TxCell, a Paris-based developer of personalized cellular immunotherapies based on regulatory T cells (Tregs), has entered into a service agreement with Lonza for the manufacture of its HLA-A2 CAR-Treg cellular product.
The HLA-A2 CAR-Treg is TxCell’s most advanced CAR-Treg product candidate and is in development for the prevention of graft rejection after organ transplantation. The technology is based on the work conducted by Prof. Megan Levings and team at the University of British Columbia (UBC) in Canada, with which TxCell has a strategic R&D collaboration since 2016.
TxCell recently finalized its CAR-Treg manufacturing process and the optimized protocol was presented by Dr Pierre Heimendinger, VP Pharmaceutical Development at the CAR-TCR summit earlier this year. Their process enables the manufacturing of clinical doses of highly stable CD45RA+ (Treg cells with the CD4+ CD25+ CD45RA+ phenotype) based CAR-Tregs in under two weeks, ready for post-production quality control. CD45RA+ targets HLA-A2, a common mismatch antigen in transplantation. Studies have shown the efficacy of HLA-A2 CAR-Treg in a preclinical GvHD model and the company is now on its way to initiate the first-in-man study in transplanted patients.
The process transfer to Lonza started in February 2018 and it will manufacture batches of HLA-A2 CAR-Treg at its production site in Geleen (The Netherlands). The product’s proven stability in terms of cellular phenotype and function after freezing and thawing will enable its shipping in a frozen state to clinical sites in Europe and US. Following process transfer, Lonza is expected to start clinical manufacturing by Q1 2019.
Stéphane Boissel, CEO of TxCell commented: “Lonza’s skill and know-how will provide the support and expertise necessary to develop our lead CAR-Treg program, which is on track to enter the clinic. Our therapy has the potential to offer transplanted patients a new option to prevent graft rejection, an area of significant unmet medical need.”
Source: TxCell names Lonza as its CAR-Treg cellular product manufacturer; Press Release