TuHURA files IND for cancer treatment TBS-2025
- TuHURA Biosciences (NASDAQ:HURA) has filed an Investigational New Drug (IND) application with the FDA for its VISTA-inhibiting antibody, TBS-2025, aimed at treating specific subsets of acute myeloid leukemia (AML) and other blood-related cancers.
- The company is targeting the initiation of a Phase 1b/2 clinical study in the second half of 2026 following guidance from the FDA.
- Following the announcement, the TuHURA share price was up at $2.32.
TuHURA Biosciences (NASDAQ:HURA) announced today that it has submitted an Investigational New Drug application to the U.S. Food and Drug Administration to advance its TBS-2025 therapy.
The company stated that this filing aligns with feedback from the FDA regarding a proposed development plan for treating molecularly defined subsets of AML, including those with NPM1 mutations.
"We are excited to be the first company to advance a VISTA-inhibiting antibody for investigation in hematologic cancers," said TuHURA President and CEO Dr. James Bianco.
The planned Phase 1b/2 study is designed to evaluate both monotherapy and combination treatments with menin inhibitors in relapsed/refractory AML and high-risk myelodysplasia (MDS) patient populations.
The company expects to move into the study phase in the second half of 2026.
This development follows an earlier IND submission in February 2026, after which the FDA indicated that a meeting would not be required and would instead provide written feedback.
TuHURA continues to focus on its broader immuno-oncology pipeline, including its Phase 3 registration trial for IFx-2.0 in Merkel Cell Carcinoma.
