC) (NCT04808908) | 16 Jun 2021 |
| 27 Apr 2021 | Trial Update | National Cancer Institute plans a phase II trial for Squamous cell cancer (Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease, Second-line therapy or greater) in USA (NCT04847466) (700336076) | 28 Dec 2021 |
| 01 Dec 2020 | Trial Update | Thai Red Cross AIDS Research Centre plans a phase II trial in HIV infections (Adjunctive therapy) in Thailand in December 2020 (SC) (NCT04505501) (700326551) | 05 May 2021 |
| 07 Aug 2020 | Trial Update | National Cancer Institute plans a phase II trial for Colorectal cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater, Combination therapy) in USA in August 2020 (SC) (NCT04491955) | 01 May 2024 |
| 01 Jul 2020 | Trial Update | National Institute of Allergy and Infectious Diseases plans a phase I trial for HIV infections (Combination therapy, Monotherapy, Treatment experienced) (SC) in July 2020 (NCT04340596) (320734) | 26 Jun 2021 |
| 30 Jun 2020 | Trial Update | NantKwest and ImmunityBio plan the phase II QUILT-88 trial for Pancreatic cancer (Combination therapy, Late-stage disease, Metastatic disease) by June 2020 (NCT04390399) (700321920) [148] | 02 Jul 2020 |
| 30 Jun 2020 | Trial Update | ImmunityBio & NantKwest plans a phase I trial for COVID-2019 infections in June 2020 (NCT04385849) [3] | 30 Apr 2024 |
| 31 Mar 2020 | Trial Update | Bristol-Myers Squibb in collaboration with Altor BioScience and Miltenyi Biotec B.V. plans a phase I trial for Squamous cell carcinoma of Head and neck cancer (Combination therapy, Late stage disease, Recurrent, Metastatic) in USA (NCT04290546) (700319404) | 27 Jul 2020 |
| 30 Oct 2018 | Trial Update | Masonic Cancer Center plans to initiate the phase II QUILT-3.034 trial in acute myeloid leukaemia and myelodysplastic syndrome in October 2018 (NCT03365661) (700291153) | 30 Apr 2024 |
| 30 Jun 2018 | Trial Update | NantKwest plans a phase II QUILT-3.057 trial for Triple negative breast cancer (First-line therapy, Combination therapy, Neoadjuvant therapy) in USA (NCT03554109) (700296690) | 23 Feb 2021 |
| 29 Jun 2018 | Trial Update | NantKwest plans the QUILT-3.088 phase II trial for Pancreatic Cancer (Metastatic disease) in USA (700297017), (NCT03563144) | 10 Sep 2019 |
| 18 May 2018 | Trial Update | Altor BioScience in collaboration with NantCell plans the QUILT-2.023 phase II trial for Non Small Cell Lung Cancer in May 2018(700295711), (NCT03520686) | 30 May 2018 |
| 17 Apr 2018 | Trial Update | National Cancer Institute plans the QuEST1 phase I/II trial for Solid tumours and Prostate cancer in USA (NCT03493945) | 20 Jun 2018 |
| 31 Jan 2018 | Trial Update | NantKwest plans the phase Ib/II QUILT-3.067 trial for Triple negative breast cancer (Second-line therapy or greater, Metastatic disease, Inoperable/Unresectable, Combination therapy) in USA (NCT03387085) | 20 Jun 2018 |
| 08 Jan 2018 | Trial Update | Altor BioScience plans the phase I QUILT-1.004 trial in volunteers in USA in January 2018 (NCT03381586) (700291750) | 16 Feb 2018 |
| 31 Dec 2017 | Trial Update | NantCell plans the phase Ib/II QUILT-3.048 trial for Urogenital cancer (Second-line therapy or greater, Combination therapy) in December 2017 (NCT03197571) (700286155) | 10 Sep 2019 |
| 31 Dec 2017 | Trial Update | NantCell plans the phase Ib/II QUILT-3.051 trial for Ovarian cancer (Combination therapy, Second-line therapy or greater) in December 2017 (NCT03197584) | 10 Sep 2019 |
| 31 Dec 2017 | Trial Update | NantCell plans the phase Ib/II QUILT-3.052 trial for Non hodgkin lymphoma (Combination therapy, Second-line therapy or greater) (NCT03169790) | 10 Sep 2019 |
| 31 Dec 2017 | Trial Update | NantCell plans the phase Ib/II QUILT-3.050 trial for Colorectal cancer (Combination therapy, Second-line therapy or greater, Metastatic disease, Recurrent) in December 2017 (NCT03169777) | 10 Sep 2019 |
| 31 Dec 2017 | Trial Update | NantCell plans the phase Ib/II QUILT-3.047 trial for Head and neck squamous cell carcinoma (Combination therapy, Second-line therapy or greater) (NCT03169764) | 10 Sep 2019 |
| 31 Dec 2017 | Trial Update | NantCell plans the phase Ib/II QUILT-3.044 trial for Non-small cell lung cancer (Combination therapy, Second-line therapy or greater) in December 2017 (NCT03169738) | 10 Sep 2019 |
| 31 Dec 2017 | Trial Update | NantCell plans the phase Ib/II QUILT-3.046 trial for Melanoma (Combination therapy, Second-line therapy or greater) (NCT03167177) | 10 Sep 2019 |
| 31 Dec 2017 | Trial Update | NantCell plans the phase Ib/II QUILT-3.045 trial for Merkel cell carcinoma (Combination therapy, Second-line therapy or greater) (NCT03167164) | 30 Apr 2024 |
| 31 Dec 2017 | Trial Update | NantCell plans the phase Ib/II QUILT-3.049 trial for Triple negative breast cancer (Second-line therapy or greater, Metastatic disease, Inoperable/Unresectable, Combination therapy) (NCT03175666) | 11 Sep 2019 |
| 30 Nov 2017 | Trial Update | NantKwest plans the phase I/II QUILT-3.060 trial for Pancreatic cancer (Combination therapy, Second-line therapy or greater) in November 2017 (NCT03329248) (700290011) | 29 Dec 2017 |
| 30 Sep 2017 | Trial Update | Altor Bioscience plans the QUILT-3.055 phase II trial for Non-small cell lung cancer(Combination therapy, Metastatic disease, Late-stage disease, Second-line therapy or greater) in USA (NCT03228667) | 10 Sep 2019 |
| 01 Jul 2017 | Trial Update | Masonic Cancer Center plans a phase I QUILT-2.021 trial for Ovarian cancer, Fallopian tube and primary peritoneal cancer (Late-stage disease, Second-line therapy or greater) in USA (NCT03054909) | 08 Nov 2017 |
| 01 Jul 2017 | Trial Update | NantCell plans a phase I/II trial for Cancer (Combination therapy, Metastatic disease, Late-stage disease, Second-line therapy or greater) (NCT03127098) | 02 May 2024 |
| 01 Jul 2017 | Trial Update | NantCell plans the phase Ib/II QUILT-3.039 trial for Pancreatic cancer (Combination therapy, Second-line therapy or greater) (NCT03136406) | 07 Sep 2017 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 02 May 2024 | Patent Information | ImmunityBio has patent protection for development and commercialization of N-803 [146] Updated 06 May 2024 |
| 02 May 2024 | Patent Information | The validity of one of European patents, EP Patent is being challenged in an opposition proceeding [146] Updated 06 May 2024 |
| 26 Apr 2024 | Phase Change - I/II | Phase-I/II clinical trials in Non-small cell lung cancer (Adjuvant therapy) in USA (SC) (NCT05642195) Updated 30 Apr 2024 |
| 25 Apr 2024 | Regulatory Status | ImmunityBio plans a meeting with the FDA in June to discuss the company’s overall survival results in PD-L1 negative and positive patients and registration plans for 2nd-line and 3rd-line NSCLC patients whose cancer did not respond or continue to respond to checkpoint therapy and for whom few alternative therapies are available [147] Updated 01 May 2024 |
| 25 Apr 2024 | Regulatory Status | Immunity announces intention to submit NDA to the US FDA for Non-small cell lung cancer (Second-line therapy or greater) in 2024 [70] Updated 30 Apr 2024 |
| 25 Apr 2024 | Regulatory Status | ImmunityBio schedules a meeting with the US FDA for registration of nogapendekin alfa inbakicept for the treatment of Non-small cell lung cancer in the US [70] Updated 30 Apr 2024 |
| 25 Apr 2024 | Scientific Update | Updated efficacy data from the phase II QUILT-3.055 trial released by ImmunityBio [70] Updated 30 Apr 2024 |
| 25 Apr 2024 | Trial Update | ImmunityBio completes phase II QUILT-3.055 trial in Non-small cell cancer, Renal cell carcinoma, Colorectal cancer, Solid tumors, Cervical cancer, Oesophageal cancer, Malignant melanoma, Merkel cell carcinoma, Squamous cell cancer, urogenital cancer, Small cell lung cancer (Combination therapy, Second-line therapy or greater) in USA (SC) (NCT03228667) [70] Updated 30 Apr 2024 |
| 22 Apr 2024 | Phase Change - Registered | Registered for Bladder cancer (Combination therapy, Second-line therapy or greater) in USA (Intravesicular) - First global approval [10] [8] Updated 30 Apr 2024 |
| 22 Apr 2024 | Regulatory Status | ImmunityBio intends to launch nogapendekin alfa inbakicept in Bladder cancer (Combination therapy, Second-line therapy or greater) in the US (Intravesicular) by mid-May 2024 [8] Updated 30 Apr 2024 |
| 01 Apr 2024 | Trial Update | Altor BioScience in collaboration with National Cancer Institute withdraws a phase II trial prior to enrolment in Prostate cancer (Monotherapy, Combination therapy, Hormone-refractory) in USA (SC) (NCT05445882) Updated 30 Apr 2024 |
| 26 Mar 2024 | Trial Update | ImmunityBio in collaboration with National Cancer Institute initiates a phase I/II trial for Colorectal cancer (Metastatic disease, Second-line therapy or greater, Combination therapy) in the USA (SC) (NCT06149481) Updated 02 May 2024 |
| 20 Mar 2024 | Trial Update | Dana-Farber Cancer Institute and ImmunityBio plans a phase I trial for Ovarian cancer (Recurrent, Combination therapy, Second-line therapy or greater, In adults, In elderly) in USA (NCT06321484) Updated 27 Mar 2024 |
| 12 Mar 2024 | Trial Update | Dana-Farber Cancer Institute in collaboration with ImmunityBio plans a phase 0 trial in Urogenital cancer/Renal Cell Carcinoma (Late-stage disease, Metastatic disease, Second-line therapy or greater, Combination therapy) in USA (SC) in April 2024 (NCT06318871) Updated 30 Apr 2024 |
| 06 Mar 2024 | Scientific Update | Pharmacodynamics data from a preclinical studies in HIV infections released by ImmunityBio [56] Updated 12 Mar 2024 |
| 21 Feb 2024 | Trial Update | ImmunityBio completes enrolment in its phase II trial for Hereditary nonpolyposis colorectal cancer (Combination therapy, Prevention) in USA (SC) (NCT05419011) [39] Updated 23 Feb 2024 |
| 16 Feb 2024 | Phase Change - II | Phase-II clinical trials in Squamous cell cancer (Metastatic disease, Late-stage disease, Second-line therapy or greater, Inoperable/Unresectable, Combination therapy, Recurrent) in USA (SC) (NCT06239220) Updated 29 Mar 2024 |
| 15 Feb 2024 | Trial Update | National Cancer Institute plans a phase I/II trial for Endometrial Cancer (Combination therapy, Metastatic disease, Late-stage disease, Second-line therapy or greater, In adults, In the elderly) in the US (IV, Infusion) (NCT06253494) Updated 30 Apr 2024 |
| 02 Feb 2024 | Trial Update | ImmunityBio plans the phase II QUILT-505 trial for Squamous cell cancer (Combination therapy, Recurrent, Metastatic disease, Inoperable/Unresectable, Late-stage disease, Second-line therapy or greater) in the US, in March 2024 (NCT06239220) Updated 29 Mar 2024 |
| 31 Dec 2023 | Patent Information | Multiple patents were issued and pending for N 803 in the US, Europe, China, Japan, Canada, and Australia [146] Updated 06 May 2024 |
| 26 Oct 2023 | Regulatory Status | The US FDA sets PDUFA date of 23 April 2024 for BLA review for Bladder cancer (Combination therapy) [11] Updated 30 Apr 2024 |
| 26 Oct 2023 | Regulatory Status | ImmunityBio announces intention to launch nogapendekin alfa inbakicept [142] Updated 06 Mar 2024 |
