Leaders from large pharma including Celgene and Amgen, biotech including NantWorks, NantKwest, Etubics, Altor Bioscience, and Precision Biologics, major academic cancer centres 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 unprecedented collaboration of multinational pharmaceutical, biotechnology companies, academic centres 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 tumour types in as many as 20,000 patients by the year 2020.
The QUILT Program
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 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 Phase 2 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.