
Kite Pharma Pauses Selected Clinical Trials
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
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
Sources: Kite Pharma, EP Vantage, AACR
Newsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.