Servier Appoints MaSTherCell for the Development of its CAR-T Cell Therapy Manufacturing Platform

GERMANTOWN, MD--(Marketwired - Jan 20, 2017) -   Orgenesis Inc. (OTCQB: ORGS), a fully-integrated cell therapy and contract development and manufacturing company, announced that its wholly-owned subsidiary, MaSTherCell S.A., specializing in the delivery of optimized process industrialization capacities to cell therapy organizations, has signed a master service agreement with Servier for the development of a manufacturing platform for allogeneic cell therapies. Under the master service agreement, MaSTherCell is developing a CAR-T cell therapy manufacturing platform, which will enable industrial and commercial manufacturing of Servier's cell therapy products. This is a critical step in the development of these products for later stage clinical trials.

Cell therapies have shown promising results in treating cancers. However so far, successful development has been mainly limited to autologous therapies. This approach, where the patient's cells are collected and then used to create a drug for that specific patient, is limited by the lack of possibility of industrialized manufacturing, thus restricting its access to few patients. Allogeneic therapies, or off-the-shelf treatments, potentially offering the technology to a higher number of patients, are developing very rapidly. However, the challenges of their manufacturing scale-up still lie ahead.

One of the most advanced cell therapies is based on CAR-T technology, where the T-cells are armed with a Chimeric Antigen Receptor. Servier is developing UCART-19 (see below About UCART-19 for more information), with two clinical trials currently ongoing in Europe, in relapsed or refractory B cell acute lymphoblastic leukemia (B-ALL), in pediatric and adult patients.

Servier selected MaSTherCell because of its leading global cell therapy CDMO position, as well as its essential broad expertise in immunotherapy products. MaSTherCell has a track record of designing and delivering cost-effective cell therapy manufacturing platforms. MaSTherCell anticipates that it will complete the development of the initial CAR-T platform in 2018. This will then be an efficient complement to the bioproduction facilities that Servier is developing at its site at Gidy (France), which will mainly focus on the production of antibodies.