OMS805 / Omeros - LARVOL DELTA

Oncology platform — OncotoX-AML/OMS805 (Businesswire) - "A first-in-human Phase 1b clinical trial evaluating OMS805, the lead drug development candidate in our OncotoX-AML program, is targeted to begin in late 2027. IND-enabling studies are underway, and we have entered into an agreement with a leading contract biologics manufacturer for process development and initial clinical supply of OMS805 drug substance. Across tumor-bearing animal models and in vitro human AML cell-line studies, OMS805 demonstrated efficacy superior to current AML standards of care. This efficacy was independent of AML-related genetic mutations, including TP53, NPM1, KMT2A, and FLT3, collectively found in approximately 90% of AML patients."

Licensing / partnership • New P1 trial • Preclinical • Acute Myelogenous Leukemia

Omeros Announces Successful Primate Study in OncotoX-AML Drug Program (Businesswire) - "Administration of only one course of OncotoX-AML treatment to immunocompetent primates demonstrated the desired pharmacologic response, specifically marked, selective, reversible, and dose-related reduction in myeloid progenitor cells - the cells that can mutate and lead to AML - by up to 99 percent. OncotoX-AML was well tolerated, without causing broader or lasting hematologic changes while preserving hematopoietic stem cells....'We look forward to advancing OncotoX-AML to the clinic, targeting a first-in-human trial for late 2027'."

First-in-human • New trial • Preclinical • Acute Myelogenous Leukemia