Insider information

Faron Initiates Phase 2 Part of BEXMAB Study of Bexmarilimab in HMA-failed MDS

• MDS patients who have failed prior HMA therapy selected as first indication to advance into Phase 2
• 3 mg/kg and 6 mg/kg doses selected in accordance with FDA’s Project Optimus initiative guidance
• Phase 2 part of the study will recruit 32 HMA-failed MDS patients for 1:1 dose randomization with possible data release after 20 patients have received more than two treatment cycles
  

Company announcement, Inside Information

TURKU, Finland and BOSTON, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pioneering macrophage reprogramming for effective anticancer immunotherapies, today announces that based on guidance from the U.S. Food and Drug Administration (FDA), hypomethylating agents (HMAs)-refractory or relapsed myelodysplastic syndromes (MDS) has been selected as the initial indication to advance to Phase 2 in the BEXMAB study investigating bexmarilimab in combination with standard of care (SoC).

The BEXMAB study is a multicenter study, taking place in Finland and the U.S., evaluating the safety and efficacy of bexmarilimab, a novel anti-Clever-1 humanized antibody, with SoC in patients with aggressive myeloid leukemias.

The Phase 2 part of the BEXMAB trial will enroll a total of 32 patients with HMA-failed MDS. Patients will be randomized 1:1 between the selected recommended doses for expansion (RDE) of 3 mg/kg or 6 mg/kg bexmarilimab before moving into a Phase 2/3 extension of the study. Data from the first 20 patients (10 per group) will be reviewed for exposure benefit for the two selected dose levels. Post selection of final dosing Faron intends to discuss a potential registrational study plan with the FDA.

“Expansion of the BEXMAB study into Phase 2 provides an opportunity to build on the very promising findings we have already observed among patients treated with bexmarilimab in the earlier stage of the trial,” said Dr. Mika Kontro, Associate Professor, Helsinki University Hospital Comprehensive Cancer Center and Principal Investigator of the BEXMAB trial. “With two good doses now established for further investigation we hope to rapidly generate further, robust data to support the potential of this novel immunotherapy in a patient group with too few treatment options available to them.”