Faron Pharmaceuticals Oy has announced the dosing of the first patient in Phase 2 of the BEXMAB trial, evaluating the safety and efficacy of bexmarilimab in combination with standard of care for patients with hypomethylating agents (HMAs)-refractory or relapsed myelodysplastic syndrome (MDS). The trial aims to recruit 32 patients and provide final and optimized dosing for a registrational study. The company is exploring further development opportunities within the bexmarilimab program following positive feedback from the recent ASH congress.
The ongoing Phase 2 part of the trial 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. The company intends to discuss a potential registrational study plan with the FDA post selection of final dosing. Dr. Birge Berns, Chief Medical Officer of Faron, expressed optimism, stating, "Refractory and relapsed MDS represents a significant therapeutic challenge, and based on the recently announced data at ASH from the Phase 1 part of this trial, we believe that bexmarilimab has the potential to save and improve the lives of HMA-failed MDS patients."
Faron is also opening additional sites to speed up the trial's rapid recruitment, with a focus on pursuing an accelerated path to approval in refractory higher risk MDS. The company will explore the immunotherapy's potential in low risk MDS as well as chronic myelomonocytic leukaemia (CMML) patients and consider further development and expansion opportunities with bexmarilimab in hematological cancers in the form of partnerships.
The BEXMAB study is an open-label Phase 1/2 clinical trial investigating bexmarilimab in combination with standard of care in acute myeloid leukemia (AML) and MDS. Bexmarilimab is Faron's wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes by targeting myeloid cell function and igniting the immune system. Faron Pharmaceuticals Ltd. is a global, clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies.