On September 14, 2026 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, reported that the U.S. Food and Drug Administration (FDA) has given clearance to TuHURA’s Investigational New Drug (IND) application for its TBS-2025 VISTA-inhibiting antibody for molecularly defined subsets of Acute Myeloid Leukemia (AML) and other blood-related cancers.
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The "Study May Proceed" notice from the FDA allows the Company to examine TBS-2025 in a Phase 1b study evaluating the safety and potential efficacy of monotherapy at different doses in patients with relapsed/refractory (r/r) mutNPM1 AML who have failed to respond to or relapsed after menin inhibitor therapy. Following review of the safety data with the FDA, the study is expected to progress to the dose-optimization stage of the trial to determine a safe and biologically effective dose. Patients with r/r mutNPM1 AML who fail menin inhibitor therapy have no approved or effective treatments and represent an unmet medical need. If TBS-2025 results in encouraging response rates during the dose optimization stage of the study, the Company will explore with the FDA the potential expansion of the trial in consideration for the opportunity for accelerated approval.
"As the only known company to advance a VISTA-inhibiting mAb through the FDA’s IND process into a Phase 1b study in mutNPM1 AML, this is a major milestone for the Company and a testament to our commitment to advancing novel therapies to address the unmet needs of patients with AML," said Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences. "Research has shown that patients whose leukemic cells express VISTA have a poor response to therapy and significantly shorter survival. Studies have demonstrated that TBS-2025’s ability to block VISTA on leukemic cells has resulted in dramatic improvement in survival in studies of murine models of human AML, and we hope to translate this promising underlying science into a potentially safe and effective new treatment for patients with AML. We are excited for this next phase of our growth and by what it could mean for patients with AML."
About TBS-2025
TBS-2025 is a unique VISTA-inhibiting monoclonal antibody. VISTA is a novel checkpoint expressed on quiescent (resting) T cells and highly expressed on myeloid cells, notably myeloid-derived suppressor cells (MDSCs). Scientific evidence demonstrates that mutNPM1 drives the expression of VISTA on leukemic blasts, which is reported to be the primary mechanism by which AML escapes recognition by the patient’s immune system, resulting in low response rates of short duration following current therapies, including recently approved menin inhibitors. When VSIR, the gene that encodes for VISTA, is edited not to produce VISTA in murine models of mutNPM1 AML, an immune response is observed and survival is enhanced. Similarly, in a murine model of AML, TBS-2025 resulted in an increase in survival comparable to the intensive chemotherapy regimen that is currently used in front line treatment of patients with AML. When combined with intensive chemotherapy, survival was markedly improved. Collectively, these translational data underscore the potential for TBS-2025 in the treatment of patients with AML.
(Press release, TuHURA Biosciences, SEP 14, 2026, View Source [SID1234670830])