TBS-2025 to be investigated in combination with a menin inhibitor in mutNPM1 r/r AML

TAMPA, Fla., Feb. 17, 2026 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, today announced that it has filed an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration's (FDA) Division of Hematologic Malignancies 1 (DHM1) for the study of TBS-2025, a novel VISTA inhibiting antibody, for the treatment of mutNPM1 relapsed/refractory (r/r) Acute Myeloid Leukemia (AML) in combination with a menin inhibitor.

The Company plans on initiating a Phase 2 study in menin inhibitor naïve patients with mutNPM1 r/r AML utilizing a Simon 2 stage design. Pending completion of FDA review and clearance, the Company currently targets initiating the Phase 2 study in early Q2 2026 with preliminary Stage 1 results in Q3 2026.

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