Biomea Fusion announces preliminary data from Phase I COVALENT-101 trial

Biomea Fusion announced preliminary topline data from its ongoing Phase I clinical trial, COVALENT-101, showcasing initial responses in relapsed/refractory AML patients with menin-dependent mutations. In the COVALENT-101 study, BMF-219 is orally administered on a daily schedule in continuous 28-day cycles. The preliminary analysis as of July 13, 2023 of Dose Level 4 showed CRs in 2 of 5 AML patients with known menin-dependent mutations. These relapsed/refractory patients had a range of prior therapies and two complete responses were observed within the first two 28-day treatment cycles with BMF-219. Patients were previously treated with standard-of-care and investigational therapies including allogeneic bone marrow transplant. Both patients who achieved CRs continue on BMF-219 treatment. Dose Level 4 is the first dose level which focused primarily on enrolling patients with known menin-dependent mutations. BMF-219 has been generally well tolerated with no QTc prolongation reported. At the time of this analysis, a total of 20 AML patients have received BMF-219 during the dose escalation portion of the COVALENT-101 study. Dose Level 4 was cleared with no dose-limiting toxicities observed, allowing for the continuation of dose escalation. Enrollment for Dose Level 5 has commenced to further optimize and explore the potential to improve upon these preliminary results.