| 26 Oct 2023 | Regulatory Status | ImmunityBio receives complete response letter from the FDA for nogapendekin alfa inbakicept in Bladder cancer [11] Updated 30 Oct 2023 |
| 26 Oct 2023 | Regulatory Status | US FDA accepts BLA for nogapendekin alfa inbakicept for Bladder cancer for review [11] Updated 30 Oct 2023 |
| 23 Oct 2023 | Regulatory Status | ImmunityBio resubmits Biologics License Application with the US FDA in USA for Bladder cancer [13] Updated 25 Oct 2023 |
| 04 Oct 2023 | Trial Update | ImmunityBio initiates enrolment in a phase I QUILT-105 stimulation trial in healthy volunteers in USA (SC) (NCT06040918) Updated 11 Oct 2023 |
| 25 Sep 2023 | Trial Update | ImmunityBio plans a phase II trial for Glioblastoma(Recurrent, Second-line therapy or greater, Combination therapy) in November 2023 (SC) (NCT06061809) Updated 04 Oct 2023 |
| 18 Sep 2023 | Trial Update | ImmunityBio plans a phase I Stimulation trial on NK cells in Healthy volunteers (NCT06040918) Updated 11 Oct 2023 |
| 28 Aug 2023 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Squamous-cell-cancer(Late-stage disease, Metastatic disease, Second-line therapy or greater) in USA (SC) Updated 28 Aug 2023 |
| 10 Jul 2023 | Scientific Update | Efficacy data from a phase I trial in Squamous cell carcinoma released by ImmunityBio [106] Updated 12 Jul 2023 |
| 22 Mar 2023 | Phase Change - II | Phase-II clinical trials in Hereditary nonpolyposis colorectal cancer (Combination therapy, Prevention) in USA (SC) (NCT05419011) Updated 05 May 2023 |
| 24 Feb 2023 | Trial Update | Altor BioScience in collaboration with Medical University of South Carolina completes a phase-I/II trial in Non-small cell lung cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater, Combination therapy, Inoperable/Unresectable, Recurrent) in USA (Parenteral) (NCT02523469) Updated 02 May 2024 |
| 17 Feb 2023 | Trial Update | Altor BioScience in collaboration with The Case Comprehensive Cancer Center completes a phase I trial for Cancer (Combination therapy) in USA (Parenteral) (NCT02890758) Updated 30 Apr 2024 |
| 19 Jan 2023 | Scientific Update | Updated efficacy data from a phase II QUILT-88 trial in Pancreatic cancer released by ImmunityBio [90] Updated 23 Jan 2023 |
| 04 Jan 2023 | Trial Update | Immunity Bio terminates phase I/II trial as trial did not meet recruiting goals in Triple-negative-breast cancer (Combination therapy, Second-line therapy or greater, Late-stage disease) in USA (SC) (NCT04927884) Updated 13 Mar 2023 |
| 01 Jan 2023 | Trial Update | ImmunityBio in collaboration with University of Minnesota and National Institute of Allergy and Infectious Diseases completes a phase I trial in HIV Infections (Adjunctive treatment) in USA (SC) (NCT04808908) Updated 02 May 2024 |
| 13 Dec 2022 | Trial Update | National Cancer Institute plans a phase I/II trial in Non-small cell lung cancer (Adjuvant therapy, Second-line therapy or greater) in USA (SC, Injection) in December 2022 (NCT05642195) Updated 30 Apr 2024 |
| 07 Dec 2022 | Trial Update | Rockefeller University initiates a phase I trial for HIV infections (Combination therapy, Treatment-experienced) in USA (SC) (NCT05245292) Updated 07 Mar 2024 |
| 16 Nov 2022 | Trial Update | ImmunityBio plans the phase I QUILT 3.092 trial for Non-Hodgkin's lymphoma (Combination therapy, Second-line therapy or greater) in USA (NCT05618925) Updated 22 Nov 2022 |
| 11 Nov 2022 | Scientific Update | Efficacy and adverse events data from phase II/III QUILT-3.032 trial for Bladder cancer released by ImmunityBio [28] Updated 16 Nov 2022 |
| 10 Nov 2022 | Regulatory Status | FDA assigns PDUFA action date of (23/05/2023) for nogapendekin alfa inbakicept for Bladder cancer (Combination therapy) [28] Updated 01 May 2024 |
| 31 Aug 2022 | Trial Update | Altor BioScience in collaboration with Masonic Cancer Center completes a phase II trial in Myelodysplastic syndromes and Acute myeloid leukemia in USA (SC) (NCT02989844) Updated 02 May 2024 |
| 28 Aug 2022 | Phase Change - No development reported | No recent reports of development identified for phase-I development in HIV-infections(Adjunctive treatment) in USA (SC, Injection) Updated 28 Aug 2022 |
| 28 Aug 2022 | Phase Change - No development reported | No recent reports of development identified for phase-II development in Fallopian-tube-cancer(Late-stage disease, Second-line therapy or greater) in USA (Intraperitoneal, Injection) Updated 28 Aug 2022 |
| 28 Aug 2022 | Phase Change - No development reported | No recent reports of development identified for phase-II development in Fallopian-tube-cancer(Late-stage disease, Second-line therapy or greater) in USA (SC, Injection) Updated 28 Aug 2022 |
| 28 Aug 2022 | Phase Change - No development reported | No recent reports of development identified for phase-II development in Ovarian-cancer(Late-stage disease, Second-line therapy or greater) in USA (Intraperitoneal, Injection) Updated 28 Aug 2022 |
| 28 Aug 2022 | Phase Change - No development reported | No recent reports of development identified for phase-II development in Ovarian-cancer(Late-stage disease, Second-line therapy or greater) in USA (SC, Injection) Updated 28 Aug 2022 |
| 28 Aug 2022 | Phase Change - No development reported | No recent reports of development identified for phase-II development in Peritoneal-cancer(Late-stage disease, Second-line therapy or greater) in USA (Intraperitoneal, Injection) Updated 28 Aug 2022 |
| 28 Aug 2022 | Phase Change - No development reported | No recent reports of development identified for phase-II development in Peritoneal-cancer(Late-stage disease, Second-line therapy or greater) in USA (SC, Injection) Updated 28 Aug 2022 |
| 28 Jul 2022 | Regulatory Status | The US FDA accepts Biologic License Application for nogapendekin alfa inbakicept for Bladder cancer for review [14] Updated 01 Aug 2022 |
| 08 Jul 2022 | Trial Update | National Cancer Institute plans a phase II trial for Castration resistant prostate cancer (Monotherapy, Combination therapy, Metastatic disease, Hormone refractory) in USA (SC) (NCT05445882) Updated 30 Apr 2024 |
| 03 Jun 2022 | Scientific Update | Efficacy and safety data from a phase II/III QUILT-3.032 trial in Bladder cancer presented at the 58th Annual Meeting of the American Society of Clinical Oncology (ASCO-2022) [27] Updated 06 Jul 2022 |
| 03 Jun 2022 | Scientific Update | Adverse events data from a phase II QUILT-88 trial in Pancreatic cancer presented at the 58th Annual Meeting of the American Society of Clinical Oncology (ASCO-2022) [89] Updated 01 Jul 2022 |
| 24 May 2022 | Phase Change - Preregistration | Preregistration for Bladder cancer (Combination therapy) in USA (Intravesicular) [12] Updated 25 May 2022 |
| 26 Apr 2022 | Phase Change - II/III | Phase-II/III clinical trials in Non-small cell lung cancer (In children, In adults, In the elderly, Combination therapy, Second-line therapy or greater) in USA (SC) [72] (NCT05096663) Updated 27 Apr 2022 |
| 08 Apr 2022 | Scientific Update | Efficacy and safety data from a phase I trial in Squamous cell carcinoma presented at the 113th Annual Meeting of the American Association for Cancer Research (AACR-2022) [105] Updated 28 May 2022 |
| 04 Apr 2022 | Trial Update | Altor BioScience Corporation in collaboration with Washington University School of Medicine terminates a phase I/II trial in Acute myeloid leukaemia and Myelodysplastic syndromes in USA (SC) due to insufficient funding (NCT01898793) Updated 02 May 2024 |
| 21 Feb 2022 | Trial Update | Rockefeller University plans a phase I trial for HIV infections (Combination therapy, Treatment-experienced) in USA (IV) (NCT05245292) Updated 07 Mar 2024 |
| 16 Feb 2022 | Trial Update | Altor BioScience in collaboration with University of Minnesota completes a phase II QUILT-2.021 trial in Peritoneal cancer (Late-stage disease, Second-line therapy or greater), Ovarian cancer (Late-stage disease, Second-line therapy or greater), Fallopian tube cancer (Late-stage disease, Second-line therapy or greater) in USA (SC, Intraperitoneal) (NCT03054909) Updated 30 Apr 2024 |
| 14 Feb 2022 | Scientific Update | Efficacy and Safety data from a phase II/III QUILT-3.032 trial in Bladder cancer released by ImmunityBio [25] Updated 16 Feb 2022 |
| 01 Feb 2022 | Scientific Update | Safety and efficacy data from a phase I trial in HIV-infection released by ImmunityBio [54] Updated 03 Feb 2022 |
| 18 Jan 2022 | Scientific Update | Efficacy and adverse events data from a phase II trial QUILT-88 in Pancreatic cancer released by ImmunityBio [88] Updated 20 Jan 2022 |
| 20 Dec 2021 | Regulatory Status | ImmunityBio announces intention to submit BLA to the US FDA for Bladder cancer, in April 2022 [26] Updated 25 May 2022 |
| 14 Dec 2021 | Trial Update | National Cancer Institute initiates a phase II trial in Gastric cancer and Head and neck squamous cell cancer (Combination therapy, Late stage disease, Metastatic disease, Inoperable/Unresectable, Second-line therapy or greater) in USA (NCT04847466) Updated 28 Dec 2021 |
| 08 Dec 2021 | Biomarker Update | Biomarkers information updated Updated 10 Dec 2021 |
| 05 Nov 2021 | Trial Update | Washington University School of Medicine in collaboration with Eli Lilly and ImmunityBio withdraws a phase II trial prior to enrolment in Non-small cell lung cancer (Combination therapy) (SC) due to lose in fundings (NCT05007769) Updated 19 Nov 2021 |
| 19 Oct 2021 | Patent Information | ImmunityBio has patent protection for nogapendekin alfa inbakicept/BCG combination therapy for bladder cancer in the US [18] Updated 21 Oct 2021 |
| 19 Oct 2021 | Scientific Update | Updated efficacy and adverse events data from the cohort B of the phase II/III QUILT-3.032 trial in Bladder cancer released by ImmunityBio [18] Updated 21 Oct 2021 |
| 14 Oct 2021 | Regulatory Status | ImmunityBio announces intention to meet with the US FDA to discuss the path for the approval of nogapendekin alfa inbakicept for Pancreatic cancer in the 2022 [87] Updated 01 May 2024 |
| 14 Oct 2021 | Scientific Update | Efficacy data from a phase II QUILT-88 trial in Pancreatic cancer released by ImmunityBio [87] Updated 18 Oct 2021 |
| 14 Oct 2021 | Trial Update | ImmunityBio completes enrolment in its phase-II QUILT-88 trial for Pancreatic cancer (Combination therapy, Second-line therapy or greater, Late-stage disease, Metastatic disease, Inoperable/Unresectable) in USA (SC) (NCT04390399) [87] Updated 18 Oct 2021 |
| 04 Oct 2021 | Trial Update | The National Cancer Institute plans to begin enrolment in the Lung-MAP trial for Non-small cell lung cancer (Combination therapy, Second-line therapy or greater) in fourth quarter of 2021 [73] Updated 27 Apr 2022 |
| 01 Oct 2021 | Trial Update | ImmunityBio terminates a phase II trial in Merkel cell carcinoma (Combination therapy, Second line therapy or greater) in USA (NCT03853317) Updated 20 Oct 2021 |
| 27 Sep 2021 | Phase Change - I/II | Phase-I/II clinical trials in Triple-negative-breast cancer (Combination therapy, Second-line therapy or greater, Late-stage disease) in USA (SC) (NCT04927884) [34] Updated 18 Oct 2021 |
