TuHURA Biosciences Showcases Promising IFx-Hu2.0 Trial Progress at ASCO 2025

TuHURA Biosciences, Inc. (NASDAQ: HURA), a company dedicated to advancing immune-oncology, recently presented an exciting update on its IFx-Hu2.0 project at the prestigious 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. This presentation highlighted the trial design for a Phase 3 study of IFx-Hu2.0 in combination with the well-known checkpoint inhibitor Keytruda® (pembrolizumab) specifically targeting patients with advanced Merkel cell carcinoma (MCC) who are naive to checkpoint inhibitors.

The poster titled "Multicenter, randomized, double-blinded, placebo-controlled trial of IFx-Hu2.0 (IFx) as adjunctive therapy with pembrolizumab (pembro) in checkpoint inhibitor (CPI)-naïve patients with advanced or metastatic Merkel cell carcinoma (MCC)" was showcased by Dr. Andrew Brohl, a Medical Oncologist at Moffitt Cancer Center. Through this trial, TuHURA strives to address the urgent need for effective treatments for MCC, which remains a rare but aggressive form of skin cancer with poor outcomes for patients who do not respond to initial therapy.

Dr. James Bianco, the President and CEO of TuHURA, emphasized the critical role of the innate immune system in overcoming tumor resistance. He stated that data from earlier Phase 1 trials indicated that intralesional administration of IFx-Hu2.0 can activate an innate immune response, generating both tumor-specific B cells and T cells. This innovative approach has the potential to help patients with MCC who have previously shown little to no response to existing checkpoint inhibitors.

The Phase 3 trial will be conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA), aiming for accelerated approval. TuHURA aims to recruit 118 CPI-naïve patients across approximately 22 to 25 U.S. clinical sites. Participants will receive IFx-Hu2.0 along with pembrolizumab for up to two years or until disease progression occurs, with response rates being the primary endpoint of the study.

In earlier Phase 1b trials focusing on patients who progressed while on therapies like pembrolizumab, IFx-Hu2.0 showed promising outcomes with an overall response rate of 63%. Positive results from ongoing follow-ups suggest potential longevity of the patient responses, some lasting up to 33 months.

The urgency in developing effective therapies for MCC cannot be overstated. While checkpoint inhibitor therapies have significantly improved outcomes, many patients experience very poor survival rates when their tumors do not respond to initial therapies, with an average survival time of less than 30 months noted in recent studies.

TuHURA's innovative technologies aim to overcome the resistance that frequently challenges cancer immunotherapy, striving to provide hope to patients grappling with the implications of advanced cancer stages. The findings presented at ASCO are a testament to TuHURA's commitment to leading a new frontier in cancer treatment, particularly where traditional therapies have fallen short.

For those interested in detailed aspects of the trial, the Trial in Progress poster, along with further information about TuHURA's initiatives and updates, can be found on the Scientific Publications page of TuHURA's website. With continued advances in immunology and therapeutic techniques, TuHURA stands at the forefront of transforming cancer treatment paradigms and enhancing patient care in oncology.