KAND 567
Alternative Names: AZD-8797; KAN-0440567; KAND-567Latest Information Update: 28 Feb 2024
At a glance
- Originator AstraZeneca
- Developer AstraZeneca; Kancera
- Class 2 ring heterocyclic compounds; Amines; Analgesics; Anti-inflammatories; Antineoplastics; Cardiovascular therapies; Neuroprotectants; Organic sulfur compounds; Pyrimidines; Small molecules; Thiazoles
- Mechanism of Action Chemokine CXCL13 inhibitors
-
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
- Phase II Myocardial infarction; SARS-CoV-2 acute respiratory disease
- Phase I/II Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
- Preclinical Spinal cord injuries
- No development reported Autoimmune disorders; Breast cancer; Cancer pain; Cardiovascular disorders
- Discontinued Multiple myeloma
Most Recent Events
- 28 Feb 2024 No recent reports of development identified for phase-I development in Myocardial-infarction in Finland (PO, Capsule)
- 06 Feb 2024 Adverse events, efficacy and pharmacodynamics data from the phase-IIa FRACTAL study in Myocardial infarction released by Kancera ,
- 06 Feb 2024 Kancera plans a registrational phase-IIb/III trial for Cardiovascular diseases
Development Overview
Introduction
KAND 567 (previously AZD 8797) is a small-molecule antagonist of the Fractalkine receptor CX3CR1, being developed by Kancera, under an agreement with Acturum Life Science and in collaboration with Uppsala University, for the treatment of myocardial infarction, SARS-COV-2 acute respiratory disease, cardiovascular inflammation, ovarian cancer and spinal cord injuries. Fractalkine is an immune-modulating factor, which transmits signals via the CX3CR1 receptor, thereby controlling the function of immune cells and cancer cells. Clinical development for fallopian tube cancer, ovarian cancer, peritoneal cancer is underway in Norway, Sweden, Denmark. Clinical development for SARS-COV-2 acute respiratory disease and ovarian cancer is underway in Sweden, whereas clinical evaluations for myocardial infraction are ongoing in the UK, England, Sweden and Finland. Preclinical development is underway in Sweden, for cardiovascular inflammation, ovarian cancer and spinal cord injuries.
No recent reports of development have been identified for cancer pain, breast cancer, and autoimmune disorders. Development for the treatment of multiple myeloma has been discontinued.
AstraZeneca originally developed KAND 567 against multiple sclerosis. Acturum Life Science later acquired the rights to the project from AstraZeneca.
As at March 2021, no recent reports of development had been identified for preclinical development in Ovarian-cancer in Sweden (PO).
As at April 2023, no recent reports of development had been identified for phase-I development in Myocardial-infarction (In volunteers) in Sweden (IV, Infusion), Finland (IV, Infusion), preclinical development in Cardiovascular-disorders in Sweden (PO), preclinical development in Ovarian-cancer in Sweden (PO).
As at February 2024, no recent reports of development had been identified for phase-I development in Myocardial-infarction in Finland (PO, Capsule).
Company Agreements
In February 2021, Kancera entered into a collaboration with SciLifeLab, which gives Kancera the opportunity to identify new starting points for drug development as needed. Kancera announced that the company is collaborating with SciLifeLab in a research study of patients with COVID-19 who have suffered from long-term symptoms. The purpose of the study is to map how the immune system affects these patients, which is expected to contribute to the development of new treatments. [1]
In September 2017, Kancera entered into a development and manufacturing agreement with Recipharm, for the manufacture of KAND 567. As part of the collaboration, Recipharm will develop the preparation that is required for effective release of KAND 567 from the capsules, as well as manufacturing the pharmaceutical product. The work is intended to be performed at Recipharm’s development facility in Solna [2]
According to the Kancera first quarter of 2016 report, Kancera entered into an agreement with Acturum Life Science AB to evaluate and further develop KAND 567, in 2015. Under the agreement, Kancera has the right to evaluate KAND 567 in preclinical studies and then to acquire the project. The agreement entails no expenses for Kancera apart from investments in the patent portfolio and in the scientific evaluation. Kancera announced that it has chosen to acquire the project. If the acquisition goes through, following preclinical studies phase, the total payment to Acturum will consist of 6 million Kancera shares divided into three tranches, which are due at pre-defined success-milestones. Both companies will share the risk in product development through the first study in man.
Acturum Life Science acquired the rights to the KAND 567 project from AstraZeneca as part of Acturum’s acquisition of the research facility in Södertälje. However, AstraZeneca has retained the rights to develop Fractalkine inhibitors against respiratory diseases.
Key Development Milestones
In February 2024, Kancera announced it's intention to initiate a phase IIb/III registrational trial in cardiovascular diseases [3] .
In July 2021, Kancera completed a phase II trial that evaluated efficacy, safety, tolerability and pharmacokinetics of KAND 567 in patients with SARS-COV-2 acute respiratory disease (KAN0006; EudraCT2020-002322-85). The open label trial was initiated in July 2020 and enrolled 40 patients in Denmark. The trial prematurely ended in Sweden. Patients will be administered with either oral KAND 567 as capsule in combination with the best standard treatment or only the best standard treatment. Earlier the Swedish Medical Products Agency had approved the clinical trial application (CTA) to conduct the phase II trial. Kancera had submitted an application to the Swedish Medicines Agency in May 2020. As at April 2021, two third patients were dosed in the trial. In February 2022, Kancera announced that the results obtained from the trial indicated favourable safety and "proof of principle" for the desired pharmacological effect on inflammatory cells [4] [5] [6] [7] [8] . In June 2021, company completed patient recruitment for the COVID-19 study after just over 80%of the originally planned number of COVID-19 patients have received their dose. The decision was made in light of the fact that the number of cases in need of hospital care has decreased significantly and the current patient base was considered sufficient to provide important and relevant results [9] .
