Biomea Fusion announces FDA IND clearance for BMF-219 in KRAS solid tumors; Phase I/Ib trial to begin

Biomea Fusion, Inc.

FDA cleared IND for BMF-219 to initiate Phase I/Ib trial (COVALENT-102) in KRAS-mutant NSCLC, CRC, and PDAC.
BMF-219 is the first menin inhibitor to enter clinical trials for solid tumors.
Preclinical data showed pan-KRAS activity across G12C, G12D, G12V, and G13D mutations.
Company already has COVALENT-101 Phase I trial in blood cancers underway.
KRAS mutations present in 25-35% of NSCLC, 35-45% of CRC, and ~90% of PDAC patients.

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