TuHURA Biosciences, Inc Appoints Craig L. Tendler M.D., Former Vice President, Oncology Clinical Development, Diagnostics, and Global Medical Affairs, Johnson & Johnson Innovative Medicine Research & Development, to its Board of Directors
TuHURA Biosciences (NASDAQ:HURA) has appointed Craig L. Tendler, M.D. to its Board of Directors effective March 10, 2025. Dr. Tendler, former Vice President of Oncology Clinical Development at Johnson & Johnson, brings significant expertise having overseen 30 major drug approvals and 13 FDA Breakthrough Designations.
This strategic appointment comes as TuHURA prepares to advance IFx-2.0 through its registrational Phase 3 clinical trial, planned for Q2 2025. The company focuses on developing novel technologies to overcome resistance to cancer immunotherapy. Dr. Tendler's experience includes overseeing worldwide approvals for treatments in prostate cancer, hematologic malignancies, lung cancer, and bladder cancer.
The appointment aligns with TuHURA's recent agreement with Kineta to acquire its VISTA inhibiting antibody, and their discovery of the delta opioid receptor's role in controlling immune suppressing capabilities of myeloid derived suppressor cells and tumor associated M2 polarized macrophages.
TuHURA Biosciences (NASDAQ:HURA) ha nominato Craig L. Tendler, M.D. nel suo Consiglio di Amministrazione a partire dal 10 marzo 2025. Il Dr. Tendler, ex Vice Presidente dello Sviluppo Clinico Oncologico presso Johnson & Johnson, porta con sé una significativa esperienza avendo supervisionato 30 approvazioni di farmaci principali e 13 Designazioni di Svolta della FDA.
Questa nomina strategica arriva mentre TuHURA si prepara a far avanzare IFx-2.0 attraverso il suo trial clinico registrativo di Fase 3, previsto per il secondo trimestre del 2025. L'azienda si concentra sullo sviluppo di tecnologie innovative per superare la resistenza all'immunoterapia contro il cancro. L'esperienza del Dr. Tendler include la supervisione delle approvazioni mondiali per trattamenti nel cancro alla prostata, nelle neoplasie ematologiche, nel cancro ai polmoni e nel cancro della vescica.
La nomina è in linea con il recente accordo di TuHURA con Kineta per acquisire il suo anticorpo inibitore VISTA e la loro scoperta del ruolo del recettore degli oppioidi delta nel controllo delle capacità immunosoppressive delle cellule soppressori derivate da mieloidi e dei macrofagi polarizzati M2 associati ai tumori.
TuHURA Biosciences (NASDAQ:HURA) ha nombrado a Craig L. Tendler, M.D. en su Junta Directiva a partir del 10 de marzo de 2025. El Dr. Tendler, ex Vicepresidente de Desarrollo Clínico Oncológico en Johnson & Johnson, aporta una experiencia significativa tras haber supervisado 30 aprobaciones de medicamentos importantes y 13 Designaciones de Avance de la FDA.
Este nombramiento estratégico se produce mientras TuHURA se prepara para avanzar IFx-2.0 a través de su ensayo clínico registral de Fase 3, programado para el segundo trimestre de 2025. La empresa se centra en desarrollar tecnologías novedosas para superar la resistencia a la inmunoterapia contra el cáncer. La experiencia del Dr. Tendler incluye la supervisión de aprobaciones mundiales para tratamientos en cáncer de próstata, malignidades hematológicas, cáncer de pulmón y cáncer de vejiga.
El nombramiento está alineado con el reciente acuerdo de TuHURA con Kineta para adquirir su anticuerpo inhibidor de VISTA, y su descubrimiento del papel del receptor de opioides delta en el control de las capacidades inmunosupresoras de las células supresoras derivadas de mieloides y los macrófagos polarizados M2 asociados a tumores.
TuHURA Biosciences (NASDAQ:HURA)는 Craig L. Tendler, M.D.를 2025년 3월 10일부터 이사회의 일원으로 임명했습니다. Tendler 박사는 Johnson & Johnson의 종양학 임상 개발 부사장을 역임한 바 있으며, 30건의 주요 약물 승인과 13건의 FDA 혁신 지정 승인을 감독한 경험이 있습니다.
