TuHURA Files IND for TBS-2025 in Combination Study for Relapsed/Refractory AML
TuHURA Biosciences filed an IND application with the FDA for TBS-2025, a VISTA inhibiting antibody, to be studied in combination with a menin inhibitor for treating mutNPM1 relapsed/refractory Acute Myeloid Leukemia.
TuHURA Biosciences, Inc. (NASDAQ:HURA) has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration's Division of Hematologic Malignancies 1 (DHM1) for the study of TBS-2025, a novel VISTA inhibiting antibody, for the treatment of mutNPM1 relapsed/refractory (r/r) Acute Myeloid Leukemia (AML) in combination with a menin inhibitor.
The company plans to initiate a Phase 2 study in early Q2 2026, pending FDA review and clearance, with preliminary results expected in Q3 2026. The trial will utilize a Simon 2 stage design in menin inhibitor naïve patients with mutNPM1 r/r AML.
TBS-2025 is a monoclonal antibody that targets VISTA, a checkpoint expressed on T cells and myeloid cells. The company acquired TBS-2025 in its acquisition by merger with Kineta Inc. on June 30, 2025. TBS-2025 is a VISTA inhibiting mAb moving into Phase 2 development in mutNPM1 r/r AML.
According to the company, scientific evidence suggests that mutations common in AML, such as mutNPM1, may drive VISTA expression on leukemic cells, potentially contributing to poor treatment response rates and reduced survival.
The drug was previously tested in a Phase 1 trial either as monotherapy or in combination with pembrolizumab in patients with various advanced cancers, where it demonstrated a favorable safety profile.
The clinical-stage biotech company is currently valued at approximately $81 million, with its stock having surged 75.76% year-to-date.
TuHURA is also developing other cancer immunotherapy candidates. The company's lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA has initiated a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda (pembrolizumab) compared to Keytruda plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma.
In addition, TuHURA is leveraging its Delta Opioid Receptor technology to develop first-in-class, bi-specific, bi-functional antibody drug conjugates (ADCs) targeting Myeloid Derived Suppressor Cells to inhibit their immune-suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.