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OMS805 (also referred to as OncotoX-AML) is a biologic drug candidate being developed by Omeros Corporation for the treatment of acute myeloid leukemia (AML), an aggressive and highly fatal bone marrow and blood cancer. It is the lead candidate in Omeros's OncotoX-AML oncology program. In preclinical studies, OMS805 demonstrated efficacy superior to current AML standards of care across tumor-bearing animal models and in vitro human AML cell-line studies, with activity independent of common AML-related genetic mutations (TP53, NPM1, KMT2A, FLT3) found in ~90% of AML patients. A first-in-human Phase 1b clinical trial is targeted to begin in late 2027, with IND-enabling studies currently underway. Omeros has partnered with a leading contract biologics manufacturer for process development and initial clinical supply.
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