Pritumumab - Nascent Biotech
Alternative Names: ACA 11; CLN-IgG; CLNH 11; Monoclonal antibody ACA 11Latest Information Update: 28 Apr 2024
At a glance
- Originator University of California, San Diego
- Developer Nascent Biotech
- Class Antineoplastics; Antivirals; Immunotherapies; Monoclonal antibodies
- Mechanism of Action Antibody-dependent cell cytotoxicity; T lymphocyte stimulants; Virus internalisation inhibitors
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Orphan Drug Status
Yes - Pancreatic cancer; Glioma
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Phase II Glioma
- No development reported Brain cancer; COVID 2019 infections; Pancreatic cancer
Most Recent Events
- 28 Apr 2024 No recent reports of development identified for phase-I development in Brain-cancer(Metastatic disease, Recurrent, Second-line therapy or greater) in USA (IV, Infusion)
- 28 Apr 2024 No recent reports of development identified for research development in COVID-2019-infections in USA (Parenteral)
- 29 Nov 2023 Nascent Biotech receives Notice of Allowance for a Method of Use patent for pritumumab in Japan
Development Overview
Introduction
Pritumumab is a natural human IgG1κ antibody purified from the parent human hybridoma, CLNH11, being developed by Nascent Biotech (previously called Nascent Biologics) for the treatment of malignant and non malignant gliomas, pancreatic cancer and brain cancer. The parent hybridoma is generated by fusion of B-lymphocytes isolated from a cervical cancer patient and the human lymphoblastoid B-cell line. Pritumumab recognises altered vimentin (ecto-domain vimentin) expressed on the cell surface of epithelial tumour cells, which is restricted to various solid tumours irrespective of the germ layer where the tissues originated. Cell surface vimentin also is a potential target in the treatment of conditions related to the coronavirus infections. The drug induces tumour cell death by antibody-dependent cell-mediated cytotoxicity. Clinical development in glioma is underway in Japan. Clinical development for brain cancer is underway in the US.
Nascent Biotech, in collaboration with Syracuse University, is also developing pritumumab for the treatment of conditions related to COVID-19 infection. Based on research, the University believes that the SARS-CoV-2 virus may be entering into the cells through the vimentin receptor, and pritumumab, through binding to vimentin, may be able to block the virus entry. Early research is underway in the US [1] [2] .
Tobacco plants will be used as an adjunct expression system for production of pritumumab, a technology of Mapp Biopharmaceutical [3] .
Jin-En International Group Holding Co. acquired Nascent Biologics and changed its name to Nascent Biotech in July 2014 [4] .
As at February 2022, no recent reports of development had been identified for preclinical development in Pancreatic-cancer in USA (IV).
As at April 2024, no recent reports of development had been identified for phase-I development in Brain-cancer (Metastatic disease, Recurrent, Second-line therapy or greater) in USA (IV, Infusion), research development in COVID-2019-infections in USA (Parenteral).
Company Agreements
Nascent Biotech and Syracuse University, in July 2020, entered into an agreement for the development of pritumumab for the potential treatment of COVID-2019 infection. The University will assess whether the antibody, through binding to cell surface vimentin, is able to potentially block SARS-CoV-2 from entering the cells, in mouse embryo fibroblast cells and lung airway epithelial cells. [1]
In July 2016, Nascent Biotech entered into an exclusive licensing agreement with Zhejiang Hisun Pharmaceutical Company for the development and commercialisation of pritumumab. Under the agreement terms, Hisun will develop, manufacture and commercialise pritumumab in China. Further, Nascent Biotech will provide to Hisun its Master Cell Bank and related technology, which will allow Hisun to manufacture and initiate clinical development of Pritumumab in China [5] .
In February 2015, Nascent Biotech, in conjunction with Mapp Biopharmaceutical, received SBIR grant of $US225 000 from National Institutes of Health (NIH) for initial development of tobacco plants as an adjunct expression system for pritumumab for the treatment of brain cancer [3] .
