Servier, Pfizer get FDA OK to start US testing of an off-the-shelf CAR-T from Cellectis
Just a month after the FDA signed off on the first US study for an off-the-shelf CAR-T therapy from Cellectis $CLLS, its partners at Servier and Pfizer $PFE now have a green light to begin treating patients in the US with UCART19, an allogeneic therapy for acute lymphoblastic leukemia.
Servier and Pfizer have a deal to co-develop UCART19, initially launching their Phase I CALM trial in the UK last summer in CD19-positive B-cell ALL. Now they can begin treating patients at a number of US centers, including the MD Anderson Cancer Center in Houston, a hotbed of cancer drug research.
Currently Kite $KITE and Novartis $NVS are far in the lead in developing the first personalized CAR-T, which reengineers T cells taken from patients into cancer therapies. Both companies are close to completing applications in search of the first FDA approval. Juno lags far behind now after killing its lead program after it was linked to the deaths of 5 patients.
Cellectis, though, is out to prove that it can safely treat cancer patients with a therapy that can be mass manufactured for all patients. By using off-the-shelf T cells, they have to prove that they can do it without triggering a dangerous immune response, which has been an issue in the compassionate use cases followed before. Now this is all being played out in the clinic for the first time.
Cellectis’ wholly owned UCART123 is a gene-edited T-cell investigational drug that targets CD123, an antigen expressed at the surface of leukemic cells in AML, tumoral cells in BPDCN. The clinical research for AML will be led at Weill Cornell by principal investigator Dr. Gail J. Roboz, sirector of the Clinical and Translational Leukemia Programs. The UCART123 clinical program for BPDCN will be led at the MD Anderson Cancer Center by Dr. Naveen Pemmaraju, an assistant professor, and Professor Hagop Kantarjian, department chair of the Department of Leukemia, Division of Cancer Medicine.
“Pfizer is excited by the potential of this investigational CAR-T approach to treating ALL and other B-Cell malignancies,” said Barbara Sasu, the VP of CAR-T Research at Pfizer. “We are looking forward to having the opportunity to investigate this approach in the U.S.”