Biomea Fusion Receives FDA Clearance for Leukemia Inhibitor's Investigational New Drug App

By Dia Gill

Biomea Fusion Inc. on Monday said the U.S. Food and Drug Administration cleared its investigational new drug application to initiate a Phase 1 clinical trial for BMF-500, an investigational covalent FLT3 inhibitor for relapsed or refractory acute leukemia in adult patients.

The Redwood City, Calif.-based clinical-stage biopharmaceutical company specializes in developing novel covalent small molecules to treat patients with genetically defined cancers and metabolic diseases. It said BMF-500 was discovered in-house at Biomea with the company's proprietary FUSION system for designing and developing covalent small molecules.

According to Biomea Fusion, covalent small molecules are synthetic compounds that form permanent bonds to target proteins and offer potential advantages over conventional non-covalent drugs, including greater target selectivity, lower drug exposure and the ability to induce more durable responses.

Write to Dia Gill at dia.gill@wsj.com

(END) Dow Jones Newswires

May 01, 2023 09:16 ET (13:16 GMT)

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