HURA News & Events

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.

TuHURA Biosciences announced that the U.S FDA Office of Orphan Products Development has granted Orphan Drug Designation to IFx-2.0 for the treatment of stage IIB to stage IV cutaneous melanoma.