Cancer Vaccine Collaborative Clinical Trials Network Appoints New Director, Expands Leadership

The Cancer Research Institute, Inc. (CRI), a U.S. nonprofit organization established in 1953 to transform cancer treatment through the development of strategies that harness the power of the immune system to detect, prevent, and eliminate cancer, and the Ludwig Institute for Cancer Research (LICR), a nonprofit research organization committed to improving the control of cancer through integrated laboratory and clinical research and novel therapeutic strategies based on the emerging understanding of cancer, today announced that Jedd D. Wolchok, MD, PhD, a clinician scientist and director of immunotherapy clinical trials at Memorial Sloan-Kettering Cancer Center and assistant member of LICR, has been named director of the Cancer Vaccine Collaborative (CVC). A joint initiative between CRI and LICR, the CVC is an academic clinical trials network dedicated to developing safe and effective therapeutic vaccines and other immunotherapies for cancer. This new class of medicines aims to strengthen our own immune systems to fight cancer with minimal or no side effects, and has the potential to benefit patients with many different cancer types. It is considered to be one of the most promising cancer treatment modalities to emerge since the advent of chemotherapy in the 1940s and 1950s.

Dr. Wolchok has taken on the role of CVC director following ten years of leadership under the program’s founding director, Lloyd J. Old, MD, who provided the vision and leadership for the CVC since he established the program in 2001. Dr. Old stepped down earlier this summer as CVC director and remains a member of the group’s leadership team.

“Immunotherapies hold great promise for cancer patients, but, as a class of medicines, they are uniquely complex,” says Jill O’Donnell-Tormey, PhD, chief executive officer and director of scientific affairs at CRI. “As the first initiative of its kind, the CVC pioneered a model for coordinated, scientifically driven clinical trials that was necessary to understand what makes these treatments work and how they can be improved for patient benefit. Today, the CVC is in an unparalleled position to guide the field in bringing next-generation cancer immunotherapies to patients, and we are confident that Jedd Wolchok, with his significant expertise as a scientist, an oncologist, and a principal investigator in clinical trials, is the ideal person to lead this charge.”

Today the CVC network comprises 19 academic clinical trial sites and immune monitoring laboratories across four continents. The CVC has conducted nearly 50 early-phase clinical trials of different therapeutic cancer vaccines involving more than 950 patients with melanoma, lung, ovarian, prostate, breast, and other cancers. Through these trials, the CVC has generated significant insights into how to enhance patient responses to therapeutic cancer vaccination and has developed advanced expertise in utilizing and refining state-of-the-art immune monitoring technologies for cancer clinical trials.

Recent milestone advances in the field, including the FDA approvals of the therapeutic prostate cancer vaccine Provenge® and the checkpoint blockade monoclonal antibody Yervoy™ for advanced melanoma, as well as the establishment of new initiatives to support cancer immunotherapy development, such as the cancer immunotherapy trials network (CITN) established in 2010 by the National Cancer Institute, have provided important validation for cancer immunotherapy and have buoyed optimism in the potential of immune-based therapies to change the way cancer is treated.

Many obstacles, however, remain to the development of optimally effective cancer immunotherapies. In particular, the inability to bring different, potentially synergistic agents together, test them in combination, and optimize them for patient benefit is seen by many as the defining challenge facing the field of cancer immunotherapy development, for both academic scientists and industry.

“Our growing body of knowledge about the human immune response to cancer, new technologies to measure and understand the clinical implications of that response, evolving regulatory frameworks that enable better evaluation of cancer immunotherapies, and increased confidence in the viability of immune-based approaches generate unprecedented opportunities for the field to come together and work on solving the remaining challenges that slow discovery and delay delivery of new medicines to cancer patients,” says Wolchok.

To overcome these challenges and capitalize more fully on present opportunities, the CVC has developed a comprehensive clinical strategy that leverages the group’s global clinical trials network, state-of-the-art immunological monitoring capabilities, expert clinical trial design and management, intellectual property, and a new model of venture philanthropy, the Cancer Vaccine Acceleration Fund (CVAF), to facilitate academic-industry partnership and accelerate development of new immune-based cancer medicines.

“The CVC/CVAF strategy is distinguished from other public and private clinical research initiatives by the remarkable breadth of the resources we can bring together to support the clinical study and development of promising cancer immunotherapies,” says Adam Kolom, managing director of the Cancer Vaccine Acceleration Fund. “With our field-wide vantage point, decade of clinical trial experience, and comprehensive scientific resources, coupled with a dedicated source of nonprofit funding to de-risk industry participation, we can help to significantly remove some of the barriers that slow or prevent immunotherapies from moving into clinical trials.”

In addition to helping to facilitate CVC access to priority immunotherapies, CVAF also puts into place terms for future return on investment back to the charity if CVAF-supported medicines become commercially successful.

