Novartis has confirmed that it will disband its cell and gene therapies unit and reintegrate the operations of that unit, including the chimeric antigen receptor (CAR) T-cell technology development, into its main organization. Approximately 120 positions will be affected by the reintegration, with a majority of positions being reassigned into other parts of the company, according to Novartis.

The company has assured that the reintegration will not interrupt its current work in the area of gene therapy. CAR T therapy involves taking a person’s own T cells (immune cells) and genetically reprogramming them to hunt and potentially kill CD19-expressing cells, including cancer cells.

Novartis’ CAR T-cell collaboration with the University of Pennsylvania (Penn) will continue. Novartis and Penn formed the collaboration in August 2012. Under the agreement, Penn granted Novartis an exclusive worldwide license to the technologies used in a trial of patients with chronic lymphocytic leukemia (CLL) as well as future CAR-based therapies developed through the collaboration. Novartis invested in the establishment of a center for advanced cellular therapeutics (CACT) at Penn and future research of the technology. Additional milestone and royalty payments to Penn are also part of the agreement.

In February 2016, Novartis and Penn unveiled the CACT, which was constructed in part through a $20-million investment from Novartis. It is expected to employ 100 specialized cell therapy professionals working across 23,610 square feet of laboratory and cell-therapy manufacturing space.

The reintegration of Novartis’ cell and gene therapies unit will not impact the company’s regulatory filing plans for its drug candidate, CTL019, an investigational CAR T cancer therapy for pediatric relapsed/refractory acute lymphoblastic leukemia. The company plans to file for regulatory approval with the US Food and Drug Administration in early 2017 and with the European Medicines Agency later in 2017.

Source: Novartis and University of Pennsylvania