Contract development and manufacturing organisation (CDMO) Lonza entered a service agreement with Cellectis, a clinical-stage biopharmaceutical company developing immunotherapies based on allogeneic gene-edited chimeric antigen receptor (CAR) T-cells.
Under the agreement, Lonza will manufacture Cellectis’ allogeneic, ‘universal’ CAR-T (UCART) product candidates targeting hematological malignancies at the former’s facilities in Geleen, Netherlands.
Cellectis currently has three UCART product candidates in Phase I clinical trials including UCART123 for acute myeloid leukemia, UCART22 for B-cell acute lymphoblastic leukemia and UCARTCS1 for multiple myeloma.
In addition, the company develops UCART19 for acute lymphoblastic leukemia, which represents the most advanced program and Cellectis’ proof-of-concept, being developed in partnership with Servier and Allogene, is in Phase I.
Asked about which of the candidates are included in the manufacturing agreement with Lonza, a spokesperson for Cellectis told us that "discussions are ongoing" about it.
UCARTs differ from known personalized CAR T-cell therapies, as they are intended to be industrialized, readily available CAR T-cells for a large patient population.
According to the companies, manufacturing of Cellectis’ product line of UCARTs, yields frozen, off-the-shelf, non-alloreactive engineered CAR T-cells with defined pharmaceutical release criteria.
The candidates included in the UCART pipeline are developed using Talen, a gene editing technology, and PulseAgile, an electroporation system which harnesses the power of the immune system in order to target and eradicate cancer cells.
Contract manufacturing from Lonza will complement Cellectis' in-house manufacturing at its two sites that are currently under construction.
One of the sites is located in Paris, France, and it is named SMART (Starting Material Realization for CAR T products). The SMART facility has an operational go-live target date of 2020.
The second site, being built in North Carolina, US, is named IMPACT (Innovative Manufacturing Plant for Allogeneic Cellular Therapies) and has an operational go-live target date of 2021.
Cellecti's spokesperson told us that the facilities will allow manufacturing for both clinical supplies and commercial products, and will be fully equipped to support a potential regulatory approval.
