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
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 resistance rather than seek to salvage patients after progression, he said.
VISTA Antibody Program Targets AML Subset
TuHURA also discussed TBS-2025, a VISTA-inhibiting antibody acquired through its June 2025 acquisition of Kineta. The company plans to advance the program into a Phase Ib/II trial in patients with NPM1-mutated acute myeloid leukemia who have failed menin inhibitors.
Bianco said VISTA is a negative checkpoint expressed in the myeloid compartment and on resting T cells. He cited research suggesting that NPM1 and FLT3-ITD mutations can drive VISTA expression on leukemic cells, potentially contributing to the lack of an immune response in AML.
The planned study will begin with an abbreviated dose-escalation phase supported by pharmacokinetic and pharmacodynamic data from prior solid-tumor studies. TuHURA expects FDA clearance next month and plans to begin the trial shortly thereafter, Bianco said.
For the initial monotherapy study, the company will look for morphologic leukemia-free state, as well as more complete response measures. Bianco said the FDA indicated it would consider morphologic leukemia-free state in this patient population, which has limited treatment options after menin inhibitor failure. If the program demonstrates safety and disease control but not a sufficient response signal in the early phase, TuHURA could proceed to a combination study with a menin inhibitor, he said.
Preclinical ADC Work and Financing
TuHURA is also developing what Bianco described as immune-modulating antibody-drug conjugates that target the delta opioid receptor on immunosuppressive cells, including myeloid-derived suppressor cells, M2 macrophages and regulatory T cells. Rather than targeting tumor cells with a cytotoxic payload, the approach is intended to reprogram an immunosuppressive tumor microenvironment, he said.
The company expects initial proof-of-concept data from animal models later this year and has submitted abstracts for the American Society of Hematology meeting, according to Bianco.
Separately, TuHURA’s largest shareholder provided a $50 million credit facility. Bianco described the five-year, interest-only facility as a non-dilutive source of operating capital. He said the shareholder owns approximately 18% of the company.
About TuHURA Biosciences (NASDAQ:HURA)
TuHURA Biosciences is a clinical‐stage biotechnology company focused on the discovery and development of novel therapeutics using high‐dimensional proteomics. The company’s core mission is to translate complex protein signatures into actionable drug targets across a range of disease areas. By integrating proteomic data with advanced computational analytics, TuHURA aims to bridge the gap between molecular disease understanding and the development of first‐in‐class therapies.
At the heart of TuHURA’s approach is its proprietary platform, which leverages multiplexed protein profiling to generate rich phenotypic maps of disease states.
