TBS-2025 - (VISTA)

June 15, 2026: TuHURA Biosciences, Inc. (NASDAQ: HURA) announced it filed an FDA Investigational New Drug (IND) application for TBS-2025, a VISTA-inhibiting monoclonal antibody, to evaluate treatment of molecularly defined subsets of acute myeloid leukemia (AML) and other blood-related cancers. The company said the IND aligns with prior FDA guidance on development as both monotherapy and in combination with menin inhibitors for AML, following FDA feedback related to an IND filed in February 2026. FDA indicated a requested meeting is unnecessary and will instead provide written responses on the proposed Phase 1b/2 plan, anticipated next month.

TuHURA is targeting initiation of a Phase 1b/2 study in 2H 2026. The Phase 1b portion will assess safety and potential efficacy of monotherapy dose levels in relapsed/refractory (r/r) AML, primarily NPM1-mutated patients who failed or relapsed after menin inhibitor therapy; the company plans to review Phase 1b data with FDA to discuss potential study expansion and an accelerated approval pathway. The Phase 2 portion is expected to test TBS-2025 plus menin inhibitors in mutNPM1 r/r AML, focusing on complete response rates and duration of response.

The release also notes TuHURA has initiated a randomized, placebo-controlled Phase 3 registration trial of IFx-2.0 + pembrolizumab vs pembrolizumab + placebo in first-line advanced/metastatic Merkel cell carcinoma.