Valbonne, France, December 18, 2017, 5.45pm CEST
TxCell SA (FR0010127662 – TXCL), a developer of cellular immunotherapies based on regulatory T cells (Tregs) for inflammation, autoimmunity and transplantation, today announces it has completed the development of its first-generation production process for its proprietary CAR-Treg technology. The process will be transferred to a contract manufacturing organization (CMO) before the start of a first-in-man clinical trial.
For its first CAR-Treg manufacturing process, TxCell has isolated a subset of Treg cells that have shown to be stable and to display a strong anti-inflammatory activity. Despite the rarity of the selected Treg subset, TxCell has successfully produced its CAR-Treg cellular product within two weeks (before post-production quality control). TxCell will present additional details on this manufacturing process at the CAR TCR Summit Europe to be held on February 20-22, 2018, in London, United Kingdom.
TxCell is currently finalizing its selection of the CMO for clinical supply of its lead HLA-A2 CAR Treg product. Once CMO contractual agreements are executed, the transfer of TxCell’s manufacturing process will follow immediately. A regulatory dossier to start a first-in-man study is expected to be filed in Q4 2018. The start of clinical development will be subject to regulatory approval and availability of appropriate funding.
“It is very important for TxCell to have completed the production process within the expected time frame for its first clinical candidate, a CAR-Treg product for solid organ transplantation. This will enable us to evaluate the potential of TxCell’s platform as soon as possible in a first-in-man study,” said Stéphane Boissel, CEO of TxCell. “Our personalized cellular approach could offer an alternative therapy to prevent chronic rejection of transplanted organs. There is a significant risk of post-transplant organ rejection. In lung transplants, for example, this results in a mortality rate of 40% to 55% five years after surgery. As a result, there remains a significant medical need for a novel therapeutic approach.”
The CAR-Treg manufacturing process developed by TxCell for the HLA-A2 CAR-Treg candidate will be applicable to its portfolio of other CD4+FoxP3+ products. The CD4+FoxP3+ Treg population is one of the three Treg populations TxCell is working on. The other two are CD8+FoxP3+ Tregs and Type 1 Tregs (Tr1).
About TxCell’s HLA-A2 CAR-Treg
The HLA-A2 CAR-Treg is TxCell’s most advanced CAR Treg product-candidate. It is based on a subset of CD4+FoxP3+ Tregs. It targets HLA A2, a common mismatch antigen in transplantation, and is in development for the prevention of chronic rejection after organ transplantation. HLA-A2 CAR Treg has shown strong efficacy in a preclinical GvHD model , and is now on track to start a first-in-man study in transplanted patients.
In June 2017, TxCell appointed Lentigen Technology, Inc. (LTI) as its contract manufacturing organization (CMO) for the GMP production of the product’s lentiviral vector.