Biomea Fusion, Inc. (BMEA) Announces FDA Cleared IND Application to Commence Phase I/Ib Trial of BMF-219

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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, announced today that the U.S. Food and Drug Administration (FDA) has cleared Biomea’s IND application to commence a Phase I/Ib trial of BMF-219, a selective, covalent inhibitor of menin in patients with NSCLC, unresectable, locally advanced or metastatic CRC and PDAC with a KRAS activating mutation.

“We are very excited to open this particular IND as we are now looking to validate the preclinical potential of BMF-219 in patients of multiple solid tumor types who have a KRAS mutation, which is currently associated with a very poor survival prognosis. “said Thomas Butler, Biomea CEO and Chairman of the Board. “In January 2022, we developed perhaps one of the most aggressive clinical development plans among peer companies to initiate clinical studies of BMF-219 in up to seven tumor types by the end of 2022. I am incredibly proud of the extraordinary efforts of our team to realize this plan, driven by the persistent and significant unmet needs of many cancer patients.

Mr. Butler continued, “I want to thank the FDA for their extraordinary efforts in eliminating our IND on time, as well as our contract research organizations, consultants, investors and of course TEAM FUSION for their commitment, their advice and support. in the generation of another large and promising IND package for the BMF-219. »

KRAS is the most frequently mutated isoform among RAS oncogenes in human solid tumors, with high prevalence in NSCLC, CRC, and pancreatic cancer. With only one approved treatment targeting KRAS G12C for locally advanced or metastatic NSCLC, KRAS-induced tumors continue to represent a significant unmet medical need. A targeted pan-KRAS inhibitor has the potential to treat 25-35% of NSCLC, 35-45% of CRC, and approximately 90% of PDAC patients.

Menin is a scaffolding protein and a required cofactor of oncogenic transcriptional proteins with functional interactions essential for the development of various cancers. As previously reported by Biomea Fusion, KRAS mutant NSCLC, CRC and PDAC cell lines and ex-vivo preclinical models were very sensitive to BMF-219. In preclinical models, high potency of BMF-219 was observed among various KRAS mutant solid tumor cell lines, but not wild-type KRAS, suggesting that BMF-219 largely inhibited mutant KRAS in these tumor models. . As a covalent inhibitor of menin, BMF-219 has demonstrated advantages over LUMIKRAS, a commercial KRAS-targeted inhibitor, in several preclinical studies due to independence of KRAS phosphorylation state in G12C tumors, and more broadly the ability to target several KRAS activating mutations.About COVALENT–102COVALENT-102 is an open-label, multicohort, multicenter, Phase I/Ib dose-finding study evaluating the safety, tolerability, and clinical activity of increasing doses of oral BMF-219 administered to patients with unresectable, locally advanced or metastatic NSCLC, CRC and PDAC with a KRAS mutation. About Non-Small Cell Lung Cancer (NSCLC) NSCLC is the most common form of lung cancer, accounting for approximately 82% of all lung cancer cases or approximately 200,000 cases in the United States each year (Source: NCI SEER Data). Additionally, the five-year survival rate of NSCLC is approximately 25%. Although lung cancer is the third most common form of cancer in the United States by incidence, it contributes to the highest number of annual cancer deaths in the United States. KRAS is the most frequently mutated oncogene in NSCLC, occurring in approximately 30% of patients. There remains a large unmet need for targeted therapies to treat all KRAS driver mutations and avoid known resistance mechanisms. About colorectal cancer (CRC)CRC is the fourth most common form of cancer and the second leading cause of cancer death in the United States, accounting for approximately 150,000 cases in the United States each year (Source: NCI SEER Data). These cancers start in the rectum or colon and can be diagnosed/identified early, even potentially as non-cancerous polyps. The five-year survival rate for CRC is about 65%. Among other mutations, KRAS mutations occur in approximately 40% of patients with CRC. These mutations may not only help predict non-response to anti-EGFR treatment, but also lead to poorer overall survival. Therefore, there is a growing unmet need for personalized therapies for patients with KRAS-mutant colorectal cancer.

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