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TAMPA, Fla. - TuHURA Biosciences, Inc. (NASDAQ:HURA), a $123 million market cap biotechnology company whose stock has declined nearly 10% over the past week, announced today that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on its Phase 3 trial for IFx-2.0, a potential adjunctive therapy for advanced and metastatic Merkel cell carcinoma (MCC). This development permits the initiation of the trial, which is expected to begin later in June 2025.
The trial, conducted under a Special Protocol Assessment (SPA) agreement with the FDA, will evaluate the efficacy of IFx-2.0 when used alongside Keytruda® (pembrolizumab), an existing treatment for MCC. The study aims to enroll 118 patients across 22 to 25 U.S. sites, with a primary endpoint of Overall Response Rate (ORR) and key secondary endpoint of Progression Free Survival (PFS).
Dr. James Bianco, President and CEO of TuHURA Biosciences, expressed gratitude for the FDA’s guidance and the opportunity to advance the trial. The resolution of the partial clinical hold also secures an additional $2.23 million from a $12.5 million Private Investment in Public Equity (PIPE) financing, which was announced on June 3, 2025. According to InvestingPro data, the company maintains a healthy liquidity position with a current ratio of 3.0, while analysts have set price targets ranging from $9.25 to $15.00, suggesting significant upside potential despite recent market volatility.
TuHURA Biosciences focuses on developing technologies to address resistance to cancer immunotherapies. IFx-2.0, their lead product candidate, is designed to overcome primary resistance to checkpoint inhibitors.
The trial’s design includes a randomized, placebo-controlled setup where participants will receive Keytruda® in both arms, with or without IFx-2.0, for a maximum of two years or until disease progression or the occurrence of Keytruda® related toxicities. Success in ORR could lead to accelerated approval, while PFS, if achieved without adversely affecting overall survival, may fulfill the criteria for regular approval without the need for a post-approval confirmatory trial.
This announcement is based on a press release statement from TuHURA Biosciences. The company’s commitment to innovation in immuno-oncology continues with the anticipated merger with Kineta, Inc. and the advancement of Kineta’s VISTA inhibiting antibody in a randomized Phase 2 trial. TuHURA also works on Delta Opioid Receptor technology to develop therapies targeting Myeloid Derived Suppressor Cells to inhibit their immune-suppressing effects and prevent acquired resistance to cancer treatments. InvestingPro analysis indicates a FAIR financial health score for the company, with additional insights available to subscribers, including 11 more ProTips and comprehensive financial metrics that could help investors better evaluate the company’s potential.
In other recent news, TuHURA Biosciences has raised $15.5 million through a private placement and warrant exercises, earmarked for advancing its cancer treatment pipeline, including a Phase 3 trial for IFx-2.0. The funding will also support a merger with Kineta, Inc., which is expected to expand TuHURA’s portfolio. TuHURA has begun a Phase 1b/2a clinical trial for IFx-Hu2.0, an immune therapy for metastatic Merkel cell carcinoma, with results anticipated by late 2025 or early 2026. The company is preparing for a Phase 3 trial under the FDA’s accelerated approval pathway, aiming to treat CPI-naïve advanced or metastatic MCC patients. Bertrand Le Bourdonnec, PhD, has been appointed as Executive Vice President, bringing expertise in drug discovery and development to TuHURA’s team. H.C. Wainwright has adjusted its price target for TuHURA to $12, maintaining a Buy rating despite the company posting a net loss wider than expected for 2024. The analyst noted TuHURA’s year-end cash position of $12.7 million, which is projected to support operations into late 2025. These developments highlight TuHURA’s ongoing efforts in advancing cancer immunotherapy treatments.
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