A coalition of pharma and biotech giants, major academic cancer centers, and community oncologists have joined with Independence Blue Cross and Bank of America to launch a coalition aimed at speeding up cancer immunotherapy development.
The National Immunotherapy Coalition (NIC) said it will focus on advancing combination immunotherapies as a next-generation standard of care in patients with cancer.
NIC has committed to promoting access to more than 60 novel and approved agents under study and to enabling rapid testing of novel immunotherapy combination protocols. These commitments will form the basis of The Cancer MoonShot 2020, in which NIC will design, initiate, and complete randomized clinical trials in patients with cancer at all stages of disease in up to 20 tumor types in as many as 20,000 patients by 2020.
Cancer MoonShot 2020 plans to rapidly enroll and complete randomized Phase II clinical trials to validate the potential of whole genome, transcriptome, and proteomic analyses, as well as evaluate novel combination immunotherapies as the next generation standard of care.
NIC also said it is launching the QUantitative Integrative Lifelong Trial (QUILT) program, designed to test new combinations of vaccines, cell-based immunotherapy, metronomic chemotherapy, low dose radiotherapy, and immunomodulators—including checkpoint inhibitors—in patients who have undergone next-generation whole genome, transcriptome, and quantitative proteomic analysis. QUILT’s goal, the coalition said, is to achieve durable, long-lasting remission for patients with cancer by harnessing and orchestrating elements of patients’ immune systems, including dendritic cell, T cell, and NK cell therapies.
QUILT will be stratified across multiple Phase I and Phase II trials, addressing tumor types including breast, lung, prostate, ovarian, brain, head and neck, multiple myeloma, sarcoma, and pancreatic cancer. Partners will collaborate on the trial protocol designs, in accordance with FDA’s guidance for industry, “Co-development of Two or More New Investigational Drugs for Use in Combination.”
Findings from the QUILT trials will inform the design of Phase III registration trials with the goal of bringing transformative advances in combination immunotherapies to patients by 2020, NIC said.
“Our knowledge in the science of genomics, proteomics, immunology, and immunotherapy has advanced and converged at an unprecedented speed, making now the time for the rapid deployment and orchestration of immunotherapy for the benefit of millions of cancer patients,” Patrick Soon-Shiong, M.D., founder and CEO of NantWorks and the Chan Soon-Shiong Institute of Molecular Medicine, said in a statement.
Independence Blue Cross has agreed to offer insurance coverage for whole genome transcriptomic tests in patients receiving immunotherapy.
“We are in discussions with the rest of the insurance industry, including Blue Cross on a national basis to encourage the industry to follow Independence’s lead,” Dr. Soon-Shiong added.
Dr. Soon-Shiong’s NantWorks and NantKwest are among the large pharmas and biotechs that have committed to the coalition. Other companies joining NIC include giants Amgen, Celgene, and Merck KGaA, as well as Etubics, Precision Biologics, and Altor Bioscience.
Institutions involved in NIC include the John P. Murtha Cancer Center at Walter Reed Military Hospital; Windber Medical Center and Windber Research Institute; Arizona State University; Johns Hopkins University School of Medicine and The Sol Goldman Pancreatic Cancer Research Center; Massachusetts General Hospital, Beth Israel Deaconess Medical Center and Harvard Medical School; Columbia University; University of Utah; the Tufts Cancer Center at Tufts Medical Center; and the Sylvester Comprehensive Cancer Center and University of Miami Miller School of Medicine.