In July 2023, Kancera announced that the trial met primary and secondary endpoints and completed the phase IIa FRACTAL trial that evaluated the safety, tolerability, anti-inflammatory and cardio-protective effects after intravenous and oral administration of KAND 567 in ST-elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (EudraCT2021-001354-53; ISRCTN18402242; 21NW0178; IRAS1003810; Sponsor-ID09603). The double-blind, parallel, randomised trial was initiated in January 2021 and enrolled 60 patients in the UK. In February 2022, Kancera announced that the trial reached the primary objective of the study [10] . In December 2022, Kancera announced that a decision has been made to enable the recruitment of an additional 10 patients to the FRACTAL study [11] [12] [4] [13] . In March 2023, company completed the enrollment of 71 patients in the trial [14] . In December 2023, Kancera released topline data from the FRACTAL study [3] [15] .
In March 2023, Kancera initiated the phase Ib/IIa KANDOVA-study in patients with ovarian cancer (EudraCT2022-002792-11; NCT06087289; KAN0007). This open-label, multicenter dose escalation study to evaluate the safety and tolerability of KAND 567, in combination with carboplatin therapy, and to determine the Recommended Phase II Dose (RPIID) of KAND 567 with an expansion cohort in women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer intends to enroll 30 participants in Norway and Sweden and may extend to Denmark [16] . . In February 2023, the Swedish Medical Products Agency approved a clinical trial application for the phase Ib/IIa KANDOVA-study in patients with ovarian cancer. The primary objective of the trial is to evaluate safety and tolerability of KAND 567 in combination with carboplatin therapy in patients with relapsed ovarian cancer. The secondary objective is to evaluate the efficacy of KAND 567. The trial intends to enrol patients in Sweden, Denmark and Norway. Earlier, in December 2022, Kancera submitted a regulatory application for clinical trial of KAND 567 to the Swedish Medical Products Agency in ovarian cancer. Previously, Kancera reported that clinical trial applications to the Danish and Norwegian regulatory agencies had been submitted and expects to receive clearance by March 2023 [12] [17] . In June 2023, Kancera reported that the first patient has been dosed in the trial [18] . As of November 2023, two patients were enrolled in the trial [19]
A capsule formulation of KAND 567 has been evaluated in a phase I study in Finland [20] .
In February 2021. Kancera completed a phase Ib trial that evaluated the safety, tolerance and exposure of KAND 567 administered intravenously in 27 healthy volunteers in Sweden and Finland. The double blind trial tria was initiated in June 2019. In March 2020, Kancera released positive data from the final part of phase Ib trial and evaluated safety, tolerability in 17 healthy volunteers with 6 volunteers in placebo. A total of 92 healthy volunteers have been tested in phase I study [21] . The start of the trial triggered the third and final payment in the form of two million shares to Acturum, in mid-July, in accordance with the ongoing agreement between the two companies [22] [23] [24] . Earlier in May 2019, Medical Products Agency and the Ethics Committee had approved the application for the study. In August 2019, first exploratory part of the trial was completed and company announced positive interim results in healthy participants. The company also announced that a supplemental application would be filed to the Medical Products Agency, for the approval of an adjusted ratio of infusion rate to concentration of KAND 567. The protocol was amended to avoid local irritation at the infusion site, observed in the interim analysis [25] [26] [22] [27] . The company applied for permission by submitting a supplemental dosing strategy to Swedish Medical Products Agency to adjust ratio of infusion rate to concentration of KAND 567. The Swedish Medical Products Agency advised the company to submit supplementary information and a new application permit in order to continue the study. In February 2020, Kancera received approval from the Finnish Medicines Agency Fimea and the Ethics Committee to start the final part of the phase Ib program for KAND 567 [28] . Earlier in November 2019, Kancera reported that it had compiled the requested information and prepared a new application, but in order to maintain the timeline for a phase IIa trial the company had elected to apply for the final part of the study in Finland instead of as previously planned in Sweden. In December 2019, company released analysis of blood samples from healthy participants [29] [30] [22] [25] .
In February 2022, Kancera announced its plans to initiate a phase Ib trial that will evaluate the tolerability of KAND 567 in combination with chemotherapy and the effect on markers that reflect the treatment's effect on the cancer disease [4] .
In February 2019, Kancera completed a phase Ia trial that evaluated the safety, tolerability and pharmacokinetic properties of KAND 567 in healthy volunteers. The randomised, double-blind, placebo-controlled trial was initiated in May 2017 and enrolled 82 healthy participants, in the Netherlands. First part of the study is single dose part of the study in which increasing single doses (8-2500 mg) of KAND 567 was given to groups of 62 healthy volunteers with and without food on different occasions. In the second part which is multiple dose part of the study, KAND 567 was given in increasing doses up to 7 days (300 - 800 mg twice a day). The second part of the study was commenced in September 2017 [31] [32] . In February 2018, Kancera announced positive results from this study. Results showed that KAND 567 blocks the fractalkine system by reducing the number of fractalkine receptors on the surface of immune cells. In February 2019, results from the 66 evaluable patients were released by the company [33] [34] [35] .
In December 2022, Kancera in collaboration with Nordic Society of Gynaecological Oncology plans a phase Ib/IIa trial of KAND 567 in combination with platinum therapy in ovarian cancer patients with relapsed disease. The trial is intended in Sweden, Denmark and Norway [17] .
In April 2021, Kancera released preclinical results which showed that KAND 567 was effective in ovarian cancer which were refractory to chemotherapy, through inhibition of DNA repair [5] .
In June 2020, Kancera released preclinical data showing nerve-protective effect of KAND 567 in disease model of spinal cord injury [6] .
In January 2019, Kancera released safety data for the preclinical toxicological study of intravenous KAND 567 [27] .
In preclinical studies, KAND 567 exhibited an anti-inflammatory effect and protected blood vessels in atherosclerosis [36]
KAND 567 showed cardiovascular protection properties in preclinical disease models [35] . KAND 567 was evaluated for efficacy and safety in a disease model of myocardial infarction and in a toxicological GLP study, respectively. The efficacy study showed that lower doses than expected provided a significant cardio-protective effect. Preliminary results from the toxicology study provided evidence pointing towards the safety of the calculated effective dose of KAND 567 [37] .
