Faron Pharmaceuticals Ltd. announced that updated data from the Phase I/II BEXMAB study continues to show significant clinical activity for bexmarilimab. By blocking Clever-1, bexmarilimab reprograms macrophages in the bone marrow, enhancing anti-tumor immunity. The data presented at ESMO 2025 included 21 treatment-naive (20 evaluable for efficacy) and 32 relapsed/refractory (r/r) HMA- failed patients with HR-MDS.
The updated data presented at ESMO 2025 reinforces the efficacy previously observed for the bexmarilimab and azacitidine combination. In 20 evaluable treatment-naive patients, the study confirmed an 85% ORR and a 45% CR rate. The most significant update is the new pharmacodynamic data that provided a clear biological explanation for the strong clinical results.
Following guidance from the FDA announced on 18 August 2025, the Company has begun preparations for the dose-optimization stage of its Phase II/III trial for bexmarilIMab, after which the trial will transition into the registrational stage with accelerated approval possibility.
