Pharmaceutical Business review

Cellectis inks deal with CELLforCURE for cGMP manufacturing of UCART123

Under the deal, CELLforCURE will implement cGMP manufacturing processes designed and developed by Cellectis.

The company will manufacture cGMP clinical batches for UCART123, the lead engineered T-cell product candidate in Cellectis’ portfolio.

UCART123 targets CD123, an antigen expressed on the surface of cancer cells in malignancies including acute myeloid leukemia and blastic plasmacytoid dendritic cells neoplasm.

Cellectis said Universal Chimeric Antigen Receptor T-cells (UCARTs) are off-the-shelf allogeneic product candidates, whose production can be industrialized and standardized with consistent pharmaceutical release criteria, over time and from batch to batch.

Cellectis executive vice president of corporate development David Sourdive said: "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."

US-based Cellectis is engaged in the development of immunotherapies based on gene edited CAR-T cells (UCART).

The company intends to develop a new generation of cancer therapies based on engineered T-cells.

In December last year, Cellectis submitted a clinical trial application to the UK Medicines & Healthcare products Regulatory Agency (MHRA) seeking approval to start UCART19 First-in-Human clinical investigation in leukemia.