TuHURA Biosciences Gets FDA Clearance for TBS-2025 in Acute Myeloid Leukemia Trial

TuHURA Biosciences has received FDA clearance for its IND application for TBS-2025 VISTA-inhibiting antibody in Acute Myeloid Leukemia and other blood-related cancers. The Phase 1b study will evaluate the safety and efficacy of monotherapy in patients with relapsed/refractory mutNPM1 AML who failed to respond to or relapsed after menin inhibitor therapy. If the trial yields encouraging response rates, TuHURA will explore accelerated approval with the FDA. This milestone is a testament to the company's commitment to advancing novel therapies for AML patients.