Core Viewpoint - TuHURA Biosciences, Inc. is set to initiate its Phase 3 accelerated approval trial for IFx-2.0 in combination with Keytruda® for advanced and metastatic Merkel cell carcinoma, following the removal of a partial clinical hold by the FDA [1][3] Group 1: Trial Details - The Phase 3 trial will evaluate IFx-2.0 as an adjunctive therapy administered weekly for three weeks alongside Keytruda®, compared to Keytruda® plus placebo [3] - The trial is expected to enroll 118 participants across approximately 22 to 25 U.S. sites, with a randomization ratio of 1:1 [3] - The primary endpoint is Overall Response Rate (ORR), with a key secondary endpoint of Progression Free Survival (PFS) [3] Group 2: Financial Aspects - The resolution of the partial clinical hold allows the company to unlock the second tranche of funding from a $12.5 million PIPE financing, triggering an additional payment of $2.23 million [1][3] - The company had previously announced this financing on June 3, 2025 [1] Group 3: Company Overview - TuHURA Biosciences focuses on developing novel technologies to overcome resistance to cancer immunotherapy, addressing primary and acquired resistance [4][5] - The lead product candidate, IFx-2.0, is designed to enhance the efficacy of checkpoint inhibitors [5]
FDA Removes Partial Clinical Hold on TuHURA Biosciences' Phase 3 Accelerated Approval Trial for IFx-2.0 in Advanced or Metastatic Merkel Cell Carcinoma