Craig Tendler, M.D., JNJ's Former Global Head of Oncology Clinical Development, to Lead TuHURA Bioscience's VISTA Program in AML and other Blood Related Cancers
Rhea-AI Summary
TuHURA Biosciences (NASDAQ: HURA) announced that Dr. Craig L. Tendler will provide strategic and operational services consistent with a Chief Medical Officer while remaining on the Board, to lead development of the VISTA‑blocking antibody TBS‑2025 in AML and other blood cancers.
Dr. Tendler brings ~30 years of oncology and hematology development experience, multiple regulatory approvals and prior leadership on JNJ's menin inhibitor program; TuHURA reports preliminary FDA feedback on early development plans.
Positive
- Experienced clinical leader added to oversee TBS-2025 development
- Direct menin inhibitor experience relevant for AML combination strategies
- Preliminary FDA feedback received on early development plan
Negative
- No clinical efficacy readouts yet for TBS-2025 in AML or blood cancers
News Market Reaction – HURA
In the Mar 23 session, HURA gained 2.06%, reflecting a moderate positive market reaction. Argus tracked a trough of -11.7% from its starting point during tracking. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Feb 17 | IND filing TBS-2025 | Positive | -15.0% | Filed IND for VISTA antibody TBS-2025 in mutNPM1 AML. |
| Feb 02 | Orphan designation | Positive | -3.0% | Received FDA Orphan Drug Designation for IFx-2.0 in melanoma. |
| Jun 24 | Phase 3 trial start | Positive | -7.1% | Initiated Phase 3 accelerated approval trial of IFx-2.0 in MCC. |
| May 05 | Phase 1b/2a start | Positive | -0.5% | Launched Phase 1b/2a study of IFx-Hu2.0 with Keytruda in MCCUP. |
| Apr 28 | AACR data update | Positive | -3.2% | Presented updated VISTA antibody and IFx-Hu2.0 clinical data at AACR. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent clinical trial catalysts have consistently seen negative next-day moves despite generally positive developments, indicating a pattern of adverse price reactions to trial news.
Over the past year, TuHURA has repeatedly reported clinical milestones, including Phase 3 and Phase 1b/2a trial initiations for IFx-2.0 and IFx-Hu2.0 and updated VISTA antibody data. These announcements, often under FDA SPA or with strong response rates, were followed by negative 24-hour moves between -0.51% and -15.04%. Today’s appointment of Dr. Craig Tendler to guide the VISTA/TBS-2025 program fits into this ongoing focus on immuno-oncology and AML development.
Key Terms
aml medical
menin inhibitor medical
checkpoint medical
oncology drug advisory committee (odac) regulatory
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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
"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
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 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
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SOURCE TuHURA Biosciences, Inc.