Earlier, in April 2017, Kancera applied to the relevant authorities in the Netherlands for authorization for clinical trials. The Medical Ethics Committee (METC) at the University Medical Center in Groningen, the Netherlands, has given approval for the initiation of the phase I study (Kancera pipeline, December 2017).
According to the Kancera company website, as of August 2016, the company intends to apply for orphan drug designation for KAND 567.
In preclinical studies, KAND 567 counteracted the onset of autoimmune disorders, as well as neuritis and pain in connection with chemotherapy against cancer [2] .
Financing information
As of December 2022, Kancera completed rights issue ensures financing of the KANDOVA study - clinical development against ovarian cancer [11] .
In February 2021, Kancera announced that the conversion of TO4 during 2020 provided Kancera with a total of approximately SEK 38.6 million, which may be utilised for an accelerated development of the company's drug projects aimed at COVID-19 and myocardial infarction, including the drug candidates KAND 567 and KAND 145 [see AdisInsight drug profile800052463] [1] .
Kancera, in November 2019, received a bridge financing of approximately SEK 14.0 million. The company intends to use the proceeds from this financing for completing the phase Ib trial of KAND 567. The company expects to receive new issue units of approximately SEK 61.4 million during first quarter of 2020.The funds from this financing will be used to carry phase IIa trial [30]
Patent Information
In August 2023, Kancera reported that the US patent office (USPTO) has issued a patent that protects the manufacturing processes for KAND567. This patent (US 116 919 88) enables Kancera to apply for data exclusivity and market protection for up to 7.5 years for the first indication approved in the United States [38] .
In March 2023, the Japan patent office granted a patent to Kancera, that protects the manufacturing processes for KAND 567 and KAND 145 [See AdisInsight drug profile 800052463]. The patent, JP7 225 379, is owned by Kancera and is valid until 2039 [39] .
In January 2023, Kancera reported that the US patent office (USPTO) has issued a patent that protects the manufacturing processes for KAND567. The patent, 11,542,281, is owned by Kancera and is valid until 2039 [40] .
In August 2019, Kancera reported that two patent applications related to KAND 567, entered the international phase, at the conclusion of the second quarter of 2019. The patent applications were filed earlier in July 2018, as reported by Kancera [22] [41] . Patents contains use of KAND 567 for the treatment and prevention of hyperinflammation in viral infections [7] .
Drug Properties & Chemical Synopsis
- Route of administration IV, PO
- Formulation Capsule, Infusion, unspecified
- Class 2 ring heterocyclic compounds, Amines, Analgesics, Anti-inflammatories, Antineoplastics, Cardiovascular therapies, Neuroprotectants, Organic sulfur compounds, Pyrimidines, Small molecules, Thiazoles
- Target Chemokine CXCL13
- Mechanism of Action Chemokine CXCL13 inhibitors
-
WHO ATC code
C01 (Cardiac Therapy)
J05A-X (Other antivirals)
L01 (Antineoplastic Agents)
N02 (Analgesics)
N07X (Other Nervous System Drugs)
-
EPhMRA code
C1 (Cardiac Therapy)
J5B9 (Antivirals, others)
L1 (Antineoplastics)
N2 (Analgesics)
N7X (All other CNS drugs)
- Chemical name (2R)-2-[[2-amino-5-[(1S)-1-phenylethyl]sulfanyl-[1,3]thiazolo[4,5-d]pyrimidin-7-yl]amino]-4-methylpentan-1-ol
- Molecular formula C19 H25 N5 O S2
- SMILES C(C(CC(C)C)NC1=C2C(=NC(=N1)SC(C)C1C=CC=CC=1)N=C(S2)N)O
-
Chemical Structure
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| Autoimmune disorders | - | - | No development reported (I) | Netherlands | PO / unspecified | Kancera | 28 Jun 2020 |
| Breast cancer | - | - | No development reported (Preclinical) | Sweden | PO / unspecified | Kancera | 28 Apr 2020 |
| Cancer pain | - | - | No development reported (I) | Netherlands | PO / unspecified | Kancera | 28 Jun 2020 |
| Cardiovascular disorders | Cardiovascular inflammation | - | No development reported (Preclinical) | Sweden | PO / unspecified | Kancera | 28 Apr 2023 |
| Fallopian tube cancer | in combination with carboplatin | Combination therapy, Late-stage disease, Recurrent, Second-line therapy or greater | Phase I/II | Norway, Sweden | PO / Capsule | Kancera | 20 Apr 2023 |
| Multiple myeloma | - | - | Discontinued (Preclinical) | United Kingdom | PO / unspecified | AstraZeneca | 15 Aug 2016 |
| Myocardial infarction | ST-elevation myocardial infarction (STEMI) | - | Phase II | United Kingdom | PO / Capsule | Kancera | 15 Nov 2021 |
| Myocardial infarction | ST-elevation myocardial infarction (STEMI) | - | Phase II | United Kingdom | IV / Infusion | Kancera | 15 Nov 2021 |
| Myocardial infarction | - | In volunteers | No development reported (I) | Finland, Sweden | IV / Infusion | Kancera | 28 Apr 2023 |
| Myocardial infarction | - | - | No development reported (I) | Finland | PO / Capsule | Kancera | 28 Feb 2024 |
| Ovarian cancer | in combination with carboplatin | Combination therapy, Late-stage disease, Recurrent, Second-line therapy or greater | Phase I/II | Norway, Sweden | PO / Capsule | Kancera | 20 Apr 2023 |
| Ovarian cancer | - | - | No development reported (Preclinical) | Sweden | PO / Capsule | Kancera | 28 Apr 2023 |
| Peritoneal cancer | in combination with carboplatin | Combination therapy, Late-stage disease, Recurrent, Second-line therapy or greater | Phase I/II | Norway, Sweden | PO / Capsule | Kancera | 20 Apr 2023 |
| SARS-CoV-2 acute respiratory disease | - | Combination therapy | Phase II | Sweden | PO / Capsule | Kancera | 02 Jul 2020 |
| Spinal cord injuries | - | - | Preclinical | Sweden | unspecified / unspecified | Kancera | 15 Jun 2020 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| AstraZeneca | Originator | United-Kingdom |
| Acturum Life Sciences | Owner | Sweden |
| Uppsala University | Collaborator | Sweden |
| Karolinska Institute | Collaborator | Sweden |
| Kancera | Collaborator | Sweden |
| Recipharm | Collaborator | Sweden |
| Nordic Society of Gynaecological - Clinical Trial Unit | Collaborator | Denmark |
| SciLifeLab | Collaborator | Sweden |
Scientific Summary
Pharmacokinetics
Phase II:
Data from the phase IIa FRACTAL study showed that the selected dosage of KAND567 resulted in an adequate plasma concentration of the drug candidate and expected effect on the fractalkine axis [15] [13] .
