Kancera AB has announced a strategic shift to focus its development resources on cardiovascular diseases, primarily targeting ST-elevation myocardial infarction (STEMI) with its fractalkine-blocking candidate drugs KAND567 and KAND145. This decision follows promising Phase IIa results from the FRACTAL study and an assessment of market approval opportunities and potential. The company plans to initiate a Phase IIb study to further evaluate the efficacy of KAND567.
Rationale Behind the Strategic Shift
The decision to prioritize cardiovascular disease development stems from the unmet medical need in STEMI treatment and the encouraging data observed in the FRACTAL study. According to Peter Selin, CEO of Kancera, focusing on a single therapeutic area will increase the company's chances of success. "We see significant opportunities for our candidate drugs in both cardiovascular diseases and cancer, but by focusing the company’s resources to one therapeutic area, our opportunity to be successful will increase," Selin stated.
Promising Results from the FRACTAL Study
The Phase IIa FRACTAL study demonstrated that KAND567, an anti-inflammatory drug candidate, has the potential to reduce intramyocardial hemorrhage in STEMI patients undergoing primary percutaneous coronary intervention (PCI). Intramyocardial hemorrhage is increasingly recognized as a significant risk factor for major adverse cardiovascular events, including death and heart failure. Currently, no treatments are available to prevent intramyocardial hemorrhage, highlighting the urgent need for effective interventions.
Development Plan and Market Potential
Kancera has outlined a comprehensive development plan leading up to market approval, which includes a randomized, blinded Phase IIb study mirroring the FRACTAL study design. This study will assess cardio-protective effects using magnetic resonance imaging (MRI) to confirm previous findings with statistical significance. Concurrently, a Phase I study of oral KAND145 administration will be conducted to potentially switch to KAND145 in a Phase III trial. The Phase III study will evaluate KAND567 (intravenous) and KAND145 (oral) in a larger patient population, using major adverse cardiovascular events (MACE) as primary endpoints.
Market access research, including interviews with regulatory experts, suggests that the proposed study design aligns with FDA and EMA requirements for market approval. Furthermore, interviews with US payers indicate a high willingness to pay for Kancera’s candidate drug if Phase III trials confirm the targeted effects on MACE observed in the FRACTAL study. The company estimates a potential annual turnover exceeding USD 1 billion in the US alone, with an expected price level surpassing $10,000 per treatment.
Commercialization Strategy and KANDOVA Study Update
Kancera intends to commercialize KAND567 and KAND145 through partnerships with specialty care companies focused on cardiovascular diseases. However, the company is also considering developing and commercializing the drug itself in selected markets, given the significant financial potential and relatively limited number of specialists prescribing the treatment. To support this strategic direction, Kancera will seek new long-term investors focused on life sciences.
As a result of the strategic focus on cardiovascular diseases, patient recruitment in the ongoing KANDOVA study in ovarian cancer has been halted. The company believes that the primary study objective, demonstrating safety and tolerability and defining the recommended dose, can be achieved with the 18 patients already enrolled. Top-line results from the KANDOVA study are expected in the fourth quarter of 2025.
