Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
The Comprehensive Immunotherapy Center A Whitepaper for the Campaign Steering Committee THE VISION Though advances in cancer treatment have improved outcomes and enhanced quality of life, the threat of relapse still looms for many patients and cancer remains the second leading cause of death in the United States. The direct medical costs of repeated treatments and the lost productivity due to recurrences are exceeded only by the personal devastation. Relapse occurs due to a small amount of dormant cells— called cancer stem cells (CSCs)—that are resistant to conventional therapies and can form new tumors and metastasize even in cases of near-complete recovery. The emerging field of immunotherapy holds the key to preventing relapse. The immune system represents the epitome of precision medicine in that everyone’s immune system is unique with regards to genetics, environmental factors and exposures over time. In 2013, Science declared immunotherapy the “breakthrough of the year.” Since then the field has continued to capture international attention and raise hopes—but so far clinical trials have mostly focused on T-cell therapies. At UC Davis we believe the body’s own natural killer (NK) cells may be the answer to eradicating CSCs. These specialized cells target CSCs to promote complete recovery, including from pernicious solid cancers or inoperable tumors, and can even help prevent cancer in the first place. Unlocking the full potential of NK cells is the next frontier in immunotherapy. Such a breakthrough would eliminate the fear of relapse for patients and their families and provide a template for other diseases that can be treated using NK cells to regulate the immune system. An emerging subspecialty on the leading edge of immunotherapy, NK cell-based therapies hold the potential to be the ultimate precision medicine. UC Davis Health System has a vision to create a full-stack center dedicated to advancing NK immunotherapy as a powerful tool in the fight against cancer and other serious medical challenges. The Comprehensive Immunotherapy Center will serve as an integrated hub for immune monitoring, assessment, genetic linkage and validation across five species—providing invaluable insights into cancer and other immune-regulated diseases. Creating new synergies by convening thought leaders across the disciplines, the center will rapidly accelerate the translation of innovative immunotherapy. These efforts would not only launch a paradigm shift in cancer treatment, but also provide critical breakthroughs in organ transplantation, autoimmune disorders including HIV, infectious diseases like Ebola virus, autism and more. Immunotherapeutic strategies can either jumpstart the immune system—as is needed with cancers, viruses and bacteria-based diseases—or slow it down in cases of autoimmunity and transplantation—representing a revolutionary common pathway for modulating the body’s response to disease. The establishment of this center represents a game-changing opportunity to advance what may be the biggest precision medicine breakthrough to date. THE RIGHT TIME AND THE RIGHT PLACE Robert Canter, associate professor of surgery, and William Murphy, professor of dermatology and internal medicine and an internationally renowned specialist in cancer and viral immunology, are poised to make a transformative impact on patient care and the field of immunotherapy. For example, they recently worked with School of Veterinary Medicine and other Health System colleagues on the first study to demonstrate the safety and efficacy of using mesenchymal stem cell therapy to treat a naturally occurring, chronic oral inflammatory disease in cats. The success of this patent-pending technique in companion feline patients could serve as a useful model for the treatment of human chronic oral inflammatory disease. Additionally, the passage of the California Stem Cell Research and Cures Act to create the California Institute for Regenerative Medicine (CIRM) has placed California at the forefront of stem cell research. The CIRM has awarded UC Davis more than $130 million in funding to date. The most recent award went to Dr. Canter and Dr. Murphy. They are leading a team that will use NK cells to target tumor CSCs in pet canines with naturally occurring sarcoma (one of the most common cancers in dogs). UC Davis is one of only two institutions in the nation that houses a veterinary school, a medical school, and a National Primate Research Center—a powerful combination that positions us to establish critical linkages across multiple species like no other institution can. Dr. Canter and Dr. Murphy are leveraging these unique assets with the following university partners to establish immunological linkages, across species, of different disease states to mirror human conditions. School of Veterinary Medicine Home to the world’s number one veterinary school, UC Davis has been a pioneer in co-clinical trials, a revolutionary approach that is playing a critical role in expediting cures. Treating more than 50,000 patients a year, we have unparalleled access to a large population of companion animals who are exposed to the same environmental factors as humans and, as a result, develop similar cancers and inflammatory diseases. These patients provide a unique window into how