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TxCell Enters Col-Treg Into Full Development For The Rare Disease Autoimmune Uveitis


1/7/2014 12:07:26 PM

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Valbonne, France, January 7, 2014. – TxCell SA, a clinical stage biotechnology company developing innovative, personalized cell-based immunotherapies using antigen-specific regulatory T-cells (Ag-Tregs) for chronic inflammatory and autoimmune diseases, today announces it has initiated a full development program with Col-Treg for the treatment of Autoimmune Uveitis. Col-Treg is TxCell’s second therapeutic candidate from its ASTrIA platform after Ovasave®, TxCell’s lead autologous Ag-Treg cell-based immunotherapy.

Autoimmune Uveitis is a serious inflammatory condition of the eye that often results in permanent vision damage. Uveitis is classified as a rare disease with a prevalence of around 35-50/100,0001, with Autoimmune Uveitis constituting 80-90% of cases2. Despite its rarity, in developed countries this autoimmune disease causes 10-15% of legal blindness. The condition also leads to 30,000 new cases of blindness per year in the US alone2 and affects around 168,000 people in Europe3.

“Though Autoimmune Uveitis is a rare disease, it is a leading cause of blindness and can take a terrible toll. Unfortunately, Autoimmune Uveitis also has very limited treatment options, and new ones are urgently needed,” said Miguel Forte, Sr. VP Clinical Development and Regulatory Affairs of TxCell.

The current first-line treatment consists of corticosteroids, often used with antimetabolites and alkylating agents. However, there are currently no approved options for the 50% of patients that become refractory to steroid compounds. The development of Col-Treg for treatment of steroid refractory patients could bring a new therapeutic possibility for these patients.

“The launch of Col-Treg, TxCell’s second full development program, will allow TxCell to potentially create a novel, personalized cellular immunotherapy approach to reduce the terrible burden of uveitis,” said Damian Marron, Chief Executive Officer of TxCell. “The development of the approach is made possible by the breadth of TxCell’s ASTrIA technology platform. This technology is central to TxCell's strategy of targeting orphan/niche indications with poor or no treatment options.”

In recent years, a number of scientific studies have examined several experimental models of Autoimmune Uveitis. Those studies have demonstrated that the administration or induction of regulatory T (Treg) cells in vivo can be used as therapeutic tools for the control of ocular inflammation. As a result, TxCell has developed Col-Treg as a proprietary personalized cellular immunotherapy. Col-Treg is based on the regulatory properties of autologous collagen-II specific regulatory T lymphocytes. It is specifically designed to exert its suppressive and anti-inflammatory action upon recognition of collagen-II, a protein present in the vitreous body of the eye. TxCell has already shown efficacy for Col-Treg in models of autoimmune diseases and has also shown absence of toxicity in a 6-month toxicology study performed under Good Laboratory Practices (GLP).

The first stage of the new Col-Treg program will be to complete the required pre-requisites for applying orphan drug designations in the European Union and in the United States and to prepare for a phase II proof of principle study to start in 2015.

In addition, TxCell will request Advanced Therapy Medicinal Product (ATMP) classification by the European Medicines Agency (EMA) for this new personalized cell-based product.

1 According to EU Regulatory Workshop – EMA/450332/2012

2 According to GlobalData Report GDHC008POA - Dec. 2013-

3 According to EMA/COMP/105735/2013

About Col-Treg

Col-Treg is a personalized cell-based immunotherapy product, based on the properties of autologous collagen II-specific regulatory T lymphocytes. Col-Treg has shown efficacy and safety in several different autoimmune disease models and has shown no toxicity in a toxicology study performed under Good Laboratory Practice (GLP). Col-Treg uses the natural properties of the patient’s own Type 1 Treg cells, which home preferentially to the sites of injury and control inflammation by multiple pathways: secreting natural immunosuppressive molecules; initiating cell-cell contact mediated suppression through surface molecules and killing of myeloid cells. These multiple mechanisms of action lead to inhibition of pro-inflammatory cell activation, proliferation and cytokine production.

About TxCell

TxCell is developing innovative personalized cell-based immunotherapies for the treatment of severe chronic inflammatory diseases with high medical need using its unique and proprietary ASTrIA technology platform based on the properties of autologous antigen-specific regulatory T lymphocytes (Ag-Tregs). The company has completed a phase I/IIa study of its lead product candidate, Ovasave® in refractory Crohn’s disease patients and has reported good tolerability and positive signals of efficacy. The company plans to initiate a phase IIb study in the same patient population. 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. The company has 38 employees based at its headquarters and at its manufacturing site in Besançon.

For more information, please visit www.txcell.com

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