On June 15, 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 it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the study of its TBS-2025 VISTA inhibiting antibody for the treatment of molecularly defined subsets of AML and other blood related cancers. The IND is being filed following detailed feedback and guidance from the FDA on the IND filed in February 2026.

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"We are excited to be the first company to advance a VISTA-inhibiting antibody for investigation in hematologic cancers, targeting molecularly defined subsets of AML, including those with NPM1 and in the future, FLT3-ITD mutations, two of the most common mutations present in approximately 60-70% of patients with AML. We also plan to include patients with relapsed/refractory (r/r) high-risk myelodysplasia (MDS), where VISTA expression, like in AML, generally correlates with low response rates and poor survival outcomes," said Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences. "Currently, there are no approved or effective treatment options for these patient populations, representing a significant unmet medical need."

Dr. Craig Tendler, Chief Medical Officer consultant overseeing the TBS-2025 development program and Board member of TuHURA Biosciences, added, "The FDA provided valuable feedback and comprehensive guidance on trial design, which we incorporated into our proposed Phase1b dose optimization trial. Our plan is to combine the Phase 1b with the Phase 2 study for a combination study design that is much more efficient and could potentially save 4-6 months in development time. We look forward to FDA’s written responses anticipated to be received next month and, depending on the responses, are targeting initiating the Phase 1b/2 trial of TBS-2025 in the second half of 2026."

The Phase 1b portion of the study will examine the safety and potential efficacy of monotherapy dose levels in relapsed/refractory (r/r) AML patients, most of whom will harbor the NPM1 mutation and have failed to respond or relapsed after menin inhibitor therapy. In the planned protocol, if a safe and biologically effective dose is identified, the Company will review the data with the FDA to discuss the potential to expand the study at a recommended Phase 2 dose determined in the Phase 1b, to pursue a potential accelerated approval pathway, a development path similar to that of menin inhibitors in this molecular subset of patients with r/r mutNPM1 AML.

It is anticipated that the Phase 2 portion of the study will explore the potential of TBS-2025 to improve complete response rates and duration of response when used in combination with menin inhibitors in patients with mutNPM1 r/r 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 has demonstrated the mutation drives the expression of VISTA on leukemic blasts, which is reported to be the primary mechanisms 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 removed 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 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 data underscore the potential for TBS-2025 in the treatment of patients with AML

TBS 2025 was initially investigated in a large Phase 1 trial as either monotherapy (n=24) or in combination with pembrolizumab (n=15) among patients with advanced, therapy refractory cancers, including breast, lung, colorectal, and ovarian cancer. The purpose of the study was to investigate its safety profile and determine the recommended Phase 2 dose for solid tumors. The drug demonstrated a favorable safety profile even at the highest dose level of 1,000mg administered every two weeks. Safety and pharmacokinetic data from this trial was helpful in designing the Phase 1b segment of the planned trial in AML.

(Press release, TuHURA Biosciences, JUN 15, 2026, View Source [SID1234668741])