| 13 Sep 2021 | Scientific Update | Updated efficacy and adverse events data from the first cohort of a phase II/III QUILT-3.032 trial in Bladder cancer released by ImmunityBio [23] Updated 17 Sep 2021 |
| 27 Aug 2021 | Trial Update | Washington University School of Medicine in collaboration with Eli Lilly and ImmunityBio plans a phase II trial for Non-small Cell Lung Cancer in the USA (NCT05007769) Updated 30 Apr 2024 |
| 21 Jun 2021 | Trial Update | ImmunityBio initiates a phase I trial in Solid tumours (Combination therapy, Late-stage disease, Metastatic disease, First-line therapy) in USA (IV) (NCT04898543) Updated 04 Aug 2021 |
| 21 Jun 2021 | Trial Update | ImmunityBio initiates a phase I trial in Solid tumours (Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in USA (IV) (NCT04898543) Updated 04 Aug 2021 |
| 16 Jun 2021 | Trial Update | ImmunityBio plans a phase I/II trial for Breast Cancer (Combination therapy, Second-line therapy or greater, Late-stage disease) [SC, Injection], in July 2021 (NCT04927884) Updated 18 Oct 2021 |
| 15 Jun 2021 | Trial Update | ImmunityBio plans the QUILT 3.058 phase Ib/II trial for Breast cancer (Late-stage disease, Second-line therapy or greater, Combination therapy, Metastatic disease) in Q3 2021 [35] Updated 30 Apr 2024 |
| 15 Jun 2021 | Regulatory Status | US FDA authorises clinical trial of combination therapy of nogapendekin alfa inbakicept in Breast cancer [35] Updated 22 Jun 2021 |
| 04 Jun 2021 | Scientific Update | Preliminary efficacy and adverse events data from the QUILT 3.055 phase II trial in Solid tumours presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [111] Updated 24 Jul 2021 |
| 21 May 2021 | Phase Change - I | Phase-I clinical trials in HIV infections (Monotherapy, Treatment-experienced) in USA (SC) [49] (NCT04340596) Updated 16 Jun 2021 |
| 21 May 2021 | Phase Change - I | Phase-I clinical trials in HIV-1 infections (Combination therapy, Treatment-experienced) in USA (SC) [49] (NCT04340596) Updated 16 Jun 2021 |
| 21 May 2021 | Trial Update | ImmunityBio plans a phase I trial for Glioblastoma (Recurrent, Combination therapy) (ImmunityBio pipeline, May 2021) Updated 21 May 2021 |
| 20 May 2021 | Scientific Update | Efficacy and adverse events data from the QUILT 3.055 phase II trial in Solid tumours released by ImmunityBio [75] Updated 26 May 2021 |
| 17 May 2021 | Trial Update | ImmunityBio plans phase I QUILT 3.076 trial in Solid tumours (Combination therapy, Late-stage disease, Metastatic disease) in USA (Parenteral) in second quarter of 2021 [123] Updated 30 Apr 2024 |
| 17 May 2021 | Regulatory Status | ImmunityBio receives US FDA approval for the phase I trial in Solid tumours (Combination therapy, Late-stage disease, Metastatic disease) in USA (Parenteral) [123] Updated 21 May 2021 |
| 04 May 2021 | Scientific Update | Efficacy and safety data from a phase I/II trial in Non-Hodgkin's lymphoma released by ImmunityBio [125] Updated 07 May 2021 |
| 29 Apr 2021 | Scientific Update | Pharmacodynamics data from a preclinical studies in HIV infections released by ImmunityBio [46] Updated 05 May 2021 |
| 23 Apr 2021 | Trial Update | National Cancer Institute plans a phase II trial for Squamous cell cancer (Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease, Second-line therapy or greater) in USA (NCT04847466) Updated 28 Dec 2021 |
| 01 Apr 2021 | Trial Update | Altor BioScience Corporation in collaboration with University of Minnesota completes a phase I trial in HIV infections (Combination therapy) in USA (SC) (NCT03899480) Updated 02 May 2024 |
| 01 Apr 2021 | Trial Update | University of Minnesota and National Institute of Allergy and Infectious Diseases initiate a phase I trial in HIV Infections (Adjunctive treatment) in USA (SC) (NCT04808908) Updated 16 Jun 2021 |
| 22 Mar 2021 | Trial Update | University of Minnesota and National Institute of Allergy and Infectious Diseases plans a phase I trial for HIV infections (Adjunctive treatment) in USA in May 2021 (SC) (NCT04808908) Updated 16 Jun 2021 |
| 19 Mar 2021 | Trial Update | ImmunityBio withdrew a phase Ib/II QUILT-3.045 trial for Merkel cell carcinoma (Combination therapy, Second-line therapy or greater) in USA (SC) (NCT03167164) Updated 30 Apr 2024 |
| 09 Mar 2021 | Company Involvement | NantKwest has been merged with ImmunityBio to form ImmunityBio Updated 11 Mar 2021 |
| 01 Mar 2021 | Phase Change - II | Phase-II clinical trials in HIV infections (Adjunctive treatment) in Thailand (SC) [46] (NCT04505501) Updated 05 May 2021 |
| 28 Jan 2021 | Scientific Update | Efficacy and adverse event data from the phase II QUILT-3.055 trial in Non-small cell lung cancer released by ImmunityBio [110] Updated 01 Feb 2021 |
| 13 Jan 2021 | Scientific Update | Interim efficacy data from a cohort C of pivotal QUILT 88 phase II trial in pancreatic cancer released by NantKwest and ImmunityBio [85] Updated 15 Jan 2021 |
| 31 Dec 2020 | Trial Update | Altor Bioscience terminates a phase I/II trial in Non-Hodgkin lymphoma (Combination therapy, Second-line therapy or greater), due to the change in drug product development strategy in USA (NCT02384954) Updated 26 Feb 2021 |
| 21 Dec 2020 | Scientific Update | Interim efficacy data and adverse events data from the first cohort of a phase II/III QUILT-3.032 trial in Bladder cancer released by ImmunityBio [20] Updated 23 Dec 2020 |
| 24 Nov 2020 | Scientific Update | Pharmacodynamics data from a preclinical study in Cancer released by ImmunityBio [139] Updated 04 Dec 2020 |
| 22 Sep 2020 | Phase Change - II | Phase-II clinical trials in Colorectal cancer (Combination therapy, Late-stage disease, Second-line therapy or greater, Metastatic disease) in USA (SC) (NCT04491955) Updated 30 Apr 2024 |
| 19 Sep 2020 | Scientific Update | Interim efficacy and adverse events data from phase I/II QuEST1 trial in Prostate cancer presented at the 45th European Society for Medical Oncology Congress (ESMO-2020) [121] Updated 15 Oct 2020 |
| 10 Aug 2020 | Trial Update | Thai Red Cross AIDS Research Centre plans a phase II trial in HIV infections (Adjunctive therapy) in Thailand in December 2020 (SC) (NCT04505501) Updated 05 May 2021 |
| 04 Aug 2020 | Trial Update | National Cancer Institute plans a phase II trial for Colorectal cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater, Combination therapy) in USA in August 2020 (SC) (NCT04491955) Updated 01 May 2024 |
| 29 Jul 2020 | Phase Change - III | Phase-III clinical trials in Non-small cell lung cancer (Metastatic disease, Late-stage disease, Combination therapy, First-line therapy) in USA (SC) (NCT03520686) Updated 26 May 2021 |
| 21 Jul 2020 | Phase Change - II | Phase-II clinical trials in Pancreatic cancer (Combination therapy, Second-line therapy or greater, Late-stage disease, Metastatic disease, Inoperable/Unresectable) in USA (SC) (NCT04390399) Updated 02 Jul 2020 |
| 20 Jul 2020 | Phase Change - I | Phase-I clinical trials in Squamous cell cancer (Combination therapy, Late stage disease, Recurrent, Metastatic disease) in USA (SC) (NCT04290546) Updated 27 Jul 2020 |
| 01 Jul 2020 | Trial Update | Masonic Cancer Center completes a phase I/II trial for Haematological malignancies (Second-line therapy or greater) in USA (IV) (NCT01885897) Updated 19 Aug 2020 |
| 22 Jun 2020 | Phase Change - II | Phase-II clinical trials in Pancreatic cancer (Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease) (as First-line maintenance therapy) in USA (SC) (NCT04390399) Updated 02 Jul 2020 |
| 21 Jun 2020 | Regulatory Status | The US FDA approves IND application for a phase II trial in Pancreatic cancer (Combination therapy, Second-line therapy or greater, First-line maintenance therapy, Late-stage disease, Metastatic disease, Inoperable/Unresectable) (SC) before June 2020 [82] Updated 12 Oct 2020 |
| 29 May 2020 | Scientific Update | Pharmacokinetics, safety and immunogenicity data from the phase I QUILT-1.004 pharmacokinetic trial presented at the 56th Annual Meeting of the American Society of Clinical Oncology (ASCO-2020) [137] Updated 14 Jun 2020 |
| 29 May 2020 | Regulatory Status | The US FDA has approves the IND application for COVID-2019 infections [3] Updated 02 Jun 2020 |
| 27 May 2020 | Trial Update | ImmunityBio & NantKwest plans a phase I trial for COVID-2019 infections in June 2020 (NCT04385849) [3] Updated 30 Apr 2024 |
| 22 May 2020 | Licensing Status | ImmunityBio & NantKwest signs a binding agreement for the joint development, manufacture and marketing of vaccines and therapeutics for COVID-2019 infections [3] Updated 02 Jun 2020 |
| 14 May 2020 | Trial Update | NantKwest and ImmunityBio plan the phase II QUILT-88 trial for Pancreatic cancer (Combination therapy, Late-stage disease, Metastatic disease) by June 2020 (NCT04390399) [148] Updated 02 Jul 2020 |
| 14 Apr 2020 | Regulatory Status | NantKwest announces intention to submit IND application to the US FDA for COVID-2019 infections Updated 20 Apr 2020 |
| 14 Apr 2020 | Trial Update | NantKwest plans a clinical trial for COVID-2019 infections in USA Updated 20 Apr 2020 |
| 09 Apr 2020 | Trial Update | National Institute of Allergy and Infectious Diseases plans a phase I trial for HIV infections (Combination therapy, Monotherapy, Treatment experienced) (SC) in July 2020 (NCT04340596) Updated 26 Jun 2021 |
| 12 Mar 2020 | Active Status Review | Clinical development is ongoing for HIV infections in USA (NCT02191098) Updated 12 Mar 2020 |
| 11 Mar 2020 | Trial Update | National Institute of Allergy and Infectious Diseases plans a clinical trial in HIV infections [55] Updated 12 Mar 2020 |
| 10 Mar 2020 | Scientific Update | Pharmacodynamics data from preclinical studies in HIV infections released by ImmunityBio [55] Updated 12 Mar 2020 |
| 10 Mar 2020 | Trial Update | ImmunityBio initiates two clinical trials for HIV infections [55] Updated 12 Mar 2020 |
| 08 Mar 2020 | Scientific Update | Pharmacodynamics data from preclinical studies in HIV infections presented at the 27th Conference on Retroviruses and Opportunistic Infections (CROI-2020) [58] Updated 07 Apr 2020 |
| 05 Mar 2020 | Trial Update | Bristol-Myers Squibb in collaboration with Altor BioScience and Miltenyi Biotec B.V. plans a phase I trial for Squamous cell carcinoma of Head and neck cancer (Combination therapy, Late stage disease, Recurrent, Metastatic) in USA (NCT04290546) Updated 27 Jul 2020 |
| 24 Feb 2020 | Trial Update | NantKwest initiates a phase II trial in Merkel cell carcinoma (Combination therapy, Second line therapy or greater) in USA [60] (NCT03853317) Updated 15 Jan 2019 |
| 14 Jan 2020 | Regulatory Status | NantKwest initiates a compassionate use expanded-access programme for Pancreatic cancer (Metastatic disease, Second-line therapy or greater) in USA (IV) before January 2020 [62] Updated 21 Jan 2020 |
| 14 Jan 2020 | Regulatory Status | The US FDA approves IND application for a compassionate use expanded-access programme for PD-L1.t-haNK in Pancreatic cancer (Metastatic disease, Second-line therapy or greater) before January 2020 [62] Updated 21 Jan 2020 |
