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Faron Pharmaceuticals Ltd on Monday said updated biomarker data strengthened the clinical profile of bexmarilimab, its lead treatment for myelodysplastic syndrome. MDS is a type of bone marrow cancer, measured via blast cell count. Bexmarilimab is an antibody therapy which aims to block the Clever-1 receptor and thereby boost ‘anti-tumour immunity.’ Turku, Finland-based immunotherapy developer Faron tested its lead asset in combination with azacitidine. First and second-phase data resulted in an 85% objective response rate and a 45% complete remission rate in treatment-naive patients with higher-risk MDS, the firm reported. Findings showed full clearance of blast cells in 55% of patients, while 23% were successful bridged to ‘potentially curative’ stem cell transplants. ‘These high response rates were observed in a difficult-to-treat population, where over 66% of patients were classified as high to very high risk at baseline,’ Faron noted. ‘The combination also showed robust activity in patients with high-risk mutations like mTP53, achieving an ORR of 78%.’ The ORR was 75% in patients with a blast count above 5%, while ORR of 100% was seen in patients with a blast count below 5%. According to the American Cancer Society, normal bone marrow has a count of 5% or less, while a count of at least 20% is required to diagnose leukaemia. According to Faron, the updated results ‘not only confirm the high response rates seen in earlier analyses but also provide a clear pharmacodynamic rationale linking the drug‘s mechanism of action directly to patient outcomes.’ Chief Scientific Officer Maija Hollmen added: ‘The clear biomarker impact in the bone marrow and unique efficacy in patients with low blast counts highlights [Bexmarilimab’s] ability to change the course of the disease.’ The company is currently preparing for second and third-phase trials, which will focus on dose optimisation, before moving to the registration stage. Faron is eyeing a potentially accelerated approval process, following guidance from the US Food & Drug Administration. The company’s shares fell 2.8% to 175.00 pence on Monday afternoon in London. Copyright 2025 Alliance News Ltd. All Rights Reserved.
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