Biomea Fusion, Inc. 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 [500 mg once daily (non-CYP3A4 inhibitor arm) and 125 mg once daily (CYP3A4 inhibitor arm), both producing comparable exposures] showed CRs in 2 of 5 AML patients with known menin-dependent mutations (KMT2Ar/MLL1r, 1 patient; NPM1, 2-patients; MLL-PTD, 1-patient; and NUP98 fusion, 1-patient).

These relapsed/refractory patients had a range of prior therapies (1 to 8) and two complete responses (1 CR, 1 CRi) 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.

Initially, patients were enrolled agnostic to mutational status; subsequently, the study protocol was amended to enrich for patients with AML harboring menin-dependent mutations. 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.

Completion of the dose escalation for the acute leukemia cohort is anticipated later this year. Biomea is planning to present additional clinical data from the COVALENT-101 study at an upcoming scientific conference, including comprehensive results from the acute leukemia patients dosed during the escalation phase.