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Biomea Fusion Doses First Patient in Phase I/Ib Clinical Trial (COVALENT-102) of BMF-219 in KRAS Mutant Solid Tumors

BMF-219 is the first menin inhibitor to be clinically studied in patients with KRAS-mutated non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and

articleBiomea Fusion, Inc.January 17, 20234/company/biomea-fusion-inc/news/biomea-fusion-doses-first-patient-in-phase-iib-clinical-trial-covalent-102-of-bmf-219-in-kras-mutant-solid-tumors
Biomea Fusion Doses First Patient in Phase I/Ib Clinical Trial (COVALENT-102) of BMF-219 in KRAS Mutant Solid Tumors

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[{"type":"text","content":"BMF-219 is the first menin inhibitor to be clinically studied in patients with KRAS-mutated non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC)A pan-KRAS inhibitor targeting multiple KRAS mutations (including G12C, G12D and G12R, among others) has the potential to treat 25-35% of NSCLC patients, 35-45% of CRC patients, and approximately 90% of PDAC patientsBMF-219 is now in clinical development across eight liquid and solid tumor types, as well as for patients with type 2 diabetes REDWOOD CITY, Calif., Jan. 17, 2023 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a biopharmaceutical company focused on the discovery and development of covalent small molecules to treat patients with genetically defined cancers and metabolic diseases, today announced that the first patient has been dosed in COVALENT-102, the company’s Phase I/Ib trial of BMF-219, an oral, selective, covalent menin inhibitor in patients with KRAS-mutated unresectable, locally advanced, or metastatic NSCLC, CRC, and PDAC. “We are eager to explore the potential of BMF-219 as a pan-KRAS inhibitor in patients with three of the most prominent KRAS-mutant solid tumor types, including those with tumors that have failed to respond to investigational and approved mutation-specific KRAS inhibitors,” said Steve Morris, M.D., Biomea’s Chief Medical Officer. “As a covalent menin inhibitor, we believe BMF-219 has critical advantages over late stage, mutation-specific inhibitors of KRAS including independence on the KRAS activation state, reduced likelihood for acquisition of resistance mutations, and its potential to address multiple activating KRAS mutations.” KRAS is the most frequently mutated isoform amongst RAS oncogenes in human solid tumors, with high prevalence in NSCLC, CRC, and PDAC. KRAS G12C, KRAS G12D and KRAS G12V are among the most common KRAS mutations. However, there are numerous other known activating KRAS mutations. With only two approved therapies both targeting only KRAS G12C for locally advanced or metastatic NSCLC, KRAS-driven tumors continue to represent a significant unmet medical need. As a covalent menin inhibitor, BMF-219 has manifested a differentiated profile over the commercially approved KRAS-targeted inhibitors LUMAKRAS (sotorasib) and KRAZATI (adagrasib) in multiple pre-clinic...

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