Results of a phase Ia study showed that efficient absorption of KAND 567 from the intestine to the blood independent of food was observed. KAND 567 stays in the blood long enough in humans to allow dosage one to two times a day. The randomized, double-blind, placebo-controlled trial assessed KAND 567 for the treatment of cancer, cancer pain and auto-immune disorders in 62 healthy participants [34] [32] .
Results from final part of the phase Ib study involving 17 healthy volunteers versus 6 in placebo, showed desired plasma concentration of KAND 567 upon intravenous infusion similar to that found in interim results from a phase Ib study in 27 evaluable volunteers. Desired effect on the immune system reaches the heart within two minutes of the start of the intravenous infusion [21] [22] [24] .
Adverse Events
Phase II:
Safety data from the phase IIa FRACTAL study showed that KAND567 is safe and tolerable at the dose level expected to be effective for treatment of high-risk STEMI patients when added to standard of care in patients undergoing acute PCI. KAND567 and placebo had similar safety profiles. No other treatment emergent adverse event was observed [15] [13] .
Results from final part of phase Ib study involving 17 healthy volunteers versus 6 healthy volunteers in placebo, of KAND 567 was found to be well tolerated by intravenous administration and it complements the phase Ia study data. Interim results from a phase Ib study in 27 evaluable volunteers, showed that KAND 567 was safe and well-tolerated, when administered as a short-term intravenous infusion, in the initial, exploratory trial phase. The follow-up part of the study however, revealed incidences of local irritation at the infusion site, when the infusion was administered for an extended period [21] [22] [24] .
Results from the single dose part and the multiple dose part of a phase Ia study showed that KAND 567 was safe and well tolerated. In single dose part of the study, no clinically relevant side effects were observed in KAND 567 treated patients in single doses up to 2500 mg. In multiple dose part of the study, KAND 567 is safe and well-tolerated up to 500 mg twice daily for 7 days with five to ten times higher plasma levels achieved than the calculated effective level for therapeutic effect in humans. Gastric side effects in the form of diarrhoea and a clinically relevant increase in markers for hepatic impairment were observed at a dose of 800 mg twice a day (total 1600 mg). However, markers for hepatic impairment returned to normal level after the end of treatment. No other clinically relevant side effects of KAND567 were noted. The randomized, double-blind, placebo-controlled trial assessed KAND 567 for the treatment of cancer, cancer pain and auto-immune disorders in 62 healthy participants [35] [34] [32] .
In preclinical toxicological study, administration of intravenous KAND567 demonstrated favourable safety profile [27] .
Pharmacodynamics
Results from a phase Ia study showed that decrease in the number of fractalkine receptors on the cell surface of specific immune cells such as NK cells, T cells and monocytes was observed in KAND 567 (300 mg, twice daily) treated patients. Invitro studies in whole blood showed that KAND 567 blocks the fractalkine signal in human immune cells at low concentrations. These findings showed that KAND567 blocks the fractalkine system through two co-operating mechanisms. The randomized, double-blind, placebo-controlled trial assessed KAND 567 for the treatment of cancer, cancer pain and auto-immune disorders in 62 healthy participants [35] [34] [32] .
Preclinical studies in animal models showed that KAND 567 has shown cardiovascular protective anti-inflammatory properties as evident by significant reduction in infarct size (internal report), stabilisation of vascular plaque (internal report) that can cause infarction and reversal of relapse (restenosis) after widening of the coronary artery with so-called vessel stents [34] .
In the phase IIa FRACTAL study, administration of KAND 567 resulted in an effective engagement of the targeted fractalkine axis, a statistically significant reduction of CX3CR1 on targeted immune cells over time in the KAND 567 group compared to the placebo group (p<0.001-0.02). A statistically significant increase of free CX3CL1 in blood plasma over time (p<0.05), did not change the levels of main sub types of leukocytes, indicating that the general immune function is maintained [3] [13] .
Preclinical studies in disease model of spinal cord injury showed that a single daily administration of KAND 567 improved the healing of spinal cord injury. An analysis of spinal cord tissue showed that KAND 567 prevented nerve cells from dying. The nerve-protective effect was due to KAND 567 suppressing the hyperinflammation that occurs after spinal cord injury. This was evident from a decreased level of the inflammation driving cytokines IL-1beta and IL-6 in the spinal cord [6] .
Immunogenicity
Summary
In phase Ib trial, the analysis of blood samples demonstrated lowered levels of an established and clinically relevant immune marker in the participants treated with KAND 567 which showed that blockage of the Fractalkine system led to a significant decrease in activity of two types of immune cells involved in inflammatory diseases and the effect was observed after two hours of infusion [29] [24] .
Therapeutic Trials
The analysis of immune cells in the blood from the phase Ia trial involving 66 evaluable patients demonstrated a statistically significant activation of the fractalkine system in the lymphoma patients compared to a group of healthy controls [33] .
