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TuHURA Biosciences files IND for TBS-2025 to treat AML, targeting Phase 1b/2 trial start in late 2026

Company Fundamentals
15 Jun 2026
PRNewsWire
View Source
Bullish
pluang ai news

TuHURA Biosciences has filed an Investigational New Drug (IND) application with the FDA for TBS-2025, a VISTA-inhibiting antibody aimed at treating molecularly defined subsets of Acute Myeloid Leukemia (AML) and other blood cancers. The FDA has provided guidance on the development plan, and TuHURA plans to start a combined Phase 1b/2 trial in the second half of 2026. This trial will test TBS-2025 as monotherapy and in combination with menin inhibitors, targeting patients with relapsed/refractory AML, especially those with NPM1 mutations. The drug has shown promising safety and efficacy signals in earlier studies, addressing a significant unmet need in AML treatment.

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