TAMPA, Fla., May 5, 2025/PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA), a Phase 3 immune-oncology company, has announced the initiation of a Phase 1b/2a trial for their lead innate immune agonist, IFx-Hu2.0. This trial is designed to evaluate the safety and feasibility of IFx-Hu2.0 as an adjunctive therapy to Keytruda® (pembrolizumab) in patients with Metastatic Merkel Cell Carcinoma of Unknown Primary Origin (MCCUP). The trial will focus on patients with deep-seated tumors without associated cutaneous tumors and will assess key secondary endpoints such as efficacy per RECIST 1.1 criteria at three and six months. Results from this study are expected by the end of Q4 2025 or early Q1 2026. Additionally, TuHURA is preparing to initiate a Phase 3 accelerated approval trial of IFx-2.0 in combination with Keytruda® for advanced or metastatic MCC patients. This trial, under a Special Protocol Assessment Agreement with the FDA, could potentially fulfill requirements for regular approval based on progression-free survival outcomes.