TxCell and Lonza enter agreement for manufacture of CAR-Treg cellular product

A Master Service Agreement has been entered by TxCell and Lonza Pharma & Biotech for the manufacture of a CAR-Treg cellular product (TX200), which is in development for the prevention of chronic rejection after organ transplantation.

“Lonza is a tremendous partner with a highly successful track record in manufacturing cell and gene therapies, including CAR-T,” said Stéphane Boissel, CEO of TxCell. “Lonza’s skill and know-how will provide the support and expertise necessary to develop our lead CAR-Treg programme, 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.”

“We have been following TxCell’s progress closely in the buoyant cellular immunotherapy space,” added Andreas Weiler, global business unit head, Emerging Technologies, Lonza Pharma & Biotech. “TxCell’s trust in Lonza further demonstrates our leadership role in the cell and gene therapy space. We are keen to remain at the forefront of cell therapy manufacturing by working with TxCell on their highly innovative CAR-Treg platform and taking part in their pioneering clinical study.”

Recently, TxCell finalised its CAR-Treg manufacturing process and started transferring over to Lonza in February this year (2018). According to Lonza’s timeline, these transfer activities and commencement of clinical manufacturing are anticipated in early 2019. As a result of this, TxCell expects to file its first CTA with TX200 early 2019.

Lonza will manufacture clinical batches of TxCell’s HLA-A2 CAR-Treg cellular product from its production site in Geleen (The Netherlands). The final product could be shipped in a frozen state to clinical sites in Europe and the US, as TxCell has already demonstrated that the drug product could be both frozen and thawed with no change in cellular phenotype and function.