이 전략적 임명은 TuHURA가 2025년 2분기로 예정된 IFx-2.0의 등록 Phase 3 임상 시험을 진행할 준비를 하는 가운데 이루어졌습니다. 이 회사는 암 면역 요법에 대한 저항을 극복하기 위한 새로운 기술 개발에 집중하고 있습니다. Tendler 박사의 경험은 전립선암, 혈액암, 폐암 및 방광암 치료의 세계적인 승인 감독을 포함합니다.
이번 임명은 TuHURA가 Kineta와 체결한 VISTA 억제 항체 인수 계약 및 골수 유래 억제 세포와 종양 관련 M2 편향 대식세포의 면역 억제 능력 조절에서 델타 오피오이드 수용체의 역할 발견과 일치합니다.
TuHURA Biosciences (NASDAQ:HURA) a nommé Craig L. Tendler, M.D. au sein de son Conseil d'Administration à compter du 10 mars 2025. Le Dr. Tendler, ancien Vice-Président du Développement Clinique en Oncologie chez Johnson & Johnson, apporte une expertise significative après avoir supervisé 30 approbations de médicaments majeurs et 13 désignations de percée de la FDA.
Cette nomination stratégique intervient alors que TuHURA se prépare à faire avancer IFx-2.0 à travers son essai clinique d'enregistrement de Phase 3, prévu pour le deuxième trimestre de 2025. L'entreprise se concentre sur le développement de technologies novatrices pour surmonter la résistance à l'immunothérapie contre le cancer. L'expérience du Dr. Tendler inclut la supervision des approbations mondiales pour des traitements dans le cancer de la prostate, les malignités hématologiques, le cancer du poumon et le cancer de la vessie.
Cette nomination est en accord avec le récent accord de TuHURA avec Kineta pour acquérir son anticorps inhibiteur VISTA, ainsi que leur découverte du rôle du récepteur opioïde delta dans le contrôle des capacités immunosuppressives des cellules suppressives dérivées des myéloïdes et des macrophages M2 polarisés associés aux tumeurs.
TuHURA Biosciences (NASDAQ:HURA) hat Craig L. Tendler, M.D. mit Wirkung zum 10. März 2025 in seinen Vorstand berufen. Dr. Tendler, ehemaliger Vizepräsident für Onkologie-Klinische Entwicklung bei Johnson & Johnson, bringt umfassende Expertise mit, da er 30 wichtige Arzneimittelzulassungen und 13 FDA-Durchbruchdesignationen überwacht hat.
Diese strategische Ernennung erfolgt, während TuHURA sich darauf vorbereitet, IFx-2.0 durch seine registrierende Phase-3-Studie voranzubringen, die für das 2. Quartal 2025 geplant ist. Das Unternehmen konzentriert sich auf die Entwicklung neuartiger Technologien zur Überwindung der Resistenzen gegen die Krebsimmuntherapie. Dr. Tendlers Erfahrung umfasst die Überwachung weltweiter Zulassungen für Behandlungen bei Prostatakrebs, hämatologischen Malignomen, Lungenkrebs und Blasenkrebs.
Die Ernennung steht im Einklang mit TuHURAs kürzlichem Abkommen mit Kineta zur Übernahme des VISTA-hemmenden Antikörpers und deren Entdeckung der Rolle des delta-Opioidrezeptors bei der Kontrolle der immunsuppressiven Fähigkeiten von myeloid-abgeleiteten Suppressorzellen und tumorassoziierten M2-polarisierten Makrophagen.
- Appointment of highly experienced board member with track record of 30 major drug approvals
- Phase 3 clinical trial for lead candidate IFx-2.0 scheduled for Q2 2025
- Strategic acquisition of Kineta's VISTA inhibiting antibody strengthens pipeline
- Novel discovery regarding delta opioid receptor's role in immune suppression
- None.
Dr. Tendler oversaw 30 Major Drug Approvals, including worldwide approvals for J&J's transformational treatments in hematologic malignancies, prostate, lung and bladder cancers
Dr. Tendler also oversaw 13 FDA Breakthrough Designations accelerating the early development of promising investigational medicines intended for treatment of serious oncology indications
TAMPA, FL / ACCESS Newswire / March 11, 2025 / TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced it has appointed Craig L. Tendler, M.D. to its Board of Directors effective March 10, 2025.