“CVAF allows us to leverage our own agents and gain access to other agents that can work synergistically with ours,” says Jonathan Skipper, PhD, executive director of technology development at LICR, “increasing their therapeutic efficacy for patients, accelerating their clinical development, and furthering our nonprofit mission by ensuring that funds are redirected back into more clinical research and trials.”

Clinical priorities for CVC/CVAF will be directed by a central Coordinating and Review Committee that, through ongoing review of results of CVC clinical trials and engagement in confidential discussions with field-leading biopharmaceutical companies, will guide strategic decision-making about the best next-generation cancer immunotherapies to pursue and to test in the near term.

To broaden the CVC’s expertise and reach, CRI and LICR have recently expanded CVC leadership to include seven new members:

• Jonathan Cebon, MBBS, PhD, FRACP, medical director of cancer services and of the joint Austin-Ludwig Oncology Unit and head of the LICR Cancer Vaccine Laboratory at Austin Heath in Melbourne, Australia
• Lawrence Fong, MD, associate professor in residence, division of hematology/oncology, department of medicine, at the University of California, San Francisco
• F. Stephen Hodi, MD, associate professor at Harvard Medical School and director of the Melanoma Center at Dana-Farber Cancer Institute/Brigham and Women’s Cancer Center
• Dirk Jaeger, MD, director of the department of medical oncology at the National Center for Tumor Diseases, University of Heidelberg, Germany
• Elizabeth M. Jaffee, MD, professor of oncology at The Johns Hopkins University Medical School and director of the Gastrointestinal Cancers Program in the department of oncology at The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
• Alexander Knuth, MD, professor and chairman of the department of oncology at the University Hospital Zurich, Switzerland
• Cassian Yee, MD, member of the clinical research division at Fred Hutchinson Cancer Research Center and professor in the medical oncology division at the University of Washington School of Medicine

On the committee, they join Dr. Wolchok and other CVC-CRC members Lloyd J. Old, MD, Adam Kolom, Jill O’Donnell-Tormey, PhD, Kunle Odunsi, MD, PhD, Herbert F. Oettgen, MD, Linda Pan, Pharm.D., Gerd Ritter, PhD, Jonathan Skipper, PhD, and Ralph Venhaus, MD

“Collectively, this group represents some of the best and most innovative thinking across the entire cancer immunotherapy field,” says Wolchok. “With their wealth of experience and diverse perspectives, this group will be instrumental in ensuring that the CVC continues to forge new ground in bringing next wave cancer immunotherapies to patients.”

Dr. Wolchok has also outlined a roadmap for the CVC over the next decade that identifies clinically-relevant scientific questions that remain unanswered and outlines a practical plan of action to resolve these questions within the next ten years. Near-term scientific objectives include the incorporation of immune modulators, such as anti-CTLA-4 and anti-PD-1, into cancer vaccine clinical trials. The CVC will also seek to add new clinical sites and to pursue opportunities for partnership, such as with other cancer charities interested in exploring immune-based clinical approaches for specific cancers or with the NCI cancer immunotherapy trials network, on which Dr. Wolchok serves as a member of the steering committee and of which several CVC investigators are members, including CVC-CRC members Drs. Fong, Hodi, Jaffee, and Odunsi, as well as CVC investigators Nina Bhardwaj, MD, PhD, at New York University Langone Medical Center, and Hassane Zarour, MD, at the University of Pittsburgh Cancer Institute.

“Breaking through the challenges that threaten to prevent us and our colleagues in this field from realizing the full potential of cancer immunotherapy is central to the CVC mission,” Wolchok says. “With the unparalleled resources of the CVC, cutting-edge strategic leadership, and a highly unique and proven model of venture philanthropy and academic-industry partnership, the CVC is poised to answer important scientific and clinical questions and make game-changing contributions to the development of cancer immunotherapies and combination vaccines, which have extraordinary potential to benefit patients and be approved for treatment over the next few years.”

Media Contact
Brian M. Brewer, Cancer Research Institute
+212.688.7515, ext. 242 or [email protected]

About the Ludwig Institute for Cancer Research
The Ludwig Institute for Cancer Research Ltd is a nonprofit research organization committed to improving the control of cancer through integrated laboratory and clinical research and novel therapeutic strategies based on the emerging understanding of cancer. The Institute translates these strategies into applications for human benefit by coupling discoveries from its basic laboratory research and renowned scientists with strong intellectual property positions, clinical development expertise, and the conduct of Institute-sponsored, GCP compliant clinical trials. The core of the Institute is concentrated at ten research locations two each in Australia, Sweden, and the U.S., and one each in Belgium, Brazil, Switzerland, and the U.K. Each research site is led by a Director who is a Member scientist of the Institute and part of the management team. For more information, visit https://www.licr.org.