Biomea Fusion Inc (NASDAQ:BMEA) released preliminary topline data from its ongoing Phase 1 COVALENT-101 trial, showcasing initial responses in relapsed/refractory AML patients with menin-dependent mutations.

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 complete responses (CRs) in 2 of 5 AML patients.

Patients were previously treated with standard-of-care and investigational therapies, including allogeneic bone marrow transplants. Both patients who achieved CRs continue on BMF-219 treatment.

Dose Level 4 is the first dose level to enroll patients with known menin-dependent mutations.

BMF-219 has been generally well tolerated, with no QTc prolongation reported.

At the time of this analysis, 20 AML patients 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 optimize further 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.

Last month, Biomea Fusion announced the presentation of new clinical data from the first two cohorts from the Phase 2 portion of its ongoing Phase 1/2 clinical study (COVALENT-111) of BMF-219 in type 2 diabetes patients.

Price Action: BMEA shares are down 9.71% at $19.44 on the last check Monday.