{"id":918690,"date":"2025-12-11T09:04:20","date_gmt":"2025-12-11T14:04:20","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/tuhura-biosciences-provides-corporate-update-following-recent-financing\/"},"modified":"2025-12-11T09:04:20","modified_gmt":"2025-12-11T14:04:20","slug":"tuhura-biosciences-provides-corporate-update-following-recent-financing","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/tuhura-biosciences-provides-corporate-update-following-recent-financing\/","title":{"rendered":"TuHURA Biosciences Provides Corporate Update Following Recent Financing"},"content":{"rendered":"
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PR Newswire<\/p>\n<\/p><\/div>\n

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\n Company’s lead Phase 3 program of IFx-2.0 as adjunctive therapy with Keytruda<\/i>\u00ae (pembrolizumab) as a first-line therapy for advanced and metastatic Merkel cell carcinoma (MCC), conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) targeting completion of enrollment Q4-2026<\/i><\/p>\n

\n A mini KOL symposium held on December 5, 2025<\/span>, provided the scientific rational for targeting VISTA in AML and the clinical applications in combination with a menin inhibitor in NPM1 mutated relapsed\/refractory AML <\/i>\n <\/p>\n

\n Oral and poster presentations at the recently concluded 57th ASH Annual Meeting showed the Delta Opioid Receptor (DOR) to be a compelling new target as the cornerstone for the Company’s bi-functional, bi-specific immune modulating Antibody Drug Conjugates (ADCs)<\/i>\n <\/p>\n

\n Recent $15.6 million<\/span> equity financing transaction provides cash runway to accomplish multiple key milestones across all three development programs <\/i>\n <\/p>\n

\n Management to host a call today, December 11, 2025<\/span>, at 8:30 am ET<\/span><\/i>\n <\/p>\n

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\n TAMPA, Fla.<\/span>
\n <\/span>, Dec. 11, 2025<\/span><\/span> \/PRNewswire\/ — TuHURA Biosciences, Inc.<\/b>\u00a0(NASDAQ:HURA) (“TuHURA”), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today provided updates across the company’s portfolio of assets, including a summary from its mini symposium held on December 5, 2025<\/span> 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<\/span> in gross proceeds, is expected to provide the cash runway to accomplish multiple key milestones across all three development programs.<\/p>\n

“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\u00ae 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<\/span> in our June 2025<\/span> PIPE financing and warrant exercise earlier this year and the recently announced $15.6 million<\/span> equity financing transaction providing us with a cash runway to accomplish multiple key milestones across all three development programs” said Dr. James Bianco<\/span>, President and Chief Executive Officer of TuHURA Biosciences.<\/p>\n

“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.”<\/p>\n

“In an encouraging development in our VISTA inhibiting antibody (TBS-2025) clinical program, at a mini symposium on December 5, 2025<\/span> prior to the ASH 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.”<\/p>\n

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.<\/p>\n

Participants at the mini symposium included: Geoffrey Uy<\/span>, MD<\/b>, 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<\/span> School of Medicine in St. Louis<\/span>; Kevin Lin<\/span>, MD, PhD Student<\/b>, Developmental, Regenerative, and Stem Cell Biology Program at the Washington University<\/span> in St. Louis<\/span>; and Tae Kon Kim<\/span>, MD, PhD,<\/b> Assistant Professor of Medicine, Division of Hematology and Oncology at Vanderbilt University<\/span> Medical Center.<\/p>\n

\n Highlights from the Company’s mini-symposium on TBS-2025. The Company’s studies and data have shown the following:<\/b>\n <\/p>\n