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TuHURA Biosciences Initiates Its Phase 3 Accelerated Approval Trial of IFx-2.0 as an Adjunctive Therapy to Keytruda® (pembrolizumab) in First Line Treatment for Advanced or Metastatic Merkel Cell Carcinoma
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 the initiation of its Phase 3 accelerated approval trial of IFx-2.0, TuHURA's lead innate immune agonist, in patients with advanced or metastatic Merkel cell carcinoma (MCC).
About this update from Tuhura Biosciences, Inc.
[{"type":"text","content":"Phase 3 trial being conducted under a Special Protocol Assessment (SPA) agreement with U.S. Food and Drug Administration (FDA) ","length":127,"tagName":"p","attribs":{}},{"type":"text","content":"Primary endpoint of Overall Response Rate (ORR) qualifies for accelerated approval process","length":90,"tagName":"p","attribs":{}},{"type":"text","content":"Key secondary endpoint of Progression Free Survival (PFS) may satisfy the requirement for a post confirmatory trial, converting accelerated approval to regular approval","length":169,"tagName":"p","attribs":{}},{"type":"text","content":"Initiation of the Phase 3 accelerated approval trial unlocks the third tranche of funds from $12.5 million PIPE financing announced on June 3, 2025","length":148,"tagName":"p","attribs":{}},{"type":"text","content":"TAMPA, Fla., June 24, 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 the initiation of its Phase 3 accelerated approval trial of IFx-2.0, TuHURA's lead innate immune agonist, in patients with advanced or metastatic Merkel cell carcinoma (MCC).","length":447,"tagName":"p"},{"type":"text","content":"IFx-2.0 is designed to overcome primary resistance to checkpoint inhibitors (CPIs), such as Keytruda® (pembrolizumab), and has demonstrated systemic anti-tumor specific immune responses (an abscopal effect) when administered intratumorally into cutaneous, subcutaneous, or accessible nodal lesions in the Company's Phase 1b trial of IFx-2.0 in patients with advanced or metastatic MCC. In the Phase 1b trial, patients with advanced or metastatic MCC who progressed on either pembrolizumab or avelumab (anti-PD(L)-1) therapy, received weekly administration of IFx-2.0 for up to three doses followed by rechallenge with anti-PD(L)-1 therapy. Results demonstrated an overall response rate of 63% (2 CR, 5 PR) with two responses lasting 23 and 33 months and five ongoing responses (6, 11, 13, 19 and 23 months) as of the last follow-up. ","length":842,"tagName":"p"},{"type":"text","content":""The initiation of IFx-2.0's Phase 3 accelerated approval trial is a significant milestone for TuHURA and for the 40% to 50% of patients with advanced or...