TxCell presents positive results for Col-Treg in a model of autoimmune uveitis at 2015 ARVO Annual Meeting, Denver, Colorado, US

Regulatory News:

TxCell SA (Paris:TXCL) (FR0010127662 – TXCL), a biotechnology company developing innovative, personalized T-cell immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, today announces that activity and tolerance data for its second lead product Col-Treg were presented through a poster presentation at the 2015 ARVO Annual Meeting, May 3-7, 2015, in Denver, Colorado, US.

The presentation was delivered by Dr. Hélène Asnagli, Preclinical Pharmacology & Safety Director, in the session entitled ‘AMD immunobiology, autoimmunity, and immunoregulation’. The poster entitled ‘Immunotherapy of Non-Infectious Uveitis using Collagen II-specific regulatory Type 1 (Col-Treg) cells’ presented preclinical efficacy and tolerability results with Col-Treg in the treatment of autoimmune uveitis. These results include pharmacokinetic and pharmacodynamic data showing a reduction in the severity of uveitis on clinical and histologic measures. In addition, TxCell has also generated GLP toxicology results that indicate a good safety profile for Col-Treg. Col-Treg is set to start a phase I/II placebo-controlled, dose-ranging proof of principle clinical study in autoimmune uveitis mid-2015. Col-Treg received orphan drug designation from the EU in December 2014.

Autoimmune uveitis is a rare debilitating inflammatory condition of the eye, often resulting in permanent vision damage. It is a leading cause of blindness in the developed world, with very limited treatment options. Because of the relatively poor tolerance profile of the existing therapies and the increased resistance to these drugs, the development of new and safer class of therapeutics to treat autoimmune uveitis is essential.

"Presenting data for Col-Treg, its second lead product from its proprietary ASTrIA platform of cellular immunotherapy, at the 2015 ARVO Annual Meeting is an important milestone for the product and for TxCell. These preliminary efficacy and tolerance data warrant further development at the clinical stage," said Dr. Arnaud Foussat, VP Research and New Products, TxCell. "TxCell is currently working with clinicians and regulatory authorities to prepare the first clinical trial with Col-Treg. There are approximately 30,000 autoimmune uveitis patients per year that are refractory to approved treatments in the US and EU alone and this is a clear unmet medical need.”

About TxCell

TxCell develops innovative, cost-effective, personalized T cell immunotherapies for the treatment of severe chronic inflammatory diseases with high medical need. TxCell has created ASTrIA, a unique and proprietary product platform based on the properties of autologous antigen-specific regulatory T lymphocytes (Ag-Tregs). The company has initiated a phase IIb study of its lead product candidate, Ovasave^® in refractory Crohn’s disease patients. This follows a phase I/IIa study in the same patient population reporting positive clinical efficacy and good tolerability. TxCell has a strategic partnership for the development of Ovasave with the Swiss company Trizell Holding SA and Ferring International Center remains the intended final commercializing party. Both companies are affiliates of the Dr Frederik Paulsen Foundation. TxCell’s second product candidate, Col-Treg is for the treatment of autoimmune uveitis, a rare disease of the eye. A placebo-controlled, dose-ranging proof of principle clinical study is planned to start in the first half of 2015. Listed on the regulated market Euronext Paris, TxCell is a spin-off of Inserm (France’s National Institute for Health and Medical Research). TxCell has 65 employees based both at the headquarters located in the Sophia Antipolis technology park, Nice, France and at its manufacturing site in Besançon. For further information visit www.txcell.com.

About ARVO

The Association for Research and Vision in Ophthalmology (ARVO) is the largest eye and vision research organization in the world. Members include nearly 12,000 eye and vision researchers from over 75 countries. ARVO advances research worldwide into understanding the visual system and preventing, treating and curing its disorders. For further information visit www.arvo.org

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Disclaimer:

This press release contains certain forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated.