TuHURA Reports Initial Data Showing Partial Responses In First Three Metastatic Merkel Cell Carcinoma Patients Treated With Ifx-2.0 Plus Keytruda

Preliminary results demonstrate major objective tumor responses in first 3 patients at 6 months 

Company to host a webcast today, October 26, 2026, at 8:30 am ET

TAMPA, Fla., Oct. 26, 2026 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, today announced initial data from the first three patients in its open-label study of IFx-2.0 as an adjunctive therapy to Keytruda® in first-line treatment of metastatic Merkel Cell Carcinoma (MCC). Results showed that each patient achieved a major objective anti-tumor response, with all three responses meeting the criteria for partial response (PR) under RECIST v.1.1 criteria. All responses were durable, as each of the responses were ongoing at the protocol-specified six-month assessment.

The Phase 1b/2a trial of IFx-2.0 is a multicenter, open-label trial designed to assess the safety and feasibility of IFx-2.0 as adjunctive therapy to Keytruda® (pembrolizumab) when administered into deep seated and/or bulky tumors accessible with CT or ultrasound guided administration in the front-line treatment of adult patients with metastatic MCC. The trial is designed to initially enroll a total of nine patients with visceral tumors including hepatic, pulmonary, or retroperitoneal or other deep seated locations using CT or ultrasound guided administration where standard-size injection needles are unable to effectively administer the intended dose of IFx-2.0.

Each patient received IFx-2.0 (0.1 mg) injected into a single deep-seated or bulky tumor once a week for three weeks. Within 48 hours of the first IFx-2.0 injection, patients received Keytruda®, followed by Keytruda® every three weeks until the earlier of disease progression, toxicity, or 2 years. Keytruda® is approved as the front-line standard of care for patients with advanced or metastatic MCC.

The primary endpoint of the study is safety and feasibility of IFx-2.0 therapy evaluated 28 days following the last dose of IFx-2.0, which is 49 days from the first IFx-2.0 infusion. The study will also evaluate key secondary endpoints, including efficacy per RECIST1.1 criteria at three and six months.