Partnership enables rapid and efficient start-up of 15,000 research sites nationwide
CULVER CITY, Calif. – March 22, 2016 - Cancer Breakthroughs 2020, the nation's most comprehensive cancer collaborative initiative formed to accelerate next-generation immunotherapy in cancer, announced today the selection of Schulman IRB as its national institutional review board (IRB) of record. Schulman will provide review services for Cancer Breakthroughs 2020's Quantitative Integrative Lifelong Trial (QUILT) program, which aims to test multiple combinations of therapies on up to 20,000 patients who have undergone next-generation whole genome, transcriptome and quantitative proteomic analysis.
"The selection of Schulman IRB, a well-respected IRB leader with a proven track record in oncology research, marks an important step in the initiation of the QUILT program and ensures that the 15,000 participating research sites will be operating quickly and with the highest levels of efficiency and quality," said Dr. Patrick Soon-Shiong, M.D., Chairman and CEO of NantKwest (Nasdaq:NK), a pioneering, next generation, clinical-stage immunotherapy company and a leader in the Cancer Breakthroughs 2020 coalition. "Schulman's unique approach to collaboration, with state-of-the-art cloud-based technology that allows for high levels of transparency, will greatly accelerate trial execution as we manage the complexities of thousands of clinical trial sites, and up to 20 tumor types in as many as 20,000 patients in order to develop next-generation cancer treatments."
As the IRB of record, Schulman will review research protocols, approve the initiation of clinical trials and monitor study conduct and compliance. Schulman’s board membership includes multiple oncologists and research professionals with experience in cancer research. The federal government mandates IRB reviews to protect the health of participants in clinical trials.
"Cancer Breakthroughs 2020, with the launch of the QUILT program, for the first time stands to remove one of the most significant barriers to winning the war on cancer - namely, the research of new cancer treatments in ‘silos’ across industry and academia," said Schulman IRB President and CEO Michael Woods. "While immunotherapies hold great promise for treating cancer, they must be researched not for their effectiveness alone, but in combination with other treatments. The QUILT program promises to do just that, and we are proud to be a part of this ambitious and critical initiative."
The QUILT program is designed to harness and orchestrate all the elements of the immune system (including dendritic cell, T cell and NK cell therapies) by testing novel combinations of vaccines, cell-based immunotherapy, metronomic chemotherapy, low dose radiotherapy and immunomodulators -- including cytokines and check point inhibitors -- in patients who have undergone next generation whole genome, transcriptome and quantitative proteomic analysis, with the goal of achieving durable, long-lasting remission for patients with cancer.
The multiple protocol designs for Phases I-III will be a collaboration between academia, pharma, and clinical scientific experts in immunotherapy in accordance with the recently published U.S. Food and Drug Administration guidance of “Co-development of Two or More New Investigational Drugs for Use in Combination.” Multiple companies are currently exploring first-in-human clinical trials as part of agreements between government agencies, including Immunology Branches of NCI, academia and community oncologists.
Multiple randomized trials testing genomically and proteomically informed novel combinations of immunotherapy agents, will pave the way to identifying cancer therapy combinations with the lowest toxicity and the highest quality of life. Both academic cancer centers and community oncologists will participate in the QUILT Program to enroll 20,000 patients by 2020. The QUILT Program will be stratified across multiple Phase I-III trials, addressing up to 20 tumor types including breast, lung, prostate, ovarian, brain, head and neck, multiple myeloma, sarcoma, pancreatic cancer, among others. Pharmaceutical and biotechnology partners have made an unprecedented commitment to make more than 60 novel immunotherapy, targeted therapy and chemotherapeutic agents available to be combined across multiple tumor types.
About The Cancer Breakthroughs 2020 Program
The Cancer Breakthroughs 2020 Program is the nation's most comprehensive cancer collaborative initiative seeking to accelerate the potential of combination immunotherapy as the next generation standard of care in cancer patients. This initiative aims to explore a new paradigm in cancer care by initiating randomized Phase II trials in patients at all stages of disease in 20 tumor types in 20,000 patients within the next 36 months. These findings will inform Phase III trials and aspirational initiative to develop an effective vaccine-based immunotherapy to combat cancer by 2020. For more information, please visit http://www.CancerBreakthroughs2020.org and follow Cancer Breakthroughs 2020 on Twitter.