Belgian CMO MaSTherCell was contracted to make the cell therapy last year after French regulator ANSM (Agence Nationale de Sécurité du Médicament) raised concerns about contamination risk at TxCell’s facility in Besancon, France.
The French T-Cell therapy firm also halted a Ph IIb study of drug – codenamed CATS29 – last year in order to restore production of supplies for the study.
T cell education
TxCell produces personalized T cell immunotherapies for severe chronic inflammatory diseases using its ASTrIA platform, which “educates” antigen-specific regulatory cells (Ag-Tregs) from the patient’s own blood sample to target autoimmune inflammatory diseases.
Harvested white blood cells are taught to recognise disease targets, multiplied by TxCell and then reinjected into the patient.
According to TxCell MaSTherCell has now “completed the manufacturing of a series of contractually defined validation runs of Ovasave.
“TxCell has submitted an amendment of its CATS29 clinical protocol. Specifically, the amendment refers to site change approval for the European national competent authority agencies that initially approved the CATS29 study through the Voluntary Harmonized Procedure (VHP).
The firm added that: “This should enable TxCell to resume CATS29 in Q2 2016, as per the planning previously announced.
It also plans to submit the amendment to the US FDA, where CATS29's Investigational New Drug (IND) dossier has been active since August 2015.
New process development lab
In other news, TxCell has set up a process industrialization laboratories and technology transfer academy facilities in Sophia Antipolis, France.
These facilities will focus on improving manufacturing process for cell therapies developed using TxCell’s ASTrIA and ENTrIA platforms.
MaSTherCell staff and employees of any other CMOs TxCell uses will be trained at the facility, which is at a lab operated by Genevrier Laboratories affiliate GenBiotech.