FDA Grants Fast Track Designation for Bexmarilimab in r/r MDS
Current TAP Partner
TURKU, Finland, August 26, 2024 - 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).
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. 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.