Kancera Advances Cardiovascular Drug Pipeline with Recardio Partnership and FDA Engagement
核心洞察
Kancera AB has partnered with US biotech Recardio Inc. to create a cardiovascular disease-focused specialty care company, with Recardio licensing candidate drugs KAND567 and KAND145.
The company expects FDA pre-IND feedback for its planned phase IIb FRACTIVE study of KAND567 in acute myocardial infarction by the end of Q2 2025.
Top-line results from the ongoing KANDOVA phase Ib/IIa study evaluating KAND567 plus carboplatin in ovarian cancer are expected in Q3 2025.
Kancera AB has provided an update on its strategic collaboration with US private biotech company Recardio Inc., highlighting progress across multiple clinical programs and regulatory preparations as the Swedish biotech company pivots toward cardiovascular disease therapeutics.
Strategic Partnership with Recardio Inc.
In March 2025, Kancera signed a letter of intent with Recardio Inc. to combine assets and create a cardiovascular disease-focused specialty care company. Under the agreement, Recardio intends to license Kancera's candidate drugs KAND567 and KAND145.
The companies have developed a joint business plan encompassing high-level development strategies for their clinical-stage programs and long-term financial planning. Joint investor meetings with potential US investors are ongoing to secure financing for the combined business plan, though Kancera notes that current macroeconomic conditions and financial market situations suggest the targeted capital raise will take longer than initially anticipated.
FRACTIVE Phase IIb Study Preparations
Kancera is preparing FRACTIVE, a planned two-armed, double-blinded, multi-center phase IIb study evaluating KAND567 in acute myocardial infarction. The study builds on positive results from the earlier phase IIa FRACTAL study.
Working with a scientific committee, the company has developed a clinical study protocol synopsis and submitted a pre-IND application to the FDA. The regulatory submission seeks formal feedback on the planned phase IIb study design and overall clinical development strategy leading to market approval. Kancera expects to present FDA feedback before the end of the second quarter 2025.
KANDOVA Ovarian Cancer Study Nearing Completion
The ongoing KANDOVA study, a one-arm, open-label, multi-center phase Ib/IIa trial, is evaluating KAND567 in combination with carboplatin in ovarian cancer patients experiencing relapse from platinum therapy. The study is being conducted across five university hospitals in Sweden, Norway, and Denmark.
All 18 recruited patients have completed their final visits, with the last patient recently conducting their last study visit. The company is currently compiling study data for statistical analysis and finalizing secondary and exploratory endpoint analyses to evaluate KAND567's anti-tumor effects. Top-line results are expected to be presented during the third quarter of 2025.
Corporate Rebranding Initiative
Kancera announced plans to change its company name to Novakand Pharma (搜索), aligning with its strategic focus on cardiovascular diseases. The formal decision will be made at the annual general meeting scheduled for May 26, 2025.
The company has applied for trademark protection with the European Union Intellectual Property Office (EU IPO). While US vaccine company Novavax has filed an objection to the trademark application, Kancera assesses that this objection can be mitigated and does not warrant changing the decision to rebrand as Novakand Pharma (搜索). Subject to shareholder approval, the new company name is planned for implementation in September 2025.
Company Profile
Kancera is a clinical-stage biotech company developing small molecule drugs with immune cell modulating mechanisms of action, focusing on cardiovascular diseases. The company's stock trades on the Nasdaq First North Premier Growth Market, with Redeye AB serving as its Certified Adviser.