Benzinga | Jan 25, 2022 08:37AM EST

Biomea Fusion Announces First Patient Dosed In BMF-219 Phase 1 Trial

Biomea Fusion, Inc. ("Biomea") (NASDAQ:BMEA), today announced that the first patient has been dosed in its Phase I clinical trial evaluating BMF-219, the company's irreversible covalent menin inhibitor, in patients with relapsed/refractory (r/r) acute leukemias, including those with MLL1/KMT2A gene rearrangements or NPM1 mutations.

"We are honored and deeply humbled by this significant milestone, which marks our successful transition to a clinical stage company. Just over four years ago, we took the concept of designing a small molecule that targets menin and brought forward BMF-219 to the clinic to significantly improve the lives of patients," said Thomas Butler, Biomea's Chief Executive Officer and Chairman of the Board. "I'm incredibly proud of our team for their ability to execute on this aggressive timeline. This signals how we intend to operate as a drug discovery and development organization -- advancing world-class science with rapid momentum and driven by an unwavering mission to improve patient outcomes and save lives. We are pursuing a novel approach to developing best-in-class molecules with our FUSION(tm) System across multiple indications and anticipate announcing our next pipeline candidate in the first half of 2022."

"Since 2017, we have focused on building a world-class discovery and development team at Biomea Fusion. We have internally developed our FUSION(tm) System, which allows us to expeditiously target validated cancer biology with breakthrough covalent chemistry. Our pipeline assets are designed to achieve higher selectivity, deeper target inactivation and thereby afford patients a greater therapeutic window. BMF-219 is just our first asset graduating now into clinical development. Our team has evolved significantly and is set up today not only to explore the full potential of BMF-219 and the inhibition of the menin pathway but also to advance several other programs into the clinic," said Ramses Erdtmann, President of Biomea Fusion. "We are an integrated biotech company engaged in all phases of drug discovery and clinical development. We have come a long way and are now set up to fully explore pre-clinically and clinically innovative therapies for the benefit of patients."

The current Phase I, open-label, multi-center, dose escalation and dose expansion study is 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). Additional information about the Phase I trial of BMF-219 can be found at ClinicalTrials.gov using the identifier NCT05153330.