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Biomea Fusion Announces First Patient Dosed with Covalent FLT3 Inhibitor BMF-500 in Relapsed or Refractory Acute Leukemia in Phase I Clinical Trial (COVALENT-103)
BMF-500, a novel 3rd generation oral covalent inhibitor of FMS-like tyrosine kinase 3 (FLT3), is the second product candidate discovered and developed by

About this update from Biomea Fusion, Inc.
[{"type":"text","content":"BMF-500, a novel 3rd generation oral covalent inhibitor of FMS-like tyrosine kinase 3 (FLT3), is the second product candidate discovered and developed by Biomea’s proprietary FUSION™ System to enter the clinic Phase I study (COVALENT-103) of BMF-500 will examine monotherapy safety and efficacy in adult patients with relapsed or refractory acute leukemia with FLT3 wild-type and FLT3 mutations, including those with co-occurring MLL1r / NPM1 mutationsBMF-500 was designed to be highly selective for FLT3 and to avoid inhibition of closely related receptors, such as cKIT that can cause myelosuppression and is thought to limit the safety and efficacy of other FLT3 inhibitorsPreclinical studies of BMF-500 have shown promising activity against all known FLT3 activating and resistance conferring mutations REDWOOD CITY, Calif., Oct. 17, 2023 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “the company”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, today 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. “Despite several late stage and approved therapies targeting FLT3, the majority of patients with AML harboring FLT3 mutations have not achieved durable remissions. We believe that BMF-500, which is designed to have key attributes of covalency, potency, and selectivity, has the capacity to fully extinguish FLT3-driven disease and the potential to combine with other targeted therapies and standard-of-care agents,” said Steve Morris, MD, Biomea’s Chief Development Officer. “Today, we have taken another important step to bring novel covalent drug candidates into the clinic by exploring the potential of BMF-500, an investigational covalent FLT3 inhibitor, in treating adult patients with relapsed or refractory acute leukemia. BMF-500 is designed to be a potent molecule and is the second covalent inhibitor we have developed in-house, demonstrating the potential of the FUSIONTM platform and our team in bringing novel assets to the clinic. Beyond single agent...