On February 17, 2026 Omeros Corporation (NASDAQ: OMER) reported the successful completion of its initial study in nonhuman primates evaluating the efficacy and safety of its OncotoX-AML cancer therapeutic platform. Omeros’ OncotoX-AML therapeutic is first targeting acute myeloid leukemia (AML), an aggressive and highly fatal bone marrow and blood cancer. The effectiveness of current AML treatments, such as chemotherapeutics and antibody-drug conjugates, are limited by substantial side effects. 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. There were no observed safety signals or meaningful changes in blood chemistry values often seen with current AML treatments.

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OncotoX-AML is an engineered biologic designed to selectively kill both AML blasts (abnormal myeloid cells) and relapse-related leukemia stem cells. Its unique mechanism of action is independent of myeloid cell genetic mutations, including TP53, NPM1, KMT2A, and FLT3, collectively found in approximately 90 percent of AML patients. In preclinical studies using patient-derived AML cells, OncotoX-AML molecules preferentially and efficiently killed myeloid cancer cells regardless of their respective mutational signature.

In multiple in vivo murine-human xenograft models, OncotoX-AML treatment consistently demonstrated superior efficacy compared to the current AML standard-of-care, namely the combination of venetoclax and azacitidine (VenAza). Across these various models, OncotoX-AML eradicated all disseminated tumors, extending survival in all animals to over 100 days without evidence of tumor recurrence, compared to a median survival increase of 8 days with VenAza. Omeros is now initiating IND-enabling studies to bring OncotoX-AML to the clinic.

"We’re excited by these data — both the efficacy results and the absence of any meaningful safety signal," stated Gregory A. Demopulos, M.D., Chairman and Chief Executive Officer of Omeros. "With the guidance of our distinguished advisory board of AML experts, we look forward to advancing OncotoX-AML to the clinic, targeting a first-in-human trial for late 2027."

AML is estimated to have been responsible for over 11,000 U.S. deaths in 2025.

(Press release, Omeros, FEB 17, 2026, View Source [SID1234662724])