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Biomea Fusion Announces FDA Clearance of Investigational New Drug Application for Irreversible Menin Inhibitor BMF-219
Biomea Fusion to transform to a Clinical Stage Company with First in Human (FIH) Clinical TrialBMF-219 advances as the first clinical stage therapeutic from
About this update from Biomea Fusion, Inc.
[{"type":"text","content":"Biomea Fusion to transform to a Clinical Stage Company with First in Human (FIH) Clinical TrialBMF-219 advances as the first clinical stage therapeutic from the company’s deep pipeline of covalent irreversible small moleculesBMF-219 is a novel, first-in-class, irreversible menin inhibitor designed to control menin’s negative impact across several indicationsFIH Study will initially enroll patients with relapsed/refractory acute leukemia, with additional indications plannedDespite novel agents in the clinic and commercial settings, acute leukemia remains a significant unmet need due to the aggressive, heterogenous nature of the disease REDWOOD CITY, Calif., Sept. 16, 2021 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a biopharmaceutical company focused on the discovery and development of irreversible small molecules to treat patients with genetically defined cancers, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug application to begin a Phase I trial of BMF-219, a selective irreversible menin inhibitor, in adult patients with relapsed or refractory acute leukemia including those with an MLL/KM2TA gene rearrangement or NPM1 mutation. “First of all, I would like to take this opportunity to thank the FDA, the Contract Research Organizations, our consultants, our investors, and of course TEAM FUSION for the commitment, guidance, support, and tireless effort in getting BMF-219, an investigational new drug, in the hands of patients in need. It was a true community effort, and we are so blessed here at Biomea to be in position to provide an impactful therapy against aggressive cancers,” said Thomas Butler, Biomea’s CEO and Chairman of the Board. “This is just the beginning for BMF-219 as we are planning to pursue multiple indications with our novel molecule. This is also just the beginning for the company, as we continue to make significant progress with our pipeline programs. We are in a strong position to continue to bring novel small molecules into the clinic and help the many patients with life threatening and life altering diseases.” “Over the past 6 months, we have brought together a first-class team of biotech professionals to tackle our next phase of growth, which will include clinical development of BMF-219 in not only liquid but also solid...