| 31 Dec 2019 | Regulatory Status | NantKwest plans to file an IND application with the US FDA for the phase III QUILT 59 trial in Non-small cell lung cancer [32] Updated 02 Jun 2020 |
| 31 Dec 2019 | Regulatory Status | NantKwest plans to file an IND application with the US FDA for the phase II QUILT 3.069 trial in Breast cancer [32] Updated 02 Jun 2020 |
| 31 Dec 2019 | Regulatory Status | The US FDA clears the IND amendment for the phase IIb QUILT 3.055 trial in Non-small cell lung cancer [32] Updated 02 Jun 2020 |
| 31 Dec 2019 | Trial Update | NantKwest plans the phase II QUILT 3.069 trial in Triple-negative-breast cancer (Combination therapy, Late-stage disease, Metastatic disease, First-line therapy, Second-line therapy or greater) in USA [32] Updated 02 Jun 2020 |
| 31 Dec 2019 | Trial Update | NantKwest plans the phase III QUILT 59 trial in Non-small cell lung cancer (Combination therapy, Late-stage disease, Metastatic disease, First-line therapy, Second-line therapy) in USA [32] Updated 02 Jun 2020 |
| 15 Dec 2019 | Trial Update | Altor BioScience in collaboration with University of Minnesota completes a phase II QUILT-3.033 trial in Acute myeloid leukaemia (Second-line therapy or greater, Combination therapy) in USA (SC) (NCT03050216) Updated 30 Apr 2024 |
| 12 Dec 2019 | Scientific Update | Efficacy and safety data from a phase I/II trial in Breast cancer presented at the 42nd Annual San Antonio Breast Cancer Symposium (SABCS-2019) [45] Updated 22 Jan 2020 |
| 04 Dec 2019 | Regulatory Status | Nogapendekin alfa inbakicept receives Breakthrough Therapy status for Bladder cancer (Combination therapy) in USA [16] Updated 09 Dec 2019 |
| 07 Nov 2019 | Scientific Update | Efficacy and adverse events data from the phase II QUILT-3.009 trial in Merkel Cell Carcinoma released by NantKwest [63] Updated 20 Nov 2019 |
| 01 Nov 2019 | Trial Update | University of Minnesota plans a phase Ib trial for HIV infections (Combination therapy) in US (NCT04144335) Updated 06 Nov 2019 |
| 09 Sep 2019 | Trial Update | University of Minnesota completes a phase I trial in HIV infections (Adjunctive treatment) in USA (NCT02191098) (Parenteral) Updated 12 Mar 2020 |
| 29 Aug 2019 | Trial Update | NantKwest withdraws the phase Ib/II QUILT-3.049 trial for Triple negative breast cancer (Second-line therapy or greater, Metastatic disease, Inoperable/Unresectable, Combination therapy) prior to initiation (NCT03175666) Updated 11 Sep 2019 |
| 23 Aug 2019 | Trial Update | NantCell withdraws the phase Ib/II QUILT-3.044 trial prior to enrolment for Non-small cell lung cancer (Combination therapy, Second-line therapy or greater) (NCT03169738) Updated 10 Sep 2019 |
| 23 Aug 2019 | Trial Update | NantCell withdraws the phase Ib/II QUILT-3.050 trial prior to enrolment for Colorectal cancer (Combination therapy, Metastatic disease, Recurrent) in USA (NCT03169777) Updated 10 Sep 2019 |
| 23 Aug 2019 | Trial Update | NantCell withdraws the phase Ib/II QUILT-3.051 trial prior to enrolment for Ovarian cancer (Combination therapy, Second-line therapy or greater) (NCT03197584) Updated 10 Sep 2019 |
| 23 Aug 2019 | Trial Update | NantCell withdraws the phase Ib/II QUILT-3.047 trial prior to enrolment for Head and neck squamous cell carcinoma (Combination therapy, Second-line therapy or greater) (NCT03169764) Updated 10 Sep 2019 |
| 23 Aug 2019 | Trial Update | NantCell withdraws the phase Ib/II QUILT-3.052 trial prior to enrolment for Non Hodgkin lymphoma (Combination therapy, Second-line therapy or greater) in USA (NCT03169790) Updated 10 Sep 2019 |
| 23 Aug 2019 | Trial Update | NantCell withdraws the phase Ib/II QUILT-3.046 trial prior to enrolment for Malignant melanoma (Combination therapy, Second-line therapy or greater) (NCT03167177) Updated 10 Sep 2019 |
| 23 Aug 2019 | Trial Update | NantCell withdraws the phase Ib/II QUILT-3.048 trial prior to enrolment for Urogenital cancer (Second-line therapy or greater, Combination therapy) (NCT03197571) Updated 10 Sep 2019 |
| 23 Aug 2019 | Trial Update | NantKwest withdraws the phase I/II QUILT-3.072 trial prior to enrolment for Liver cancer (Combination therapy, Late-stage disease, Inoperable/Unresectable, Second-line therapy or greater) in USA (NCT03563170) Updated 10 Sep 2019 |
| 23 Aug 2019 | Trial Update | NantKwest withdraws the phase II QUILT-3.088 trial prior to enrolment for Pancreatic Cancer (Metastatic disease, First-line therapy) in USA (NCT03563144) Updated 10 Sep 2019 |
| 07 Jun 2019 | Scientific Update | Efficacy, pharmacodynamics and adverse event data from a phase I/II QUILT-3.067 trial in Breast cancer released by NantKwest [36] Updated 07 Jun 2019 |
| 03 Jun 2019 | Scientific Update | Efficacy and adverse event data from a phase I/II QUILT-3.08 trial in Pancreatic cancer presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO-2019) [92] [36] Updated 07 Jun 2019 |
| 31 May 2019 | Scientific Update | Efficacy and adverse events data from a phase Ib trial in Bladder cancer presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO-2019) [21] Updated 15 Jun 2019 |
| 14 May 2019 | Trial Update | NantKwest withdraws the phase II QUILT-3.057 trial in Triple-negative-breast cancer (First-line therapy, Combination therapy, Neoadjuvant therapy) in USA prior to enrolment (NCT03554109) Updated 23 Feb 2021 |
| 14 May 2019 | Trial Update | NantKwest withdraws the QUILT-3.091 phase Ib/II trial for Chordoma (Inoperable/Unresectable) in USA prior to enrolment (NCT03647423) Updated 22 May 2019 |
| 01 May 2019 | Trial Update | Altor BioScience Corporation in collaboration with University of Minnesota initiates a phase I trial in HIV infections (Combination therapy) in USA (SC) (NCT03899480) Updated 02 May 2024 |
| 28 Apr 2019 | Phase Change - No development reported | No recent reports of development identified for phase-I development in HIV-infections(Adjunctive treatment) in USA (Parenteral) Updated 28 Apr 2019 |
| 28 Apr 2019 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Solid-tumours(Inoperable/Unresectable, Late-stage disease, Metastatic disease) in USA (IV, Infusion) Updated 28 Apr 2019 |
| 28 Apr 2019 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Solid-tumours(Inoperable/Unresectable, Late-stage disease, Metastatic disease) in USA (SC, Injection) Updated 28 Apr 2019 |
| 04 Mar 2019 | Scientific Update | Pharmacodynamics data from a preclinical studies presented at the 26th Conference on Retroviruses and Opportunistic Infections (ROI-2019) [57] Updated 03 May 2019 |
| 11 Dec 2018 | Phase Change - II | Phase-II clinical trials in Cervical cancer (Combination therapy, Second-line therapy or greater, Metastatic disease) in USA (SC) (NCT03228667) [75] Updated 26 May 2021 |
| 11 Dec 2018 | Phase Change - II | Phase-II clinical trials in Colorectal cancer (Combination therapy, Second-line therapy or greater) in USA (SC) (NCT03228667) [75] Updated 26 May 2021 |
| 11 Dec 2018 | Phase Change - II | Phase-II clinical trials in Gastric cancer (Combination therapy, Metastatic disease, Second-line therapy or greater, Late-stage disease) in USA (SC) (NCT03228667) [75] Updated 26 May 2021 |
| 11 Dec 2018 | Phase Change - II | Phase-II clinical trials in Liver cancer (Combination therapy, Second-line therapy or greater) in USA (SC) (NCT03228667) [75] Updated 26 May 2021 |
| 11 Dec 2018 | Phase Change - II | Phase-II clinical trials in Malignant melanoma (Second-line therapy or greater, Combination therapy, Metastatic disease) in USA (SC) (NCT03228667) [75] Updated 26 May 2021 |
| 11 Dec 2018 | Phase Change - II | Phase-II clinical trials in Merkel cell carcinoma (Metastatic disease, Second-line therapy or greater, Combination therapy) in USA (SC) (NCT03228667) [75] Updated 26 May 2021 |
| 11 Dec 2018 | Phase Change - II | Phase-II clinical trials in Oesophageal cancer (Second-line therapy or greater, Late-stage disease, Metastatic disease, Combination therapy) in USA (SC) (NCT03228667) [75] Updated 26 May 2021 |
| 11 Dec 2018 | Phase Change - II | Phase-II clinical trials in Renal cell carcinoma (Late-stage disease, Second-line therapy or greater, Combination therapy) in USA (SC) (NCT03228667) [75] Updated 26 May 2021 |
| 11 Dec 2018 | Phase Change - II | Phase-II clinical trials in Small cell lung cancer (Second-line therapy or greater, Metastatic disease, Combination therapy) in USA (SC) (NCT03228667) [75] Updated 26 May 2021 |
| 11 Dec 2018 | Phase Change - II | Phase-II clinical trials in Solid tumours (Combination therapy, Second-line therapy or greater, Metastatic disease, Inoperable/Unresectable) in USA (SC) (NCT03228667) [75] Updated 26 May 2021 |
| 11 Dec 2018 | Phase Change - II | Phase-II clinical trials in Squamous cell cancer (Combination therapy, Second-line therapy or greater, Metastatic disease) in USA (SC) (NCT03228667) [75] Updated 26 May 2021 |
| 11 Dec 2018 | Phase Change - II | Phase-II clinical trials in Urogenital cancer (Combination therapy, Second-line therapy or greater, Metastatic disease, Late-stage disease) in USA (SC) (NCT03228667) [75] Updated 26 May 2021 |
| 05 Sep 2018 | Trial Update | NantKwest plans the QUILT-3.091 phase Ib/II trial for Chordoma (Unresectable) in USA , (NCT03647423) Updated 05 Sep 2018 |
| 28 Jul 2018 | Trial Update | NantKwest initiates enrolment in the QUILT-3.080 phase I/II trial in Pancreatic cancer (Combination therapy, Second-line therapy or greater) in USA (IV) (NCT03586869) Updated 07 Jun 2019 |
| 20 Jun 2018 | Trial Update | NantKwest plans a phase II QUILT-3.057 trial for Triple negative breast cancer (First-line therapy, Combination therapy, Neoadjuvant therapy) in USA (NCT03554109) Updated 23 Feb 2021 |
| 20 Jun 2018 | Trial Update | NantKwest plans the QUILT-3.088 phase II trial for Pancreatic Cancer (Metastatic disease) in USA , (NCT03563144) Updated 10 Sep 2019 |
| 01 Jun 2018 | Phase Change - II | Phase-II clinical trials in Non-small cell lung cancer (Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease, Recurrent, Second-line therapy or greater) in USA (Parenteral) [80] Updated 18 Jun 2018 |
| 01 Jun 2018 | Scientific Update | Efficacy and adverse events data from a phase Ib/II trial in Non-small cell lung cancer presented at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO-2018) [80] Updated 18 Jun 2018 |
| 25 May 2018 | Phase Change - I/II | Phase-I/II clinical trials in Liver cancer (Combination therapy, Inoperable/Unresectable, Late-stage disease, Second-line therapy or greater) in USA (SC) (NCT03563170) Updated 11 Sep 2019 |
| 25 May 2018 | Trial Update | NantKwest initiates enrolment in the QUILT 3.071 phase I/II trial for Colorectal cancer (Combination therapy, Metastatic disease, late-stage disease, Second-line therapy or greater) in USA (NCT03563157) Updated 29 Jun 2018 |
| 22 May 2018 | Trial Update | Altor BioScience in collaboration with The Case Comprehensive Cancer Center initiates a phase I trial for Cancer (Combination therapy) in USA (Parenteral) (NCT02890758) Updated 30 Apr 2024 |
