TuHURA Biosciences Appoints Amanda Garofalo, MSHS, as Senior Vice President of Clinical Operations
Mrs. Garofalo brings over 20 years of experience in Phase I-IV drug and biologic development
TAMPA, Fla., April 7, 2026 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, today announced Amanda Garofalo, MSHS, as Senior Vice President (SVP) of Clinical Operations.
Mrs. Garofalo, who brings over 20 years of clinical and development experience, will work closely with Craig Tendler, M.D., and oversee day-to-day clinical operations.
"We warmly welcome Amanda to the TuHURA team," said James Bianco, M.D., President and Chief Executive Officer of TuHURA Biosciences. "Her extensive experience across all stages of biotech drug development will greatly enhance our efforts as we continue to advance our clinical programs from our IFx-2.0 Phase 3 accelerated approval trial, to TBS-2025 advancing to its Phase 1b/2 trial, and pre-clinical planning for our early-stage antibody drug conjugates (ADCs) program. We look forward to working with her as we advance towards our clinical milestones this year."
Mrs. Garofalo, a distinguished twenty-year industry veteran with global leadership experience in Phase I-IV drug and biologic development, joins TuHURA from Parabilis Medicines (formerly FOG Pharmaceuticals), where she enabled enrollment, data availability and due diligence activities necessary to execute an oversubscribed, privately funded $305M Series F funding round. Prior, Mrs. Garofalo was the Head of Oncology Delivery, Clinical Delivery & Patient Centricity at EMD Serono where she was responsible for a portfolio of over 200+ Oncology Ph I-IV sponsored and non-sponsored clinical trials, managed access programs, post-marketing surveillance and real-world evidence (RWE) studies. Before that, Mrs. Garofolo directed the submission of 3 new IND submissions in just 12 months, resulting in the successful commencement of the anti-TIGIT, CD-73 inhibitor, and A2a/A2b adenosine receptor antagonist programs at Arcus Biosciences. Mrs. Garofalo has also served as the Global Clinical Program Lead at Indivior; Senior Clinical Project Manager at Medimmune; and various positions at GlaxoSmithKline Pharmaceuticals including Clinical Investigation Lead and Operations and Science Leader. Mrs. Garofalo received a Master of Science in Health Science with a focus in Clinical Research Administration from George Washington University and a Bachelor of Science in Biology from the College of William and Mary. She also completed an Advanced Management Program at The Wharton School of Business.
About TuHURA Biosciences, Inc.
TuHURA Biosciences, Inc. (NASDAQ:HURA) is a Phase 3 immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer.
TuHURA's lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA is conducting a single randomized placebo-controlled Phase 3 accelerated approval registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma (MCC).
In addition to its innate immune agonist product candidate, TuHURA acquired TBS-2025 in its acquisition by merger with Kineta Inc. on June 30, 2025. TBS-2025 is a VISTA inhibiting mAb advancing to Phase 1b/2 development in mutNPM1 r/r AML. In addition, TuHURA is leveraging its Delta Opioid Receptor technology to develop first-in-class, bi-specific, bi-functional ADCs targeting Myeloid Derived Suppressor Cells to inhibit their immune-suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.
For more information, please visit www.tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains certain "forward-looking statements" within the meaning of, and subject to the safe harbor created by Section 27A of the Securities Act, Section 21E of the Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These Forward-Looking Statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases, you can identify these statements by forward-looking words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "should," "would," "project," "plan," "expect," "goal," "seek," "future," "likely," or the negative or plural of these words or similar expressions. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements are described in detail in our registration statements, reports and other filings with the SEC, which are available on TuHURA's website and at www.sec.gov.
The forward-looking statements and other information contained in this press release are made as of the date hereof, and TuHURA does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws.
Investor Contact:
Monique Kosse
Gilmartin Group
[email protected]
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SOURCE TuHURA Biosciences, Inc.