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Biomea Fusion Receives FDA Clearance to Begin Phase I Trial of BMF-219

NEW YORK – Redwood City, California-based Biomea Fusion has received permission from the US Food and Drug Administration to begin a Phase I trial of its selective irreversible menin inhibitor BMF-219 involving advanced acute myeloid leukemia patients with certain molecular aberrations.

Following the FDA's clearance of its investigational new drug application for the irreversible small molecular inhibitor BMF-219, the company is readying a Phase I dose-escalation and -expansion trial of the drug involving relapsed or refractory AML patients who harbor MLL/KM2TA gene rearrangements or NPM1 mutations.

The company, however, plans to study BMF-219 beyond AML. "This is just the beginning for BMF-219 as we are planning to pursue multiple indications with our novel molecule," Biomea CEO Thomas Butler said in a statement. "This is also just the beginning for the company, as we continue to make significant progress with our pipeline programs."

Earlier this year, Biomea raised $56 million in a Series A funding round, which it is using to advance BMF-219 for hematologic and solid tumor indications, in which menin and MLL are highly expressed.