BN104 + intensive chemotherapy or venetoclax + azacitidine

BN104 + intensive chemotherapy or venetoclax + azacitidine is an investigational combination therapy for acute myeloid leukemia (AML) and other acute leukemias with specific genetic mutations, such as KMT2A gene rearrangement, NPM1 gene mutation, and NUP98 rearrangement. The regimen combines BN104—a novel, potent, highly selective oral menin inhibitor developed by BioNova Pharmaceuticals—with either standard intensive chemotherapy or the combination of venetoclax (a BCL-2 inhibitor) plus azacitidine (a hypomethylating agent). This approach targets leukemias driven by menin-dependent oncogenic pathways and is being evaluated in Phase I/II clinical trials for safety, pharmacokinetics, and preliminary efficacy in newly diagnosed or relapsed/refractory patients. After initial combination therapy cycles, patients may continue on BN104 monotherapy as maintenance if they achieve remission[1][3][7].