On December 11, 2025 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, reported updates across the company’s portfolio of assets, including a summary from its mini symposium held on December 5, 2025 focused on targeting VISTA in AML, the scientific rational and clinical applications in NPM1 mutated r/r AML in combination with a menin inhibitor. The company’s recently announced financing transaction, which provides for $15.6 million in gross proceeds, is expected to provide the cash runway to accomplish multiple key milestones across all three development programs.
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"2025 was a transformational year for us, having initiated our accelerated approval Phase 3 trial of IFx-2.0 as an adjunctive therapy to Keytruda in front-line MCC, having completed the merger with Kineta bringing a Phase 2 ready VISTA inhibiting antibody to our pipeline and having presented data positioning the DOR as a promising new target in overcoming resistance to checkpoint inhibitors. We were pleased to raise $15 million in our June 2025 PIPE financing and warrant exercise earlier this year and the recently announced $15.6 million equity financing transaction providing us with a cash runway to accomplish multiple key milestones across all three development programs" said Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences.
"We look forward in 2026 to the expected completion of enrollment for our Phase 3 study of IFx-2.0 in MCC, and anticipate receiving FDA clearance to initiate our randomized Phase 2 trial of physician’s choice of menin inhibitor vs a menin inhibitor+TBS-2025, our VISTA inhibiting antibody, in NPM1 mutated r/r AML. We also expect to present preliminary data from our IFx-2.0 basket trial; data on inhibiting DOR on MDSCs, TAMs and T regs at a scientific conference in 2Q; and proof-of-concept data in animal models for our lead ADC at a scientific conference in Q4 2026."
"In an encouraging development in our VISTA inhibiting antibody (TBS-2025) clinical program, at a mini symposium on December 5, 2025 prior to the ASH (Free ASH Whitepaper) meeting, several key opinion leaders, provided valuable insights and recommendations on our Phase 2 clinical trial plans for TBS-2025, in AML. There was clear enthusiasm for the potential of combining TBS-2025 with a menin inhibitor both in NPM1 r/r/ AML, in high-risk AML and in patients with AML who are unfit for intensive therapies. The KOLs noted that while menin inhibitors have become standard of care in NPM1 mutated AML, there still exists a significant unmet medical need, citing the relatively low CR rate and short duration of response as the two obstacles to improving clinical benefit in these patients."
Dr. Bianco continued, "The VISTA gene is the only checkpoint upregulated in patients with AML, notably among high-risk AML. It has been shown that VISTA expression on leukemic blasts is the primary culprit in the low response rate and short duration of response in AML. Targeting VISTA represents the first potential for immunotherapy to improve the treatment outcomes in AML, not just NPM1 mutated AML was the consensus opinion from the group," concluded Dr. Bianco.
Participants at the mini symposium included: Geoffrey Uy, MD, Co-chair of the Leukemia Committee for the ALLIANCE for Clinical Trials in Oncology, and Professor of Medicine, Division of Oncology, Section of Bone Marrow Transplantation at Washington University School of Medicine in St. Louis; Kevin Lin, MD, PhD Student, Developmental, Regenerative, and Stem Cell Biology Program at the Washington University in St. Louis; and Tae Kon Kim, MD, PhD, Assistant Professor of Medicine, Division of Hematology and Oncology at Vanderbilt University Medical Center.
Highlights from the Company’s mini-symposium on TBS-2025. The Company’s studies and data have shown the following:
VISTA was shown to be the only checkpoint highly upregulated in patients with AML with the highest expression in poor-risk subtypes. Its expression is seen in AML with or without common mutations like DNMT3A, NPM1, FLT-3.
VISTA expression on AML contributes to low response rate and short duration of response among patients with NPM1 mutated AML treated with menin inhibitors.
TBS-2025 provided survival advantage comparable to standard front line combination chemotherapy while significantly improving survival when used in combination with front line chemotherapy in murine model of VISTA expressing AML
Inhibition of VISTA, either through gene silencing or an inhibiting antibody, and inhibition of menin signaling pathway significantly improves survival in murine models of AML
Speaker Bios:
Tae Kon Kim, MD, PhD, Assistant Professor of Medicine, Division of Hematology and Oncology, Vanderbilt University Medical Center. Dr. Kim investigates mechanisms of immune evasion in leukemia and develops new immunotherapeutic strategies. Trained under Dr. Lieping Chen, a pioneer in immuno-oncology, his work explores emerging co-inhibitory pathways and approaches to selectively prevent graft-versus-host disease while preserving graft-versus-leukemia activity. Selected Honors received by Dr. Kim include: American Society of Hematology (ASH) (Free ASH Whitepaper) Scholar Award; American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Career Development Award; Evans MDS Young Investigator Award; American Cancer Society Clinician Scientist Development Grant; Forbeck Scholar Award.
Geoffrey L. Uy, MD, Professor of Medicine, Division of Oncology, Section of Bone Marrow Transplantation, Washington University School of Medicine, Research Member, Siteman Cancer Center. Dr. Uy is a hematopoietic stem cell transplant specialist and serves as Medical Director for Clinical Research in the Division of Oncology. His research centers on innovative therapies for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), with a focus on improving outcomes for patients with high-risk myeloid malignancies.
Kevin Yin, MD, PhD Student, Developmental, Regenerative, and Stem Cell Biology Program Washington University in St. Louis. Dr. Yin studies how initiating mutations in AML shape immune escape mechanisms and contribute to leukemia progression. His work aims to define AML–immune interactions to support the development of next-generation immunotherapies. Dr. Yin’s research is being conducted under Timothy J. Ley, MD, group who serves as his PhD advisor. Dr Ley’s research group focuses on the genetics and genomics of acute myeloid leukemia (AML). His lab studies the development of normal and leukemic blood cells. His work is focused on identifying the mutations and epigenetic events that are responsible for the initiation and progression of AML. Dr. Ley led the team that sequenced the first cancer genome from an AML patient. He has gone on to develop projects that will use whole genome sequencing to help diagnose and treat patients with AML
Conference Call Information
Management will host a conference call and webcast today, December 11, 2025, at 8:30 am Eastern Time, to discuss the corporate update and recent financing. Call details and dial-in information are as follows:
Thursday, December 11th @ 8:30 am ET
Toll Free: 1-800-225-9448
Alternate: 1-203-518-9708
(Press release, TuHURA Biosciences, DEC 11, 2025, View Source [SID1234661383])