Inside information

Faron Announces First HMA-failed MDS Patient Dosed with Bexmarilimab as part of Phase 2 of BEXMAB Trial

• Phase 2 of the trial aims to recruit 32 patients with HMA-failed MDS and to provide final and optimized dosing for registrational study
• Company is exploring further development opportunities within the bexmarilimab program in hematological cancer patients following positive feedback from the recent ASH congress

Company Announcement, Inside Information

TURKU, Finland and BOSTON, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, today 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.

“Dosing of the first patients in this advanced part of the BEXMAB study is another significant milestone in the bexmarilimab program, and we want to thank our clinical network again for the rapid advancement of our program," said Dr. Birge Berns, Chief Medical Officer of Faron. "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.“