TuHURA Biosciences Highlights Phase III IFx Push, AML Trial Plans at Canaccord

TuHURA is advancing IFx into a Phase III trial with pembrolizumab as a first-line treatment for advanced Merkel cell carcinoma. The 118-patient study is expected to complete enrollment in the second half of next year, with top-line results anticipated in late next year or early 2028. The company plans to begin a Phase Ib/II trial of its VISTA-inhibiting antibody, TBS-2025, in patients with NPM1-mutated AML who have failed menin inhibitors. TuHURA expects FDA clearance next month and may later evaluate combination treatment with a menin inhibitor. TuHURA is also pursuing preclinical immune-modulating antibody-drug conjugates and expects animal proof-of-concept data later this year. Its largest shareholder provided a $50 million, five-year credit facility described as non-dilutive operating capital.

TuHURA Biosciences NASDAQ: HURA outlined plans for its late-stage immuno-oncology pipeline at the Canaccord Genuity Growth Conference, highlighting an ongoing Phase III study of IFx in first-line advanced Merkel cell carcinoma, a planned AML trial for its VISTA-inhibiting antibody, and preclinical work on immune-modulating antibody-drug conjugates. President and CEO Jim Bianco said the company is focused on addressing primary and acquired resistance to cancer immunotherapies through three technology platforms.

TuHURA expects to complete enrollment in its Phase III Merkel cell carcinoma trial in the second half of next year, with top-line data anticipated around late next year or early 2028, he said.

Phase III IFx Study in Merkel Cell Carcinoma The company’s lead program, IFx, is being studied alongside pembrolizumab in patients with advanced or metastatic Merkel cell carcinoma. Bianco described Merkel cell carcinoma as an aggressive, polyomavirus-driven skin cancer for which many patients present with advanced disease. Pembrolizumab or avelumab are standard first-line treatments, but Bianco said roughly half of patients do not respond and have no alternative therapies. IFx uses plasmid DNA encoding a bacterial protein that is injected into accessible tumor lesions. According to Bianco, the approach is intended to prompt an innate immune response and subsequently generate tumor-specific T-cell and B-cell responses, potentially enabling patients to respond to checkpoint inhibition. In an earlier study, 13 patients with Merkel cell carcinoma had previously progressed on a PD-1 or PD-L1 inhibitor before receiving IFx and then being rechallenged with the same class of checkpoint inhibitor. Bianco said the study included durable complete and partial responses, although three patients did not respond.

The ongoing Phase III trial is a 118-patient, randomized study comparing IFx plus pembrolizumab with pembrolizumab plus placebo injection. The company initially planned for 21 to 25 sites but is now considering approximately 40 sites, with about 30 already enrolling, Bianco said. TuHURA reached an agreement with the FDA under a Special Protocol Assessment for the trial. The design uses objective response rate as the basis for potential accelerated approval, while progression-free survival is a key secondary endpoint that Bianco said could fulfill the confirmatory requirement as data mature. He said the company would not need to have a separate confirmatory study underway at the time of a potential biologics license application submission. Bianco said the decision to move IFx directly into the first-line setting followed discussions with the FDA’s Oncology Center of Excellence under its Project FrontRunner initiative. The agency encouraged the company to evaluate whether IFx could prevent treatment resist...