FDA Lifts Clinical Hold on TuHURA Biosciences’ IFx-2.0 Trial for Merkel Cell Carcinoma Advancement

FDA's Crucial Decision on TuHURA Biosciences

On June 9, 2025, TuHURA Biosciences, Inc., a prominent player in the immune-oncology sector, celebrated a pivotal turn in its clinical journey as the FDA lifted a partial hold on its Phase 3 accelerated approval trial for IFx-2.0. This development is particularly significant for patients battling advanced or metastatic Merkel Cell Carcinoma (MCC). The trial aims to explore IFx-2.0 as a complementary treatment to the established Keytruda® (pembrolizumab).

Background of the Clinical Hold

Prior to this momentous decision, the FDA had imposed a manufacturing-related partial clinical hold on TuHURA's trial, raising concerns regarding specific aspects of the study's execution. However, under a Special Protocol Assessment (SPA) agreement with the FDA, the company engaged in collaborative discussions leading to the successful resolution of the hold. Dr. James Bianco, President and CEO of TuHURA, expressed great appreciation for the guidance and prompt feedback received from the FDA’s Office of Therapeutic Products and the Oncology Center of Excellence, emphasizing the constructive relationship between the agency and the company.

Initiating the Phase 3 Trial

With the hold now lifted, TuHURA is poised to initiate the Phase 3 trial in late June 2025, commencing clinical site activations. The upcoming trial will assess IFx-2.0 as an adjunctive therapy, administered weekly for three weeks, while patients concurrently receive Keytruda®. This dosing regimen will be compared against a control group receiving Keytruda® in conjunction with a placebo. The trial anticipates enrolling approximately 118 patients across 22 to 25 sites throughout the U.S.

The primary objective of the trial is to evaluate the Overall Response Rate (ORR) among participants, with key secondary outcomes focusing on Progression-Free Survival (PFS), safety, duration of response, and overall survival metrics. Achieving success in the primary endpoint of ORR could enable TuHURA to gain accelerated approval for IFx-2.0, which could rapidly bring this potentially life-saving therapy to patients in need.

Funding and Future Prospects

The resolution of the clinical hold also triggers the release of additional funds from TuHURA's recent financial ventures, including a $12.5 million PIPE financing conducted on June 3, 2025. This infusion of cash aims to support the ongoing development of TuHURA’s innovative oncological therapies, marking a strategic advance in the company’s growth trajectory.

In addition to advancing the IFx-2.0 trial, TuHURA is exploring further opportunities to expand its pipeline. Following a potential merger with Kineta, Inc., the company aims to propel Kineta’s VISTA inhibiting antibody into a randomized Phase 2 trial, targeting areas of significant unmet need in oncology treatment.

Conclusion

As TuHURA Biosciences embarks on this crucial phase of its clinical investigation, the lifting of the FDA's hold represents a significant milestone in the quest to provide effective treatment for advanced Merkel Cell Carcinoma. The upcoming trial of IFx-2.0 is set to play a crucial role in not only advancing cancer treatment options but also in reshaping the future of immunotherapy. By harnessing innovative techniques to overcome resistance to current therapies, TuHURA is not only contributing to the field of immune-oncology but also instilling hope for countless patients and their families. For more updates on this exciting journey, stay connected with TuHURA through their official website and social media channels.