Niraparib Tosylate/Abiraterone Acetate

Distinguished physician with a career spanning over 29 years in drug development and medical affairs highlighted by blockbuster successes in hematology and oncology Coordinated and achieved more than 30 Oncology regulatory approvals and 15 new medical entity approvals, including four biologic or cell therapy approvals for various stages of multiple myeloma currently generating more than $16 billion in worldwide sales TAMPA, Fla., March 23, 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 Dr. Craig L. Tendler will provide strategic, operational and other related services consistent with those of a Chief Medical Officer (CMO). He will also continue with his current role as member of the Board of Directors. Dr. Tendler will work with the Company to oversee clinical development strategy and operations of the company's pipeline, including its VISTA inhibiting antibody, TBS-2025. "Craig has been an active and valued member of our Board and enthusiastically agreed to provide strategic, operational and other related services consistent with those of a CMO. His decades of clinical and regulatory experience in accelerating drug development across therapeutic areas, notably in hematologic malignancies, will be of particular value to our TBS-2025 program," said Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences. "I am confident that his recent leadership role and strategic contributions to JNJ's menin inhibitor, bleximenib in NPM1 mutated AML, will prove invaluable to our regulatory pathway and development of TBS-2025 in AML and other blood related cancers. I look forward to working with Craig as we unlock the value in VISTA and other clinical programs." Dr. Craig Tendler, added, "I am excited about the potential benefits of TBS-2025 for blood- related cancers where the negative checkpoint, VISTA, has been implicated in playing a critical immunosuppressive role in both therapy failure and poor overall survival in AML, particularly in the molecularly defined subset of NPM1 mutated AML. We have already received preliminary feedback from the Division of Hematologic Malignancies I of the FDA on the early development plan and will continue to work closely with the Agency to accelerate the clinical development of TBS-2025, both as monotherapy and in combination with menin inhibitors, an area where I have substantial experience." Dr. Tendler, a distinguished thirty-year industry veteran, will provide strategic and operational services consistent with those of a CMO while continuing his role as a member on the TuHURA Board of Directors. Dr. Tendler is a seasoned professional, previously serving as the Vice President, Oncology Clinical Development, Diagnostics, and Global Medical Affairs of Johnson & Johnson Innovative Medicine Research & Development. During his tenure at JNJ, Dr. Tendler and his team worked in collaboration with the FDA and the European Medicines Agency to secure the worldwide approvals of transformational treatments in prostate cancer (ZYTIGA®, AKEEGA®, and ERLEDA®), hematologic malignancies (DARZALEX®, CARVYKTI®, TECVAYLI®, TALVEY®, IMBRUVICA®) as well as for lung (RYBREVANT®) and bladder cancer (BALVERSA®). He has been a leader and key participant in four Oncology Drug Advisory Committee (ODAC) presentations, achieved 13 FDA breakthrough designations, and led clinical diligence teams for numerous oncology business development opportunities culminating in Janssen's acquisitions of Cougar Biotechnology, Aragon Pharmaceuticals, and TARIS Biomedical along with Janssen's co-development agreements with Legend Biotech, Pharmacyclics/AbbVie, Tesaro/GSK, Yuhan Corporation, and GenMab A/S. Prior to joining Johnson & Johnson Innovative Medicine, Dr. Tendler served as the Vice President of Oncology Clinical Research and Chair of the Oncology Licensing Committee at the Schering-Plough Research Institute. In addition to his pharmaceutical industry experience, he has served as Co-Chair of the Friends of Cancer Research Corporate Council, member of the Bloomberg New Economy International Cancer Coalition, and member of the Admissions Committee, Mount Sinai School of Medicine. He was an Assistant Professor of Pediatrics/Hematology-Oncology at the Mount Sinai School of Medicine and an NIH physician-scientist grant recipient and research fellow at the National Cancer Institute in Bethesda, Maryland. Dr. Tendler earned his undergraduate degree from Cornell University and graduated from the Mount Sinai School of Medicine, New York City, with high honors and induction into the Alpha Omega Alpha Medical Society. 