NeoStem, Inc. and its subsidiary, Progenitor Cell Therapy LLC (“PCT”), together with Adaptimmune Limited and Adaptimmune LLC (collectively, “Adaptimmune”), announced a Services Agreement under which PCT will provide services to support Adaptimmune’s NYESO-1c259-T cell therapy product being developed for multiple oncology indications (for more information with respect to Adaptimmune’s clinical trials, see clinicaltrials.gov, identifiers NCT01350401, NCT01343043 and NCT01352286).
PCT’s services will include the transfer and qualification of Adaptimmune’s manufacturing process for its NYESO-1c259-T cell therapy product candidate at PCT’s facility in Allendale, New Jersey and subsequent manufacturing of the product for Adaptimmune’s clinical trials.
Adaptimmune develops products containing unique engineered T cell receptors for the treatment of cancer and infectious diseases. The company has a research base in Oxford, UK and a clinical base in Philadelphia, Pennsylvania.
In December, at the American Society of Hematology conference, Adaptimmune announced encouraging preliminary results from its expanded multiple myeloma trial. Related trials in melanoma and sarcoma are also recruiting patients.
PCT is an internationally recognized contract development and manufacturing organization with facilities in Allendale, New Jersey and Mountain View, California. The company has expertise in GMP manufacture for cell therapies, including dendritic cells, stem cells and T cells. Notably, PCT provided manufacturing for the pivotal studies for Dendreon’s Provenge®, the first cell therapy approved for cancer treatment.
“With our sights set on future pivotal trials for our T cell therapy products, we have invested significant effort towards establishing capabilities within Adaptimmune that support expansion of our clinical platform in terms of both scale and compliance with FDA requirements beyond phase I/II. Our relationship with PCT is an important component,” said James Noble, Chief Executive Officer of Adaptimmune. “PCT’s impressive level of experience in the burgeoning field of cell therapy, combined with their flexible capacity and professionalism, are among the reasons we selected them for this critical role for our T cell product.”
“We are excited to enter into this agreement with Adaptimmune, an innovator for T cell therapy to treat cancers,” said Robert A. Preti, PhD, President and Chief Scientific Officer of PCT. “Given our extensive experience with technology transfer, process qualification and GMP manufacturing, we feel PCT will be an asset to Adaptimmune as it develops its product for the U.S. commercial market.”
Dr. Robin L. Smith, NeoStem’s Chairman and Chief Executive Officer, stated that, “PCT’s expertise is recognized globally as demonstrated by the services agreement executed with Adaptimmune. As PCT continues to expand its GMP manufacturing capabilities and focus to support the development of an increasingly wide range of cell therapies under development, it remains focused on providing outstanding client services.”