Faron Pharmaceuticals Ltd. announced that the first patient has been dosed in Phase 2 of the BEXMAB trial that evaluates the safety and efficacy of bexmarilimab, in combination with standard of care (SoC) in patients with hypomethylating agents (HMAs)-refractory or relapsed myelodysplastic syndrome (MDS), an aggressive myeloid leukemia with very few treatment options. The ongoing, randomized parallel-assigned Phase 2 part is enrolling 32 HMA-failed MDS patients at 3 mg/kg and 6 mg/kg dose levels of bexmarilimab. Dose levels have been selected in accordance with the FDA's Project Optimus initiative, which aims to reform the paradigm of dose optimization and selection in oncology drug development.

Patients are being randomized 1:1 between the doses before moving into a Phase 2/3 study expansion. As previously detailed, data from the first 20 patients (10 per dose group) will be reviewed for exposure-to-benefit to compare the two selected dose levels. Post selection of final dosing, Faron intends to discuss a potential registrational study plan with the FDA.

Faron is currently opening additional sites to speed up the trial's rapid recruitment, ahead of a future registrational study. The Company's key focus is to pursue an accelerated path to approval in refractory higher risk MDS, where no treatment option exists. Given the positive results to date, the Company will also explore the immunotherapy's potential in low risk MDS as well as chronic myelomonocytic leukaemia (CMML) patients, who are currently treated with HMA-based therapies treatment upon worsening of disease and consider further development and expansion opportunities with bexmarilimab in hematological cancers in the form of partnerships.