Biomea Fusion presents ‘positive’ clinical data for BMF-219

Biomea Fusion reports it presented “positive” clinical data for BMF-219, an investigational covalent menin inhibitor, in relapsed / refractory AML patients with menin-dependent mutations at the 65th American Society of Hematology, or ASH, Annual Meeting. As of the October 31, 2023, out of 29 patients dosed in the Phase I of COVALENT-101, nearly half, or 45%, of the participants received prior Hematopoietic Stem Cell Transplant and the median prior lines of therapy was 3. A total of 7 patients were selected as evaluable for efficacy. The efficacy evaluable population includes AML patients who meet the following criteria: dosed at or near predicted efficacious dose. Within this patient population 2 Complete Responses, or CRs, were observed with a mean time to response of 1.8 months. In the CYP inhibitor arm, BMF-219 showed increasing plasma pharmacokinetic exposure with escalating dose levels, and the ability to achieve systemic exposures predicted to be efficacious based on preclinical acute leukemia models. Further dose escalation is still needed to achieve target AUC. “We are very excited to present the clinical update at ASH on our targeted, covalently binding menin inhibitor, BMF-219, achieving durable and sustained CRs in patients with menin inhibitor-sensitive acute leukemia, even at suboptimal dosing levels. The gene expression data we presented here validates the proposed mechanism of action of BMF-219 and is in-line with our preclinical models,” said Steve Morris, M.D., Chief Development Officer at Biomea.