Key TxCell Patent to Be Granted in Japan for Its Lead Product Ovasave®

Regulatory News:

TxCell SA (Paris:TXCL), a biotechnology company developing innovative, personalized cellular immunotherapies using regulatory T-cells to treat severe chronic inflammatory and autoimmune diseases, announces today that the Japan Patent Office has indicated that it intends to grant to TxCell a key patent in Japan to cover its lead product Ovasave^® and its application to inflammatory bowel disease (IBD).

Specifically, the patent covers the administration of a composition that consists of at least one human Type-1 Treg cell population directed against a food antigen from the common human diet. The equivalent patent has already been granted in the USA (2015), Australia (2015) and Russia (2013). Other corresponding patent applications for Ovasave in IBD are pending in major markets globally.

TxCell now owns or controls more than 126 patents that provide coverage for its first platform ASTrIA. These patents are related to the characterisation, production and use of Ag-Tregs for the treatment of chronic autoimmune inflammatory diseases.

"Recent positive developments in both the regulatory field and product approvals means that Japan has become a key market for cellular immunotherapy,” said Stéphane Boissel, Chief Executive Officer of TxCell. "The grant of this latest key patent in Japan will help to achieve TxCell’s ambitious objectives in expanding our global reach. In addition, TxCell has dedicated years of effort in research and development to establish a robust international intellectual property portfolio. This patent coverage will be critical for our ongoing efforts to make cellular immunotherapies available to the large number of patients with a variety of conditions with unmet medical need.”

About ASTrIA
ASTrIA (Antigen Specific Treg for Inflammation and Autoimmunity) is a TxCell proprietary cellular immunotherapy product platform composed of autologous antigen specific Type 1 Regulatory T cells (Ag-Treg). Ag-Treg based products from the ASTrIA platform are produced from the peripheral blood of patients. After white blood cell isolation, CD4+ T cells are educated to recognize a specific antigen. Antigen educated Treg cells are then isolated and expanded ex-vivo. Ovasave®, the first Ag-Treg product candidate from the ASTrIA platform, has been developed for the treatment of Inflammatory Bowel Disease (IBD) and is composed of ovalbumin-specific Type 1 Treg cells. Ovasave is currently in a European Phase IIb clinical study in severe Crohn's Disease, entitled CATS29. Col-Treg is the second candidate from the ASTrIA platform and is composed of type-2 Collagen-specific Type 1 Treg cells. Col-Treg is developed for the treatment of steroid-refractory non-infectious uveitis.

About TxCell: www.txcell.com
TxCell is a publicly listed biotechnology company that develops platforms for innovative, personalized T cell immunotherapies for the treatment of severe chronic inflammatory and autoimmune diseases with high unmet medical need. TxCell is the only clinical stage cellular therapy company dedicated to the science of regulatory T lymphocytes (Tregs). Tregs are a recently discovered T cell population for which anti-inflammatory properties have been demonstrated. Ovasave®, TxCell’s lead product candidate, is currently in a phase IIb clinical trial in refractory Crohn’s disease patients. Col-Treg, its second product candidate, for the treatment of autoimmune uveitis, should enter clinical trials in 2016. Based in Sophia-Antipolis, France, TxCell is listed on Euronext Paris and currently has 47 employees.

Disclaimer:
This press release contains certain forward-looking statements concerning TxCell and its business. Such forward-looking statements are based on assumptions that TxCell considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward-looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of TxCell registered by the French Financial Markets Authority (Autorité des marchés financiers) on June 11, 2015 under number R. 15-049, and in the update of the registration document filed with the AMF on January 25, 2016 under number D.15-0402-A01, available on the Company’s website (www.txcell.com) and to the development of economic conditions, financial markets and the markets in which TxCell operates. The forward-looking statements contained in this press release are also subject to risks not yet known to TxCell or not currently considered material by TxCell. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of TxCell to be materially different from such forward-looking statements.

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