Faron Reports 43% Remission Rate in High-Risk Blood Cancer Trial

Faron Pharmaceuticals has reported a significant increase in complete remission rates to 43% in its Phase 1/2 BEXMAB trial for high-risk myelodysplastic syndrome (HR-MDS) patients, up from 28% in earlier data. This improvement, achieved with the combination of bexmarilimab and azacitidine, more than doubles the 16-17% remission rate historically observed with azacitidine alone, indicating the drug’s potential as a disease-modifying agent. The data, prepared for an upcoming FDA End-of-Phase 2 meeting, shows deepening patient responses over time and complements a previously reported 50% composite complete remission rate, which includes both complete and near-complete responses. Faron aims to advance bexmarilimab into a randomized registrational trial to seek accelerated FDA approval, which could enhance its market positioning and provide new treatment hope for HR-MDS patients. The company’s lead asset, bexmarilimab, is an anti-Clever-1 humanized antibody designed to reprogram myeloid cells and reduce cancer immunosuppression, currently being tested in combination with standard therapies. Executives at Faron have expressed optimism about the compelling and clinically meaningful data sets to support their discussions with the FDA.