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TuHURA Biosciences Welcomes Amanda Garofalo as Senior Vice President of Clinical Operations

TuHURA Biosciences, Inc. (NASDAQ: HURA), a leading player in Phase 3 immuno-oncology development, has announced a significant addition to its executive leadership. Amanda Garofalo, MSHS, known for her extensive expertise in drug and biologics development, has been appointed as the Senior Vice President of Clinical Operations as of April 7, 2026. This strategic move is anticipated to bolster TuHURA’s mission to innovate cancer therapies, particularly in overcoming resistance to immunotherapy.

Mrs. Garofalo arrives at TuHURA with over two decades of experience in the biotechnology sector, having previously led major clinical programs in various prestigious organizations. Her history includes remarkable contributions at Parabilis Medicines—formerly FOG Pharmaceuticals—where she played a crucial role in executing an oversubscribed $305 million Series F funding round by enhancing enrollment and data availability processes.

At EMD Serono, Mrs. Garofalo’s leadership was pivotal in managing a portfolio of over 200 oncology clinical trials spanning Phases I to IV, including managed access programs and real-world evidence studies. She has also driven clinical projects with impressive timelines, directing multiple Investigational New Drug submissions at Arcus Biosciences that resulted in the advancement of several promising therapies into clinical human trials.

TuHURA’s President and CEO, Dr. James Bianco, expressed enthusiasm regarding Garofalo’s appointment, stating, “We warmly welcome Amanda to the TuHURA team. Her extensive experience across all stages of biotech drug development will greatly enhance our efforts as we continue to advance our clinical programs.” Garrifalo is expected to closely collaborate with Craig Tendler, M.D., as she manages the day-to-day operations associated with TuHURA’s ongoing clinical trials.

The company's lead product, the immune agonist IFx-2.0, aims to address primary resistance encountered in cancer immunotherapies. It is currently undergoing a randomized, placebo-controlled Phase 3 trial designed to evaluate its effectiveness as a supplement to Keytruda® in treating patients with advanced or metastatic Merkel cell carcinoma. Furthermore, TuHURA is transitioning its recently acquired asset, TBS-2025, to Phase 1b/2 development in the treatment of certain blood cancers.

The integration of a seasoned professional like Garofalo into TuHURA’s framework is viewed as a pivotal step towards achieving key clinical milestones crucial for the company’s future. Her exemplary track record in clinical project management positions her as an asset in steering TuHURA’s innovative initiatives in cancer treatment.

With Garofalo at the helm of clinical operations, TuHURA aims to leverage her experience and knowledge to enhance the efficacy and efficiency of its clinical development programs, ultimately aiming to deliver novel therapies to patients grappling with cancer. This shift not only highlights the bold strides TuHURA is making but also reflects its commitment to addressing significant challenges encountered in cancer treatment.

As TuHURA continues its journey forward, the company plans to further engage with the oncology community, refining strategies to bring its groundbreaking therapies to fruition. For those interested in staying connected with TuHURA and learning more about their innovative approaches, the company encourages visits to their website and their social media channels.

In conclusion, Amanda Garofalo's appointment as SVP of Clinical Operations represents an exciting opportunity for TuHURA to strengthen its clinical programs, leveraging her proven expertise to enhance the company's overall impact in the fight against cancer.