MaSTherCell to Supply TxCell With Clinical Batches of Ovasave for Phase 2b Crohn’s Disease Study

MaSTherCell to Supply TxCell With Clinical Batches of Ovasave for Phase 2b Crohn’s Disease Study
Cell therapy and regenerative medicine provider, Orgenesis, Inc., recently disclosed that its wholly-owned subsidiary, MaSTherCell, a contract development and manufacturing organization (CDMO), has signed an agreement of understanding with TxCell in France. The memorandum covers the manufacturing of clinical supplies of Ovasave, the company's leading therapeutic. Ovasave is classified as an antigen-specific autologous T-regulatory somatic cell treatment, currently still undergoing tests as a potential drug for inflammatory bowel disease (IBD), such as Crohn's disease and ulcerative colitis. As per the memorandum of understanding, the two companies have agreed to hold discussions on the long-term clinical and commercial production of TxCell products by MaSTherCell. Ovasave supplies produced by MaSTherCell will be utilized by TxCell in an ongoing Phase 2b study, dubbed CATS29, as a treatment for Crohn's disease. The production of the initial clinical batch is estimated to reach completion as early as the second quarter of 2016. CATS29 is a multi-center, randomized, double-blinded, placebo-controlled, multi-dose and multi-injection 4-parallel group study that will involve 160 patients with severe refractory Crohn’s disease. The study will take place in 30 sites across Austria, Belgium, France, Germany, Italy, UK, and may soon be extended to sites in the US. Ovasave was recently granted Fast Track Designation by the US FDA 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.
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