In connection with the release of the financial interim report for the second quarter of 2023,
Operational update concerning KAND567
Kancera’s drug candidate KAND567 is currently being studied in two clinical trials, the FRACTAL and the KANDOVA studies:
- In the FRACTAL study, a phase IIa study conducted in collaboration with the
NHS Foundation , KAND567 treatment of myocardial infarction patients undergoing percutaneous coronary intervention is being studied. All analyses of data related to the primary and secondary endpoints have been completed and the study database has been validated and locked. The study sponsor, NHS, has estimated that the remaining work of unblinding of data and compilation of data for statistical analysis will require approximately two months. Kancera’s aim is to present top line data by September this year, but as the timeline for NHS’s remaining activities is somewhat uncertain,Kancera expects that presentation of top line results may be postponed intol Q4. - In the KANDOVA study, a combined phase Ib/IIa study, treatment of ovarian cancer patients with KAND567 in combination with carboplatin is being studied. The first patient enrolled has now gone through three treatment cycles with KAND567 and carboplatin. The objective of the first part of the study, phase Ib, is to determine the highest tolerable and safe dose of KAND567 and the recommended dose for the second part of the study, phase IIa. The first part of the study is designed as an intra-patient dose escalation study, in which the patient initially receives a low dose of KAND567. If this dose is tolerated, the patient will receive a higher dose during the next treatment cycle. Accordingly, the first patient has tolerated the three initial dose levels and will now receive the fourth, and highest planned, dose. As of today, patient enrollment has been initiated at one study site, the
Karolinska University Hospital in Solna,Sweden . Patient enrollment at additional three sites inSweden ,Norway andDenmark are expected to be initiated during the third quarter.Kancera expects that six-twelve patients will be required for the phase Ib part of the study and, based on the current status,Kancera expects that phase Ib will be completed in the first half of next year. The goal is to present top line results from the complete study before the end of 2024.
Operational update concerning KAND145
KAND145 is Kancera’s second generation fractalkine-blocking drug candidate and a further development of KAND567. KAND145 is a so called “pro drug”, meaning that it is converted to KAND567 in the human body after administration. KAND145 has certain improved product properties, e.g. the opportunity for higher peroral dose formulation, which makes it more suitable for treatment of cancer. Kancera’s overall development plan for treatment of cancers with fractalkine blockers is to switch over from KAND567 to KAND145 following the completion of the KANDOVA study.
The review of Kancera’s regulatory application to conduct a phase I study of KAND145 is still ongoing. As previously described, this application has been submitted via the new central EMA process for clinical studies that became mandatory from
Operational update concerning other R&D activities
The main focus for Kancera’s business is the fractalkine program and development of the two fractalkine-blocking drug candidates KAND567 and KAND145. More than 90 percent of the company’s resources are allocated to these drug candidates. In addition to the fractalkine program, Kancera’s research pipeline consists of KAN571, a ROR1 inhibitor. In October last year, the company presented promising data from preclinical studies indicating a potential for treating resistant B-cell malignancies with KAN571 and the intention to evaluate this further in studies in vivo was announced. However, when
Other operational updates
As has been reported, the outcome of the exercise period for warrants of series TO6 resulted in approximately 25 percent of outstanding warrants being utilized, adding approximately
On
About the FRACTAL study
The FRACTAL study is an ongoing clinical phase IIa study of Kancera’s fractalkine-blocking drug candidate KAND567 in myocardial infarction patients undergoing percutaneous coronary intervention. The study, a two-arm, double-blinded and placebo-controlled study, is conducted in collaboration with the
About the KANDOVA study
The KANDOVA-study is an ongoing combined phase Ib/IIa study of KAND567 in combination with carboplatin therapy in ovarian cancer patients with relapsed disease. The study, a one-arm, open-label, multi-centre study is planned to be conducted at several leading university hospitals in
About the KAND145 first-in-human study
The study is a randomized, double-blind and placebo-controlled phase I study of KAND145 in healthy subjects to evaluate safety, tolerability, pharmacological effect, food effect after oral single and multiple ascending dosing of KAND145 and drug-drug interaction after multiple ascending dosing. The study is being conducted at two sites in
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Phone: +46 (0)8-5012 60 80
Visit Kancera’s web page: https://www.kancera.com/en
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