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HURA 資訊
HURA 事件
TuHURA Biosciences Files IND for TBS-2025 with FDA
TuHURA Biosciences announced that it has filed an Investigational New Drug application with the U.S. 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. The company is targeting initiation of the Phase 1b/2 study in the second half of 2026.
TuHURA Biosciences Files INDA for TBS-2025 with FDA
TuHURA Biosciences has filed an Investigational New Drug Application, or INDA, with the FDA's Division of Hematologic Malignancies 1 for the study of TBS-2025, a novel VISTA inhibiting antibody, for the treatment of mutNPM1 relapsed/refractory Acute Myeloid Leukemi, or AML, in combination with a menin inhibitor. TBS-2025 is a unique VISTA-inhibiting monoclonal antibody acquired by the company in its acquisition by merger with Kineta on June 30, 2025. The company plans on initiating a Phase 2 study in menin inhibitor naive patients with mutNPM1 r/r AML utilizing a Simon 2 stage design. Pending completion of FDA review and clearance, the company currently targets initiating the Phase 2 study in early Q2 with preliminary Stage 1 results in Q3.
TuHURA Biosciences IFx-2.0 Receives Orphan Drug Designation
TuHURA Biosciences announced that the U.S FDA Office of Orphan Products Development has granted Orphan Drug Designation to IFx-2.0 for the treatment of stage IIB to stage IV cutaneous melanoma.
TuHURA Biosciences Announces Kintara REM-001 Clinical Trial Success
TuHURA Biosciences announced that Kintara's REM-001 clinical trial of ten metastatic cutaneous breast cancer patients met its primary endpoint demonstrating safety with signs of clinical efficacy following eight weeks of follow-up for such patients. Pursuant to the terms of the Contingent Value Rights Agreement dated as of October 18, 2024, by and between TuHURA Biosciences, Inc. and the rights agent, Equiniti Trust Company, as a result of the trial and the completion of the follow-up, the milestone required for the release of an aggregate of 1,539,958 shares of TuHURA common stock to legacy Kintara Therapeutics stockholders has been achieved. The holders of CVRs are entitled to receive shares of TuHURA common stock, subject to the terms of the CVR Agreement and any applicable withholding.
TuHURA Biosciences Secures $15.6 Million Financing to Advance AML Research
TuHURA Biosciences provided 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. 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
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