Novartis Partners with French CDMO for CAR-T-Cell Therapy MfgBy
Novartis has signed an agreement with CELLforCURE, a contract development and manufacturing organization and part of the biopharmaceutical company, LFB, to produce chimeric antigen receptor T-cell (CAR-T) therapies at CELLforCURE’s bioproduction site in Les Ulis, France. The company says that production could start in 2019 following the transfer of Novartis’ manufacturing technology to CELLforCURE.
CELLforCURE is a company specializing in t cell and gene therapies, and it has an industrial platform located in Les Ulis, France for producing cell- and gene therapies. Established as a pharmaceutical company in 2013, CELLforCURE, operates a contract development and manufacturing organization. The company obtained two GMP certificates from the French health authority, Agence Nationale de Sécurité du Médicament et des Produits de Santé, in 2016 for producing experimental and commercial therapy drugs.
Novartis says the decision to manufacture CAR-T therapies in commercial and clinical phases in France is part of its global supply strategy. Between 2015–2019, Novartis invested over EUR 900 million ($1.05 billion) on the expansion of its center in Huningue, France, the construction of a new head office building in Rueil-Malmaison, France, as well as research and development projects.
CELLforCURE will be responsible for producing CAR-T therapies, which are considered a type of personalized medicine. The manufacturing process used by CELLforCURE in France will be the same technology and process developed by Novartis at its site in Morris Plains, New Jersey.
To produce CAR-T cells, a patients’ T-cells (white blood cells called lymphocytes) are collected using a specialized procedure known as “leukapheresis” and then frozen in a process called cryopreservation. The cells will be transferred to the Les Ulis, France site, where scientists will modify the cells so that they can recognize specific receptors that are part of cancer cells. The patient’s cells will be infused back into the hospitalized patient. In responding patients, the reprogrammed cells multiply to identify and destroy tumor cells which were previously unrecognizable for the immune system.
Novartis’ Kymriah (tisagenlecleucel), its CAR-T therapy, was approved by the US Food and Drug Administration in August 2017 for treating B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second relapse or later. It was later approved in May 2018 by the FDA for treating relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. In June 2018, Kymriah was recommended for approval by an advisory committee of the European Medicines Agency for treating two B-cell malignancies: B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse in patients up to 25 years of age and diffuse large B-cell lymphoma (DLBCL) that is relapsed or refractory after two or more lines of systemic therapy in adults. If approved by the European Commission, Kymriah will be the first CAR-T cell therapy available in the European Union for both DLBCL and B-cell ALL, according to information from the companies.