TuHURA Biosciences Gets FDA Clearance for TBS-2025 Cancer Trial

TuHURA Biosciences has received FDA clearance for its Investigational New Drug application for TBS-2025, a VISTA-inhibiting antibody, to treat molecularly defined subsets of Acute Myeloid Leukemia (AML) and other blood-related cancers. The "Study May Proceed" notice from the FDA allows TuHURA to conduct a Phase 1b study to evaluate TBS-2025's safety and potential efficacy in patients with relapsed/refractory mutNPM1 AML who have failed menin inhibitor therapy. If the study yields encouraging results, TuHURA may explore expansion of the trial for accelerated approval.