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Monday, May 1, 2023

Biomea Fusion: FDA OKs IND for leukemia therapy

 

  • BMF-500, a novel 3rd generation covalent inhibitor of fms-like tyrosine kinase 3 (FLT3), is the second investigational compound, discovered and developed by Biomea’s FUSION™ System, to advance to the clinic.

  • Phase I study (COVALENT-103) of BMF-500 will examine its safety and efficacy in patients with relapsed or refractory acute leukemia with FLT3 wild-type and FLT3 mutations, including those with MLLr / NPM1 mutations.

  • BMF-500 has demonstrated approximately 20-fold greater potency compared to Gilteritinib in acute myeloid leukemia (AML) cell lines, MV-4-11 and MOLM-13.

  • BMF-500 has demonstrated more than 50-fold greater potency compared to the clinically investigated reversible menin/MLL inhibitors in acute myeloid leukemia (AML) cell lines, MV-4-11 and MOLM-13.

  • BMF-219 and BMF-500 preclinical combination shows greater than additive cell killing in acute leukemia cell lines and patient samples.

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