Biomea Fusion, Inc. announced that the first patient has been dosed in COVALENT-103, the company's Phase I trial of BMF-500, an investigational covalent FLT3 inhibitor developed using the proprietary FUSIONTM System, in adult patients with relapsed or refractory acute leukemia. Additional information about the Phase I clinical trial of BMF-500 can be found at ClinicalTrials.gov using the identifier NCT05918692. BMF-500 was designed to have a therapeutic profile to allow for combinations with standard of care and/or novel targeted agents like BMF-219, Biomea's investigational covalent menin inhibitor currently in clinical development for solid and liquid tumors as well as diabetes.

Previous data presented at the 2022 American Society of Hematology (ASH) Annual Meeting showed BMF-500's picomolar affinity for inhibition of activating FLT3 mutations, including FLT3-ITD and various tyrosine kinase domain (TKD) mutations. These data also showed complete tumor suppression in mouse models of FLT3-ITD AML, with no tumor regrowth even after treatment cessation. Data presented at the 2023 American Association for Cancer Research (AACR) Annual Meeting exhibited the potential utility of combination strategies to achieve higher antileukemic cell killing with reduced concentrations of BMF-500 and BMF-219.

While FLT3-specific and pan-tyrosine kinase inhibitors are approved by the FDA across various lines of therapy in AML, these agents have produced relatively low rates of durable responses and overall survival remains an unmet need. The company are utilizing proprietary FUSION?? System to discover, design and develop a pipeline of next-generation covalent-binding small molecule medicines designed to maximize clinical benefit for patients with various cancers and metabolic diseases, including diabetes.

Any such statements in this press release that are not statements of historical fact, including statements regarding the clinical and therapeutic potential of product candidates and development programs, including BMF-219 and BMF-500, the potential of BMF-219 as a treatment for various types of cancer and diabetes, research, development and regulatory plans, the progress of ongoing and upcoming clinical trials, including COVALENT-101, COVALENT-102, COVALENT-111 study of BMF-219 in type 2 diabetes, and Phase II study of BMF in type 1 diabetes, COVALENT-112, and the timing of such events, may be deemed to be forward-looking statements. Any forward-looking statements in this release that are based on current expectations, estimates and projects only as the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or in the future.