Amgen, Celgene, Independence Blue Cross, Bank of America and many more collaborate to deliver immunotherapies more quickly to cancer patients through historic drug development alliance.
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.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.