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The company has completed development of a first-generation production process for its chimeric antigen receptor regulatory T cell product portfolio and is selecting a CMO for clinical supply.
TxCell, a French developer of cellular immunotherapies based on regulatory T cells (Tregs), has completed the development of a first-generation production process for its proprietary chimeric antigen receptor regulatory T cell (CAR-Treg) product portfolio, the company announced on Dec. 18, 2017. The process will be transferred to a contract manufacturing organization (CMO) before the start of a clinical trial, according to the company.
To develop this first CAR-Treg manufacturing process, TxCell isolated a subset of Treg cells that demonstrated stability and that displayed a strong anti-inflammatory activity. The process was developed for the company’s CAR-Treg candidate and will be applicable to its portfolio of other CAR-Treg products. The company is working on three Treg populations: CD4+FoxP3+, CD8+FoxP3+, and Type 1 Tregs.
The company’s most advanced CAR-Treg product candidate, which is based on a subset of the CD4+FoxP3+ Treg population, targets HLA A2, a common mismatch antigen in transplantation. The candidate is in development for preventing chronic rejection after organ transplantation.
The company is finalizing its selection of a CMO to provide clinical supply of its lead HLA-A2 CAR Treg product candidate. TxCell will transfer its manufacturing process to the CMO upon execution of contractual agreements. The company plans to file a regulatory dossier to start a first-in-man study in the fourth quarter of 2018. The start of clinical development is subject to regulatory approval and the availability of appropriate funding.
In June 2017, the company appointed Lentigen Technology, a Gaithersburg, MD-based CMO, for the GMP production of the product’s lentiviral vector. The company will present additional details on its manufacturing process at the CAR TCR Summit Europe in London in February 2018.