TuHURA Biosciences filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration’s Division of Hematologic Malignancies 1 (DHM1) for its VISTA‑inhibiting antibody TBS‑2025 in combination with a menin inhibitor for patients with relapsed or refractory NPM1‑mutated acute myeloid leukemia (AML). The IND filing, dated February 17, 2026, targets a rare but high‑need AML population that has limited treatment options.
The TBS‑2025 asset entered TuHURA’s pipeline through the company’s merger with Kineta Inc., completed on June 30, 2025. The merger added a Phase 2‑ready candidate to TuHURA’s portfolio, expanding the company’s focus beyond its lead IFx‑2.0 program and positioning it to pursue a potentially high‑impact therapy in a niche AML market.
TuHURA plans to launch a Phase 2 study of the TBS‑2025/menin inhibitor combination in menin‑inhibitor‑naïve patients in early Q2 2026, with preliminary Stage 1 results expected in Q3 2026. The combination seeks to improve complete remission (CR) and CR with partial hematologic recovery (CRh) rates and their duration, addressing the current 25‑30% response rates and short duration seen with menin inhibitors alone. The company also intends to seek FDA guidance on an accelerated approval pathway if the trial demonstrates meaningful benefit.
Dr. James Bianco, TuHURA’s President and CEO, explained that VISTA expression on leukemic blasts driven by mutNPM1 contributes to immune evasion and poor treatment response. “Adding TBS‑2025 to a menin inhibitor may markedly increase both the CR/CRh rate and its duration, potentially addressing this unmet medical need,” he said. The company’s strategy is to leverage the favorable safety profile of TBS‑2025, previously demonstrated in a Phase 1 trial for solid tumors, to accelerate development in AML.
The IND filing represents a significant diversification of TuHURA’s pipeline and a strategic move to capture a sizable market opportunity in relapsed or refractory NPM1‑mutated AML. By combining a VISTA inhibitor with a menin inhibitor, TuHURA aims to create a therapy that could outperform existing menin‑based treatments, potentially leading to accelerated regulatory approval and a new revenue stream for the company.
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