The regulatory "Study May Proceed" notice allows TuHURA to launch a Phase 1b clinical trial targeting a specific subset of leukemia patients—those with mutNPM1 AML who have previously failed menin inhibitor therapy. This cohort currently lacks effective treatment options, making the development of the VISTA-inhibiting monoclonal antibody a significant focus for the Tampa-based company.
Dr. James Bianco, President and CEO of TuHURA, emphasized the milestone, noting that VISTA expression on leukemic cells is linked to poor patient survival and immune system evasion. The upcoming study will first evaluate the safety and efficacy of TBS-2025 as a monotherapy. If the trial yields positive results during the initial dose-optimization phase, the company intends to coordinate with the FDA to discuss a potential pathway toward accelerated approval. Preclinical research in murine models showed that blocking VISTA with TBS-2025 significantly improved survival rates, often matching the outcomes of intensive standard chemotherapy.
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