PARIS & LES ULIS, France--(BUSINESS WIRE)--Regulatory News:
Cellectis (Alternext: ALCLS.PA), a leader in the development of adoptive immunotherapies based on engineered allogeneic CART cells (UCART) and CELLforCURE, the largest commercial industrial facility for the production of innovative therapeutic cell therapies in Europe, a subsidiary of the biopharmaceutical group LFB, announce that they have entered into an agreement for the cGMP manufacturing of clinical batches of Cellectis’ allogeneic CART cells.
Pursuant to this agreement, CELLforCURE 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 tumor antigen stand out as a genuine therapeutic innovation in the treatment of various forms of leukemias, lymphomas and solid tumors.
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 favorable 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 center 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 CELLforCURE 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.”
About Cellectis
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. Cellectis capitalizes on its 14 years of expertise in genome engineering, based on TALEN™, meganucleases and the state-of-the-art electroporation technology Pulse Agile, to create a new generation of cancer immunotherapy for treating leukemias and solid tumors. Cellectis adoptive cancer immunotherapy for chronic and acute leukemias is based on the first allogeneic T-cell chimeric antigen receptor (CAR) technology. CAR technologies are designed to target surface antigens expressed on cells. These treatments reduce toxicities associated with current chemotherapeutics and have the potential for curative therapy. The Cellectis Group is focused on life sciences and uses leading genome engineering technologies to build innovative products in various fields and markets. Cellectis is listed on the NYSE Alternext market (ticker: ALCLS). To find out more about us, visit our website: www.cellectis.com
About CELLforCURE
CELLforCURE is the cell therapy dedicated subsidiary of the French Biopharmaceutical LFB Group.
CELLforCURE 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. CELLforCURE operates in a large scale facility located at Les Ulis (France) and currently employs 35 people. www.cellforcure.com
About LFB
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. Number one in France and in 6th place worldwide in the field of plasma-derived medicinal products, the LFB group is also one of the leading European companies in the development and production of proteins and of innovative treatments based on biotechnology.
With a sustained research effort, the LFB group has a growth strategy that seeks to extend its activities at an international level. The LFB group currently markets products in 30 countries around the world and had a global turnover of 477 million euros in 2013. www.lfb.fr
Disclaimer
This press release and the information contained herein do not constitute an offer to sell or subscribe, or a solicitation of an offer to buy or subscribe for shares in Cellectis in any country. This press release contains forward-looking statements that relate to the Company’s objectives based on the current expectations and assumptions of the Company’s management only and involve unforeseeable risk and uncertainties that could cause the Company to fail to achieve the objectives expressed by the forward-looking statements.
