TuHURA Biosciences, Inc. (NASDAQ:HURA) (“TuHURA” or the “Company”), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, today announced that the U.S. Food and Drug Administration (FDA) has given clearance to TuHURA’s Investigational New Drug (IND) application for its TBS-2025 VISTA-inhibiting antibody for molecularly defined subsets of Acute Myeloid Leukemia (AML) and other blood-related cancers.

The “Study May Proceed” notice from the FDA allows the Company to examine TBS-2025 in a Phase 1b study evaluating the safety and potential efficacy of monotherapy at different doses in patients with relapsed/refractory (r/r) mutNPM1 AML who have failed to respond to or relapsed after menin inhibitor therapy. Following review of the safety data with the FDA, the study is expected to progress to the dose-optimization stage of the trial to determine a safe and biologically effective dose. Patients with r/r mutNPM1 AML who fail menin inhibitor therapy have no approved or effective treatments and represent an unmet medical need. If TBS-2025 results in encouraging response rates during the dose optimization stage of the study, the Company will explore with the FDA the potential expansion of the trial in consideration for the opportunity for accelerated approval.