Novartis selects French CDMO to make CAR T-cell therapies
French drugmaker and contract development and manufacturing organisation (CDMO) Cell for Cure has announced it will make chimeric antigen receptor (CAR) T-cell therapies for Novartis at its bioproduction facility in Paris.
According to the agreement, Cell for Cure will employ the same technology and process developed by Novartis at its US-based Morris Plain facility, where the Swiss firm produces Kymriah (tisagenlecleucel) for the US market. Kymriah first received US Food and Drug Administration (FDA) approval in August 2017 to treat acute lymphoblastic leukaemia (ALL).
Manufacturing of the CAR T-cell therapies – which use a patient’s own modified T-cells to identify and destroy tumour cells – could start in 2019 following a technology transfer to Cell for Cure’s Les Ulis facility.
According to Cell for Cure, once a patient’s T-cells are collected and frozen, they will be “transferred to the Les Ulis site where experts will modify the cells so that they can recognise specific receptors that are part of cancer cells. Following safety and quality testing, the patient’s cells will be infused back into the hospitalised patient.”
The news comes days after the European Medicines Agency (EMA) announced its Committee for Medicinal Products for Human Use (CHMP) had granted positive opinion of two CAR T-cell therapies: Novartis’ Kymriah and Kite Pharmaceutical’s Yescarta (axicabtagene ciloleucel).
The European Commission will now review the therapies for regulatory approval across the 28 EU Member States, as well as Norway, Iceland and Liechtenstein.
Cell for Cure’s CDMO business is also responsible for producing Cellectis’ gene-edited ‘off-the-shelf’ CAR T-cell candidates. Last month, the US Food and Drug Administration (FDA) approved Cellectis’ UCART22 for clinical trials.