Interim report for fourth quarter 2021, 1 January – 31 December 2021 Kancera AB (publ.), org.nr. 556806-8851
The year in brief
October – December
Financial summary for the fourth quarter
January – December
Financial summary for the entire period
Significant events during the fourth quarter
Significant events after the end of the fourth quarter
Significant events during the period January to December 2021
Start of cardiac study and new steps towards
clinical study against ovarian cancer
The FRACTAL study of KAND567 in patients with myocardial infarction: First patients recruited
Kancera is developing a new class of small molecule drug candidates for inflammation and cancer. During the year we made significant progress in both the development program against inflammation-driven injuries in heart attacks and in the program aimed at cancer. The recruitment of patients for the Phase IIa clinical trial of KAND567 in myocardial infarction patients is proceeding according to plan. With the current recruitment rate of four to six patients per month, we look to be able to complete patient recruitment during the fourth quarter of 2022. The study is conducted at Freeman Hospital and James Cook Hospital in the UK and is focused on evaluating the safety profile and cardioprotective effect of KAND567 in a total of 60 patients with a major myocardial infarction in the anterior wall of the heart muscle (STEMI). The drug candidate is administered for three days and patients are followed up 90 days after the first dose. During the study, markers for heart protection effect, inflammation and general health are evaluated. Top-line data are expected four to six months after the last patient is treated, around the turn of the year 2023.
COVID-19: Results from Phase II clinical study of KAND567
Medical expertise pointed out early in the pandemic that hyper-inflammation could be a major contributor to the severe symptoms that afflicted some patients. This motivated Kancera to carry out a less targeted phase IIa study of KAND567 in COVID-19 with the primary goal to show safety and secondary goals to show lung protective effect and pharmacological effect on the immune system. We reached the primary objective of the study with results showing that the chosen dosage resulted in a desired concentration of KAND567 in the blood and that this dose was well tolerated in this population of patients with an acute and severe inflammatory onset. A lung protection effect could not be evaluated, partly due to the limited size of the study, while the extensive molecular profiling shows that KAND567 had a pharmacological effect on the immune system. Taken together, these results strengthen the continued development of KAND567 against harmful inflammation.
Several established and widely used anti-inflammatory drugs have already been shown to help with COVID-19. Against this background, Kancera has chosen to continue to focus on the company's main tracks, i.e. inflammatory conditions where the trigger for initiating treatment is clear and where broad-spectrum anti-inflammatory drugs do not help. These disease states include inflammation associated with acute myocardial infarction and recurrent relapses of autoimmune disease. Kancera's direction and focus is exemplified by the ongoing study of KAND567 in myocardial infarction patients at Freeman Hospital in the UK.
Cancer: an efficient path to the first patient study
The KAND145 development project has reached several important milestones during the fourth quarter. A recent preclinical study shows that KAND145 in combination with chemotherapy effectively reduces the tumor size in chemotherapy-resistant ovarian cancer. In parallel, we have conducted 14-day toxicological studies that have been successful. This means that during the first quarter we can continue with 28-day toxicological studies in preparation for clinical studies. With the overall preclinical data, we then intend to define a safe and effective dose for future clinical studies. Provided we achieve good results, we plan to submit an application for permission during the second quarter of 2022 to conduct a clinical study in patients.
Compared to its sister molecule KAND567, KAND145 has several properties that make it more effective and easier for the cancer patient to take orally and it is better adapted for intravenous treatment.
To gain time in the clinical development of KAND145, we plan to take advantage of clinical data for our most advanced drug candidate KAND567, which is made possible by the similarity of the substances and the amount of existing clinical data for KAND567. We plan to achieve the time saving by conducting two clinical studies in parallel. Firstly, a clinical phase I study of KAND145 to document the drug candidate's pharmacokinetic properties and tolerability in healthy individuals. Secondly through a clinical phase Ib study with KAND567 in which we intend to evaluate the tolerability of combination treatment with chemotherapy and the effect on markers that reflect the treatment's effect on the cancer disease.
With these two parallel studies as a foundation, a subsequent more comprehensive clinical study of KAND145 against ovarian cancer can start in 2023 and deliver results approximately 6–12 months earlier than in a scenario where only KAND145 is used for these studies. Results from this study approach could also provide early and significant support for a new treatment principle with Fractalkine blockers against ovarian cancer.
New addition to the management team
Our portfolio of unique small molecule blockers of the Fractalkine system has been shown to control both the immune system and the sensitivity of cancer cells in chemotherapy and we look forward to future steps in the clinical development in each area. As the projects develop, our commercial focus increases, and in December 2021, Peter Selin was therefore recruited to a position as Executive Vice President Corporate Development and Vice President with responsibility for business development, strategic partnerships and out-licensing. Peter has previously held senior positions in both business development and operations at Oasmia Pharmaceuticals, Inceptua Group and Sobi and is a welcome addition to the company's management when he takes office on or before May 1.
Solna, February 18, 2022
Thomas Olin, CEO