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Precigen, Inc. (NASDAQ: PGEN) today announced clinical implementation of its UltraPorator™ system, a device exclusive to Precigen for the scale-up of rapid and cost-effective decentralized manufacturing of UltraCAR-T® therapies. Precigen and its clinical partners have now successfully dosed the first patients with UltraCAR-T cells manufactured using the UltraPorator system. The patients were dosed with PRGN-3005 UltraCAR-T cells in the intraperitoneal (IP) arm of the ongoing Phase 1 study for advanced ovarian cancer patients conducted in collaboration with the University of Washington/Fred Hutchinson Cancer Research Center and with PRGN-3006 UltraCAR-T cells in the ongoing Phase 1/1b study for patients with relapsed or refractory acute myeloid leukemia (AML) and higher risk myelodysplastic syndrome (MDS) conducted in collaboration with the Moffitt Cancer Center. UltraCAR-T eliminates ex vivo expansion, which reduces manufacturing time to allow for rapid next day administration of UltraCAR-T cells following non-viral gene transfer.
"Dosing the first patients with UltraCAR-T cells manufactured using our proprietary UltraPorator system in both of our UltraCAR-T trials represents a major advance in our ability to transform how personalized cancer therapies are manufactured and administered within a medical center's own labs. This milestone positions UltraPorator as the essential go-to platform for cell therapy manufacturing," said Helen Sabzevari, PhD, President and CEO of Precigen. "Our long-term goal is to streamline the process of oncology drug manufacturing so that healthcare professionals can treat their patients as quickly as possible in a commercially viable and expedient way."
UltraPorator is a high-throughput, semi-closed electroporation system for reprogramming T-cells using Precigen's next generation Sleeping Beauty non-viral gene transfer technology. UltraPorator reduces manufacturing risk and allows the medical center to generate UltraCAR-T cells within its own facilities. UltraPorator is capable of handling the electroporation of billions of T-cells in minutes, and further streamlines the UltraCAR-T overnight manufacturing process, allowing for rapid manufacturing of UltraCAR-T cells in higher doses and quantities, which is critical as the Company moves to expansion phases for its clinical studies.
"Current methods for non-viral gene transfer require labor intensive, manual handling of samples, which may increase contamination risk, requires multiple batches and involves extensive hours to manufacture a single dose," said Mary L. (Nora) Disis, MD, faculty member at the University of Washington and Fred Hutchinson Cancer Research Center and one of the lead investigators for the PRGN-3005 study. "The UltraPorator system is a critical piece of the puzzle for personalized manufacturing by significantly reducing processing times, further streamlining UltraCAR-T manufacturing and allowing us to deliver personalized treatment to patients faster than ever."
"Time is critical when selecting and administering treatment to relapsed or refractory AML patients," said David A. Sallman, MD, lead investigator for the PRGN-3006 study at the Moffitt Cancer Center. "The ability to conveniently manufacture PRGN-3006 UltraCAR-T cells using the UltraPorator device overnight and administer treatment the next day can be a game-changer for these patients."
Precigen: Advancing Medicine with Precision™Precigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated unique therapies toward clinical proof-of-concept and commercialization. For more information about Precigen, visit www.precigen.com or follow us on LinkedIn.