Faron Pharmaceuticals (FARN) , a clinical-stage biopharma company focused on anticancer immunotherapies, announced that per US FDA guidance it has selected hypomethylating agents (HMAs)-refractory or relapsed myelodysplastic syndromes (MDS) as the initial indication to advance to Phase 2 in its BEXMAB study.
BEXMAB is a multicenter study, taking place in Finland and the US, evaluating the safety and efficacy of bexmarilimab, a novel anti-Clever-1 humanized antibody, with standard of care (SoC) in patients with aggressive myeloid leukemias.
The Phase 2 part of the BEXMAB trial will enroll 32 patients with HMA-failed MDS. The patients will be randomised 1:1 between the selected recommended doses for expansion (RDE) of 3 mg/kg or 6 mg/kg bexmarilimab before moving to a Phase 2/3 extension of the study.
Data from the first 20 patients will be reviewed for exposure benefit for the two selected dose levels. Post-selection of final dosing, Faron will discuss a potential registrational study plan with the FDA.
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More positive news from Faron, building on promising Phase 1 data from patients treated with bexmarilimab. Having established 2 good doses for further investigation in collaboration with the US FDA, the company can now move to generating further data to support its novel cancer immunotherapy for patients with few treatment options available today.
The milestone moves closer to commercialisation the first macrophage-targeting immunotherapy for patients with aggressive myeloid leukemias. Bexmarilimab data from Phase 1 of the trial has been very encouraging, showing continued efficacy signals and long duration of responses. In Phase 1, Bexmarilimab produced a 50% remission rate in doublet dose cohorts, with 8 of 11 patients achieving complete remission in the bone marrow.
The treatment addresses a significant unmet medical need in MDS, which has not had a new effective treatment in decades. Faron expects to open additional recruitment sites in the US and Europe to keep up with the rapid pace of development. FARN shares moved 7.8% higher on the news.
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