In April 2012, Nascent Biotech and Catalent Pharma Solutions entered into a product development agreement. Under the terms of the agreement, Catalent will use its GPEx® technology to engineer a cell line expressing pritumumab. Catalent will be responsible for the production of purified monoclonal antibody for Nascent's phase I/II trials [6] .
Nascent Biotech entered into a licensing agreement for pritumumab with a Japanese scientist in July 2009. Pritumumab was initially generated in 1982 by Dr. Glassy, CEO and co-founder of Nascent Biotech, then taken to Japan and licensed to a Japanese party [7] .
Key Development Milestones
Cancer
In August 2023, Nascent Biotech announced that the US FDA approved to initiate phase II trial for brain cancer [8] . As of April 2023, Nascent Biotech submitted phase II clinical trial protocol to the US FDA for review and approval and plans to initiate phase II clinical trial for brain cancer [9] .
In June 2023, Nascent Biotech announced its intention to initiate a phase II trial of pritumumab as single agent and in combination with checkpoint inhibitors in both recurrent gliomas and upfront with chemoradiation in newly diagnosed gliomas [10] .
In March 2023, Nascent Biotech completed a phase I trial which determined the safety, tolerability and the recommended phase II dose (RP2D) of pritumumab in patients with recurrent gliomas or with brain metastases (NCT04396717; 08091967) [11] . Previously In December 2020, Nascent Biotech initiated the phase I trial, and the open label, non-randomised study enrolled 42 patients in the US [12] [13] . As of June 2022, Nascent Biotech has completed dosing of third cohort from the trial [14] . In September 2022, Nascent Biotech has completed dosing and enrollment of the fourth cohort in the trial [15] . In January 2023, Nascent Biotech has completed and closed the enrollment of fifth and final cohort of patients in the safety and dose escalation trial [16] . As of January 2023, the company intends to prepare for submission of trial data and the phase II clinical trial protocol to the US FDA for evaluation [17] . As of April 2023, Nascent Biotech reported that the US FDA received data from phase I trail that evaluated safety and tolerability of pritumumab for primary and metastatic brain cancers. About 30 days after filing, the company expects the US FDA to make its initial remarks [9] . In June 2023, Nascent Biotech presented data from the trial at American Society of Clinical Oncology (ASCO-2023) [18] .
In December 2020, Nascent Biotech announced that, the US FDA removed a partial clinical hold on IND of pritumumab to commence a phase I trial for the treatment of brain cancer. In December 2018, Nascent Biotech received IND clearance from the US FDA to initiate the trial. However at a later date, a full clinical hold was imposed by the FDA on the IND. Eventually, the company received a letter from the FDA directing conversion of the 'full' clinical hold to a 'partial' clinical hold [13] [19] .
In August 2015, Nascent Biotech announced its plan to file for an Investigational New Drug exemption [20] .
In October 2014, the US FDA granted orphan drug designation to pritumumab for the treatment of patients with glioma [20] [21] . In April 2016, the company also received orphan drug designation for the treatment of pancreatic cancer [22] .
Phase II efficacy and phase I safety trials in patients with glioma, were conducted in Japan by various institutes in a total of 249 patients. Positive overall response rates were demonstrated in early and late phase II trials. Additionally, data from the late phase II trial showed a five-year survival rate of 25%. In a phase I trial, pritumumab showed a good safety profile [23] .
Nascent Biotech intends to initiate trials in other epithelial cancers such as breast, lung, colon and pancreas [20] .
In April 2018, Nascent Biotech presented preclinical data for pritumumab at the 109th Annual Meeting of the American Association for Cancer Research (AACR-2018). The study evaluated ability of pritumumab mAb to target pancreatic cancer cells and inhibit pancreatic tumour growth. Pritumumab bound to the cell surface of patient pancreatic cancer tissue and to the surface of established pancreatic cancer cells in culture. This antibody binding induced antibody-dependent cell-mediated cytoxicity (ADCC). Additionally, pritumumab significantly inhibited pancreatic tumour growth in a xenograft mouse model [24] .
In April 2016, preclinical data of pritumumab were presented at the 107th Annual Meeting of the American Association for Cancer Research (AACR-2016) [25] .