| 18 May 2018 | Phase Change - II | Phase-II clinical trials in Non-small cell lung cancer (Metastatic disease, First-line therapy, Late-stage disease, Combination therapy) in USA (SC) (NCT03520686) Updated 30 May 2018 |
| 10 May 2018 | Trial Update | Altor BioScience in collaboration with NantCell plans the QUILT-2.023 phase II trial for Non Small Cell Lung Cancer in May 2018, (NCT03520686) Updated 30 May 2018 |
| 01 May 2018 | Phase Change - I/II | Phase-I/II clinical trials in Solid tumours (Combination therapy, Second-line therapy or greater) in USA (SC) (NCT03493945) Updated 20 Jun 2018 |
| 01 May 2018 | Phase Change - II | Phase-II clinical trials in Non-small cell lung cancer (Combination therapy, Metastatic disease, Late-stage disease, Second-line therapy or greater) in USA (IV) (NCT03228667) Updated 23 May 2018 |
| 11 Apr 2018 | Trial Update | National Cancer Institute plans the QuEST1 phase I/II trial for Solid tumours and Prostate cancer in USA (NCT03493945) Updated 20 Jun 2018 |
| 09 Apr 2018 | Trial Update | Altor BioScience in collaboration with University of Minnesota withdraws a phase II trial in Myelodysplastic syndrome and Acute myeloid leukemia in USA(SC) prior to enrolment (NCT03365661) Updated 30 Apr 2024 |
| 16 Mar 2018 | Phase Change - I/II | Phase-I/II clinical trials in Triple negative breast cancer (Combination therapy, Inoperable/Unresectable, Metastatic disease, Second-line therapy or greater) in USA (unspecified route) (NCT03387085) Updated 20 Jun 2018 |
| 13 Mar 2018 | Trial Update | Altor BioScience completes the phase I QUILT-1.004 trial in healthy volunteers in USA (SC) (NCT03381586) Updated 10 Sep 2019 |
| 04 Mar 2018 | Scientific Update | Safety and pharmacodynamics data from a phase I trial in HIV-infection presented at the 25th Conference on Retroviruses and Opportunistic Infections [53] Updated 23 Apr 2018 |
| 21 Feb 2018 | Trial Update | Altor BioScience completes a phase I/II trial in Pancreatic cancer (Combination therapy, Late-stage disease) in USA (SC) (NCT02559674) Updated 10 Sep 2019 |
| 13 Jan 2018 | Phase Change - I/II | Phase-I/II clinical trials in Squamous cell cancer (Combination therapy, Second-line therapy or greater) in USA (NCT03387111, [102] Updated 08 Feb 2018 |
| 08 Jan 2018 | Trial Update | NantKwest plans the phase Ib/II QUILT-3.067 trial for Triple negative breast cancer (Second-line therapy or greater, Metastatic disease, Inoperable/Unresectable, Combination therapy) in USA (NCT03387085) Updated 20 Jun 2018 |
| 08 Jan 2018 | Trial Update | Altor BioScience initiates the phase I QUILT-1.004 trial in healthy volunteers in USA (SC) (NCT03381586) Updated 16 Feb 2018 |
| 02 Jan 2018 | Trial Update | NantKwest initiates enrolment in the phase I/II QUILT3-070 trial for Pancreatic cancer (Combination therapy, Second-line therapy or greater) in USA (NCT03387098) Updated 08 Jan 2018 |
| 29 Dec 2017 | Trial Update | Altor BioScience plans the phase I QUILT-1.004 trial in volunteers in USA in January 2018 (NCT03381586) Updated 16 Feb 2018 |
| 09 Dec 2017 | Trial Update | Masonic Cancer Center plans to initiate the phase II QUILT-3.034 trial in acute myeloid leukaemia and myelodysplastic syndrome in October 2018 (NCT03365661) Updated 30 Apr 2024 |
| 09 Dec 2017 | Scientific Update | Efiicacy, pharmacokinetics, pharmacodynamics and adverse events data from a phase I/II trial in Haematological malignancies presented at the 59th Annual Meeting and Exposition of the American Society of Hematology (ASH-Hem-2017) [119] Updated 03 Jan 2018 |
| 07 Dec 2017 | Trial Update | NantCell completes a phase-I/II trial in Solid tumour(Combination therapy, Late-stage disease, Second-line therapy or greater, Metastatic disease) in USA (SC) (NCT03127098) Updated 13 Sep 2019 |
| 01 Dec 2017 | Trial Update | Altor Bioscience completes a phase I trial in Solid tumours (Late-stage disease, Metastatic disease, Inoperable/Unresectable) in USA (NCT01946789) Updated 24 Apr 2019 |
| 08 Nov 2017 | Trial Update | NantKwest plans the phase I/II QUILT-3.060 trial for Pancreatic cancer (Combination therapy, Second-line therapy or greater) in November 2017 (NCT03329248) Updated 29 Dec 2017 |
| 06 Nov 2017 | Trial Update | NantKwest initiates enrolment in the phase I/II QUILT-3.060 trial for Pancreatic cancer (Combination therapy, Second-line therapy or greater) in USA (NCT03329248) Updated 29 Nov 2017 |
| 04 Nov 2017 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Malignant-melanoma(Late-stage disease) in USA (IV, Infusion) Updated 04 Nov 2017 |
| 24 Oct 2017 | Trial Update | Masonic Cancer Center completes enrolment in the phase I/II trial for Haematological malignancies (second-line therapy or greater) in USA (IV) before October 2017 (NCT01885897) Updated 03 Jan 2018 |
| 19 Sep 2017 | Phase Change - II | Phase-II clinical trials in Fallopian tube cancer (Late-stage disease, Second-line therapy or greater) in USA (SC, Intraperitoneal) (NCT03054909) Updated 08 Nov 2017 |
| 19 Sep 2017 | Phase Change - II | Phase-II clinical trials in Ovarian cancer (Late-stage disease, Second-line therapy or greater) in USA (SC, Intraperitoneal) (NCT03054909) Updated 08 Nov 2017 |
| 19 Sep 2017 | Phase Change - II | Phase-II clinical trials in Peritoneal cancer (Late-stage disease, Second-line therapy or greater) in USA (SC, Intraperitoneal) (NCT03054909) Updated 08 Nov 2017 |
| 14 Aug 2017 | Phase Change - I/II | Phase-I/II clinical trials in Pancreatic cancer (Combination therapy, Second-line therapy or greater) in USA (unspecified route) (NCT03136406) Updated 07 Sep 2017 |
| 27 Jul 2017 | Trial Update | Altor Bioscience plans the QUILT-3.055 phase II trial for Non-small cell lung cancer(Combination therapy, Metastatic disease, Late-stage disease, Second-line therapy or greater) in USA (NCT03228667) Updated 10 Sep 2019 |
| 29 Jun 2017 | Trial Update | NantCell plans the phase Ib/II QUILT-3.051 trial for Ovarian cancer (Combination therapy, Second-line therapy or greater) in December 2017 (NCT03197584) Updated 10 Sep 2019 |
| 26 Jun 2017 | Phase Change - I/II | Phase-I/II clinical trials in Solid tumours (Combination therapy, Late-stage disease, Second-line therapy or greater, Metastatic disease) in USA (SC) (NCT03127098) Updated 29 Sep 2017 |
| 20 Jun 2017 | Trial Update | NantCell plans the phase Ib/II QUILT-3.048 trial for Urogenital cancer (Second-line therapy or greater, Combination therapy) in December 2017 (NCT03197571) Updated 10 Sep 2019 |
| 02 Jun 2017 | Trial Update | NantCell plans the phase Ib/II QUILT-3.044 trial for Non-small cell lung cancer (Combination therapy, Second-line therapy or greater) in December 2017 (NCT03169738) Updated 10 Sep 2019 |
| 02 Jun 2017 | Trial Update | NantCell plans the phase Ib/II QUILT-3.050 trial for Colorectal cancer (Combination therapy, Second-line therapy or greater, Metastatic disease, Recurrent) in December 2017 (NCT03169777) Updated 10 Sep 2019 |
| 02 Jun 2017 | Trial Update | NantCell plans the phase Ib/II QUILT-3.047 trial for Head and neck squamous cell carcinoma (Combination therapy, Second-line therapy or greater) (NCT03169764) Updated 10 Sep 2019 |
| 02 Jun 2017 | Trial Update | NantCell plans the phase Ib/II QUILT-3.052 trial for Non hodgkin lymphoma (Combination therapy, Second-line therapy or greater) (NCT03169790) Updated 10 Sep 2019 |
| 02 Jun 2017 | Phase Change - II/III | Phase-II/III clinical trials in Bladder cancer (Combination therapy, Second-line therapy or greater) in USA (Intravesicular) [17] (NCT03022825) Updated 05 May 2017 |
| 01 Jun 2017 | Trial Update | NantCell plans the phase Ib/II QUILT-3.045 trial for Merkel cell carcinoma (Combination therapy, Second-line therapy or greater) (NCT03167164) Updated 30 Apr 2024 |
| 01 Jun 2017 | Trial Update | NantCell plans the phase Ib/II QUILT-3.049 trial for Triple negative breast cancer (Second-line therapy or greater, Metastatic disease, Inoperable/Unresectable, Combination therapy) (NCT03175666) Updated 11 Sep 2019 |
| 01 Jun 2017 | Trial Update | NantCell plans the phase Ib/II QUILT-3.046 trial for Melanoma (Combination therapy, Second-line therapy or greater) (NCT03167177) Updated 10 Sep 2019 |
| 16 May 2017 | Phase Change - II | Phase-II clinical trials in Acute myeloid leukaemia (Second-line therapy or greater, Combination therapy) in USA (SC) (NCT03050216) Updated 13 Jun 2017 |
| 12 May 2017 | Scientific Update | Efficacy and adverse events data from a phase Ib/II trial in Bladder cancer presented at the 112th Annual Meeting of the American Urological Association (AUA-2017) [29] Updated 17 Jul 2017 |
| 09 May 2017 | Regulatory Status | The US FDA authorises an Investigational New Drug Application for a phase Ib/II trial enrolment for Pancreatic cancer [98] Updated 13 Jun 2017 |
| 02 May 2017 | Regulatory Status | Nogapendekin alfa inbakicept receives Fast Track designation for Bladder cancer (Combination therapy) in USA (Intravesicular) [17] Updated 05 May 2017 |
| 27 Apr 2017 | Trial Update | NantCell plans a phase I/II trial for Cancer (Combination therapy, Metastatic disease, Late-stage disease, Second-line therapy or greater) (NCT03127098) Updated 02 May 2024 |
| 19 Apr 2017 | Trial Update | NantCell plans the phase Ib/II QUILT-3.039 trial for Pancreatic cancer (Combination therapy, Second-line therapy or greater) (NCT03136406) Updated 07 Sep 2017 |
| 22 Feb 2017 | Trial Update | Masonic Cancer Center plans a phase I QUILT-2.021 trial for Ovarian cancer, Fallopian tube and primary peritoneal cancer (Late-stage disease, Second-line therapy or greater) in USA (NCT03054909) Updated 08 Nov 2017 |
| 13 Feb 2017 | Trial Update | Masonic Cancer Center, University of Minnesota plans a phase II trial for Acute myeloid leukaemia (Recurrent) in USA (NCT03050216) Updated 14 Feb 2017 |
| 31 Jan 2017 | Phase Change - II | Phase-II clinical trials in Merkel cell carcinoma (Late-stage disease, Combination therapy) in USA (IV) [64] (NCT02465957) Updated 21 Jun 2017 |
| 30 Jan 2017 | Trial Update | Immunity Bio in collaboration with National Institutes of Health initiates a phase II trial for Acute myeloid leukaemia (Second-line therapy or greater) in USA (SC) (NCT02782546) Updated 02 May 2024 |
| 17 Jan 2017 | Trial Update | Altor Bioscience Corporation plans the phase II/III QUILT-3.032 trial for Bladder cancer (Combination therapy) in USA (Intravesicular) (NCT03022825) Updated 23 Jan 2017 |
| 07 Dec 2016 | Trial Update | Masonic Cancer Center, University of Minnesota plans a phase II trial for Acute myeloid leukaemia and Myelodysplastic syndromes (Prevention of relapse) in USA (SC) (NCT02989844) Updated 15 Dec 2016 |
| 16 Nov 2016 | Regulatory Status | NantKwest intends to file an IND application with the US FDA in USA for Solid tumours [65] Updated 22 Nov 2016 |
| 16 Nov 2016 | Trial Update | NantKwest plans a pivotal transitional trial for Solid tumours (Combination therapy) in USA [65] Updated 22 Nov 2016 |
| 02 Nov 2016 | Phase Change - II | Phase II in Acute myeloid leukaemia in USA (SC) (NCT02989844) Updated 15 Dec 2016 |
| 02 Nov 2016 | Phase Change - II | Phase II in Myelodysplastic syndromes in USA (SC) (NCT02989844) Updated 15 Dec 2016 |
