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Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.
The National Institute of Health will conduct an internal review of the National Cancer Institute’s cell manufacturing facilities, which will affect multiple Kite projects.
Kite Pharma announced on April 16, 2016, that its cell manufacturing facilities at the National Cancer Institute (NCI) are undergoing a voluntary internal review by the National Institutes of Health (NIH). Jacob Plieth of EP Vantage pointed out on April 17 that as a result of the announcement, at least eight chimeric antigen receptor T (CAR-T) cell or T-cell receptor studies have been suspended at NCI. Although not all of the collaborative projects between Kite and NCI will be affected, all of the projects in which NCI has Cooperative Research and Development Agreements (CRADAs) with Kite will be halted-with the exception of their collaborative project on CD19.
While the process improvements at the facilities involving sterile materials occur, the trials cannot enroll new patients, although Kite noted it will continue to administer treatment to current enrollees. Kite wrote in a prepared statement, “The review of NCI’s manufacturing facilities is not related to KTE-C19 or Kite’s manufacturing capabilities.” The company said despite the pausing of the trials related to the MAGE antigen, it “remains on track to file an [investigational new drug application] with the FDA by the end of the year” for its product candidate targeting MAGE-A3 for the treatment of solid tumors.
The T-cell receptor candidates targeting MAGE-A3 are unlike many of the CAR-T therapies that have recently been in the news. “The majority of studies on T cell-based cancer immunotherapy focus on CD8 T cells due to their capability to kill tumor cells directly. However, evidence from preclinical and clinical studies indicates that another type of T cell, CD4 T cell, can also induce tumor regression,” wrote senior author of a study on MAGE-A3, Steven A. Rosenberg, MD, PhD, chief of the Surgery Branch at NCI, in a press release during the American Association for Cancer Research (AACR) meeting. Rosenberg said that this is the first clinical trial testing an immunotherapy that uses gene-engineered CD4 helper T cells against metastatic cancer.
Sources: Kite Pharma, EP Vantage, AACR