TxCell set to transfer production process for candidate organ rejection cell therapy to CMO
The French biotech is focused on CAR-Tregs are composed of a chimeric antigen receptor (CAR) attached to a Treg, which are T cells that regulate the immune response. Unlike tumour-targeting CAR-Ts, CAR-Tregs treat autoimmune diseases.
TxCell said the production process it has developed is capable of manufacturing a batch of CAR-Treg product within two weeks.
The firm is also selecting a contract manufacturing organisation (CMO) that will make its lead candidate – a therapy for graft-versus-host disease – for which it intends to seek approval to move into clinical development in 2018.
A spokesman told us "The field of CAR-Ts to target cancer is a crowded place. However, whilst the CAR-Treg space in which TxCell is operating contains no real competition, and TxCell is the first mover, this requires unique manufacturing solutions. This is why TxCell has worked with a number of CMOs specialising in cell therapy to deliver the best solutions to specific parts of TxCell manufacturing processes. We have narrowed down the selection to a shortlist and are currently finalising selection and contractual arrangements.
"TxCell is working with Lentigen on an ongoing basis. Lentigen will be making the viral vector to genetically modify Treg cells and turn them into CAR-Treg cells. Lentigen specialises in these viral vectors, they are not part of the shortlisted CMOs for the whole cellular product manufacturing” he said.
TxCell added the manufacturing process developed for the HLA-A2 CAR-Treg candidate is applicable to other products based on CD4+FoxP3+ Tregs.
In addition, the firm is developing equivalent processes for candidate therapies that based on other Tregs it has isolated.
TxCell has previously hired Belgian CMO MaSTherCell and US-based PCT, a subsidiary of Caladrius Biosciences, to make its candidate products for clinical development.
