NEW YORK – Biomea Fusion on Monday said it will begin evaluating its FLT3 inhibitor BMF-500 in a Phase I clinical trial for certain acute myeloid leukemia patients.
The US Food and Drug Administration cleared the Redwood City, California-based firm's investigational new drug application to begin the Phase I COVALENT-103 study of BMF-500 in relapsed or refractory AML patients with FLT3-wild type and FTL3-mutated cancers and those whose cancers harbor MLLr/NPM1 mutations.
According to Biomea Fusion, the third-generation FLT3 receptor tyrosine kinase inhibitor has demonstrated high target selectivity and minimal off-target toxicity in preclinical studies, and early cell-line studies have suggested that BMF-500 could have increased potency and cytotoxicity versus Astellas' earlier-generation FLT3 inhibitor Xospata (gilteritinib). Biomea Fusion's agent can potentially be combined with standard of care or other targeted agents including the menin inhibitor BMF-219, which the company also is developing.
"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," Biomea CEO Thomas Butler said in a statement. "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."