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CCM-445 is a novel, orally bioavailable small molecule inhibitor developed by CCM Biosciences targeting FMS-like tyrosine kinase 3 (FLT3). It is designed specifically for the treatment of acute myeloid leukemia (AML), with a unique ability to overcome both FLT3 internal tandem duplication (ITD) and tyrosine kinase domain (TKD) resistance mutations, including D835Y and F691L. Preclinical data presented at ASCO 2025 indicate that CCM-445 significantly outperforms current-generation FLT3 inhibitors such as gilteritinib in models of AML with or without resistance mutations. Unlike other investigational agents, CCM-445 demonstrates favorable pharmacokinetics and high selectivity for FLT3, minimizing off-target effects[1][2][3][7].
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