"We are honored and thrilled to have Craig join our Board of Directors. His extensive experience in creating and overseeing development plans, including integration of biomarkers and diagnostics and overseeing comprehensive data-generation activities for all products in the oncology portfolio while at J&J, from proof of concept through registration and lifecycle management, will be a valuable asset to TuHURA as we advance IFx-2.0 through its registrational Phase 3 clinical trial planned to begin in second quarter 2025 and while we pursue optimal positioning of our pipeline of novel therapeutics focused on overcoming resistance to cancer immunotherapy," commented James Bianco, M.D., President and Chief Executive Officer of TuHURA. "His experience in overseeing major oncology business development opportunities, culminating in the acquisition/co-development of practice-changing oncology products, will be valuable in assisting the Company in evaluating potential corporate collaborations and potential acquisitions of other novel therapeutics to add to the Company's pipeline."
"His impressive track record achieving worldwide approvals for transformational treatments in prostate cancer (ZYTIGA, AKEEGA, and ERLEADA), hematologic malignancies (DARZALEX, CARVYKTI, TECVAYLI, TALVEY, IMBRUVICA), as well as for lung (RYBREVANT) and bladder cancer (BALVERSA), will supplement the Board's broad expertise with proven results across all aspects of oncology drug development at a critical juncture in TuHURA's development programs," noted James Manuso, Ph.D., Chairman of TuHURA's Board of Directors.
Dr. Tendler added, "TuHURA has established a science-based portfolio of novel complementary technologies and late-stage drug candidates that I believe has the potential to make a significant impact on the immuno-oncology treatment landscape. The data demonstrated to date are promising and underscore the ability of one of their potential therapeutics, IFx-2.0, to overcome resistance to immune checkpoint inhibitor therapy, a much-needed advance to further the patient benefit of this important class of cancer immuno-therapeutics. With their recent agreement with Kineta to acquire its VISTA inhibiting antibody, leveraging their novel discovery of the critical role the delta opioid receptor may play in controlling the immune suppressing capabilities of myeloid derived suppressor cells (MDSCs) and tumor associated M2 polarized macrophages, I feel this is an optimal time to bring my experience in oncology drug development to the Board and to management. I look forward to contributing to the continued growth and future success of the Company."
Dr. Tendler previously served as Vice President, Oncology Clinical Development, Diagnostics, and Global Medical Affairs of Johnson & Johnson Innovative Medicine Research & Development (Retired). In this position, he was responsible for creating and overseeing robust development plans, including optimal integration of biomarkers and diagnostics, and comprehensive data generation activities for all products in the oncology portfolio, from proof of concept through registration and lifecycle management. He worked closely with teams in early development and the disease areas of focus to implement a seamless end-to-end oncology clinical research strategy that incorporated compelling science, broad clinical trial access to diverse populations, and addressed areas of high unmet medical need.
During his tenure at Johnson & Johnson, 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 ERLEADA), hematologic malignancies (DARZALEX, CARVYKTI, TECVAYLI, TALVEY, IMBRUVICA), as well as for lung (RYBREVANT) and bladder cancer (BALVERSA). He has played an instrumental role in achieving 13 FDA breakthrough designations for accelerating the early development of promising investigational medicines intended for the treatment of serious oncology conditions.
Prior to joining Johnson & Johnson Innovative Medicine, Craig 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, Craig 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 a 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 registration-stage 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 drug candidate, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA is preparing to initiate in the second quarter 2025, a single randomized placebo-controlled Phase 3 registration=directed trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® and placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma.
In addition to its innate immune agonist candidates, following the closing of the previously announced proposed merger with Kineta, TuHURA plans to advance its VISTA inhibiting antibody into a phase two trial in combination with a menin inhibitor in NPM1 mutated relapsed or refractory AML. Leveraging its discovery of the central role the Delta Opioid Receptor plays in modulating the immunosuppressive effects of myeloid derived suppressor cells (MDSCs) and tumor associated M2 polarized macrophages on the tumor microenvironment (TME), the Company is also developing non-tumor targeting ADCs and APCs to convert the TME to an immunogenic phenotype, potentially overcoming acquired resistance to checkpoint inhibitors and cellular therapies.
For more information, please visit tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn.
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. Examples of such forward-looking statements include but are not limited to express or implied statements regarding TuHURA's expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding clinical trials and research and development programs, in particular with respect to TuHURA's IFx-Hu2.0 product candidate and its ADC and PDC development program, and any developments or results in connection therewith. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. 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 the combined company's website, and at www.sec.gov.
You are cautioned that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from those set forth in the forward-looking statements. 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. Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy any securities.
Investor Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
tuhura@jtcir.com
SOURCE: TuHURA Biosciences, Inc.
View the original press release on ACCESS Newswire
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