ONC001

**ONC001** is a first-in-class antibody-drug conjugate (ADC) developed by OncoPrecision Therapeutics targeting **CD64** (Fcγ receptor I), a myeloid-restricted receptor highly expressed on monocytes and macrophages in diseases like chronic myelomonocytic leukemia (CMML) and M4/M5 acute myeloid leukemia (AML). It leverages a proprietary discovery engine combining patient-derived biology and AI-enhanced screening to select a high-affinity antibody paired with optimized payload and linker chemistry, minimizing off-target toxicity to healthy hematopoiesis while delivering robust cytotoxicity to resistant disease subsets. Preclinical data demonstrate selective engagement of patient-derived CMML/AML cells, activity against standard-of-care resistant samples, and strong efficacy in heterotopic/orthotopic models; it is advancing through IND-enabling studies with an oral presentation at ASH 2025.