Regulatory News:

TxCell SA (Paris:TXCL) (FR0010127662 TXCL), a biotechnology company developing innovative, cost-effective, personalized T cell immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, announces today that Dr. Miguel Forte, Sr. VP Clinical Development and Regulatory Affairs, TxCell, will present at the Cell & Gene Therapy Forum 2015, January 26-28, 2015 at Grand Hayatt in Washington DC, United States.

Dr Fortes presentation will be on critical success factors for a successful transition of cell therapy candidates to the clinic. The presentation is scheduled for Monday, January 26, 2015 at 14.30 p.m. EST. A roundtable debate discussing the most important topics raised will follow the presentation.

Dr. Forte will use as examples TxCells lead product candidate, Ovasave and second product candidate, Col-Treg from TxCells innovative proprietary ASTrIA technological platform. Ovasave is targeted at refractory Crohns disease and is currently evaluated in a placebo-controlled phase IIb study. Col-Treg is in development for the rare eye disease autoimmune uveitis. Col-Treg is planned to move into a first clinical study in the first half of 2015.

The key elements in the presentation include gathering strong pre-clinical and preliminary clinical data. Dr. Forte will also cover key process development activities necessary to provide the most robust and transferable manufacturing process and business model establishment and the development of a clear regulatory strategy. Dr. Forte will also present a roundup, from his perspective, on market access including economic viability and therapeutic adoption.

Patients with chronic inflammatory and autoimmune diseases that have no current therapeutic options continue to present significant unmet medical needs. As TxCell is one of the most advanced companies in the field of T-cell immunotherapy, we share our experiences regarding the development of innovative therapeutic approaches. This will benefit of the entire scientific community, said Miguel Forte, Sr. VP Clinical Development and Regulatory Affairs, TxCell. The Cell & Gene Therapy Forum 2015 is an ideal event to position biotechnology companies developing new value-adding treatments and strategies, like TxCells personalized antigen specific Treg cell-based therapies.

The Cell & Gene Therapy Forum is a meeting designed to help advance regulatory, manufacturing, research and commercial strategies and drive cell and gene therapy products forward. The Forum enables to gather executives from biotechnology companies, representatives of big pharma and big biotech, regulators, and public and private investors.

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 technology 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 Crohns 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. TxCells 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 Euronext-Paris, TxCell, a spin-off of Inserm (Frances National Institute for Health and Medical Research) is located in the Sophia Antipolis technology park, Nice, France. The company has 56 employees based at its headquarters and at its manufacturing site in Besanon.

For more information, please visit http://www.txcell.com

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TxCell to Present Its Experience with Cell Therapy at the Cell & Gene Therapy Forum 2015, Washington

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