TxCell SA, a developer of cellular immunotherapies based on regulatory T cells (Tregs) for inflammation, autoimmunity and transplantation, has completed the development of its first-generation production process for its CAR-Treg technology. The process will be transferred to a contract manufacturing organization (CMO) for first-in-man clinical trials.

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. TxCell has successfully produced its CAR-Treg cellular product within two weeks (before post-production quality control).

TxCell is currently finalizing its selection of the CMO for clinical supply of its lead HLA-A2 CAR‑Treg product. Once CMO 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 4Q18.

“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 Stephane Boissel, chief executive officer of TxCell. “Our personalized cellular approach could offer an alternative therapy to prevent chronic rejection of transplanted organs.”