Cellectis, a leader in the development of adoptive immunotherapies based on engineered allogeneic CART cells (UCART) and CELL for CURE, a subsidiary of the biopharmaceutical group LFB, have entered into an agreement for the cGMP manufacturing of clinical batches of Cellectis’ allogeneic CART cells. Pursuant to this agreement, CELL for CURE will be responsible for the manufacturing of cGMP clinical batches for candidates from Cellectis’ UCART product family.
The candidates from UCART (for Universal Chimeric Antigen Receptor – T cells) product family are allogeneic cell therapy products based on the CAR (Chimeric Antigen Receptor) technology combined with genome engineering. Engineered allogeneic T-lymphocytes bearing a CAR directed at a tumour antigen stand out as a genuine therapeutic innovation in the treatment of various forms of leukaemias, lymphomas and solid tumours.
UCARTs are special in that they are “off-the-shelf” allogeneic products. This brings major advantages over the autologous procedures currently undergoing clinical testing. UCARTs’ production can be industrialized and thereby standardized, with consistent pharmaceutical release criteria, over time and from batch to batch. Each future patient may thus be treated by immediately receiving a single dose of a standard product with consistent quality. The favourable cost of such industrially manufactured treatments may help making them available to a broad patient population and avoiding risks associated with the processing and the timing required for an autologous CART process. In addition, such allogeneic products may be shipped in advance and would be accessible to any cancer centre in the world without the need to invest on a local CART processing facility.
Dr Mathieu Simon, MD, Executive Vice President at Cellectis stated: “ We are very pleased of this partnership with CELLforCURE, a unique brand-new industrial platform dedicated to cell therapies and equipped with a state-of-the-art GMP manufacturing facility. It will ensure that Cellectis will have, in the long term, the means for the clinical development of its UCART product family and will add robustness to our ongoing regulatory applications. Moreover, it is a new way to manufacture cost-effectively CART cell products, and thus making them broadly and immediately available to patients. cGMP manufacturing of allogeneic CART cells is a paradigm change in cancer adoptive immunotherapies.”
Pierre-Noël Lirsac, CEO of CELL for CURE declared: “This partnership, signed with a company such as Cellectis, confirms the fast development of innovative therapies and the relevance of an industrial platform to manufacture these new treatments. We are proud to contribute to Cellectis’ efforts, thanks to the flexibility of our large scale facility, aiming at developing this innovative treatment in oncology based on a brand new technology.”
Cellectis is a biopharmaceutical company focused on oncology. The company’s mission is to develop a novel generation of therapy based on engineered T-cells to treat cancer.
CELL for CURE is the cell therapy dedicated subsidiary of the French Biopharmaceutical LFB Group. CELL for CURE brings solutions to its customers for industrial development of cell and gene therapy processes, contract manufacturing services for clinical trials and market, and provides regulatory and pharmaceutical services.
LFB is a biopharmaceutical group that develops, manufactures, and markets medicinal products indicated in the treatment of serious and often rare diseases in several major therapeutic fields: hemostasis, immunology, and intensive care.