Biomea Fusion receives FDA clearance for IND of BMF-500 in relapsed/refractory acute leukemia

Biomea Fusion, Inc.

FDA cleared IND for BMF-500, a novel covalent FLT3 inhibitor, to begin Phase I trial COVALENT-103 in adult patients with relapsed or refractory acute leukemia.
BMF-500 is the second investigational compound from Biomea's FUSION System to enter the clinic.
Preclinical data: BMF-500 showed ~20-fold greater potency than gilteritinib and >50-fold greater than reversible menin/MLL inhibitors in AML cell lines.
Combination of BMF-500 and BMF-219 showed greater than additive cell killing in acute leukemia cell lines and patient samples.
BMF-500 designed for high target selectivity with minimal off-target liabilities; potential for combinations with standard of care or BMF-219.

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