Nascent Biotech completed a toxicology study of pritumumab conducted in monkey and rat, in compliance with FDA guidance, wherein no in life toxicities were observed in the two species studied [20] .
Covid-2019-infetions
In March 2020, company initiated in vitro studies of pritumumab for the treatment of patients infected with COVID-19. The testing has started to check the ability of pritumumab to interfere with the virus binding to its target cells and provide treatment against this devastating pandemic. Earlier company announced the intention to initiate research for pritumumab as a possible treatment for patients infected with the COVID-19 virus strain [2] [26] .
Financing information
In August 2020, Nascent Biotech closed a direct private placement with aggregate proceeds of $US740,000. The company intends to use the proceeds to complete the required testing for removing the partial clinical trial hold, imposed by the US FDA [see above] and will permit the company to initiate a phase I trial in brain cancer [19]
Nascent Biotech raised $US2.1 million since March 2014, which was used to advance the development of pritumumab, to support the filing of an Investigational New Drug exemption [20] .
Patent Information
In November 2023, Nascent Biotech received a "Method-of-Use" patent from the Japanese Patent Office (JPO) covering pritumumab, and its ability to cross the blood brain barrier. The patent recognizes the ability of the compound to act as a monotherapy, as well as act of a potential conjugate, to transport therapies across the blood brain barrier [27]
The US Patent and Trademark Office, in March 2021, issued a Notice of Allowance for a "Method of Use" patent covering pritumumab, and its ability to cross the blood brain barrier. The patent recognizes the ability of the compound to act as a monotherapy, as well as act of a potential conjugate, to transport therapies across the blood brain barrier [28] .
Pritumumab is covered by 11 issued patents in the US (4 618 577, 4 761 377, 5 093 261, 5 155 036, 5 286 647, 5 589 573, 5 602 027, 6 051 229, 6 051 387, 6 051 693, and 6 165 467).
Drug Properties & Chemical Synopsis
- Route of administration IV, Parenteral
- Formulation Infusion, unspecified
- Class Antineoplastics, Antivirals, Immunotherapies, Monoclonal antibodies
- Target Cell surface receptor; T lymphocyte; Virus internalisation
- Mechanism of Action Antibody-dependent cell cytotoxicity; T lymphocyte stimulants; Virus internalisation inhibitors
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WHO ATC code
J05 (Antivirals for Systemic Use)
L01F (Monoclonal antibodies and antibody drug conjugates)
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EPhMRA code
J5 (Antivirals for Systemic Use)
L1G (Monoclonal Antibody Antineoplastics)
- Chemical name Immunoglobulin G, anti-(human vimentin) (human monoclonal CLN G11 gamma1-chain), disulfide with human monoclonal CLN G11 kappa-chain, dimer
- Molecular formula C6440 H9968 N1708 O2016 S42
- CAS Registry Number 499212-74-7
Biomarkers Sourced From Trials
| Indication | Biomarker Function | Biomarker Name | Number of Trials |
|---|---|---|---|
|
anaplastic astrocytoma |
Eligibility Criteria |
Alkaline phosphatase (ALPL) |
|
|
astrocytoma |
Eligibility Criteria |
Alkaline phosphatase (ALPL) |
|
|
brain cancer |
Eligibility Criteria |
Alkaline phosphatase (ALPL) |
|
|
brain metastases |
Eligibility Criteria |
Alkaline phosphatase (ALPL) |
|
|
Chordoma |
Eligibility Criteria |
Alkaline phosphatase (ALPL) |
|
|
Craniopharyngioma |
Eligibility Criteria |
Alkaline phosphatase (ALPL) |
|
|
glioblastoma |
Eligibility Criteria |
Alkaline phosphatase (ALPL) |
|
|
glioma |
Eligibility Criteria |
Alkaline phosphatase (ALPL) |
|
|
medulloblastoma |
Eligibility Criteria |
Alkaline phosphatase (ALPL) |
|
|
Meningioma |
Eligibility Criteria |
Alkaline phosphatase (ALPL) |