| 04 Oct 2016 | Licensing Status | Altor Bioscience and NantKwest agree to co-develop combination immunotherapies for Cancer [2] Updated 07 Oct 2016 |
| 21 Sep 2016 | Trial Update | The Case Comprehensive Cancer Center plans a phase I trial for Cancer in USA (NCT02890758) Updated 21 Sep 2016 |
| 01 Jul 2016 | Phase Change - I/II | Phase-I/II clinical trials in Pancreatic cancer (Combination therapy, Late-stage disease) in USA (SC) (NCT02559674) Updated 29 Aug 2016 |
| 11 Apr 2016 | Company Involvement | Altor BioScience establishes CRADA with the National Cancer Institute for the development of nogapendekin alfa inbakicept and ALT 801 [5] Updated 13 Apr 2016 |
| 08 Jan 2016 | Phase Change - I/II | Phase-I/II clinical trials in Non-small cell lung cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater, Combination therapy, Inoperable/Unresectable, Recurrent) in USA (Parenteral) (NCT02523469) Updated 15 Dec 2016 |
| 06 Oct 2015 | Company Involvement | Altor receives phase II SBIR grant from NCI for nogapendekin alfa inbakicept development in Non-Hodgkin lymphoma [141] Updated 10 Oct 2015 |
| 23 Sep 2015 | Trial Update | Altor Bioscience plans a phase I/II trial for Pancreatic cancer (Combination therapy, Late-stage disease) in USA (NCT02559674) Updated 29 Sep 2015 |
| 17 Aug 2015 | Trial Update | Medical University of South Carolina and Altor BioScience plan a phase Ib/II trial for Non-small cell lung cancer (Combination therapy, Late-stage disease, Metastatic disease) in USA (NCT02523469) Updated 17 Aug 2015 |
| 01 Jun 2015 | Phase Change - I | Phase-I clinical trials in HIV infections (Adjunctive treatment) in USA (Parenteral) (NCT02191098) Updated 15 Dec 2016 |
| 01 Apr 2015 | Phase Change - I/II | Phase-I/II clinical trials in Non-Hodgkin's lymphoma (Second-line therapy or greater, Combination therapy) in USA (SC) (NCT02384954) Updated 02 May 2024 |
| 01 Apr 2015 | Phase Change - I/II | Phase-I/II clinical trials in Non-Hodgkin's lymphoma (Combination therapy, Second-line therapy or greater) in USA (IV) Updated 17 Mar 2015 |
| 01 Oct 2014 | Phase Change - I/II | Phase-I/II clinical trials in Multiple myeloma (Second-line therapy or greater) in USA (IV/SC) (NCT02099539) Updated 12 Sep 2014 |
| 10 Sep 2014 | Licensing Status | Nogapendekin alfa inbakicept licensed to Beike Biotechnology in China [6] Updated 12 Sep 2014 |
| 19 Aug 2014 | Company Involvement | Altor BioScience receives SBIR grant from the National Cancer Institute for nogapendekin alfa inbakicept development in Non-muscle invasive bladder cancer [145] Updated 21 Aug 2014 |
| 11 Aug 2014 | Trial Update | Altor BioScience Corporation in collaboration with Washington University School of Medicine initiates a phase I/II trial in Acute myeloid leukaemia and Myelodysplastic syndromes in USA (SC) (NCT01898793) Updated 02 May 2024 |
| 21 Jul 2014 | Phase Change - I/II | Phase-I/II clinical trials in Bladder cancer (Combination therapy) in USA (Intravesicular) (NCT02138734) Updated 21 Aug 2014 |
| 10 Jul 2014 | Trial Update | Altor BioScience plans a phase I proof of principle trial for HIV infections in USA (NCT02191098) Updated 28 Aug 2014 |
| 17 Jun 2014 | Company Involvement | Altor BioScience receives SBIR grant from the National Cancer Institute for nogapendekin alfa inbakicept development in Multiple myeloma [69] Updated 06 Nov 2014 |
| 13 May 2014 | Trial Update | Altor BioScience plans a phase Ib/II trial for Bladder cancer (combination therapy) in USA (NCT02138734) Updated 20 May 2014 |
| 01 May 2014 | Phase Change - I | Phase-I clinical trials in Solid tumours (Late-stage disease, Inoperable/Unresectable, Metastatic disease) in USA (IV) (NCT01946789) Updated 24 Apr 2019 |
| 01 May 2014 | Phase Change - I | Phase-I clinical trials in Solid tumours (Late-stage disease, Metastatic disease, Inoperable/Unresectable) in USA (SC) (NCT01946789) Updated 24 Apr 2019 |
| 26 Mar 2014 | Trial Update | Altor BioScience plans a phase Ib/II trial of nogapendekin alfa inbakicept for Multiple myeloma in USA (NCT02099539) Updated 15 Apr 2014 |
| 21 Nov 2013 | Phase Change - Preclinical | Preclinical trials in Viral infections in USA (IV) prior to November 2013 Updated 21 Nov 2013 |
| 11 Nov 2013 | Phase Change - I/II | Phase-I/II clinical trials in Haematological malignancies (second-line therapy or greater) in USA (IV) Updated 21 Nov 2013 |
| 11 Nov 2013 | Phase Change - Preclinical | Preclinical trials in Multiple myeloma in USA (IV) prior to November 2013 Updated 21 Nov 2013 |
| 15 Aug 2013 | Patent Information | Altor BioScience has patent protection for nogapendekin alfa inbakicept composition-of-matter in the US [136] Updated 21 Oct 2021 |
| 15 Aug 2013 | Regulatory Status | The US FDA approves IND application for nogapendekin alfa inbakicept in Malignant melanoma [136] Updated 20 Nov 2013 |
| 02 May 2012 | Company Involvement | Altor BioScience and the Melanoma Research Alliance intend to jointly sponsor a planned clinical trial of nogapendekin alfa inbakicept in Malignant melanoma [135] Updated 20 Nov 2013 |
References
-
ImmunityBio and NantKwest Complete Merger.
Media Release -
Altor BioScience Corporation and NantKwest Inc. Announce Co-Development Agreement to Advance Innovative Natural Killer Cell Combination Immunotherapies for the Treatment of Cancer.
Media Release -
ImmunityBio & NantKwest Sign COVID-19 Joint Development, Manufacturing and Marketing Agreement; ImmunityBio Selected for Operation Warp Speed to Develop Novel Adenovirus COVID-19 Vaccine.
Media Release -
NantKwest and ImmunityBio Sign Collaboration Agreement for Joint Development, Manufacturing, Marketing, and Commercialization of COVID-19 Vaccine and Related Therapeutics.
Media Release -
Altor BioScience Corporation Partners with the National Cancer Institute to Further Develop Altors ALT-803 and ALT-801 Cancer Immunotherapeutics.
Media Release -
Altor BioScience and Shenzhen Beike Biotechnology Announce License Agreement for Immunotherapeutic ALT-803 in China.
Media Release -
Florida Biologix(Rm) Announces Manufacturing Agreement with Altor BioScience.
Media Release -
ImmunityBio Announces FDA Approval of ANKTIVA(Rm), First-in-Class IL-15 Receptor Agonist for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer.
Media Release -
HIGHLIGHTS OF PRESCRIBING INFORMATION: ANKTIVA? Internet-Doc 2024;.
Available from: URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761336s000lbl.pdf -
FDA Roundup: April 23, 2024.
Media Release -
FDA Accepts ImmunityBio's BLA Resubmission as Complete and Sets New PDUFA Date.
Media Release -
ImmunityBio Submits Biologics License Application for N-803 Plus BCG for Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma in Situ.
Media Release -
ImmunityBio Announces Biological License Application Resubmission for N-803 in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer Carcinoma-In-Situ.
Media Release -
ImmunityBio Announces FDA Acceptance of Biologics License Application for N-803 in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer Carcinoma In Situ.
Media Release -
ImmunityBio Completes GMP Drug Substance Manufacturing Sufficient for 170,000 Doses of ANKTIVA(Rm).
Media Release -
ImmunityBio Granted FDA Breakthrough Therapy Designation for N-803 IL-15 Superagonist in Non-Muscle Invasive Bladder Cancer.
Media Release -
Altor BioScience Corporation Announces FDA Fast Track Designation for Lead Candidate ALT-803 in Patients with Non-Muscle Invasive Bladder Cancer.
Media Release -
ImmunityBio Announces Primary Endpoint Met in a Second Indication in Bladder Cancer Trial with 57% Disease-Free Survival in Patients with BCG Unresponsive Papillary Disease.
Media Release -
ImmunityBio Announces Oral Presentation of Phase 2/3 Clinical Trial Results of Patients with BCG-Unresponsive Bladder Cancer Carcinoma at the Upcoming American Urological Associations Annual Meeting.
Media Release -
ImmunityBio Announces Primary Endpoint Met of Phase 2/3 Trial for BCG Unresponsive Non-Muscle Invasive Bladder Cancer CIS with 72% Complete Response Rate.
Media Release -
Chamie K, Lee JH, Rock A, Rhode PR, Soon-Shiong P. Preliminary phase 2 clinical results of IL-15RalphaFc superagonist N-803 with BCG in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) patients. ASCO-2019 2019; abstr. 4561.
Available from: URL: http://abstracts.asco.org/239/AbstView_239_271693.html -
NantKwest Announces Promising First in Human Clinical Results of 300 Doses Of CD16 Targeted, Off-The-Shelf Cryopreserved Natural Killer Cells (haNK) in a Novel Cancer Memory Vaccine Immunotherapy.
Media Release -
ImmunityBio Announces Positive Durable Responses in BCG Unresponsive Bladder Cancer Patients with a Complete Response Rate of 72%, Median Duration of Complete Response of 19.9 Months, and 85% Remaining Cystectomy-free in Phase 2/3 Trial.
Media Release -
QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer
ctiprofile -
ImmunityBio Announces Over 24 Months Median Duration of Complete Remission, with 100% NMIBC CIS Patient Survival, Setting a New Magnitude of Benefit in Patients with BCG Unresponsive Bladder Cancer.
Media Release -
ImmunityBio Provides Updated Status of Biologics License Application (BLA) for VesAnktiva Plus BCG for Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma in Situ.
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Chamie K, Chang SS, Gonzalgo M, Kramolowsky EV, Sexton WJ, Bhar P, et al. Final clinical results of pivotal trial of IL-15RalphaFc superagonist N-803 with BCG in BCG-unresponsive CIS and papillary nonmuscle-invasive bladder cancer (NMIBC). ASCO-2022 2022; abstr. 4508.
Available from: URL: https://meetings.asco.org//abstracts-presentations/209231 -
NEJM Evidence Publishes Results for ImmunityBios QUILT 3.032 Registrational Trial of IL-15 Superagonist N-803 Plus BCG in Patients with Bladder Cancer.
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Rosser CJ, Nix J, Ferguson L, Wong HC. Phase Ib Trial of Alt-803, an Il-15 Superagonist, plus Bacillus Calmette Guerin (Bcg) for the Treatment of Bcg-Naive Patients with Non-Muscle-Invasive Bladder Cancer (Nmibc). AUA-2017 2017; abstr. MP15-12.
Available from: URL: https://doi.org/10.1016/j.juro.2017.02.497 -
A Study of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With Non-Muscle Invasive Bladder Cancer
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An Open-Label Randomized Phase 2 Trial Of The NANT NEOADJUVANT Triple-Negative Breast Cancer (TNBC) VACCINE VS Standard-Of-Care For The Neoadjuvant Treatment Of Subjects With TNBC
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NantKwest 10-K 2019. Internet-Doc 2020;.
Available from: URL: https://www.sec.gov/Archives/edgar/data/1326110/000156459020012816/nk-10k_20191231.htm -
Open-Label Phase 1b/2 Study of Sacituzumab Govitecan-Hziy Plus Chemoimmunotherapy for the Treatment of Subjects With Advanced Triple-Negative Breast Cancer After Prior Therapy
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Hoag First Hospital in Orange County to Enroll Patients in NK Cell Therapy Clinical Trial for Triple-Negative Breast Cancer Patients.
