On June 22, 2022 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), reported that the first patient has been dosed in the MM cohort of COVALENT-101, the company’s Phase I clinical trial evaluating BMF-219, Biomea’s covalent menin inhibitor, in patients with R/R AML, ALL, DLBCL, and MM (Press release, Biomea Fusion, JUN 22, 2022, View Source [SID1234616163]).
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"From the very beginning of our journey, we have been exploring and validating the broad potential of covalently inhibiting the scaffold protein, menin, in a host of liquid and solid tumors. Menin’s broad role in a variety of tumor types is rather striking. Based on the outstanding translational work of our team, we have seen compelling preclinical activity using BMF-219 in MM subtypes, especially those that are driven by MYC, a protein essential to the growth of numerous tumor types," said Steve Morris, MD, Chief Medical Officer of Biomea Fusion.
"Today, we have taken the first step to explore the clinical potential of BMF-219, a single-agent covalent menin inhibitor, in treating relapsed / refractory multiple myeloma patients. This represents the second cancer type, as well as the first cancer type outside of AML, to be studied with BMF-219. We are committed to delivering innovative medicine to patients in need, including those with R/R MM. I am incredibly proud of our team for their dedication as they continue to explore the boundaries of where science is leading us. Our mission is fundamentally driven by the wish to help cure patients of their disease. I would like to thank the entire Biomea team, including our participating clinical sites and wonderful collaborators, for their work quality and brilliance in achieving this very important milestone," said Thomas Butler, CEO, Chairman of the Board and Co-Founder of Biomea.
About COVALENT-101
A Phase I, open-label, multi-center, dose escalation and dose expansion study designed to assess the safety, tolerability, and pharmacokinetics / pharmacodynamics of once daily oral dosing of BMF-219 in patients with r/r acute leukemias —including subpopulations where menin inhibition is expected to provide a therapeutic benefit (e.g., patients with MLL1/KMT2A gene rearrangements or NPM1 mutations). The study has been expanded to include cohorts for patients with R/R multiple myeloma and R/R diffuse large B-cell lymphoma. Additional information about the Phase I clinical trial of BMF-219 can be found at ClinicalTrials.gov using the identifier NCT05153330.
About Multiple Myeloma (MM)
MM is a cancer of plasma cells, which make antibodies (immunoglobulins) and are mainly located in the bone marrow. As cancerous cells proliferate and migrate from the bone marrow, organ damage occurs due to excess immunoglobulins in bones and blood and the general weakening of bones. Approximately 35,000 people in the U.S. are diagnosed with MM each year and the 5-year relative survival rate is ~56% (Source: NCI SEER Data). The need is greatest among patients with relapsed or refractory disease, with overall survival as low as 6 months in some patients. Additionally, it is estimated that more than 60% of MM patients have menin dependent genetic drivers (MYC addicted or driven) and that these drivers are more common in the relapsed or refractory setting.