|
|
non-small cell lung cancer |
Eligibility Criteria |
Alkaline phosphatase (ALPL) |
|
|
oligodendroglioma |
Eligibility Criteria |
Alkaline phosphatase (ALPL) |
|
|
pituitary cancer |
Eligibility Criteria |
Alkaline phosphatase (ALPL) |
Biomarker
| Drug Name | Biomarker Name | Biomarker Function |
|---|---|---|
| Pritumumab - Nascent Biotech | Alkaline phosphatase (ALPL) | Eligibility Criteria |
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| Brain cancer | - | Metastatic disease, Recurrent, Second-line therapy or greater | No development reported (I) | USA | IV / Infusion | Nascent Biotech | 28 Apr 2024 |
| COVID 2019 infections | - | - | No development reported (Research) | USA | Parenteral / unspecified | Nascent Biotech | 28 Apr 2024 |
| Glioma | - | - | Phase II | Japan | IV / unspecified | Nascent Biotech | 29 Jan 2016 |
| Pancreatic cancer | - | - | No development reported (Preclinical) | USA | IV / unspecified | Nascent Biotech | 28 Feb 2022 |
Orphan Status
| Indication | Patient Segment | Country | Organisation | Event Date |
|---|---|---|---|---|
| Glioma | - | USA | Nascent Biotech | 28 Oct 2014 |
| Pancreatic cancer | - | USA | Nascent Biotech | 25 Apr 2016 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| University of California, San Diego | Originator | USA |
| Nascent Biotech | Owner | USA |
| Zhejiang Hisun Pharmaceutical | Licensee | China |
| Mapp Biopharmaceutical | Technology Provider | USA |
| National Institutes of Health (USA) | Funder | USA |
| Syracuse University | Collaborator | USA |
| Catalent Pharma Solutions | Collaborator | USA |
Scientific Summary
Pharmacokinetics
Brain cancer
Phase I
In a phase I trial, preliminary pharmacokinetic (PK) data shows volume of distribution as 38.36 mL/kg and clearance of pritumumab as 0.1305 mL/h/kg. The half-life of pritumumab was found to be 12.5 days [18] [12] .
Analysis of a blood brain barrier model showed minimal distribution of pritumumab in normal brain tissues and significant binding in tumour areas of brain tissues. This indicated that the monoclonal antibody product crosses the tumour brain barrier [25] .
Adverse Events
A total of 10 patients with malignant gliomas were treated with pritumumab IV once or twice a week for 4 weeks, in a phase I trial. No toxicities were observed [23] .
In a phase II study, 42 patients with malignant gliomas received pritumumab IV once or twice a week for 24 weeks. Mild adverse reactions were reported in 2/21 evaluable patients [29] .
Brain cancer
Phase I
In a phase I trial, out of 15 patients, 13 patients discontinued treatment due to disease progression, one due to PI discretion for an unrelated CNS infection, and one withdrew for personal reasons. There were no dose-limiting toxicities to this natural human IgG mAb. The most common adverse events at least possibly attributed to pritumumab were fatigue (53.3%) and constipation (33.3%). Other rare side effects, possibly related to pritumumab, occurred at 6.7% were nausea, joint tenderness, dehydration, hypomagnesemia, neuropathy, pruritus, scalp dryness, dry skin (face), and depression. There were no Grade 3, 4, or 5 adverse events attributed to pritumumab. Single agent pritumumab is safe up to a dose of 16.2 mg/kg every 7 days in brain tumour patients [18] [12] .
Pharmacodynamics
Summary
A concentration-dependent study of pritumumab-mediated antibody-dependent cell-mediated cytotoxicity (ADCC) showed an EC50 of 39.6 ng/ml. Additional studies of pritumumab showed effective prevention of tumour growth in a xenograft model with nude athymic mice but not in SCID mice [25] .
Binding specificity evaluated using flow cytometry and immunohistochemical analysis, western blot analysis and ADCC activity confirmed the comparability of a recombinant version of pritumumab, made using the GPEx® system in CHO cells, and the original hybridoma [25] .