Phase II:
Topline data from the phase IIa FRACTAL study in patients (n=61) with ST-elevation myocardial infarction (STEMI) showed that the study met the primary objective to confirm the favorable safety and tolerability profile of KAND567. the secondary objective to demonstrate signals of clinically relevant cardio-protective effects was also met. Reduction of intramyocardial hemorrhage incidence (57% and 38% in KAND 567 and placebo group, respectively) (p=0.19). The reduction in the KAND 567 group is perceived to be clinically relevant as IM hemorrhage is strongly correlated with an increased risk of developing heart failure. Reduction of left ventricular (LV) thrombosis incidence (2.7% and 17.6% in KAND 567 and placebo group, respectively) (p=0.05). All other markers of cardiac function and integrity were in favor of the KAND 567 group when comparing change Day 3 and Day 90. The reduced incidence of LV thrombosis was achieved on top of an intensive anticoagulant and antiplatelet therapy [3] [15] [13] .
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Dec 2023 | Trial Update | Kancera and Nordic Society of Gynaecological Oncology plans the phase Ib/IIa KANDOVA trial for Ovarian cancer (Combination therapy, Second-line therapy or greater,) in Sweden, Denmark and Norway in 2023 [17] | 27 Feb 2024 |
| 31 Mar 2023 | Regulatory Status | Kancera plans to file regulatory application submission for clinical trial for Ovarian cancer in Denmark and Norway in first quarter of 2023 [17] | 28 Feb 2023 |
| 31 Mar 2023 | Regulatory Status | Kancera anticipates approval of clinical trial applications from the Danish and Norwegian regulatory agencies for Ovarian cancer in March 2023 [12] | 28 Feb 2023 |
| 01 Jan 2022 | Trial Update | Kancera plans a clinical trial for Cancer, in early 2022 [42] | 24 Mar 2021 |
| 30 Jun 2021 | Trial Update | Kancera plans the phase IIa FRACTAL trial for Myocardial infarction (PO) in the United Kingdom, in the first half of 2021 (700302310) (9313672) (EudraCT2021-001354-53) [30] | 06 Dec 2021 |
| 30 Mar 2021 | Regulatory Status | Kancera in collaboration with Newcastle University Hospital Foundation announces intention to submit application to UK MHRA to initiate a phase IIa trial for Myocardial infarction in the United Kingdom, during the first quarter of 2021 (9313672) [21] | 24 Feb 2021 |
| 30 Jun 2019 | Regulatory Status | Kancera plans to file regulatory application with the Japanese Pharmaceuticals and Medical Devices Agency for a IIa trial in Myocardial infarction in the second quarter of 2019 [37] | 28 Nov 2018 |
| 30 Jun 2019 | Trial Update | Kancera plans a phase Ib trial in healthy volunteers in Sweden, in June 2019 (IV) [27] | 26 Jun 2019 |
| 31 Mar 2019 | Regulatory Status | Kancera plans to file regulatory application with the Medical Products Agency for a phase Ib trial in healthy volunteers in the first quarter of 2019 [37] | 28 May 2019 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 28 Feb 2024 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Myocardial-infarction in Finland (PO, Capsule) Updated 28 Feb 2024 |
| 06 Feb 2024 | Scientific Update | Adverse events, efficacy and pharmacodynamics data from the phase-IIa FRACTAL study in Myocardial infarction released by Kancera [3] , Updated 13 Feb 2024 |
| 06 Feb 2024 | Trial Update | Kancera plans a registrational phase-IIb/III trial for Cardiovascular diseases [3] Updated 13 Feb 2024 |
| 20 Dec 2023 | Scientific Update | Topline adverse event, efficacy and pharmacokinetic data from the phase IIa FRACTAL study in Myocardial infarction released by Kancera [15] , Updated 13 Feb 2024 |
| 18 Aug 2023 | Patent Information | Kancera has patent protection for KAN D567 in the USA [38] Updated 22 Aug 2023 |
| 31 Jul 2023 | Trial Update | Kancera completes a phase IIa FRACTAL trial in Myocardial infarction in the UK (EudraCT2021-001354-53) (ISRCTN18402242) Updated 07 Aug 2023 |
| 28 Apr 2023 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Myocardial-infarction(In volunteers) in Finland (IV, Infusion) Updated 28 Apr 2023 |
| 28 Apr 2023 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Myocardial-infarction(In volunteers) in Sweden (IV, Infusion) Updated 28 Apr 2023 |
| 28 Apr 2023 | Phase Change - No development reported | No recent reports of development identified for preclinical development in Cardiovascular-disorders in Sweden (PO) Updated 28 Apr 2023 |
| 28 Apr 2023 | Phase Change - No development reported | No recent reports of development identified for preclinical development in Ovarian-cancer in Sweden (PO) Updated 28 Apr 2023 |
| 20 Apr 2023 | Phase Change - I/II | Phase-I/II clinical trials in Fallopian tube cancer (Combination therapy, Late-stage disease, Recurrent, Second-line therapy or greater) in Sweden (PO) [38] (NCT06087289) Updated 22 Aug 2023 |
| 20 Apr 2023 | Phase Change - I/II | Phase-I/II clinical trials in Ovarian cancer (Recurrent, Combination therapy, Late-stage disease, Second-line therapy or greater) in Sweden (PO) [38] (NCT06087289) Updated 22 Aug 2023 |
| 20 Apr 2023 | Phase Change - I/II | Phase-I/II clinical trials in Peritoneal cancer (Combination therapy, Recurrent, Late-stage disease, Second-line therapy or greater) in Sweden (PO) [38] (NCT06087289) Updated 22 Aug 2023 |
| 27 Mar 2023 | Phase Change - I/II | Phase-I/II clinical trials in Fallopian tube cancer (Late-stage disease, Combination therapy, Recurrent, Second-line therapy or greater) in Norway (PO) (EudraCT2022-002792-11) Updated 30 Jun 2023 |
