Core Insights - Biomea Fusion, Inc. announced updated preliminary clinical data from the ongoing Phase I COVALENT-103 trial of BMF-500 in adults with relapsed or refractory acute leukemia, highlighting sustained clinical responses and encouraging survival rates in FLT3-mutant AML patients [1][8] Clinical Activity Observed - Among 27 enrolled patients, 9 of 11 efficacy-evaluable FLT3m patients showed bone marrow blast reduction, with 5 achieving over 50% reduction [7] - One FLT3m patient achieved complete remission with incomplete hematologic recovery (CRi) sustained for 6 cycles, while another achieved a morphologic leukemia-free state (MLFS) [7] - Two of four efficacy-evaluable FLT3 wild-type patients achieved durable disease control for at least 120 days [7] Pharmacokinetics/Pharmacodynamics - BMF-500 demonstrated good compartmental penetration, with bone marrow and plasma concentrations being comparable [7] - The median overall survival (mOS) for all treated FLT3m patients was 3.8 months for Arm A and 3.5 months for Arm B, which is an improvement compared to the historical mOS of 2.1 months for similar patients [7] Ongoing Dose Escalation - Dose escalation is ongoing at 200 mg BID for Arm A and 75 mg BID for Arm B, with no dose-limiting toxicities reported [7][13] - The company plans to conclude the internal development of BMF-500 in oncology and is exploring strategic partnerships to advance the program [8] About BMF-500 - BMF-500 is an investigational, orally bioavailable, covalent small molecule inhibitor of FLT3, designed to be highly potent and selective, with encouraging potential demonstrated in preclinical studies [10]

REDWOOD CITY, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, today announced that preliminary clinical data from the Phase I COVALENT-103 trial of BMF-500 in adults with acute leukemia (AL) were selected for a poster presentation at the European Hematology Association (EHA) 2025 Congress, taking place June 12–15 in Milan, Italy. The presentation will highlight emerging safety, pharmacokinetics/pharmacodynamics ...