The Tampa-based immuno-oncology firm aims to launch a Phase 1b/2 clinical trial in the second half of 2026. This development program focuses on patients with relapsed or refractory AML, particularly those harboring NPM1 mutations, who currently face limited effective treatment options. By inhibiting VISTA—a checkpoint often exploited by leukemia cells to evade the immune system—the company hopes to improve response rates in patients who have failed to benefit from existing menin inhibitor therapies.
Company leadership noted that the trial design incorporates direct feedback from federal regulators, potentially accelerating the development timeline by several months. Dr. James Bianco, CEO of TuHURA, emphasized that the study will evaluate TBS-2025 both as a monotherapy and in combination with menin inhibitors. The FDA has indicated it will provide written guidance on the proposed plan, bypassing the need for an in-person meeting. If successful, the study could open a pathway toward accelerated approval for this high-risk patient population, addressing a critical medical need where VISTA expression typically correlates with poor survival outcomes.
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