TxCell personalized cell-based immunotherapies using antigen-specific regulatory T-cells (Ag-Tregs) for chronic inflammatory and autoimmune diseases.

TxCell SA, a biotechnology company developing innovative, personalized cell-based immunotherapies using antigen-specific regulatory T-cells (Ag-Tregs) for chronic inflammatory and autoimmune diseases, announces today that it received a Manufacturing Accreditation delivered by the French National Agency for Drug Safety (ANSM). The status has been received for its cell therapy production site in Besançon, France.

The TxCell manufacturing facility, located at the French National Blood Center of Bourgogne Franche-Comté region, is now authorized to produce biological investigational medicinal products in accordance with the European Union Directives 2001/83/EC and 2001/20/EC, as required for the manufacturing of Advance Therapy Medicinal Product (ATMP).

TxCell’s lead autologous Ag-Treg cell-based immunotherapy, Ovasave®, is currently in phase II development for the treatment of Crohn’s disease in patients who are refractory to current treatments. Ovasave has been classified as ATMP since 2009 by the European Medicines Agency (EMA). The newly accredited TxCell manufacturing facility will enable production of pharmaceutical grade batches of Ovasave for the next phase IIb study, planned to start mid-2014.

“This manufacturing accreditation from ANSM is a key milestone in the planned future development and growth of TxCell,” said Damian Marron, Chief Executive Officer. “This is essential for scaling up manufacturing of TxCell’s lead product Ovasave for our forthcoming Phase IIb in refractory Crohn’s Disease. This in turn allows us to accelerate the development of all our innovative, personalized cell-based immunotherapies. These therapies target niche and orphan indications for which there are few or no treatment options and a high unmet medical need. There are currently 160,000 such patients per year in Europe and in the US for Crohn’s Disease alone*.”

“This Manufacturing Accreditation recognizes the quality of our facility designed to produce highly innovative, personalized cell based immunotherapy products.” said Eric Pottier, Executive Director Supply Chain & Qualified Person. “This is a reward for the ongoing investment by TxCell and the TxCell team. We also wish to thank the French National Blood Center for contributing their strong expertise in the cell therapy production field, in particular Dr. Pierre Tiberghien, Scientific Director, and Dr. Pascal Morel, Director.”

The TxCell manufacturing facility contains 440m² of premises. These premises includes 120m² of cleanroom suits of which 80m² are Grade B suits under GMP EU classification, TxCell has a manufacturing capacity of more than 20 cell therapy batches in parallel.

* According to PharMetrics Analysis, September 2008

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About TxCell

TxCell, a spin-off of Inserm (France’s National Institute for Health and Medical Research) is located in the Sophia Antipolis technology park, Nice, France. It is developing innovative personalized cell-based immunotherapies for the treatment of severe chronic inflammatory diseases with high medical need using its unique and proprietary technology platform based on the properties of autologous antigen-specific regulatory T lymphocytes (Ag-Tregs). The company has completed a PhI/IIa study in refractory Crohn’s disease patients and has reported good tolerability and positive signals of efficacy. The company plans to initiate a PhIIb study in the same patient population. The company has 38 employees based at its headquarters and at its manufacturing site in Besançon.

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About the French National Blood Service (“”)

The French National Blood Service (“Etablissement Français du Sang (EFS)”) is the only civilian operator for transfusion in France. Blood transfusion includes blood, plasma and platelet donation. The EFS is present on the whole territory (including overseas departments) with its 153 collecting sites and its 40,000 mobile collecting spaces. Research at EFS is fully associated with medical and technical activities of the institution. Research activities are separated into 20 laboratories in 12 regional EFS sites, including the EFS Bourgogne Franche Comté Center. In 2012, research at the EFS involved 129 researchers, engineers and technicians, with a budget of EUR 21 million.

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