Rapidly produced non-viral CAR-T arrives, and cell therapy based on the "Sleeping Beauty" system has been designated by the FDA as fast track
Release date:
2022-05-25
Recently, Precigen announced that its product PRGN-3006 UltraCAR-T has been granted Fast Track designation by the FDA for the treatment of relapsed or refractory (r/r) acute myeloid leukemia (AML). The therapy is a multigene autologous CAR-T cell therapy that utilizes Precigen's proprietary non-viral gene delivery system to simultaneously express CD33 CAR, membrane-bound interleukin-15 (mbIL15) and a kill switch. In January 2020, the FDA also granted PRGN-3006 orphan drug designation (ODD).
Recently, Precigen announced that its product PRGN-3006 UltraCAR-T has been granted Fast Track designation by the FDA for the treatment of relapsed or refractory (r/r) acute myeloid leukemia (AML). The therapy is a multigene autologous CAR-T cell therapy that utilizes Precigen's proprietary non-viral gene delivery system to simultaneously express CD33 CAR, membrane-bound interleukin-15 (mbIL15) and a kill switch. In January 2020, the FDA also granted PRGN-3006 orphan drug designation (ODD).
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