| 27 Mar 2023 | Phase Change - I/II | Phase-I/II clinical trials in Ovarian cancer (Combination therapy, Late-stage disease, Recurrent, Second-line therapy or greater) in Norway (PO) (EudraCT2022-002792-11) Updated 30 Jun 2023 |
| 27 Mar 2023 | Phase Change - I/II | Phase-I/II clinical trials in Peritoneal cancer (Combination therapy, Recurrent, Late-stage disease, Second-line therapy or greater) in Norway (PO) (EudraCT2022-002792-11) Updated 30 Jun 2023 |
| 23 Mar 2023 | Patent Information | Kancera has patent protection for the manufacturing processes for KAND 567 and KAND 145 in Japan [39] Updated 24 Mar 2023 |
| 01 Mar 2023 | Trial Update | Kancera completes enrolment in the phase IIa FRACTAL trial for Myocardial infarction in the UK ((EudraCT2021-001354-53) (ISRCTN18402242) Updated 07 Mar 2023 |
| 16 Feb 2023 | Regulatory Status | Kancera anticipates approval of clinical trial applications from the Danish and Norwegian regulatory agencies for Ovarian cancer in March 2023 [12] Updated 28 Feb 2023 |
| 16 Feb 2023 | Regulatory Status | Kancera files clinical trial applications for KAND 567 with the Danish and Norwegian regulatory agencies for Ovarian cancer [12] Updated 28 Feb 2023 |
| 16 Feb 2023 | Regulatory Status | Swedish Medical Products Agency approves IND application for KAND 567 in Ovarian cancer (Second-line or greater; Combination therapy) [12] Updated 28 Feb 2023 |
| 30 Jan 2023 | Patent Information | Kancera has patent protection for KAND567 in the USA [40] Updated 02 Feb 2023 |
| 22 Dec 2022 | Trial Update | Kancera and Nordic Society of Gynaecological Oncology plans the phase Ib/IIa KANDOVA trial for Ovarian cancer (Combination therapy, Second-line therapy or greater,) in Sweden, Denmark and Norway in 2023 [17] Updated 27 Feb 2024 |
| 22 Dec 2022 | Regulatory Status | Kancera plans to file regulatory application submission for clinical trial for Ovarian cancer in Denmark and Norway in first quarter of 2023 [17] Updated 28 Feb 2023 |
| 22 Dec 2022 | Regulatory Status | Kancera files an regulatory application for clinical trial with the Swedish Medical Products Agency in Sweden for Ovarian cancer [17] Updated 03 Feb 2023 |
| 18 Feb 2022 | Trial Update | Kancera plans a phase I trial in Cancer (Combination therapy) [4] Updated 01 Mar 2022 |
| 18 Nov 2021 | Scientific Update | Safety and efficacy data from a phase IIa trial in COVID-2019 infections released by Kancera Updated 07 Dec 2021 |
| 15 Nov 2021 | Phase Change - II | Phase-II clinical trials in Myocardial infarction in United Kingdom (IV) (Eudra CT 2021-001354-53) (ISRCTN18402242) Updated 06 Dec 2021 |
| 15 Nov 2021 | Phase Change - II | Phase-II clinical trials in Myocardial infarction in United Kingdom (PO) (Eudra CT 2021-001354-53) (ISRCTN18402242) Updated 06 Dec 2021 |
| 07 Aug 2021 | Trial Update | Kancera completes a phase II clinical trials in SARS-COV-2 acute respiratory disease (Combination therapy) in Sweden (PO) (EudraCT2020-002322-85) Updated 01 Mar 2022 |
| 22 Jul 2021 | Trial Update | Kancera discontinues a phase II clinical trials in SARS-COV-2 acute respiratory disease (Combination therapy) in Denmark (PO) (EudraCT2020-002322-85) Updated 30 Jul 2021 |
| 16 Jun 2021 | Trial Update | Kancera completes patient recruitment in phase II trial in SARS-COV-2 acute respiratory disease [9] Updated 27 Jun 2021 |
| 21 Apr 2021 | Active Status Review | Preclinical development is still ongoing in Ovarian cancer in Sweden (PO) [5] Updated 23 Apr 2021 |
| 28 Mar 2021 | Phase Change - No development reported | No recent reports of development identified for preclinical development in Ovarian-cancer in Sweden (PO) Updated 28 Mar 2021 |
| 22 Mar 2021 | Trial Update | Kancera plans a clinical trial for Cancer, in early 2022 [42] Updated 24 Mar 2021 |
| 19 Feb 2021 | Trial Update | Kancera completes a phase Ib trial in Myocardial infarction (In volunteers) in Finland and Sweden (IV) Before February 2021 Updated 05 Mar 2021 |
| 19 Feb 2021 | Licensing Status | Kancera and SciLifeLab agree to co-develop KAND 567 for COVID-2019 infections [1] Updated 24 Feb 2021 |
| 15 Jan 2021 | Phase Change - I | Phase-I clinical trials in Myocardial infarction in Finland (PO), before January 2021 [20] Updated 21 Jan 2021 |
| 26 Nov 2020 | Other | Chemical structure information added Updated 26 Nov 2020 |
| 10 Jul 2020 | Regulatory Status | Swedish Medical Products Agency approves clinical trial application for KAND 567 in COVID-2019 infections Updated 16 Jul 2020 |
| 02 Jul 2020 | Phase Change - II | Phase-II clinical trials in SARS-COV-2 acute respiratory disease (Combination therapy) in Sweden (PO) (EudraCT2020-002322-85) Updated 27 Aug 2020 |
| 28 Jun 2020 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Autoimmune-disorders in Netherlands (PO) Updated 28 Jun 2020 |
| 28 Jun 2020 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Cancer-pain in Netherlands (PO) Updated 28 Jun 2020 |
| 15 Jun 2020 | Phase Change - Preclinical | Preclinical trials in Spinal cord injuries in Sweden (unspecified route) [6] Updated 22 Jun 2020 |
| 15 Jun 2020 | Scientific Update | Pharmacodynamics data from preclinical trial in Spinal cord injuries released by Kancera [6] Updated 22 Jun 2020 |
| 15 Jun 2020 | Trial Update | Kancera plans a phase II trial for SARS-COV-2 acute respiratory disease (PO, Capsule) [6] Updated 22 Jun 2020 |
| 15 May 2020 | Regulatory Status | Kancera submits application for phase II trial for Hyperinflammation in viral infections to Swedish Medicines Agency [7] Updated 22 May 2020 |
