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Juno's JCAR015 gets breakthrough designation in ALL

November 25, 2014 5:11 AM UTC

FDA granted breakthrough therapy designation to JCAR015 from Juno Therapeutics Inc. (Seattle, Wash.) for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia. Juno partner Memorial Sloan Kettering Cancer Center (MSKCC) filed for the designation.

JCAR015 comprises autologous T cells expressing the 19-28z chimeric antigen receptor (CAR) specific to the CD19 antigen. Juno, which filed this month to raise $150 million in an IPO, aims to start a Phase II trial of the product in mid-2015 in ALL. ...