TxCell 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 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.
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).
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.