French biotech company Cellectis (Euronext Paris: ALCLS) has entered into a new agreement for the current Good Manufacturing Practices (GMP) production 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.
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