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Faron Pharmaceuticals Ltd on Wednesday announced data for its investigational immunotherapy bexmarilimab, ahead of an upcoming meeting with the US Food & Drug Administration. The Turku, Finland-based clinical-stage biopharmaceutical company reported an increase in the complete remission rate in patients with frontline or treatment-naive high-risk myelodysplastic syndrome, in data from its phase 1/2 Bexmab trial, which compared the combination therapy of bexmarilimab and the current standard-of-care azacitidine. The complete remission rate increased to 43%, or 9 out of 21 patients, an improvement on the 28% rate seen in earlier data and more than double the 16% to 17% rate seen in patients treated with azacitidine alone. Bexmarilimab is Faron Pharma’s investigational immunotherapy. It is a humanised antibody with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function, according to Faron Pharma’s website. Myelodysplastic syndrome is a rare type of blood cancer affecting the bone marrow. Symptoms include fatigue, breathlessness when doing light exercise, bleeding more than usual, and getting ill a lot or taking longer than usual to recover from illnesses. ‘The continued maturation of the Bexmab data demonstrates bexmarilimab’s profound impact as a disease-modifying agent,’ said Chief Medical Officer Petri Bono. ‘Seeing the complete remission rate strengthen over time to 43%, which complements the robust 50% [composite] complete remission we have already reported, is very encouraging.’ He added: ‘It provides us with two compelling and clinically meaningful data sets for discussion with the [US Food & Drug Administration] and gives us confidence in proposing a randomised registrational trial designed for accelerated approval with either complete remission or composite complete remission as the primary endpoint.’ The data was prepared for an upcoming end-of-phase 2 meeting with the FDA. Faron Pharma shares rose 10% to 215.00 pence each on Wednesday afternoon in London, giving it a market capitalisation of £255.6 million. Copyright 2025 Alliance News Ltd. All Rights Reserved.
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