| 28 Apr 2020 | Phase Change - No development reported | No recent reports of development identified for preclinical development in Breast-cancer in Sweden (PO) Updated 28 Apr 2020 |
| 06 Mar 2020 | Regulatory Status | Kancera in collaboration with Newcastle University Hospital Foundation announces intention to submit application to UK MHRA to initiate a phase IIa trial for Myocardial infarction in the United Kingdom, during the first quarter of 2021 [20] [21] Updated 24 Feb 2021 |
| 06 Mar 2020 | Scientific Update | Final adverse events and pharmacokinetics data from a phase Ib trial in Myocardial infarction released by Kancera [21] Updated 17 Mar 2020 |
| 05 Feb 2020 | Regulatory Status | Kancera received approval from the Finnish Medicines Agency Fimea and the Ethics Committee to start the final part of the phase Ib program for Myocardial infarction for KAND 567 [28] Updated 25 Feb 2020 |
| 04 Dec 2019 | Scientific Update | Immunogenicity data from a phase Ib trial in Healthy volunteers released by Kancera [29] Updated 26 Dec 2019 |
| 26 Nov 2019 | Trial Update | Kancera plans the phase IIa FRACTAL trial for Myocardial infarction (PO) in the United Kingdom, in the first half of 2021 [20] (EudraCT2021-001354-53) [30] Updated 06 Dec 2021 |
| 23 Aug 2019 | Regulatory Status | Kancera submits supplemental dosing strategy for the continued implementation of the study to Swedish Medical Products Agency in August 2019 (9273407;9273422) Updated 03 Sep 2019 |
| 23 Aug 2019 | Patent Information | Kancera has pending patent applications for KAND 567 in undisclosed territories outside Sweden [22] Updated 28 Aug 2019 |
| 23 Aug 2019 | Scientific Update | Interim pharmacokinetics and adverse events data from a phase Ib trial in Healthy volunteers released by Kancera [22] Updated 28 Aug 2019 |
| 04 Jun 2019 | Phase Change - I | Phase-I clinical trials in Myocardial infarction (In volunteers) in Finland (IV) [30] Updated 06 Dec 2019 |
| 04 Jun 2019 | Phase Change - I | Phase-I clinical trials in Myocardial infarction (In volunteers) in Sweden (IV) [23] Updated 26 Jun 2019 |
| 24 May 2019 | Trial Update | Kancera plans a phase Ib trial in healthy volunteers in Sweden, in June 2019 (IV) [27] Updated 26 Jun 2019 |
| 24 May 2019 | Regulatory Status | Medical Products Agency approves application for phase Ib trial of KAND 567 in healthy volunteers [27] Updated 28 May 2019 |
| 09 Feb 2019 | Scientific Update | Efficacy data from phase Ia trial in Healthy volunteers released by Kancera [33] Updated 13 Feb 2019 |
| 09 Feb 2019 | Trial Update | Kancera completes a phase Ia pharmacokinetic trial in Healthy volunteers [33] Updated 13 Feb 2019 |
| 01 Jan 2019 | Scientific Update | Preclinical adverse events data for intravenous KAND 567 released by Kancera [27] Updated 28 May 2019 |
| 23 Nov 2018 | Regulatory Status | Kancera plans to file regulatory application with the Medical Products Agency for a phase Ib trial in healthy volunteers in the first quarter of 2019 [37] Updated 28 May 2019 |
| 23 Nov 2018 | Phase Change - Preclinical | Preclinical trials in Myocardial infarction in Sweden (IV) [37] Updated 29 Mar 2019 |
| 23 Nov 2018 | Regulatory Status | Kancera plans to file regulatory application with the Japanese Pharmaceuticals and Medical Devices Agency for a IIa trial in Myocardial infarction in the second quarter of 2019 [37] Updated 28 Nov 2018 |
| 09 Jul 2018 | Patent Information | Kancera files for patent protection for KAND 567 in Sweden, prior to July 2018 [41] Updated 13 Jul 2018 |
| 09 Jul 2018 | Trial Update | Kancera plans a phase IIa trial for Cancer [41] Updated 13 Jul 2018 |
| 30 Jun 2018 | Phase Change - Preclinical | Preclinical trials in Cardiovascular disorders (Cardiovascular inflmmation) in Sweden (PO) [37] Updated 28 Nov 2018 |
| 28 Feb 2018 | Scientific Update | Pharmacokinetics, pharmacodynamics and adverse events data from a phase Ia trial in Cancer released by Kancera [34] Updated 28 Feb 2018 |
| 28 Feb 2018 | Trial Update | Kancera in collaboration with Karolinska Institutet plans a clinical trial in Cancer [34] Updated 28 Feb 2018 |
| 20 Feb 2018 | Trial Update | Kancera plans clinical trials for myocardial infarction and Lymphoma [35] Updated 22 Feb 2018 |
| 14 Sep 2017 | Licensing Status | Kancera enters into development and manufacturing agreement with Racipharm for KAND 567 in the treatment of Cancer pain [2] Updated 20 Sep 2017 |
| 31 May 2017 | Phase Change - I | Phase-I clinical trials in Cancer in Netherlands (PO) (Kancera pipeline, December 2017) Updated 08 Dec 2017 |
| 31 May 2017 | Phase Change - I | Phase-I clinical trials in Autoimmune disorders in Netherlands (PO) [31] Updated 04 Dec 2017 |
| 31 May 2017 | Phase Change - I | Phase-I clinical trials in Cancer pain in Netherlands (PO) [31] Updated 04 Dec 2017 |
| 30 Apr 2017 | Regulatory Status | Kancera applies to the relevant authorities in the Netherlands for authorization for clinical trials (Kancera pipeline, December 2017) Updated 07 Dec 2017 |
| 31 Mar 2016 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for Multiple myeloma in United Kingdom prior to this date (PO) Updated 15 Aug 2016 |
| 31 Mar 2016 | Phase Change - Preclinical | Preclinical trials in Cancer pain, Breast cancer and Ovarian cancer in Sweden (PO) Updated 15 Aug 2016 |
| 31 Dec 2006 | Phase Change - Preclinical | Preclinical trials in Multiple myeloma in United Kingdom (PO) Updated 15 Aug 2016 |
References
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Interim report for fourth quarter 2020, 1 January - 31 December 2020.
