TuHURA Biosciences, Inc. (NASDAQ: HURA), a Phase 3 registration-stage immuno-oncology company, announced the appointment of Craig L. Tendler, M.D. to its Board of Directors effective March 10, 2025. Dr. Tendler previously served as Vice President of Oncology Clinical Development, Diagnostics, and Global Medical Affairs at Johnson & Johnson Innovative Medicine Research & Development.
During his tenure at Johnson & Johnson, Dr. Tendler oversaw 30 major drug approvals and 13 FDA Breakthrough Designations. His leadership was instrumental in securing worldwide approvals for transformational oncology treatments including ZYTIGA, AKEEGA, and ERLEADA for prostate cancer; DARZALEX, CARVYKTI, TECVAYLI, TALVEY, and IMBRUVICA for hematologic malignancies; RYBREVANT for lung cancer; and BALVERSA for bladder cancer.
"We are honored and thrilled to have Craig join our Board of Directors," commented James Bianco, M.D., President and Chief Executive Officer of TuHURA. "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."
Dr. Bianco emphasized that Tendler's expertise will be particularly valuable as the company advances IFx-2.0 through its registrational Phase 3 clinical trial, planned to begin in the second quarter of 2025. Additionally, his experience in overseeing major oncology business development opportunities will assist the company in evaluating potential corporate collaborations and acquisitions to expand its pipeline.
James Manuso, Ph.D., Chairman of TuHURA's Board of Directors, noted that Dr. Tendler's "impressive track record achieving worldwide approvals for transformational treatments" will supplement the Board's expertise at a critical juncture in TuHURA's development programs.
Strategic Significance for TuHURA's Immuno-Oncology Pipeline
TuHURA Biosciences is focused on developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, addressing a significant unmet need in oncology. The company's lead candidate, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors.
Dr. Tendler expressed optimism about joining TuHURA's board: "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."
He also highlighted the company's recent agreement with Kineta to acquire its VISTA inhibiting antibody, which leverages TuHURA's 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.
Upcoming Clinical Development Plans
TuHURA is preparing to initiate a single randomized placebo-controlled Phase 3 registration-directed trial of IFx-2.0 in the second quarter of 2025. The trial will evaluate 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.
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 acute myeloid leukemia (AML).
The company is also developing non-tumor targeting antibody-drug conjugates (ADCs) and antibody-payload conjugates (APCs) to convert the tumor microenvironment to an immunogenic phenotype, potentially overcoming acquired resistance to checkpoint inhibitors and cellular therapies.
Dr. Tendler's Background
Prior to his role at Johnson & Johnson, Dr. Tendler served as the Vice President of Oncology Clinical Research and Chair of the Oncology Licensing Committee at the Schering-Plough Research Institute. His experience extends beyond the pharmaceutical industry, having 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 at Mount Sinai School of Medicine.
Dr. Tendler's academic background includes serving as an Assistant Professor of Pediatrics/Hematology-Oncology at the Mount Sinai School of Medicine and as a NIH physician-scientist grant recipient and research fellow at the National Cancer Institute in Bethesda, Maryland. He earned his undergraduate degree from Cornell University and graduated from the Mount Sinai School of Medicine with high honors and induction into the Alpha Omega Alpha Medical Society.
This strategic appointment comes at a pivotal time for TuHURA as it advances its innovative immuno-oncology pipeline aimed at addressing the significant challenge of resistance to cancer immunotherapies.
