Orgenesis Inc., a cell therapy and regenerative medicine company, announced that its wholly owned subsidiary, MaSTherCell, a contract development and manufacturing organisation (CDMO) has entered into a memorandum of understanding with France-based TxCell, to manufacture clinical batches of Ovasave, TxCell’s lead product.
Ovasave is an antigen specific autologous T regulatory somatic cell therapy in development for the treatment of inflammatory bowel disease. As part of the MoU, MaSTherCell and TxCell also agreed to enter into discussions for the long-term clinical and commercial manufacturing by MaSTherCell of TxCell products.
Ovasave batches manufactured by MaSTherCell will be used by TxCell in its ongoing phase 2b trial, CATS29, for the treatment of Crohn’s disease. The first clinical batches could be manufactured by MaSTherCell as soon as Q2 2016. CATS29 is a multi-center, randomized, double-blinded, placebo-controlled, multi-dose and multi-injection 4-parallel groups study. The trial has been designed to include 160 severe refractory Crohn’s disease patients. It is currently on-going in 30 study sites in 6 countries including Austria, Belgium, France, Germany, Italy, the United Kingdom, and may be extended into the US The United States Food and Drug Administration recently granted Fast Track designation to Ovasave for the treatment of moderate to severe Crohn’s disease.
“MaSTherCell is a European leader in cellular therapy products manufacturing with a significant track record in production of clinical materials. This strategic relationship with MaSTherCell is very important to TxCell,” said Stéphane Boissel, chief executive officer of TxCell.
Vered Caplan, chairperson and chief executive officer of Orgenesis, commented, “We are pleased that MaSTherCell has entered into a substantial cell manufacturing agreement with TxCell for Ovasave, in an indication that has a clear unmet need which may best be treated through a cutting edge cell therapy like Ovasave. We look forward to working very closely with TxCell to deliver unparalleled manufacturing services for its trial.”
TxCell develops innovative, personalised T cell immunotherapies for the treatment of severe chronic inflammatory diseases with high medical need.