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FDA Authorizes ImmunityBio Study of Anktiva and PD-L1 t-haNK to Increase Effectiveness of Trodelvy in Triple-Negative Breast Cancer.
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NantKwest, NantCell and NantOmics to Provide Updated Preclinical and Clinical Data in Four Abstracts at Part of the American Society of Clinical Oncology Annual Meeting.
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NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy Combining Innate High-affinity Natural Killer (haNK) Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy
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A Phase IIB Clinical Trial of the Multitargeted Recombinant Adenovirus 5 (CEA/MUC1/Brachyury) Vaccine (TRI-AD5) and IL-15 Superagonist N-803 in Lynch Syndrome
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ImmunityBio Announces Full Accrual of First Two Phases of Cancer Vaccine Trial in Participants with Lynch Syndrome and Initiation of Randomized Controlled Phase of the Trial.
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Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With BinTrafusp Alfa (M7824 or TGF-beta "Trap"/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT)
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Phase I/II Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Cancer (mCRC)
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NANT Colorectal Cancer (CRC) Vaccine: Combination Immunotherapy in Subjects With Recurrent or Metastatic CRC
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NANT Colorectal Cancer (CRC) Vaccine: A Phase 1b/2 Trial of the NANT CRC Vaccine vs Regorafenib in Subjects With Metastatic CRC Who Have Been Previously Treated With Standard-of-Care Therapy
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CytRx Corporation Highlights Aldoxorubicin's Inclusion In New NantCell Inc. Colorectal Cancer Clinical Trial.
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Kistler M, Nangia C, To C, Sender L, Lee J, Jones F, et al. Safety and efficacy from first-in-human immunotherapy combining NK and T cell activation with off-the-shelf high-affinity CD16 NK cell line (haNK) in patients with 2nd-line or greater metastatic triple-negative breast cancer (TNBC). SABCS-2019 2019; abstr. P5-04-02.
Available from: URL: http://link.adisinsight.com/r7ELa -
ImmunityBio Announces Launch of Phase 2 Trial of IL-15 Superagonist Anktiva With Antiretroviral Therapy to Inhibit HIV Reservoirs.
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Reducing HIV Persistence in Lymph Nodes by Interleukin-15 (IL-15) Receptor Super-agonist (N-803) in Individuals With Acute HIV Infection
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An Open Label, Single Arm Study of the Safety and Antiretroviral Activity of Two Long-acting Broadly Neutralizing Antibodies Plus an IL-15 Superagonist in ART-treated Adults Living With HIV During Analytical Treatment Interruption
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ImmunityBio Announces HIV Clinical Pipeline with Opening of a Phase 1 HIV Cure Study in Patients Off Therapy and a Phase 2 Study in Acutely Infected Patients.
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A Phase I Clinical Trial of the Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) With and Without Combination Broadly Neutralizing Antibodies to Induce HIV-1 Control During Analytic Treatment Interruption
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Effect of N-803 on B Cell Follicles in Antiretroviral Treated HIV Disease
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Proof of Principle Study of Pulse Dosing of IL-15 to Deplete the Reservoir in HIV Infected People on Optimized ART With Undetectable Plasma HIV RNA
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Davis Z, Thorkelson A, Anderson J, Wong HC, Karn J, Dobrowlski C, et al. A Phase 1 Study of Alt-803 (Il-15 Superagonist) to Clear Latent Hiv Reservoirs. CROI-2018 2018; abstr. 356.
Available from: URL: http://www.croiconference.org/sessions/phase-1-study-alt-803-il-15-superagonist-clear-latent-hiv-reservoirs -
ImmunityBio Announces Promising Clinical Study Results for Kick and Kill HIV Cure Strategy to Reduce HIV Viral Load with Anktiva (N-803) Therapy.
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ImmunityBio Announces Durable Virus Control of SHIV Without Anti-Retroviral Therapy by Activating NK and Memory T Cells With N-803, an IL-15 Superagonist.
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NIAID-Sponsored Study Shows N-803 Combined with Neutralizing Antibodies Could Lead to Sustained HIV Viral Control After Discontinuation of Antiretroviral Therapy.
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McBrien JB, Mavigner M, Smith SA, White ER, Vanderford T, Estes JD, et al. N-803 Induces Robust Siv Reactivation in Art-Treated Cd8-Depleted Macaques. CROI-2019 2019; abstr. 390.
Available from: URL: http://www.croiconference.org/sessions/n-803-induces-robust-siv-reactivation-art-treated-cd8-depleted-macaques -
Lim S-Y, Osuna CE, Lee J, Silva-Ayala D, Vikhe P, Chen E, et al. Combination Il-15 Therapy in a Shiv Nhp Model. CROI-2020 2020; abstr. 79.
Available from: URL: http://www.croiconference.org/sessions/combination-il-15-therapy-shiv-nhp-model -
QUILT-3.063: A Phase 2 Study of Combination Therapy With an IL-15 Superagonist (N-803), Off-the-shelf CD16-targeted Natural Killer Cells (haNK), and Avelumab Without Cytotoxic Chemotherapy in Subjects With Merkel Cell Carcinoma (MCC) That Has Progressed on or After Treatment With a Checkpoint Inhibitor
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NantKwest Announces Launch of Merkel Cell Carcinoma Phase II Trial Deploying Novel Triple Combination of off-the-Shelf Natural Killer haNK(R) Cell Therapy with Superagonist IL-15 Cytokine Therapy and PD-L1 Checkpoint Inhibitor Therapy.
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NantKwest Doses First Patient in Phase 2 Single-Arm Trial of Metastatic Merkel Cell Carcinoma Therapy With Off-the-Shelf CD16 Natural Killer Cells.
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NantKwest and ImmunityBio Announce Complete Response in Metastatic Pancreatic Cancer in the First Patient to Receive PD-L1 Tumor-Targeted Natural Killer Cells (PD-L1.t-haNK) Combined with N-803 IL-15 Fusion Protein.
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NantKwest Announces Presentation of Positive Phase 2 Clinical Data of Natural Killer Cell Therapy in Metastatic Merkel Cell Carcinoma at SITC 2019.
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NantKwest Form 10-K, March 2017. Internet-Doc 2017;.
Available from: URL: https://www.sec.gov/Archives/edgar/data/1326110/000156459017004430/nk-10k_20161231.htm -
NantKwest Announces Achievement of End Point in Merkel Cell Carcinoma Phase II Trial With Evidence of Efficacy of Activated Natural Killer (aNK) Cells in Solid Tumors.
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Phase 2 Study of aNK (Activated NK-92 Natural Killer Cells) Infusions in Combination With ALT-803 (IL-15) in Patients With Stage III (IIIB) or Stage IV Merkel Cell Carcinoma (MCC)
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NANT Merkel Cell Carcinoma (MCC) Vaccine: Combination Immunotherapy in Subjects With MCC Who Have Progressed on or After Anti-programmed Death-ligand 1 (PD-L1) Therapy
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A Phase I/II Study of ALT-803 in Patients With Relapsed or Refractory Multiple Myeloma
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Altor BioScience Initiates Clinical Development of its Novel IL-15 Super Agonist ALT-803 for Relapsed / Refractory Multiple Myeloma Supported by a Newly Awarded Phase II SBIR Grant from NCI.
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ImmunityBio Announces Positive Overall Results of Anktiva Combined With Checkpoint Inhibitors in NSCLC, Meeting Scheduled with FDA to Discuss Registration Path in Lung Cancer.
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A Phase II/III Study of N-803 (ALT-803) Plus Pembrolizumab Versus Standard of Care in Participants With Stage IV or Recurrent Non-Small Cell Lung Cancer Previously Treated With Anti-PD-1 or Anti-PD-L1 Therapy (Lung-MAP Non-Match Sub-Study)
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ImmunityBio Announces First Participants Have Been Enrolled in Lung-MAP Trial Studying Anktiva to Activate NK and T Cells in Non-Small Cell Lung Cancer.
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National Cancer Institute Selects ImmunityBio's N-803 IL-15 Receptor Agonist to Combine with Keytruda in 700-Site Lung-MAP Clinical Trial of a Chemo-Free Therapy.
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QUILT 2.023: A Phase 3, Open-Label, 3-Cohort Randomized Study of N-803, in Combination With Current Standard of Care VS Standard of Care as First-Line Treatment for Patients With Advanced or Metastatic NSCLC.
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ImmunityBio to Present Preliminary Phase 2 Data of 68% Durable Disease Control with Anktiva Plus Checkpoint Inhibitor in First 140 Patients Enrolled with Lung Cancer and Multiple Tumor Types Who Failed Prior Checkpoint Therapy at ASCO 2021.
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A Phase II, Single-center, Open-label Study of Ramucirumab, Atezolizumab and N-803 After Progression on Any Immune Checkpoint Blocker in NSCLC (RAN)
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Phase I/II Evaluation of a Cancer Lysate Vaccine and Montanide(R) ISA-51 VG With or Without the IL-15 Super-Agonist N-803 as Adjuvant Therapy for PD-L1 Negative Non-Small Cell Lung Cancer
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NANT Non-small Cell Lung Cancer (NSCLC) Vaccine: Combination Immunotherapy in Subjects With NSCLC Who Have Progressed After Treatment With Programmed Cell Death Protein 1 (PD-1)/Programmed Death-ligand 1 (PD-L1) Inhibitors
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A Phase IB/II Study of Nivolumab In Combination With ALT-803 In Patients With Pretreated, Advanced, or Metastatic Non-Small Cell Lung Cancer
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Wrangle JM, Velcheti V, Patel M, Garrett-Mayer E, Hill EG, Farhad M, et al. ALT-803, an IL-15 superagonist, in combination with nivolumab in metastatic non-small cell lung cancer: Ongoing experience and biomarker development from a non-randomized, open-label, phase Ib/II trial. ASCO-2018 2018; abstr. 3008.
Available from: URL: http://abstracts.asco.org/214/AbstView_214_229297.html -
Progress Report on Cancer Breakthroughs 2020 Project Presented by Dr. Soon-Shiong at J.P. Morgan Healthcare Conference.
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CytRx Highlights Use of Licensed Drug Aldoxorubicin in Treatment of Former Senate Majority Leader Harry Reids Pancreatic Cancer.
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Open-label, Randomized, Comparative Phase 2 Study of Combination Immunotherapy Plus Standard-of-care Chemotherapy Versus Standard-of-care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer
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NantKwest, ImmunityBio Add Third-Line Cohort to Phase 2 Pancreatic Cancer Trial; Opens Study to Patients Who Have Failed All Approved Standards of Care.
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NantKwest, ImmunityBio Announce Positive Interim Data on Survival Rates in Metastatic Pancreatic Cancer Trials.
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ImmunityBio Announces 100th Patient Dosed with Proprietary Natural Killer Cells; NK Trials Cover Multiple Indications.
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CytRx Highlights ImmunityBio's Completion of Enrollment in Phase 2 Study of Advanced Metastatic Pancreatic Cancer Treatment.
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ImmunityBio Announces Results of Phase 2 Metastatic Pancreatic Cancer Trial at ASCO GI With Median Overall Survival of 6.3 Months in Patients With Third-Line Disease, More Than Doubling Historical Survival.
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Seery TE, Nangia CS, McKean HA, Bhar P, Sender LS, Reddy SK, et al. Phase 2 Quilt 88 trial of DAMP inducers combined with IL15 superagonist, N-803, and anti-PD-L1 NK cell therapy more than doubles historical overall survival in patients with third- to sixth-line advanced pancreatic cancer. ASCO-2022 2022; abstr. 4147.
Available from: URL: https://meetings.asco.org//abstracts-presentations/210969 -
ImmunityBio Announces Presentation at ASCO GI 2023 of Fully Enrolled Trial in Third-Line and Greater Pancreatic Cancer and Update on FDA Type B Meetings Regarding Paths to Registration.
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QUILT-3.088 NANT Pancreatic Cancer Vaccine: Phase II Randomized Trial of the NANT Pancreatic Cancer Vaccine vs. Standard-of-Care as First- Line Treatment for Patients With Metastatic Pancreatic Cancer
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Seery TE, Kistler M, Sender LS, Lee JH, Shinde AM, Annamalai A, et al. Innate and adaptive immunotherapy: An orchestration of immunogenic cell death by overcoming immune suppression and activating NK and T cell therapy in patients with third line or greater metastatic pancreatic cancer. ASCO-2019 2019; abstr. e15787.
