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TuHURA Biosciences Appoints Amanda Garofalo, MSHS, as Senior Vice President of Clinical Operations

MWN-AI** Summary

TuHURA Biosciences, Inc. (NASDAQ: HURA), a company focused on Phase 3 immuno-oncology therapies aimed at overcoming resistance to cancer immunotherapy, has appointed Amanda Garofalo, MSHS, as its new Senior Vice President of Clinical Operations. With over two decades of experience in the drug and biologics development sectors spanning all clinical phases, Garofalo is expected to play a pivotal role in enhancing TuHURA’s clinical processes. She will collaborate closely with Craig Tendler, M.D., overseeing daily clinical operations.

James Bianco, M.D., President and CEO of TuHURA, expressed enthusiasm regarding Garofalo's extensive background, highlighting her crucial contributions as the firm advances its clinical programs, including the IFx-2.0 Phase 3 accelerated approval trial and the TBS-2025 transitioning into Phase 1b/2 trials.

Garofalo joins TuHURA from Parabilis Medicines, where she was instrumental in executing a $305 million Series F funding round through effective management of clinical trial enrollments and data availability. Her prior experience includes leading the oncology delivery division at EMD Serono and securing the submission of three new Investigational New Drug (IND) applications within a year at Arcus Biosciences.

Her educational background features a Master of Science in Health Science focusing on Clinical Research Administration from George Washington University as well as a Bachelor of Science degree in Biology from the College of William and Mary. She also completed an Advanced Management Program at The Wharton School.

TuHURA is dedicated to advancing cutting-edge technologies designed to tackle common issues associated with cancer immunotherapy failures. With Garofalo’s appointment, the company aims to strengthen its operational capabilities and clinical strategy as it progresses in its commitment to cancer treatment advancements.

MWN-AI** Analysis

TuHURA Biosciences Inc. (NASDAQ: HURA) recently made a strategic move by appointing Amanda Garofalo, MSHS, as its Senior Vice President of Clinical Operations. With over 20 years of experience in drug and biologic development across all phases, Mrs. Garofalo is poised to enhance TuHURA's clinical operations as it advances its cancer immunotherapy programs.

Investors should view this appointment as a pivotal development for TuHURA, particularly given the company's focus on overcoming resistance to cancer treatments— a key issue in the oncology space. Amanda Garofalo’s leadership comes at a critical time as the company heads into major clinical milestones, particularly with its IFx-2.0 Phase 3 accelerated approval trial, which targets patients with advanced Merkel Cell Carcinoma.

Garofalo’s distinguished background— including her previous roles at Parabilis Medicines and EMD Serono— equips her with essential insights and strategies for driving clinical success. Her experience in executing complex clinical trials and managing large oncology portfolios positions TuHURA to effectively navigate the challenges of clinical development. This could provide a significant boost to investor confidence, especially as the company prepares for its Phase 1b/2 trial of TBS-2025 and focuses on its innovative antibody-drug conjugate programs.

Given the competitive landscape of oncology biotech, TuHURA's strategic hiring reflects an intention to bolster its operational framework and clinical oversight. Investors seeking growth in the biotech sector should consider TuHURA’s upward trajectory and potential value if it can successfully leverage Garofalo’s expertise to achieve its clinical milestones. However, investors should remain cognizant of the inherent risks associated with clinical trials, which could impact stock performance in the short term. Overall, this leadership change suggests a well-informed move that could yield positive long-term results for TuHURA Biosciences investors.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: PR Newswire

PR Newswire

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
Monique@GilmartinIR.com

 

SOURCE TuHURA Biosciences, Inc.

FAQ**

How does Amanda Garofalo's extensive background in drug and biologic development impact TuHURA Biosciences Inc. HURA's Phase 3 clinical trial with IFx-2.0 and what specific strategies will she implement to enhance operational efficiency?
Amanda Garofalo's extensive background in drug and biologic development will enhance TuHURA Biosciences Inc.'s Phase 3 clinical trial with IFx-2.0 by applying strategic operational efficiencies through streamlined processes, rigorous oversight, and adaptive trial methodologies.
Given Amanda Garofalo's previous success in managing a portfolio of over 200 oncology clinical trials, what advancements does TuHURA Biosciences Inc. HURA anticipate in its clinical operations under her leadership for TBS-2025's Phase 1b/2 trial?
Under Amanda Garofalo's leadership, TuHURA Biosciences Inc. anticipates enhanced efficiency, innovative trial design, and strategic collaborations in clinical operations for TBS-2025's Phase 1b/2 trial, leveraging her extensive experience in oncology research management.
With TuHURA Biosciences Inc. HURA focusing on overcoming resistance in cancer immunotherapy, how will Amanda Garofalo’s leadership influence the development of the company’s early-stage antibody drug conjugates (ADCs) program?
Amanda Garofalo's leadership at TuHURA Biosciences Inc. will likely drive innovative strategies and foster collaboration that accelerate the development of early-stage ADCs, enhancing their potential to overcome resistance in cancer immunotherapy.
Considering her experience with IND submissions, what key challenges does Amanda Garofalo foresee in advancing TuHURA Biosciences Inc. HURA's pipeline, and what measures will she adopt to ensure timely progress in clinical milestones?
Amanda Garofalo anticipates challenges such as navigating regulatory requirements and potential delays in clinical trials for TuHURA Biosciences Inc. HURA's pipeline, and she plans to adopt proactive stakeholder engagement and robust project management to ensure timely milestones.

**MWN-AI FAQ is based on asking OpenAI questions about TuHURA Biosciences Inc. (NASDAQ: HURA).

TuHURA Biosciences Inc.

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