Date: 2016-01-11
Type of information: Clinical research agreement
Compound: Cancer MoonShot 2020 Program
Company: The National Immunotherapy Coalition - Altor Bioscience (USA - FL) Amgen (USA - CA) Celgene (USA - NJ) Etubics (USA - WA) Merck KGaA (Germany) NantKwest (USA - CA) NantWorks (USA - CA) Precision Biologics (USA - TX)
Therapeutic area: Cancer - Oncology
Type agreement: collaboration R&D clinical research
Action mechanism:
Disease: breast cancer, lung cancer, prostate cancer, ovarian cancer, brain cancer, head and neck cancer, multiple myeloma, sarcoma, pancreatic cancer
Details: * On January 11, 2016, leaders from large pharma including Celgene and Amgen, biotech including NantWorks, NantKwest, Etubics, Altor Bioscience, and Precision Biologics, major academic cancer centers and community oncologists announced the launch of The National Immunotherapy Coalition (NIC), a historic alliance, in collaboration with Independence Blue Cross, one of the nation’s largest payers and Bank of America, one of the largest self-insured companies in the U.S, with a singular focus: accelerating the potential of combination immunotherapies as the next generation standard of care in patients with cancer. This collaboration of multinational pharmaceutical, biotechnology companies, academic centers and community oncologists will make possible access to over 60 novel and approved agents under exploration in the war against cancer and will enable rapid testing of novel immunotherapy combination protocols, forming the basis of The Cancer MoonShot 2020. The NIC will design, initiate and complete randomized clinical trials in cancer patients with cancer at all stages of disease in up to 20 tumor types in as many as 20,000 patients by the year 2020. The QUILT (QUantitative Integrative Lifelong Trial) 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 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 Phase 1 and 2 protocol designs will be a collaboration between academia, pharma, and clinical scientific experts in immunotherapy in accordance with the recent published FDA guidance of “Co-development of Two or More New Investigational Drugs for Use in Combination.” 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 1 and Phase 2 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. The mission of the Cancer MoonShot 2020 Program is to rapidly enroll and complete randomized Phase 2 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 combines the efforts of major academic centers but also the community oncologists, enabling accelerated recruitment of patients to multiple Phase II trials. Utilizing a secure cloud-based infrastructure to integrate and enable the participation of both major academic and community oncologists at a national scale, the goal is 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 Program will inform the design of Phase 3 registration trials, with the goal of bringing transformative advances in combination immunotherapies to cancer patients by 2020. In this collaboration, large pharmaceutical and biotechnology companies --NantWorks, NantKwest, Etubics, Precision Biologics, and Altor Bioscience—along with others, have agreed to contribute their novel immunotherapy molecules (adenovirus vaccines, neoepitopes antibodies, NK cells...), to accelerate the development of next generation immunotherapy combination cancer therapies across all tumor types. Celgene will also participate in the Cancer MoonShot 2020 Program by applying its library of important molecules, both approved and in the development pipeline, to the QUILT Program. The successful accrual of 20,000 patients by 2020 will require both community oncologists and major medical centers to collaborate for the common good. The partnership also anticipates the participation of the military health system. The ambitious goals of the Cancer MoonShot 2020 Program were presented at a meeting hosted by Vice President Joseph Biden at his Naval Observatory residence in Washington DC on December 1, 2015, where members of the coalition presented their shared vision for translating the promise of precision medicine through the delivery of combination immunotherapy to routine clinical cancer care, as well as their shared commitment to accelerate the development of immunotherapy and vaccine therapy as the next generation evolution of cancer care. Attendees of that meeting, convened and chaired by Dr. Soon-Shiong, included leadership from the pharmaceutical industry representing large pharma and biotech, leadership from national payers including Independence Blue Cross and Bank of America and healthcare leaders from security and interoperability organizations including Allscripts and Blackberry. Major academic cancer centers represented at this meeting included center directors from Massachusetts General Hospital, Johns Hopkins University, University of Miami, University of Utah, Tufts Cancer Center and the John P Murtha Cancer Center at Walter Reed as well as representatives from the oncologists in the community.
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