TuHURA Biosciences said the FDA cleared its IND application for TBS-2025, a VISTA-inhibiting monoclonal antibody, and issued a "Study May Proceed" notice. The clearance allows a Phase 1b trial to assess the safety and potential efficacy of TBS-2025 as a monotherapy at different doses in patients with relapsed or refractory mutNPM1 acute myeloid leukemia who failed to respond to or relapsed after menin inhibitor therapy. Following a safety review with the FDA, the study is expected to enter dose optimization to identify a safe and biologically effective dose. If the trial produces encouraging response rates, TuHURA plans to discuss potential trial expansion with the FDA and the possibility of pursuing accelerated approval.