In preclinical immunoreactivity studies using cell lines and human tissue, pritumumab had a marked reaction with malignant glioma cell lines and tissue; however, the compound did not react to normal cell lines, or normal adult or fetal brain tissue or other extraneural tissue [23] .
Therapeutic Trials
Glioma
In a phase II study, patients with malignant gliomas were treated with pritumumab IV twice a week for 24 weeks. The overall response rate was 27%. The five-year survival rate in a group of 66 patients was 25% [23] .
In another phase II study, 42 patients with malignant gliomas received pritumumab IV once or twice a week for 24 weeks. The overall response rate for the 21 patients who could be evaluated was 38.1%. The response rates for patients who received pritumumab once or twice a week were 14.2 and 50.0%, respectively [29] .
Brain cancer
Phase I
In a phase I trial, the partial response showed nearly a 98.0% and 40.8% reduction in 2 tumor lesions for 17 months on study. There were no dose-limiting toxicities to this natural human IgG mAb [18] [12] .
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Dec 2020 | Trial Update | Nascent Biotech plans a phase I trial in Brain cancer (Metastatic disease) in USA later in 2020 (IV, Infusion) (NCT04396717) (700259759) [19] | 18 Dec 2020 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 28 Apr 2024 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Brain-cancer(Metastatic disease, Recurrent, Second-line therapy or greater) in USA (IV, Infusion) Updated 28 Apr 2024 |
| 28 Apr 2024 | Phase Change - No development reported | No recent reports of development identified for research development in COVID-2019-infections in USA (Parenteral) Updated 28 Apr 2024 |
| 29 Nov 2023 | Patent Information | Nascent Biotech receives Notice of Allowance for a Method of Use patent for pritumumab in Japan [27] Updated 13 Feb 2024 |
| 22 Aug 2023 | Regulatory Status | US FDA approves the protocol to initiate a phase II trial for brain cancer [8] Updated 13 Feb 2024 |
| 13 Jun 2023 | Scientific Update | Efficacy, adverse events and pharmacokinetics data from phase I trial in Brain cancer presented at American Society of Clinical Oncology (ASCO-2023) [18] Updated 13 Jun 2023 |
| 02 Jun 2023 | Trial Update | Nascent Biotech plans a phase II trial for Glioma (Monotherapy, Combination therapy, Second-line therapy or greater, Newly diagnosed) [10] Updated 04 Jul 2023 |
| 18 Apr 2023 | Regulatory Status | Nascent Biotech submits phase II clinical trial protocol to US FDA for Brain cancer [9] Updated 24 Apr 2023 |
| 01 Mar 2023 | Trial Update | Nascent Biotech completes a phase-I trial in Brain cancer (Second-line therapy or greater, Metastatic disease, Recurrent) in USA (IV) [11] Updated 16 Mar 2023 |
| 25 Jan 2023 | Regulatory Status | Nascent Biotech plans to submit phase II clinical trial protocol to the US FDA for evaluation [17] Updated 21 Feb 2023 |
| 18 Jan 2023 | Trial Update | Nascent Biotech completes enrolment in Phase-I clinical trial in Brain cancer (Second-line therapy or greater, Metastatic disease, Recurrent) in USA (IV) (NCT04396717) [16] Updated 24 Jan 2023 |
| 13 Sep 2022 | Trial Update | Nascent plans a phase II trial for Brain cancer in USA [15] [9] Updated 04 Oct 2022 |
| 14 Jun 2022 | Trial Update | Nascent plans a phase II trial for Lung cancer and Breast cancer (Metastatic, Second line therapy or greater) in USA and China [14] Updated 17 Jun 2022 |
| 28 Feb 2022 | Phase Change - No development reported | No recent reports of development identified for preclinical development in Pancreatic-cancer in USA (IV) Updated 28 Feb 2022 |
