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Phase 3 accelerated approval trial of IFx-2.0 as adjunctive therapy with Keytruda® (pembrolizumab) as a first-line therapy for advanced and metastatic Merkel cell carcinoma (MCC) is underway, conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) Company's Delta Opioid Receptor (DOR) technology selected for an oral presentation, along with 2...
Oral presentation highlights the first time it's been demonstrated that the DOR is expressed on tumor-associated MDSCs, and that DOR inhibition reprograms multiple mechanisms of MDSC- induced immunosuppression representing a new target in overcoming acquired resistance to cancer immunotherapy The first demonstration that DOR is expressed on Tumor-Associated Macrophages (TAMs), with DOR inhibiti...
TAMPA, Fla. , Aug. 20, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immune-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, today announced that management will present at the 27th Annual H.C.
Completed the acquisition of Kineta, Inc. and its VISTA inhibiting monoclonal antibody (mAb), now named "TBS-2025;" planning to initiate a Phase 2 trial in relapsed/refractory NPM1-mutated Acute Myeloid Leukemia (AML) in combination with a menin inhibitor in 2H 2025 Initiated a Phase 3 accelerated approval trial of IFx-2.0 as adjunctive therapy with Keytruda® (pembrolizumab) as a first-line the...
TAMPA, Fla. , July 1, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced that the Company has been added to the Russell 3000® Index, with automatic inclusion in the Russell 2000® Index, as a part of the 2025 Russell indexes annual ...
Acquisition adds Phase 2 ready novel VISTA inhibiting monoclonal antibody (mAb) to TuHURA's late-stage immuno-oncology pipeline TuHURA planning to initiate a Phase 2 randomized trial involving VISTA inhibiting antibody in 2nd Half 2025 Completion of the acquisition unlocks the fourth tranche of funds from $12.5 million aggregate PIPE financing announced June 3, 2025 TAMPA, Fla. , June 30, 2025 ...
Phase 3 trial being conducted under a Special Protocol Assessment (SPA) agreement with U.S. Food and Drug Administration (FDA) Primary endpoint of Overall Response Rate (ORR) qualifies for accelerated approval process Key secondary endpoint of Progression Free Survival (PFS) may satisfy the requirement for a post confirmatory trial, converting accelerated approval to regular approval Initiation...
TAMPA, Fla. and SEATTLE , June 23, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced with Kineta, Inc. (OTC Pink:KANT) ("Kineta"), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncol...
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