Media Release -
Recipharm and Kancera collaborate to manufacture clinical trial supply.
Media Release -
Kancera presents the statistical analysis of top line data from the FRACTAL study.
Media Release -
Interim report for fourth quarter 2021, 1 January - 31 December 2021 Kancera AB (publ.), org.nr. 556806-8851.
Media Release -
Kancera provides an update on the development of the company's pharmaceutical project and nominates a new drug candidate.
Media Release -
Kancera's drug candidate KAND567 has a positive effect on mobility in a preclinical model of spinal cord injury.
Media Release -
Kancera applies for a Phase II study with KAND567 in covid-19 patients.
Media Release -
KAND567 Versus Placebo in Subjects Hospitalized with COVID-19. A Phase II, Randomized, 2-Arm Parallel-Group, Double-blind Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics
ctiprofile -
Kancera has completed patient recruitment for the COVID-19 study with KAND567.
Media Release -
Kancera reports that the FRACTAL-study is on track to report top line results in Q3 2023.
Media Release -
Interim Report Fourth Quarter 2022 January 1 - December 31 2022 Kancera AB (publ.), org.nr. 556806-8851.
Media Release -
Kancera reports that the Swedish Medical Products Agency has approved the application to conduct the KANDOVA-study and that Dr. Hanjing Xie has been appointed to Chief Medical Officer.
Media Release -
A Phase IIa, randomized, two-arm parallel-group, placebo-controlled, double-blind, multi-centre trial to evaluate the safety, tolerability, anti-inflammatory and cardio-protective effects after intravenous and oral administration of KAND567 in ST-elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention
ctiprofile -
Kancera reports that patient enrollment to the FRACTAL-study is completed and that top line results will be presented in Q3 2023.
Media Release -
Kancera reports positive top line results from the FRACTAL study.
Media Release -
KANDOVA - A two-part Phase Ib/IIa study to evaluate the safety and tolerability of KAND567, in combination with carboplatin therapy, and to determine the Recommended Phase II Dose (RPIID) of KAND567. An open-label, multicenter dose escalation study with an expansion cohort in women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
ctiprofile -
Kancera submits regulatory application to conduct clinical study in ovarian cancer and enters into collaboration with the Nordic Society of Gynaecological Oncology.
Media Release -
Kancera reports dosing of first patient in the KANDOVA study.
Media Release -
Kancera provides operational update in connection with release of financial interim report for third quarter 2023.
Media Release -
Kancera provides update on successful phase I study and planned phase II study with KAND567 treatment following heart attack.
Media Release -
Kancera reports positive results from the final part of the phase Ib program for KAND567 .
Media Release -
Kancera: Interim report for the second quarter 2019, 1 January - 30 June 2019.
Media Release -
Kancera announces start of clinical Phase Ib study of KAND567.
Media Release -
A supplementary phase 1b study to evaluate safety, tolerance and exposure of KAND567 administered intravenously in healthy subjects
ctiprofile -
Kancera announces positive interim results and a minor delay in ongoing Phase Ib clinical study of KAND567.
Media Release -
Kancera develops the dosing strategy for KAND567 which means an added delay of the phase 1b study .
Media Release -
INTERIM REPORT FOR THE FIRST QUARTER 2019, 1 January - 31 March 2019.
Media Release -
Kancera has received approval to start the final part of the phase Ib program for KAND567.
Media Release -
Kancera reports in-depth analysis of the Phase Ib program with KAND567, showing the desired effect on the human immune system.
Media Release -
Interim report for the third quarter 2019, 1 January - 30 September 2019.
Media Release -
Kancera performs the second partial payment for the Fractalkine project.
Media Release -
A phase Ia trial to evaluate the safety, tolerability and pharmacokinetic properties of KAND-567 in Healthy Subjects
ctiprofile -
Kancera reports results from analyses of the Fractalkine system in lymphoma patients' immune cells.
Media Release -
Kancera reports results from clinical Phase I study and strategy for continued development of KAND567.
Media Release -
Kancera AB (publ) Reports Positive Results from a Phase I Study in Healthy Subjects With its Lead Immunoregulating Drug Candidate KAND567.
Media Release -
Kancera's research will be highlighted at this year's largest conference on cardiovascular diseases.
Media Release -
INTERIM REPORT FOR KANCERA AB (publ) 1st January - 30th September 2018.
Media Release -
Kancera provides operational update in connection with release of financial interim report for second quarter.
Media Release -
The Japan patent office has issued a patent that protects the manufacturing processes for KAND567 and KAND145.
Media Release -
Kancera provides operational update for its Fractalkine-blocking drug candidates KAND567 and KAND145.
Media Release -
A new patent application from Kancera lays the foundation for the development of additional drug candidates in the Fractalkine project.
Media Release -
Pioneering research results for Kancera's Fractalkine blockers may pave the way for new treatment for ovarian cancer.
Media Release
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