Cellectis Enters into New Agreement with CELLforCURE for the cGMP Manufacturing of UCART123 for Hematological Malignancies
Published on January 19, 2016
January 19, 2016 – New York, N.Y. & Les Ulis, France – Cellectis (Alternext: ALCLS – Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), announced that it entered into a new agreement for the cGMP manufacturing of UCART123 clinical batches, Cellectis’ lead product candidate, with CELLforCURE, an LFB group company and the largest industrial facility for clinical and commercial production of innovative cell therapies in Europe. CELLforCURE will be in charge of implementing cGMP manufacturing processes designed and developed by Cellectis.
Following the recent successful production of UCART19, pursuant to this second agreement CELLforCURE will be responsible for the manufacturing of cGMP clinical batches for UCART123, the lead engineered T-cell product candidate in Cellectis’ wholly owned portfolio. UCART123 targets CD123, an antigen expressed on the surface of cancer cells in malignancies, such as acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cells neoplasm (BPDCN).
UCARTs (Universal Chimeric Antigen Receptor T-cells) are “off-the-shelf” allogeneic product candidates. Their production can be industrialized and standardized with consistent pharmaceutical release criteria, over time and from batch to batch.
Peripheral Blood Monoculear Cells from healthy donors are transduced and genetically edited with Cellectis’ TALEN® technology to seek and destroy cancer cells. This approach could lead to a drug that would be cost-effective, made readily available - “off the shelf” - to broad patient populations in hospitals without need for local CAR-T processing facilities and easily distributed across all geographies.
Dr. David J.D. Sourdive, Executive Vice President Corporate Development, Cellectis, stated: “The manufacturing campaign for UCART123 consolidates Cellectis’ GMP processes and our expertise in its industrialization while allowing Cellectis to further enhance and improve the manufacturing of its UCART product candidates.”
Dr. André Choulika, Chairman & CEO, Cellectis, added: “We are very pleased with our continued collaboration with CELLforCURE, a unique industrial platform dedicated to cell and gene therapies and equipped with a state-of-the-art cGMP manufacturing facility to foster the clinical development of UCART123. Cellectis’ cGMP manufacturing of allogeneic CAR T-cells is a paradigm change in cancer adoptive immunotherapies, for the patient's benefit.”
Pierre-Noël Lirsac, CEO of CELLforCURE stated: “The technical and pharmaceutical experience of the CELLforCURE team is a real asset, bringing its expertise to manufacture Cellectis’ cost-effectively CAR T-cell products, thus helping to make them broadly and immediately available to patients.”
Leopold Bertea, Head of the Global bioproduction division of the LFB group, added: “This new agreement confirms the excellence of the collaboration between Cellectis and CELLforCURE. We are proud to contribute to such an exciting challenge.”