TuHURA Biosciences Inc (HURA) News & EventsHURATuHURA Biosciences Inc

TuHURA Biosciences Reports Initial Data on IFx-2.0

TuHURA Biosciences 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. Results showed that each patient achieved a major objective anti-tumor response, with all three responses meeting the criteria for partial response 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 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 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. "While preliminary and only reported in 3 patients, these results highlight that it is feasible to utilize CT or ultrasound guided administration of IFx-2.0 safely to patients with large bulky and or deep-seated tumors. This is also the first time we have administered IFx-2.0 with Keytruda(R) in the front line treatment setting of patients with metastatic MCC and may serve as a proxy to the potential response rates in the ongoing randomized placebo controlled Phase 3 trial, which is also being conducted in the front line treatment of patients with advanced or metastatic MCC as an adjunct with Keytruda," said Dr. James Bianco, President and Chief Executive Officer at TuHURA Biosciences. "Approximately 30% of patients with metastatic MCC present without cutaneous or superficial nodal involvement. If we continue to see this high response rate in patients in this trial, we will explore the potential to expand the number of patients in the trial and discuss with the FDA its potential to supplement the ongoing Phase 3 trial, should that study successfully meet the primary endpoint. We look forward to additional patient data in the coming months, and we will seek to present the data at an appropriate scientific conference next year."

TuHURA Biosciences Secures Patent for TBS-2025

TuHURA Biosciences announced that the USPTO has issued a patent which provides coverage for TBS-2025, TuHURA's VISTA inhibiting antibody, as well as antigen-binding fragments, modifications to the frameworks and Fc regions of the antibody, and bi-specific/multi-specific antibodies across all classes of human antibodies. Additionally, the patent provides coverage for use as a single agent or in combination with radiotherapy, chemotherapy, targeted therapies, tyrosine kinase inhibitor therapies, and immune checkpoint inhibitors, including PD-1 inhibitors. The patent term extends to February 18, 2042, prior to any potential patent term adjustment and/or regulatory patent term extension.

TuHURA Biosciences Granted U.S. Patent No. 12,734,168

TuHURA Biosciences announced that the United States Patent and Trademark Office has issued U.S. Patent No. 12,734,168 entitled, "Delta Opioid Receptor Antagonists Reprogram Immunosuppresive Microenvironment to Boost Immunotherapy." The patent is directed to, among other things, administration of DOR antagonists to subjects having cancer associated with DOR expressing Myeloid Derived Suppressor Cells. It is further directed to uses of a variety of DOR antagonist combination therapies in treating, inhibiting, reducing, ameliorating, and/or preventing cancer and/or metastasis. The patent, issued on September 15, 2026, covers administering a DOR antagonist to cancer subjects and mediating immunosuppressive myelopoiesis. Additionally, the patent discloses applications of DOR antagonists not only with bi-specific or bi-functional ADC technology, but also in the context of autologous or allogeneic adoptive cellular immunotherapies such as CAR-T, Treg or TIL cellular therapies. The patent term runs through 2043 before any patent term extension.