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 has initiated a single randomized placebo-controlled Phase 3 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. In addition to its innate immune agonist product candidates, TuHURA acquired TBS-2025 in its acquisition by merger with Kineta Inc. on June 30, 2025. TBS-2025 is a VISTA inhibiting mAb moving into Phase 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 antibody drug conjugates (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 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 . 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] SOURCE TuHURA Biosciences, Inc. 21% more press release views with Request a Demo

The interim analysis of the Talapro-3 trial revealed what Pfizer called a “strong trend” toward improved overall survival. Pfizer is eyeing an earlier use of its PARP inhibitor Talzenna after a positive phase 3 trial in metastatic hormone-sensitive prostate cancer (mHSPC).The phase 3 Talapro-3 trial met its primary endpoint by showing the combo of Talzenna and Pfizer and Astellas’ prostate cancer drug Xtandi significantly reduced the risk of tumor progression or death compared with Xtandi and placebo. This was in patients with homologous recombination repair (HRR) gene-mutated mHSPC, Pfizer announced in a Thursday, March 19 release.The radiographic progression-free survival result “markedly exceeded” the prespecified target of a 37% improvement, according to the company. Pfizer described the efficacy as “consistent” between BRCA-mutated and non-BRCA-mutated subgroups. The interim analysis also revealed what Pfizer called a “strong trend” toward improved overall survival, a key secondary endpoint. The New York pharma also cited benefits in other secondary endpoints such as overall response rate, duration of response and time to PSA progression.With the positive readout, Pfizer said it plans to discuss these results with global regulators for potential submissions for approvals. HRR mutations are found in about 25% of metastatic prostate cancers and are associated with a worse prognosis, Pfizer’s chief oncology officer, Jeff Legos, Ph.D., noted in a statement. Despite existing treatment, 50% to 65% of patients with metastatic castration-sensitive prostate cancer progress to metastatic castration-resistant prostate cancer (mCRPC) within two years, according to Pfizer.As the Talzenna-Xtandi combo is already approved in HRR-mutated mCRPC, the “unprecedented results” from Talapro-3 show its potential to benefit patients earlier in the disease course, Legos added.The Talapro-3 readout gives Pfizer another opportunity to expand the reach of Talzenna after a recent FDA snub in a broader mCRPC population. In May 2025, an FDA advisory committee voted unanimously against the approval of Talzenna and Xtandi for mCRPC patients without HRR gene mutations, based on data from the phase 3 Talapro-2 trial. The FDA, after questioning the validity of Talapro-2’s findings in the non-mutant subgroup, followed the panel’s recommendation in June with a label update for Talzenna to only add new overall survival data in its existing HRR-mutated mCRPC indication. Before the latest Talzenna readout, the FDA had approved Johnson & Johnson’s two-drug PARP combo Akeega in BRCA2-mutated mHSPC. Talzenna could be the first PARP inhibitor to enter a broader HRR-mutant mHSPC setting. Compared with Xtandi, the leading androgen receptor inhibitor, Talzenna is a relatively small product within Pfizer’s oncology portfolio and the PARP inhibitor class. In 2025, Talzenna generated $182 million in sales, up 55.6% year on year. Xtandi received its mHSPC nod from the FDA in 2019 and then became the first androgen receptor inhibitor approved in nonmetastatic castration-sensitive prostate cancer in 2023.Besides Talzenna, Pfizer is also pairing Xtandi with its experimental EZH2 inhibitor mevrometostat in mHSPC in the phase 3 Mevpro-3 trial. The phase 3 Mevpro-1 trial for the drug and Xtandi in mCRPC following treatment with J&J’s Zytiga is expected to read out this year.Editor's Note: The story has been corrected to reflect that J&J's Akeega is already FDA-approved in an mHSPC subset.