TuHURA Biosciences Receives FDA IND Clearance for TBS-2025 in Relapsed/Refractory AML
TAMPA, Fla. – February 17, 2026 – TuHURA Biosciences, Inc. (NASDAQ: HURA) announced today the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for TBS-2025, a VISTA inhibiting antibody, to treat relapsed/refractory (r/r) Acute Myeloid Leukemia (AML) with NPM1 mutations. The application was filed with the FDA’s Division of Hematologic Malignancies 1 (DHM1).
Phase 2 Trial Planned
TuHURA plans to initiate a Phase 2 study in patients with NPM1-mutated r/r AML who have not previously received menin inhibitors, utilizing a Simon 2 stage design. The company anticipates beginning the trial in early Q2 2026, with preliminary Stage 1 results expected in Q3 2026, pending FDA review and clearance of the IND application.
Scientific Rationale for Combination Therapy
According to Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences, “There is a broad body of scientific evidence showing that leukemogenic mutations common in AML, such as mutNPM1, may drive the expression of VISTA on the surface of leukemic cells, which contribute to low response rates to therapy and markedly reduced overall survival.”
While menin inhibitors have offered a new treatment option for patients with mutNPM1 r/r AML, complete remission (CR) or complete remission with hematologic recovery (CRh) rates remain generally below 25% and are often short-lived, highlighting an unmet medical require. TuHURA believes that combining TBS-2025 with a menin inhibitor may significantly improve both the CR/CRh rate and its duration.
About TBS-2025
TBS-2025 is a VISTA-inhibiting monoclonal antibody acquired by TuHURA through its merger with Kineta Inc. On June 30, 2025. VISTA, or VSIR, is a checkpoint protein expressed on quiescent T cells and myeloid cells. Research suggests that mutNPM1 and mutDNM3TA, common mutations in AML, can increase VISTA expression on leukemic cells, contributing to poor treatment response and relapse rates. By inhibiting VISTA, TBS-2025 aims to enhance the immune system’s ability to recognize and attack leukemia cells.
In a previous Phase 1 trial conducted by Kineta, TBS-2025 demonstrated a favorable safety profile in patients with advanced, therapy-refractory cancers, including breast, lung, colorectal, and ovarian cancer, even at the highest dose of 1,000mg every two weeks. Based on pharmacokinetic and pharmacodynamic data, TuHURA has identified 750mg every three weeks as the optimal dose for the Phase 2 study.
About TuHURA Biosciences
TuHURA Biosciences is a Phase 3 immuno-oncology company focused on developing therapies to overcome resistance to cancer immunotherapy. The company’s lead program, IFx-2.0, is an innate immune agonist being evaluated in a Phase 3 trial as an adjunctive therapy to Keytruda® (pembrolizumab) for first-line treatment of advanced or metastatic Merkel Cell Carcinoma. In addition to TBS-2025, TuHURA is also developing Delta Opioid Receptor technology to create bispecific antibody-drug conjugates (ADCs) targeting Myeloid Derived Suppressor Cells.
For more information, visit www.tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on current beliefs, expectations, and assumptions and are subject to risks and uncertainties. Actual results may differ materially from those described in the forward-looking statements. See TuHURA’s filings with the SEC for a more detailed discussion of these risks and uncertainties.
Investor Contact:
Monique Kosse
Gilmartin Group
[email protected]
SOURCE TuHURA Biosciences, Inc.