The Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for TBS-2025, a novel VISTA-inhibiting antibody, for the treatment of relapsed or refractory acute myeloid leukemia (AML). The therapy will be studied in combination with a menin inhibitor for patients harboring the mutNPM1 mutation.
The manufacturer of the therapy, TuHURA Biosciences, is planning on initiating a phase 2 study and reported in a press release that it plans to use a Simon 2-stage design and focus on patients who have not previously received a menin inhibitor. Pending final review, the trial is targeted to begin in early Q2 2026, with preliminary results expected in the third quarter of 2026. If the combination proves successful, the company intends to seek guidance on an accelerated approval pathway, according to a press release by TuHURA Biosciences, Inc.
“Given the strong scientific rationale, we believe adding TBS-2025 to a menin inhibitor may markedly increase both the remission rate and its duration,” said Dr. James Bianco, president and CEO of TuHURA Biosciences.
