TuHURA receives FDA clearance for leukemia drug trial

TuHURA Biosciences Inc. has received FDA clearance for its Investigational New Drug application for TBS-2025, a VISTA-inhibiting antibody targeting Acute Myeloid Leukemia and other blood-related cancers. The FDA's Study May Proceed notice allows TuHURA to conduct a Phase 1b study evaluating the safety and potential efficacy of monotherapy in patients with relapsed/refractory mutNPM1 AML who have failed to respond to or relapsed after menin inhibitor therapy.

This milestone, according to TuHURA's CEO, Dr. James Bianco, marks the company as the only known entity to advance a VISTA-inhibiting monoclonal antibody through the FDA's IND process into a Phase 1b study in mutNPM1 AML. If TBS-2025 demonstrates encouraging response rates during the dose optimization stage, TuHURA plans to explore with the FDA the potential expansion of the trial for accelerated approval.

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