treatment of cats and dogs might be translated to help human patients. By developing the most clinically relevant animal models, we can speed the pace and efficacy of testing prior to clinical trials. Comprehensive Cancer Center One of only 44 National Cancer Institute-designated centers in the nation and ranked among the top 1% of cancer centers, the Comprehensive Cancer Center’s partnership with the School of Veterinary Medicine is one of only a few programs of its kind nationwide. The Comparative Oncology Program is a recognized leader in translational science and collaborates closely with the Center for Companion Animal Health and the School of Medicine. This year, the group recently published a novel immunotherapy in dogs with advanced cancer in which tumors were metastasized in the lungs. The immunotherapy resulted in dramatic tumor regression in several of the dogs with melanoma or sarcoma. This same group also administered mesenchymal stem cells to cats with a severe inflammatory disease which results in partial protection from the disease. If animal trials continue to be successful, these new immune-modulating regimens could make their way into use for people. Institute for Regenerative Cures With renovation and equipment funded by the California Institute for Regenerative Medicine, the UC Davis Institute for Regenerative Cures houses two key resources: the nation’s second largest stem cell program—providing leadership in translational efforts spanning many different diseases—and Northern California’s largest Good Manufacturing Practice (GMP) facility. The GMP facility has the capability to expand autologous cells (adult stem cells taken directly from the patient, minimizing the risk of rejection), develop large batches of “off-the-shelf” cells (minimizing the amount of time a patient must wait for treatment), and to perform clinical trials. 2 THE OPPORTUNITY Imagine cancer survivors and their families living free from fear of relapse. Or the recipient of a heart transplant resting easy, knowing there is virtually no risk of transplant rejection. New treatments and cures for Ebola virus, HIV and other deadly diseases could enter the clinical trial phase at a pace unheard of until now. The tremendous promise of NK immunotherapy is not only longer lives, but also improved quality of life for a diverse array of patients. By marshaling UC Davis’ remarkable resources and brainpower, the Comprehensive Immunotherapy Center will bring new hope to patients and their families, provide an innovative model for similar medical challenges, realize significant cost savings at the societal level, and enable countless individuals to live full and productive lives. The center will also be the premier destination for training in immunotherapy, enhancing our ability to recruit the best and brightest graduate students and post-doctoral researchers from around the world. The focal point of the center will be a state-of-the-art immune monitoring core. The core will comprise both cutting-edge technologies and a group of highly specialized experts dedicated to providing laboratory services and translational research to support immune monitoring during cancer immunotherapy, vaccination, and other types of immune-modulating therapies. Robust and cost-effective immune monitoring assays are essential for measuring how patients’ immune systems respond to different treatments and identifying important biomarkers of clinical outcome. The immune monitoring core will also offer patient specimen processing and storage, data archiving, data reporting and data mining and archiving support for clinical and translational studies. The insights gained may help transition promising therapies from animal models to the clinical trial phase to standard of care. In partnership with the research community and private biotech industry, core staff will work to test and develop new technologies for immune monitoring. The core’s partnerships with the world’s top-ranked veterinary school, a National Primate Research Center, a NCI-designated comprehensive cancer center, and the resources of a leading public institution will distinguish our core from its peers and position UC Davis at the forefront of translational immunotherapy. MOVING FORWARD Creating a state-of-the-art immunotherapy center will require physical space, start-up funds, and longterm support. UC Davis Health System has a number of existing research buildings that could be converted. Start-up funding would support outfitting a converted building with outpatient clinical space, materials testing facilities, device development space for industry partnership, a science core facility with imaging tools and other research resources, and administrative space. The goal of long-term funding is to protect the time of our clinicians and researchers and thereby foster an environment conducive to rapid and customized translational solutions. A projected annual personnel cost of $X million would support a center director, a clinical trials specialist, veterinary staff, post-doctoral scientists who specialize in natural killer and cancer stem cells, and administrative staff. Ten years of salary support would provide an optimal environment for channeling efforts toward actionable therapies. The total cost is estimated to be $X million in start-up funding and $X million over ten years. 3