Biomea Fusion announces two poster presentations at ASH meeting 2023

Biomea Fusion announced that abstracts related to BMF-219, a novel, investigational covalent menin inhibitor, currently in Phase 1 clinical study across multiple liquid and KRAS-mutated solid tumors, and BMF-500, a novel, investigational covalent FMS-like tyrosine kinase 3 inhibitor currently in Phase 1 clinical study in FLT3-mutated acute leukemias, have been accepted for presentation at the upcoming American Society of Hematology Annual Meeting, to be held in San Diego from December 9-12, 2023. Both BMF-219 and BMF-500 were originated in-house with Biomea’s proprietary FUSION system platform, which discovers and designs next-generation covalent-binding small molecule product candidates. Title: Covalent Menin Inhibitor BMF-219 in Patients with Relapsed or Refractory Acute Leukemia: Preliminary Phase 1 Data from the COVALENT-101 Study. Conclusion: BMF-219 is generally well tolerated with no DLT observed with no pts discontinuing therapy due to toxicity. BMF-219 dose escalation is ongoing and approaching target exposure. BMF-219 demonstrates early signs of clinical activity in different genomic subgroups. The trial is ongoing and includes enrollment for pts diagnosed with AL, DLBCL, MM and CLL. Title: COVALENT-103: A Phase 1, Open-Label, Dose-Escalation, and Dose-Expansion Study of BMF-500, an Oral Covalent FLT3 Inhibitor, in Adults with Acute Leukemia. Objectives: The primary objective of the study is to evaluate safety and tolerability and to determine the optimal biological dose/ recommended Phase 2 dose of BMF-500 oral monotherapy based on evaluation of available PK/ PD, safety and efficacy data. Secondary objectives include characterization of the pharmacodynamics and pharmacokinetics of BMF-500, and assessment of its antitumor activity per modified Cheson criteria or the NCCN Clinical Practice Guidelines as determined by the investigator. Endpoints include best overall response rate, complete remission, duration of response, relapse-free survival and overall survival.