| 02 Sep 2021 | Biomarker Update | Biomarkers information updated Updated 02 Oct 2021 |
| 02 Mar 2021 | Patent Information | Nascent Biotech receives Notice of Allowance for a Method of Use patent for pritumumab in USA [28] Updated 08 Mar 2021 |
| 15 Dec 2020 | Phase Change - I | Phase-I clinical trials in Brain cancer (Second-line therapy or greater, Metastatic disease, Recurrent) in USA (IV) (NCT04396717) [13] Updated 18 Dec 2020 |
| 24 Aug 2020 | Trial Update | Nascent Biotech plans a phase I trial in Brain cancer (Metastatic disease) in USA later in 2020 (IV, Infusion) (NCT04396717) [19] Updated 18 Dec 2020 |
| 28 Jul 2020 | Licensing Status | Nascent Biotech and Syracuse University enter into an agreement for the development of pritumumab for COVID-2019 infections [1] Updated 31 Jul 2020 |
| 17 Jun 2020 | Trial Update | Nascent Biotech plans a preclinical trial in COVID-2019 infections Updated 22 Jun 2020 |
| 19 Mar 2020 | Phase Change | Early research in COVID-2019 infections in USA (Parenteral) [2] Updated 26 Mar 2020 |
| 31 Dec 2018 | Regulatory Status | The US FDA imposes full clinical hold for IND application of prospective planned phase I trial for Brain cancer before December 2018 Updated 28 Aug 2020 |
| 11 Dec 2018 | Regulatory Status | The US FDA approves the IND application to initiate a phase I trial in Brain cancer before December 2018 Updated 28 Aug 2020 |
| 11 Dec 2018 | Regulatory Status | The US FDA directs Nascent Biotech to move its IND application from full clinical hold to partial hold before December 2018 Updated 28 Aug 2020 |
| 01 Jan 2018 | Phase Change - Preclinical | Preclinical trials in Pancreatic cancer in USA (IV) [24] Updated 25 Apr 2018 |
| 19 Jul 2016 | Licensing Status | Nascent Biotech enters into an exclusive licensing agreement with Zhejiang Hisun Pharmaceutical Company for development, manufacture and commercialisation of pritumumab in China [5] Updated 22 Jul 2016 |
| 25 Apr 2016 | Regulatory Status | Pritumumab receives Orphan Drug status for Pancreatic cancer in USA [22] Updated 18 May 2016 |
| 14 Apr 2016 | Scientific Update | Pharmacodynamics and pharmacokinetics data from preclinical studies in Cancer presented at the 107th Annual Meeting of the American Association for Cancer Research (AACR-2016) [25] Updated 30 Apr 2016 |
| 29 Jan 2016 | Phase Change - II | Phase-II clinical trials in Glioma in Japan (IV) Updated 29 Jan 2016 |
| 13 Aug 2015 | Regulatory Status | Nascent Biotech plans to file an IND exemption application with the US FDA in USA [20] Updated 20 Aug 2015 |
| 26 Feb 2015 | Company Involvement | Nascent Biotech and Mapp Biopharmaceutical receive SBIR grant from National Institutes of Health (USA) for pritumumab development in Brain cancer [3] Updated 04 Mar 2015 |
| 28 Oct 2014 | Regulatory Status | Pritumumab receives Orphan Drug status for Glioma in USA [21] Updated 19 Aug 2015 |
| 29 Jul 2014 | Company Involvement | Nascent Biologics is now called Nascent Biotech [4] Updated 04 Mar 2015 |
| 20 Apr 2012 | Active Status Review | Although no recent development has been reported for pritumumab, Nascent Biologics is planning to conduct phase I/II trials in Glioma in the US Updated 20 Apr 2012 |
| 01 Dec 2009 | Scientific Update | Efficacy, adverse event and pharmacodynamic data from preclinical and clinical trials published in the Journal of Human Antibodies [23] Updated 18 Apr 2012 |
| 17 Aug 2001 | Phase Change - No development reported | No-Development-Reported for Glioma in Japan (IV) Updated 17 Aug 2001 |
| 17 Jan 1995 | Phase Change - II | Phase-II clinical trials for Glioma in Japan (IV) Updated 17 Jan 1995 |
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