Faron Pharmaceuticals (FARN) Study Result summary

Study background and rationale

• Bexmarilimab is a first-in-class monoclonal antibody targeting Clever-1, a receptor highly expressed in immunosuppressive macrophages and associated with poor outcomes in cancers like MDS and AML, aiming to reprogram macrophages and enhance anti-tumor immunity.

• High-risk MDS patients have limited treatment options, with bone marrow transplant feasible for only 5-10% and median survival after standard therapies as low as 4-6 months.

• The study used updated 2023 response criteria, emphasizing blood count recovery and patient-centric outcomes.

• The BEXMAB trial was presented at ASCO 2025 in a Rapid Oral Abstract Session.

Study design and patient population

• Open-label Phase 1/2 study included relapsed/refractory and newly diagnosed high-risk MDS patients, combining bexmarilimab with azacitidine.

• Dose escalation tested 1, 3, and 6 mg/kg; phase 2 focused on 3 and 6 mg/kg for dose optimization, with 3 mg/kg selected for Phase 3.

• 21 frontline and 32 relapsed/refractory patients enrolled, median ages 72 and 74, with a significant proportion harboring TP53 mutations.

• Most patients were high or very high risk at baseline, with severe anemia and infections.

Safety and tolerability

• Bexmarilimab plus azacitidine was generally well tolerated, with most adverse events being low grade and related to expected blood count suppression.

• Discontinuation due to bexmarilimab-related adverse events was low (2%), and no bexmarilimab-related deaths occurred.

• The combination was well-tolerated in a frail population, supporting use in older, frail patients.