HURA News & Events

TuHURA Biosciences announced that it has filed an Investigational New Drug application with the U.S. FDA for the study of its TBS-2025 VISTA inhibiting antibody for the treatment of molecularly defined subsets of AML and other blood related cancers. The IND is being filed following detailed feedback and guidance from the FDA on the IND filed in February 2026. The company is targeting initiation of the Phase 1b/2 study in the second half of 2026.

TuHURA Biosciences has filed an Investigational New Drug Application, or INDA, with the FDA's Division of Hematologic Malignancies 1 for the study of TBS-2025, a novel VISTA inhibiting antibody, for the treatment of mutNPM1 relapsed/refractory Acute Myeloid Leukemi, or AML, in combination with a menin inhibitor. TBS-2025 is a unique VISTA-inhibiting monoclonal antibody acquired by the company in its acquisition by merger with Kineta on June 30, 2025. The company plans on initiating a Phase 2 study in menin inhibitor naive 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 with preliminary Stage 1 results in Q3.