Biomea says FDA clearance of IND application to begin Phase I trial of BMF-500

Biomea Fusion announced that the U.S. Food and Drug Administration, FDA, has cleared the company’s Investigational New Drug, IND, application to begin a Phase I trial, COVALENT-103, of BMF-500, an investigational covalent FLT3 inhibitor, in adult patients with relapsed or refractory acute leukemia. "BMF-500 is an exceptionally potent molecule and the second covalent inhibitor we have developed in-house and advanced to the clinic showing high target selectivity and inhibition. We are planning single agent studies of BMF-500 as well as combination studies with BMF-219 to explore the potential of this powerful dual-mechanistic approach to amplify and sustain patient treatment responses," said Thomas Butler, Biomea’s CEO and Chairman of the Board. "I would like to thank the FDA, our contract research organizations partners, our consultants, our investors, and of course TEAM FUSION for the commitment, guidance, support, and tireless effort in getting BMF-500 from bench to the clinic. It has been a true community effort, and we are humbled by the opportunity to potentially help patients fight and win against these aggressive cancers."