NeoStem, Inc. and its subsidiary, Progenitor Cell Therapy (PCT), have entered a services agreement with Kite Pharma to provide cell therapy process development and manufacturing services for Kite's lead Autologous T Cell Therapy (eACT) clinical development program.
Kite Pharma’s eACT is designed to restore the immune system's ability to recognize and eradicate tumors. Kite's lead eACT clinical development program, anti-CD19 CAR T cells, aims to treat aggressive lymphoma. PCT will provide process development services, technology transfer and implementation of the manufacturing process, including manufacturing, packaging, labeling, quality control testing, and product release and storage.
Kite will access capacity at PCT's CA facility, which recently brought online an additional Class 10,000 clean environment room (CER), bringing the total active CERs at the facility to seven. Additionally, PCT's NJ facility recently completed an extensive renovation that added two CERs, bringing the total number to five, in addition to doubling office space.
Marc Better, Ph.D., Kite's vice president of Product Sciences, said, "In our mission to rapidly advance products that harness the power of immunotherapy, we have seen substantial progress in our lead programs in exclusive collaboration with the National Cancer Institute, including impressive clinical results in lymphoma patients highlighted at the recent American Society of Hematology meeting. We believe that PCT offers industry-leading experience and expertise that will help speed progress toward Kite-sponsored clinical studies in the U.S."