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The Immunity Boosters A Conversation with Dr. Kunle Odunsi ith a strong emphasis on innovative, high-impact, phase I clinical research studies, RPCI’s new Center for Immunotherapy is bringing together “a critical mass of clinical investigators and scientists who are focused on a wide range of cancer types,” says Center Director Kunle Odunsi, MD, PhD. That intellectual capital—brought together with an immune-analysis facility, a therapeutic cell-production facility and a support system for partnerships with industry and academic centers—puts RPCI on the fast track toward developing effective new immunotherapies. Although some other cancer centers in the US include some of those components, “it is unusual for them to function under one umbrella, in synergy,” explains Dr. Odunsi. W The Center is testing several strategies, including cancer vaccines, antibody therapy, cellular therapy and immune-response modifiers. One critical component of those efforts is the cGMP Therapeutic Cell Production Facility (TCPF), the first of its kind in Upstate New York. This self-contained modular unit can produce immune cells under the strict purity and sterility conditions required by the FDA and New York State. ABOUT THE CENTER’S DIRECTOR Kunle Odunsi, MD, PhD, FRCOG, FACOG Chair, Department of Gynecologic Oncology Professor of Gynecologic Oncology, Division of Surgical Subspecialties Research Program Director, Division of Gynecologic Oncology Director, Center for Immunotherapy Professor of Gynecology & Obstetrics, School of Medicine and Biomedical Sciences, University at Buffalo Director, US Cancer Vaccine Collaborative Program, Cancer Research Institute/Ludwig Institute for Cancer Research “This unique resource allows us, for the first time, to conduct cellular therapies, where we take immune cells from patients, expand them in the TCPF and give them back to patients,” says Dr. Odunsi. With each immunotherapy approach, “the tumor may respond by developing mechanisms to escape from immune attack. Therefore, we are focusing on understanding how best to generate positive, high-quality immune cells, and how best to counteract some of the negative influences, especially those generated by the tumor environment.” The Center also houses a critical “sister” facility, the Immune Analysis Facility (IAF), which “uses highly sophisticated techniques to measure individual patient immune-function parameters at baseline and at various intervals after the treatment,” explains Dr. Odunsi. “This allows us to understand how the immune therapy under study is working to produce desirable immunologic effects, and if not, how best to further optimize the therapy.” “Our studies are proof-of-concept trials, testing different variables in order to identify the most effective method for generating high-quality immune responses against human cancers.” To generate answers quickly and efficiently, the Center is equipped to conduct coordinated, parallel, phase I clinical research studies, each generating information about a single variable. While traditional phase I clinical studies gauge safety and toxicity before moving on to phase II, “our phase I immunotherapy studies are out of the box of the traditional phase I paradigm,” explains Dr. Odunsi. “Our studies are proofof-concept trials, testing different variables to identify the most effective method for generating high-quality immune responses against human cancers. Our IAF enables us to examine the depth and breadth of immune responses generated by the different variables, and we then take the best strategy to phase II clinical research studies. “When planning new trials, we strategically identify variables that we need to test, based on basic and preclinical studies conducted at RPCI or other institutions. Once we understand what a particular investigator is testing in a clinical trial, another investigator sets up a similar trial, but adds a single variable. This model allows us to monitor the results with our immune-analysis facility and generate novel insights into the impact of the single variables on immune responses in humans. Conducting these studies in parallel, not in sequence, is another major strength of the center. “We will generate novel understandings, novel insights, into the impact of single variables on immune responses in humans—not in mice.” Kunle Odunsi, MD, PhD CAREER HIGHLIGHTS • MD, University of Ife, College of Health Sciences, Ile-Ife, Nigeria • PhD, Weatherall Institute of Molecular Medicine, John Radcliffe Hospital, Oxford, UK • OBGYN Residency: Yale University School of Medicine • Gynecologic Oncology Fellowship: Roswell Park Cancer Institute • Fellow, Royal College of Obstetricians and Gynaecologists (UK) • Fellow, American College of Obstetricians and Gynecologists • Board Certifications: Obstetrics & Gynecology and Gynecologic Oncology, American Board of Obstetrics & Gynecology • Research interests: Mechanisms of interaction of the immune system with human ovarian cancer; development of cancer vaccine therapies; early detection of ovarian cancer. T H E C E N T E R ’ S S C I E N T I F I C A D V I S O RY C O M M I T T E E Dr. Candace Johnson Dr. Kelvin Lee Dr. Protul Shrikant Strategic guidance for the Center for Immunotherapy is provided by a Scientific Advisory Committee chaired by Kelvin Lee, MD, the Jacobs Family Chair of Immunology; Vice Chair, Department of Medicine, and Co-Leader, Tumor Immunology and Immunotherapy CCSG Program, RPCI. Other members include Candace Johnson, PhD, the Robert, Anne and Lew Wallace Endowed Chair for Translational Research and Deputy Director, RPCI; Nina Bhardwaj, MD, PhD, Professor of Medicine, Pathology and Dermatology and Director, Tumor Vaccine Program, New York University; Alexander Knuth, MD, Chair for Internal Medicine and Oncology, University of Zurich, Switzerland; and Protul Shrikant, PhD, Associate Professor, Department of Immunology, RPCI.