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TuHURA Files Investigational New Drug Application for TBS-2025 in the Treatment of Blood-Related Cancers
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 (AM
About this update from Tuhura Biosciences, Inc.
[{"type":"text","content":"TBS-2025 to be investigated in combination with a menin inhibitor in mutNPM1 r/r AML","length":84,"tagName":"p","attribs":{}},{"type":"text","content":"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.","length":608,"tagName":"p"},{"type":"text","content":"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.","length":305,"tagName":"p"},{"type":"text","content":""There is a broad body of scientific evidence showing that leukemogenic mutations common in AML, such as mutNPM1, may drive the expression of VISTA on the surface of leukemic cells, which contribute to low response rates to therapy and markedly reduced overall survival," said Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences.","length":365,"tagName":"p"},{"type":"text","content":""While the introduction of menin inhibitors for the treatment of mutNPM1 r/r AML has provided these patients with the first approved therapy, CR/CRh rates across the class are generally <25% and of short duration, underscoring the continued unmet medical need." Dr. Bianco continued, "Given the strong scientific rationale, we believe adding TBS-2025 to a menin inhibitor may markedly increase both the CR/CRh rate and its duration, potentially addressing this unmet medical need. If successful, the Company would seek FDA guidance on the potential for developing TBS-2025 under FDA's accelerated approval pathway."","length":642,"tagName":"p"},{"type":"text","content":"About TBS-2025TBS-2025 is a unique VISTA-inhibiting monoclonal antibody ac...