TxCell SA (France) and Lonza Pharma & Biotech (Switzerland) entered into a Master Service Agreement for the manufacture of TxCell’s HLA-A2 CAR-Treg cellular product (TX200), which is in development for the prevention of chronic rejection after organ transplantation.
TxCell recently finalized its CAR-Treg manufacturing process and the transfer to Lonza started in February 2018. According to Lonza’s timeline, completion of transfer activities and start of clinical manufacturing is now expected by Q1 2019. Accordingly, TxCell now expects to file its first CTA with TX200 in the first part of 2019.
Lonza will manufacture clinical batches of TxCell’s HLA-A2 CAR-Treg cellular product from its production site in Geleen (NL). The final product could be shipped in a frozen state to clinical sites in Europe and the United States, as TxCell has already demonstrated that the drug product could be both frozen and thawed with no change in cellular phenotype and function.
TxCell, a spin off of Inserm (France’s National Institute for Health and Medical Research) located in the technology park of Sophia Antipolis, near Nice in Southern France, is developing cell-based immuno-therapies for the treatment of severe chronic inflammatory diseases with high medical need using its unique and proprietary technology platform based on the properties of Type 1 regulatory T lymphocytes.