Finland-based biopharmaceutical company Faron Pharmaceuticals Ltd (AIM:FARN) (First North:FARON) declared on Monday that it will progress its lead asset bexmarilimab, a novel precision cancer immunotherapy, into a registrational Phase 2/3 trial in treatment-naïve higher-risk myelodysplastic syndrome (HR-MDS), following positive feedback from the US Food and Drug Administration (FDA).

The FDA advised the company to prioritise frontline development, which could enable approval across the entire HR-MDS population. The planned study will evaluate bexmarilimab in combination with azacitidine, beginning with a dose optimisation run-in comparing 1 mg/kg and 3 mg/kg regimens before moving seamlessly into the registrational stage.

Accelerated approval will be sought based on interim data from frontline patients, with composite complete remission (CR + CReq) confirmed by the FDA as an acceptable primary endpoint under IWG 2023 criteria. Overall Survival will serve as a co-primary endpoint, while composite complete remission (cCR) will be assessed as a key secondary measure.

The FDA also endorsed Faron's non-clinical and manufacturing plans, clearing the path toward regulatory submission.

Bexmarilimab is a wholly-owned precision immunotherapy designed to reprogramme macrophages by targeting the Clever-1 receptor, reversing immunosuppression, and enhancing response to standard of care therapies. It is currently being investigated in the ongoing BEXMAB Phase I/II trial in acute myeloid leukemia and MDS.

Faron is focused on advancing novel immunotherapies to expand the impact of cancer treatment by harnessing the immune system.