TxCell SA, a biotechnology company developing innovative, personalized cellular immunotherapies using regulatory T-cells to treat severe chronic inflammatory and autoimmune diseases, has launched its new process industrialization laboratories and technology transfer academy facilities in Sophia Antipolis, France.

These new facilities will be primarily dedicated to the improvement of the existing TxCell manufacturing process for its ASTrIA platform as well as to the development of a manufacturing process for its new ENTrIA platform. These developments will be primarily achieved by combining the integration into the manufacturing process of findings from TxCell research with industry advancements in the life science and technology industries. The outcome will be an increase in automation and economic efficiencies as well as a shortening of the manufacturing process of all TxCell products across all of its platforms.

“TxCell is the only clinical stage cellular therapy company dedicated to the science of regulatory T lymphocytes (Tregs). As a result, TxCell is integrating its own research with recent technological advancements across a variety of fields to make the manufacturing process of our product portfolio as economic as possible,” said Miguel Forte, COO of TxCell. “The new TxCell facilities will be dedicated to accelerating the development of the commercial manufacturing process for products that result from the TxCell ASTrIA platform. In addition, it will allow the development of a new manufacturing process for products derived from the new TxCell ENTrIA platform.”

The facilities will also host the TxCell Academy for Technology Transfer. The academy will be responsible for educating and training all contract manufacturing partners (CMOs, including MaSTherCell). In addition, the academy will train future strategic partners (licensed and/or co-developing pharmaceutical companies) on the manufacturing processes of TxCell’s personalized cellular therapies. This will have the aim of facilitating and accelerating all transfer of TxCell technologies to third parties.  

These new facilities will be based in Sophia Antipolis, in the premises of GenBiotech, an affiliate company of the Genevrier Laboratories.

“The opening of the new process development and technology transfer laboratories in the facilities of GenBiotech is a great development for TxCell,” said Stéphane Boissel, CEO of TxCell. “A significant part of TxCell’s strategic focus for the next three years will include improving the manufacturing process for the current group of products from the TxCell ASTrIA platform as well as developing a process for products from the new TxCell ENTrIA platform. In addition, in the context of a rapidly developing market for cellular therapy technologies, educating our manufacturing partners and future strategic partners about these processes will be crucial for TxCell. This initiative will be instrumental for TxCell to advance the development of critically needed personalized cellular therapies.”

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(R), 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.

ENTrIA (Engineered Treg for Inflammation and Autoimmunity) is the second TxCell proprietary cellular immunotherapy product platform and is composed of Chimeric Antigen Receptor engineered Foxp3+ Regulatory T cells (CAR-Treg). After their isolation from the blood of patients, Foxp3+ Treg cells are genetically modified by transduction with Chimeric Antigen Receptors (CAR). The CAR introduced into FoxP3+ Treg cells is designed to allow Foxp3+ Treg cell activation and immuno-modulation through in vivo recognition of a protein present in inflamed areas in patients suffering from autoimmune and chronic inflammatory diseases.

The creation of GenBiotech, a spinoff of the Laboratoires Genevrier results of 15 years of strategic involvement in biotechnological research with one goal: to improve the quality of life of patients in the field of rheumatology, dermatology and gynecology worldwide.