The programme has been jointly developed by TxCell, a biotech based in Valbonne, France, and the University of British Columbia to develop a therapy capable of preventing chronic transplant rejection.
The treatment is based on regulatory T lymphocytes (Tregs), where the antigen specificity is brought by a chimeric antigen receptor (CAR-Treg). The HLA-A2 CAR-Treg, known as TX200, has been in development since late 2016 and has progressed to being able to enter clinical trials in 2019.
Due to Txcell taking up its licensing option, the biotech will now possess exclusive rights to further develop the drug candidate and to commercialise it, should it prove to be effective in trials.
Stéphane Boissel, CEO of TxCell, answered our questions asking how the therapy could improve on standard treatment: “The objective in using a CAR-Treg to prevent transplant rejection is to induce immune tolerance of the graft by the host, which is not the case of existing immunosuppressive regimens.”
One of the weaknesses of current methods of treatment, noted in the press release, is that they can require lifelong treatment to prevent rejection of donor organs. The first in man study will allow TxCell to determine whether its CAR-Treg programme can prevent such chronic rejection.
The process of manufacturing CAR T therapies is notoriously time-consuming and expensive but Boissel detailed the biotech’s plan for manufacture, telling us: “TxCell’s CAR-Treg manufacturing process is no different from that of a CAR-T seen in oncology, although this cell isolation step is very specific to us. We have a 12-step process that includes cell isolation, transduction of the CAR in the isolated cells and CAR-tranduced cells expansion. It takes less than two weeks, excluding quality control.”
Since late last year, it has been known that TxCell was looking for a partner for the production of the therapy and it was announced at the end of May that TxCell had signed a manufacturing agreement with Lonza.