Precigen nabs FDA nod for manufacturing UltraCAR-T therapies

By The Science Advisory Board staff writers

October 15, 2020 -- Precigen has been granted clearance by the U.S. Food and Drug Administration (FDA) for its UltraPorator system. The system also had a successful technology transfer to clinical sites and will be used as a manufacturing device for Precigen's investigational UltraCAR-T therapies.

The UltraPorator system is a high-throughput, semiclosed electroporation system for reprogramming T cells using the company's nonviral gene transfer technology.

UltraCAR-T is composed of genetically modified autologous T cells that simultaneously express an antigen-specific chimeric antigen receptor (CAR), membrane-bound interleukin-15 (IL-15), and a kill switch. Including the gene encoding membrane-bound IL-15 slows the aging of UltraCAR-T cells leading to increased expansion of cells in vivo. The kill switch allows for rapid destruction of UltraCAR-T cells in the event of any adverse events, which increases the safety profile of the therapy.

The new device improves on current methods of gene transfer that rely on electroporation devices that require manual handling of samples and multiple batches. UltraPorator can handle the electroporation of billions of T cells in minutes and further streamlines the UltraCAR-T overnight manufacturing process.

The FDA has cleared UltraPorator as a manufacturing device for clinical trials of Precigen's investigational UltraCAR-T therapies in compliance with current good manufacturing practices (cGMP). The company has successfully completed technology transfer of the UltraPorator system for the manufacturing of UltraCAR-T in ongoing clinical trials for PRGN-3005 in ovarian cancer and PRGN-3006 in acute myeloid leukemia.

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