TxCell SA, a biotechnology company, announces 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 immunocellular therapy,” 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.”
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.
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.