TuHURA Advances TBS-2025 into Phase 2 AML Trial with VISTA Inhibition
Event summary
- TuHURA Biosciences filed an Investigational New Drug (IND) application with the FDA for TBS-2025, a VISTA-inhibiting antibody.
- The Phase 2 trial will evaluate TBS-2025 in combination with a menin inhibitor for mutNPM1 relapsed/refractory Acute Myeloid Leukemia (AML).
- TBS-2025 was acquired by TuHURA through a merger with Kineta Inc. on June 30, 2025.
- The Phase 2 trial is expected to initiate in early Q2 2026, with preliminary Stage 1 results anticipated in Q3 2026.
- Current menin inhibitor therapies for mutNPM1 r/r AML have CR/CRh rates below 25% and short duration.
The big picture
The development of TBS-2025 addresses a significant unmet need in the treatment of relapsed/refractory AML, a disease with poor prognosis and limited therapeutic options. The acquisition of TBS-2025 by TuHURA expands its immuno-oncology pipeline and leverages the company’s expertise in overcoming resistance to cancer immunotherapy. The reliance on a menin inhibitor as a combination partner introduces a dependency on the continued success and market penetration of that class of drugs.
What we're watching
- Clinical Efficacy
- The success of the Phase 2 trial hinges on whether the combination of TBS-2025 and a menin inhibitor significantly improves response rates and duration compared to existing therapies, which currently have limited efficacy.
- Regulatory Pathway
- TuHURA's stated intention to pursue accelerated approval will depend heavily on the Phase 2 data and FDA’s assessment of the unmet medical need in this patient population.
- Competitive Landscape
- The emergence of other VISTA inhibitors or novel AML therapies could diminish TBS-2025’s potential market share and necessitate a differentiated clinical profile for success.
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