Cellectis selects Lonza for off-the-shelf CAR-T manufacture

CDMO Lonza will make clinical batches of an allogeneic CAR-T cell candidate from its facility in the Netherlands for French firm Cellectis.

Cellectis has a range of ‘UCART’ off-the-shelf chimeric antigen receptor (CAR) T-cell therapies in development for hematological malignancies, based on its TALEN gene-editing technology.

To support this, the French biopharma has selected Swiss contract development and manufacturing organization (CDMO) Lonza to supply clinical materials from its facility in Geleen, added to its cell and gene therapy network through the acquisition of Dutch firm PharmaCell B.V. in May 2017.

Image: iStock/Meletios Verras

The deal, financial details of which have not been divulged, “increases our global capabilities and allows Cellectis to further strengthen its manufacturing expertise,” said William Monteith, EVP of Technical Operations at Cellectis.

“This agreement not only bolsters our product supply for clinical trials, but it ensures that we are producing first-rate product candidates so that we can potentially deliver new hope to patients living with certain blood cancers.”

CAR-T products have seen commercial success in the forms of Novartis’ Kymriah (tisagenlecleucel) and Kite’s Yescarta (axicabtagene ciloleucel). However, both these approved therapies are autologous, meaning in a purely personalized manner that the patient’s own cells are the starting material.

Allogeneic cell therapies, meanwhile, are not based on the specific patient but rather come from healthy donor cells or from renewable stem cells. While an allogeneic CAR-T therapy is yet to reach approval, due to their ‘off-the-shelf’ nature such products are expected to be cheaper to make.

The supply from Lonza will supplement Cellectis’ own network, which it has invested heavily in.

In May, the firm told us it is constructing its IMPACT plant – Innovative Manufacturing Plant for Allogeneic Cellular Therapies – in Raleigh, North Carolina. The reported cost of the site, expected to be operational in 2021, will be $68 million.

Meanwhile, the firm is building a plant in Paris, France known as the SMART – Starting Material Realization for CAR-T products – facility, set to produce critical starting material supply for UCART clinical studies and commercial products.