Available from: URL: http://abstracts.asco.org/239/AbstView_239_270711.html -
QUILT-3.080: Phase 1B/2 Trial Of The NANT Pancreatic Cancer Vaccine As Treatment For Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-Of-Care Therapy
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NANT Pancreatic Cancer Vaccine: Molecularly Informed Integrated Immunotherapy Combining Innate High-affinity Natural Killer (haNK) Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy
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CytRx Corporation Highlights Dosing of the First Patient in Licensee NantCell Inc. Clinical Trial Investigating Cell-Based Therapy in Combination with Multiple Anti-Cancer Agents, Including Aldoxorubicin, in Patients with Metastatic Pancreatic Cancer.
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NANT Pancreatic Cancer Vaccine: Molecularly Informed Integrated Immunotherapy Combining Innate High-affinity Natural Killer (haNK) Cell Therapy With Adaptive T-cell Therapy (Adenovirus, Yeast, Fusion Protein Vaccine) in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy
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Phase Ib/II Study of ALT-803 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Advanced Pancreatic Cancer
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NantKwest and NantCell Announce FDA Authorization for the NANT Cancer Vaccine Clinical Trials, the First Novel Combination of Innate and Adaptive Immunotherapy in Patients with Pancreatic Cancer.
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NANT Pancreatic Cancer Vaccine: Combination Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy
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A Phase 2 Trial of PD-L1 t-haNK, N-803 IL-15 Superagonist (Anktiva), and Cetuximab for Immunotherapy-treated Patients With Recurrent, Metastatic HNSCC (QUILT-505)
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NANT Head and Neck Squamous Cell Carcinoma (HNSCC) Vaccine: Combination Immunotherapy in Subjects With HNSCC Who Have Progressed on or After Chemotherapy and Anti-programmed Cell Death Protein 1 (PD-1)/Programmed Death-ligand 1 (PD-L1) Therapy
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CytRx Corporation Highlights Second NantCell Inc. Clinical Trial Evaluating Immuno-Oncology Agents and Cell-based Therapies in Combination with Aldoxorubicin in Patients with Advanced Squamous Cell Carcinoma.
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QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Molecularly Informed Integrated Immunotherapy Combining (haNK) Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With SCC Who Have Progressed on or After Platinum-based Chemotherapy and Anti-programmed Cell Death Protein 1 (PD-1)/Programmed Death-ligand 1 (PD-L1) Therapy
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A Phase 1 Trial of CTLA-4 Inhibition, With or Without Cetuximab, and in Combination With Memory-like Natural Killer (NK) Cell Immune Cell Therapy in Advanced Head & Neck Cancer
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Hanna GJ, Coleman K, Birch G, Redd RA, Alonso A, Bednarz S, et al. A phase 1 trial of cytokine-induced memory-like (CIML) natural killer (NK) cell therapy with IL-15 superagonist in advanced head and neck cancer: Part 1 results. AACR-2022 2022; abstr. CT540.
Available from: URL: https://www.abstractsonline.com/pp8/#!/10517/presentation/20604 -
Phase 1 Study Indicates Allogeneic Cytokine-Induced Memory-Like Natural Killer Cells Plus N-803 May Induce Tumor Regression in Advanced Head-and-Neck Cancer Patients.
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Phase 1b, Randomized, Blinded, Placebo-controlled Study of the Safety of Therapeutic Treatment With an Immunomodulary Agent N-803 in Adults With COVID-19
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A Phase II Study of N-803 Alone or in Combination With BN-Brachyury Vaccine or Bintrafusp Alfa (M7824) for Participants With Castration Resistant Prostate Cancer
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QUILT-3.055: A Phase IIb, Multicohort, Open-Label Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With PD-1/PD-L1 Immune Checkpoint Inhibitors
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ImmunityBio Announces Positive Phase 2 Results Showing That Anktiva Restores the Activity of Checkpoint Inhibitors in Patients Who Have Relapsed Checkpoint Immunotherapy in Non-Small Cell Lung Cancer.
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Wrangle JM, Awad MM, Badin FB, Rubinstein MP, Bhar P, Garner C, et al. Preliminary data from QUILT 3.055: A phase 2 multi-cohort study of N803 (IL-15 superagonist) in combination with checkpoint inhibitors (CPI). ASCO-2021 2021; abstr. 2596.
Available from: URL: https://meetinglibrary.asco.org/record/196017/abstract -
QUILT-2.021: Randomized Study of Single Course of Intraperitoneal (IP) ALT-803 Followed by Subcutaneous (SQ) Maintenance ALT-803 Versus Subcutaneous (SQ) Maintenance ALT-803 Only After 1st Line Chemotherapy for Advanced Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
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A Phase II Study of Immunotherapy Combination: Irradiated PD-L1 CAR-NK Cells Plus Pembrolizumab Plus N-803 for Subjects With Recurrent/Metastatic Gastric or Head and Neck Cancer
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Relapse Prophylaxis With IL-15 Super Agonist N-803 in Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome Following Reduced Intensity Conditioning (RIC) Allogeneic Stem Cell Transplantation
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QUILT-3.033: Haploidentical Donor Natural Killer (NK) Cell Infusion With Subcutaneous ALT-803 in Adults With Refractory or Relapsed Acute Myelogenous Leukemia
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QUILT-3.034: Multi-Center Trial of Non-Myeloablative TCRa/b Deplete Haploidentical Hematopoietic Cell Transplantation With Post HCT ALT-803 in High-Risk Myeloid Diseases
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A Phase 1 Study of Cytokine-induced Memory-like NK Cells in Patients With Relapsed and Refractory AML
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IL-15 Super Agonist ALT-803 to Treat Relapse Of Hematologic Malignancy After Allogeneic Stem Cell Transplantation
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Romee R, Cooley S, Berrien-Elliott M, Westervelt P, Verneris MR, Wagner JE, et al. First-in-Human Clinical Trial of the IL-15 Super-Agonist Complex ALT-803 for Patients Relapsed after Allogeneic Hematopoietic Cell Transplantation. ASH-Hem-2017 2017; abstr. 274.
Available from: URL: https://ash.confex.com/ash/2017/webprogram/Paper108416.html -
A Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1)
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Redman JM, Madan RA, Karzai F, Bilusic M, Cordes L, Marte J, et al. Efficacy of BN-brachyury (BNVax) + bintrafusp alfa (BA) + N-803 in castration-resistant prostate cancer (CRPC): Results from a preliminary analysis of the Quick Efficacy Seeking Trial (QuEST1). ESMO-2020 2020; abstr. 616MO.
Available from: URL: https://www.sciencedirect.com/science/article/pii/S0923753420408713 -
Phase 1 Open-Label Study of Autologous M-CENK in Subjects With Locally Advanced or Metastatic Solid Tumors
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FDA Authorizes ImmunityBio to Conduct a Trial of its First-in-Human, Cryopreserved, Memory Cytokine-Enriched NK Cell (m-ceNK) Platform in Solid Tumors.
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A Phase 1/2 Study of ALT-803 in Patients With Relapse/Refractory Indolent B Cell Non-Hodgkin Lymphoma in Conjunction With Rituximab
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ImmunityBio Announces 78 Percent Complete Response Following Chemotherapy-Free Combination of IL-15 Superagonist Anktiva with Rituxan in Relapsed Non-Hodgkin Lymphoma Patients.
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Phase 1b/2 Study of ETBX-011 (Ad5 [E1-, E2b-]-CEA(6D)) Vaccine in Combination With ALT-803 (Super-agonist IL-15) in Subjects Having CEA-Expressing Cancer
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Molecularly Informed Integrated Immunotherapy Combining Innate High-affinity Natural Killer (haNK) Cell Therapy w/ Adenoviral & Yeast-based Vaccines to Induce T-cell Responses in Subjects w/ Advanced, Unresectable & Untransplantable HCC
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NANT Ovarian Cancer Vaccine: Combination Immunotherapy in Subjects With Epithelial Ovarian Cancer Who Have Progressed on or After Standard-of-care (SoC) Therapy
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QUILT-3.048: NANT Urothelial Cancer Vaccine: Combination Immunotherapy in Subjects With Urothelial Cancer Who Have Progressed on or After Chemotherapy and Anti-programmed Cell Death Protein 1 (PD-1)/Programmed Death-ligand 1 (PD-L1) Therapy
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NANT Melanoma Vaccine: Combination Immunotherapy in Subjects With Melanoma Who Have Progressed on or After Chemotherapy and Anti-programmed Cell Death Protein 1 (PD-1)/Programmed Death Ligand 1 (PD-L1) Therapy
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NANT Non-Hodgkin Lymphoma (NHL) Vaccine: Combination Immunotherapy in Subjects With Relapsed CD20-positive NHL
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Single Center Study Evaluating The Effects Of N-803 Stimulation On The Expansion, Enrichment, And Proliferation Of Natural Killer Cells Collected By Apheresis
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Phase I Trial of Universal Donor NK Cell Therapy in Combination With ALT-803
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A Phase 1 Study of the Clinical and Immunologic Effects of ALT-803, a Novel Recombinant IL-15 Complex in Patients With Advanced Solid Tumors: Melanoma, Renal Cell, Non-Small Cell Lung and Squamous Cell Head and Neck Cancer
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Altor BioScience and the Melanoma Research Alliance to Co-Support Clinical Studies of Altor's Novel IL-15 Superagonist for Metastatic Melanoma.
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Altor BioScience Launches its Proprietary IL-15 Superagonist ALT-803 into Clinical Trials against Cancer.
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Wrangle JM, Rubinstein MP, Mart C, Azar JH, Williams C, Swiderska-Syn M, et al. Phase I trial characterizing the pharmacokinetic profile and NK and CD8+ t cell expansion with n-803, a chimeric IL-15 superagonist, in healthy volunteers. ASCO-2020 2020; abstr. e15008.
Available from: URL: https://meetinglibrary.asco.org/record/189273/abstract -
QUILT-1.004: A Single Center, Open-label, Pharmacokinetic Study of Subcutaneous ALT-803
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ImmunityBio Announces Publication of Preclinical Data Demonstrating IL-15 Superagonist N-803 Improves Natural Killer-Mediated Tumor Cell Killing.
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Precision Biologics along with Dr Christina Annunziata, MD, PhD, from the NCI are presenting at the AACR Annual Meeting.
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Altor Bioscience Announces NCI Phase II SBIR Grant Award and Publication Supporting Ongoing Clinical Trial of IL-15 Super Agonist ALT-803 in Combination with Anti-CD20 Antibody Therapy for Relapsed / Refractory Non-Hodgkin Lymphoma.
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ImmunityBio Announces $320 Million Investment by Oberland Capital, with $210 Million Funded at Closing, Bringing Total Financing in 2023 to $850 Million.
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ImmunityBio Announces $470 Million Equity and Debt Financing From Founder, Dr. Patrick Soon-Shiong and Nant Entities.
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NantKwest Chairman & CEO Dr. Patrick Soon-Shiong Exercises $39 Million in Warrants and Options in Support of NK's Natural Killer Cell Strategic Vision Beyond Check Point Immunotherapy.
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Altor BioScience Awarded SBIR Phase II Grant by NCI for Clinical Development of its Novel IL-15 Super Agonist for Non-muscle Invasive Bladder Cancer.
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ImmunityBio 10-K. Internet-Doc 2024;.
Available from: URL: https://www.sec.gov/ix?doc=/Archives/edgar/data/1326110/000132611024000037/ibrx-20231231.htm -
ImmunityBio Announces Positive Overall Survival Results of Anktiva Combined With Checkpoint Inhibitors in Non-Small Cell Lung Cancer; Meeting Scheduled with FDA to Discuss Registration Path for ANKTIVA in Lung Cancer.
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NantKwest and ImmunityBio to Initiate a Phase 2 Study of Immunotherapy for Metastatic Pancreatic Cancer.
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CytRx Corporation Highlights Significant Positive Events From its Two Licensed Drugs Arimoclomol and Aldoxorubicin.
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Chamie K, Chang S, Gonzalgo M, Kramolowski E, Reddy S, Bhar P, et al. Phase 2/3 Clinical Results of Il-15Ralphafc Superagonist N-803 with Bcg in Bcg-Unresponsive Non-Muscle Invasive Bladder Cancer (Nmibc) Carcinoma in-Situ (Cis) Patients. AUA-2021 2021; abstr. PD09-05.
Available from: URL: https://www.auajournals.org/doi/abs/10.1097/JU.0000000000001977.05 -
A dose escalation study of ALT-803 in patients relapsed after allogeneic hematopoietic cell transplantation
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