FDA Grants Fast Track Designation for Bexmarilimab

Key highlights

• Given the strong data seen in Phase 1 and continuing in Phase 2 of Faron's BEXMAB trial, the FDA has granted Fast Track Designation (FTD) for bexmarilimab for the treatment of r/r MDS
• FTD further strengthens the bexmarilimab program by offering clinical development and commercialization benefits

TURKU, Finland - Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER-1 receptor targeting approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumors, today announces that their lead candidate bexmarilimab has been granted Fast Track Designation for the treatment of relapsed or refractory myelodysplastic syndrome (r/r MDS) in combination with azacitidine by the USA Food and Drug Administration (the FDA).

Fast Track Designation is granted by the FDA for products that are intended for the treatment of serious or life-threatening disease or conditions, which demonstrate the potential to address an unmet medical need. The designation offers the opportunity for frequent interactions with the FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval, as well as eligibility for rolling submission of a New Drug Application.

Given the previously reported promising results in both Phase 1 and 2 of Faron's BEXMAB trial when treating r/r MDS patients using a combination of bexmarilimab and azacitidine to overcome primary or developed resistance to azacitidine, bexmarilimab has been granted Fast Track Designation subsequent to the accelerated development plan proposed by the FDA in July 2024. "This news highlights the urgency for new treatment options besides HMAs for the treatment of higher-risk MDS and solidifies our case that bexmarilimab can overcome resistance to HMAs", says Dr. Juho Jalkanen CEO of Faron. Relapsed or refractory myelodysplastic syndrome is an aggressive and deadly form of blood cancer, for which there is very limited treatment option and a median survival of only 5-6 months. The standard of care for higher-risk MDS is azacitidine or another hypomethylating agent (HMA). Unfortunately, the majority of patients eventually relapse or are non-responsive to HMAs, which then leads to r/r MDS. Currently around 180,000 - 510,000 people globally live with an MDS diagnosis.

"r/r MDS is a serious life-threatening condition with limited treatment options and therefore highly significant unmet medical need. Our trial results to date in hypomethylating agent (HMA)-failed MDS have shown bexmarilimab's efficacy to induce deep, clinically meaningful responses for these patients. This FDA Fast Track Designation significantly strengthens bexmarilimab's position to become a new cornerstone treatment of r/r MDS and will facilitate the development of bexmarilimab for full market approval in r/r MDS. It also represents a significant additional recognition of the potential of myeloid cell reprogramming in overcoming resistance and activating immune system in the treatment of various hematological and solid tumors" says Dr. Bono, the CMO of Faron.

About Bexmarilimab

About Faron Pharmaceuticals Ltd.