Investigating bexmarilimab in hematological malignancies
Faron’s current priority is its Phase I/II BEXMAB trial, investigating the safety, tolerability and preliminary efficacy of bexmarilimab in combination with standard of care therapies, azacitidine, and azacitidine + venetoclax, in relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
addressing an urgent need
Relapsed/refractory AML and MDS have extremely poor survival rates and viable treatment options. The majority of leukemias develop in patients over 60 years of age and the long-term survival (meaning 5-year survival, the definition of cure in AML) has stalled at 30 per cent.
Novel approaches such as immunotherapy could potentially help here, especially for patients over 60 years of age who cannot tolerate intensive chemotherapies and for patients who relapse without effective therapies available.
powerful indication of therapeutic potential
Latest data from the BEXMAB trial are a powerful indication of the therapeutic potential of bexmarilimab in hematological malignancies with bexmarilimab well tolerated across the trial and efficacy signals across all patient cohorts (an increasing bexmarilimab dose and in combination with azacitidine as a doublet, and azacitidine + venetoclax as a triplet therapy).
The trial is advancing quicky with the second triplet cohort (3mg/kg + azacitidine + venetoclax) open for enrollment.
Additional efficacy read-outs for all cohorts are expected in the upcoming months and Faron plans to seek FDA advice during Q3 2023 on its potential path to submitting a Biologics License Application (BLA) to the US Food and Drug Administration (FDA).
powerful indication of therapeutic potential
Latest data from the BEXMAB trial are a powerful indication of the therapeutic potential of bexmarilimab in hematological malignancies with bexmarilimab well tolerated across the trial and efficacy signals across all patient cohorts (an increasing bexmarilimab dose and in combination with azacitidine as a doublet, and azacitidine + venetoclax as a triplet therapy).
In the most recent data readout, three of five patients in the 6 mg/kg bexmarilimab + azacitidine doublet cohort achieved objective responses; eight of 15 objective responses were observed in all three doublet dosing cohorts and one patient has stayed on treatment for 13 months.
The updated BEXMAB data supports advancement to Phase II in H2 2023 focusing on standard of care relapsed/refractory AML and MDS patients failing hypomethylating agents (HMA). Faron plans to seek FDA advice during Q3 2023 on its potential path to submitting a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) in H1 2025.