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Aug 13, 2012
 |  BioCentury  |  Product Development

Three-Patient POC

Phase I data for CART-19 cancer immunotherapy key to Novartis-UPenn deal

The University of Pennsylvania's Phase I proof-of-concept data for its targeted T cell therapy were enough to convince Novartis AG the technology could have advantages over earlier immunotherapies.

Last week, the university granted Novartis exclusive, worldwide rights to develop and commercialize chimeric antigen receptor (CAR) immunotherapies for cancer. The deal includes CART-19, which completed the Phase I trial in chronic lymphocytic leukemia (CLL).

CART-19 is a lentiviral vector containing a gene that encodes a chimeric protein consisting of an antigen recognition domain specific to CD19 and an immunostimulatory domain.

To create the autologous immunotherapy, lymphocytes are extracted from patients with CD19+ CLL and T cells are transduced with CART-19. The cells are cultured for nine days to allow the transduced cells to expand and then the T cells are reinfused into the patient.

In the blood stream, the transduced T cells express the CD19 antibody on their surface and become activated when they encounter the CD19 antigen.

Upon binding the CD19 antigen, the immunostimulatory domain of the chimeric antibody is triggered, resulting in immune-mediated tumor cell death.

In the Phase I trial in three patients with CD19+ CLL, CART-19 resulted in a complete response within one month of treatment in two patients who also had sustained remission of their disease. The third patient achieved a partial response. Results were published in the New England Journal of Medicine last August.

According to...

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