January 15, 2016.
Dr. Patrick Soon-Shiong, M.D., Founder and CEO of biotech NantWorks, announced the launch of Cancer MoonShot 2020 Program and the National (USA) Immunotherapy Coalition (NIC), a collaboration of leaders across the healthcare ecosystem from biotech, large pharma, major cancer centers and insurers. The mission of the program is to rapidly enroll and complete randomized Phase II clinical trials to validate the potential of panomic (whole genome, transcriptome and proteomic) analyses and to evaluate novel combination immunotherapies as the next generation standard of care.
This coalition aims to use a secure cloud-based infrastructure to complete randomized clinical trials in patients with cancer at all stages of disease, across up to 20 tumor types in 20,000 patients within the next 36 months. By comparing standards of care to the next paradigm of less toxic immunotherapy combination therapy, the findings of these in the randomized QUILT (QUantitative Integrative Lifelong Trial) Program will inform the design of Phase III registration trials, with the goal of bringing transformative advances in combination immunotherapies to cancer patients by 2020.
The multiple Phase I and II protocol designs will be a collaboration between academia, pharma, and clinical scientific experts in immunotherapy in accordance with the recent FDA Guidance of “Co-development of Two or More New Investigational Drugs for Use in Combination.”
Dr. Soon-Shiong, noted in a press release the importance of immunotherapy in oncology. However, while many companies are developing dozens of agents to activate the immune system, the problem is that they are each on their own individual development path. “If we follow the current path of drug development, it may take 40 or 50 years before we have worked out the right cocktail combination and countless lives will be lost as a result of this inefficiency.”
Read the full release.