Precigen's UltraPorator™ Receives FDA Clearance for Manufacturing UltraCAR-T® Cells in Clinical Trials
"UltraPorator is a game-changer for rapid manufacturing of UltraCAR-T therapy for our PRGN-3005 clinical trial," said
The UltraPorator device is a high-throughput, semi-closed electroporation system for reprograming T-cells using
"UltraPorator is poised to transform the manufacturing and accessibility of CAR-T therapies for cancer patients," said Dr.
The UltraCAR-T platform is differentiated from the current generation of CAR-T therapies that rely on a long and complex manufacturing process that includes the use of viral vectors and several weeks of CAR-T cell expansion in centralized facilities before treatment is administered to patients. UltraCAR-T is comprised of genetically modified autologous T-cells that simultaneously express an antigen-specific CAR, membrane bound IL-15 and a kill switch. The inclusion of the gene encoding membrane bound IL-15 slows the aging of UltraCAR-T cells, which results in superior expansion of cells in vivo, eliminating the need for multiple weeks of expansion in culture. The kill switch, which allows for rapid destruction of UltraCAR-T cells in the event of any significant adverse events, has the potential to improve the safety profile of UltraCAR-T therapies.
Current methods for gene transfer rely on electroporation devices requiring labor intensive and manual handling of samples which may increase contamination risk and require multiple batches and extensive hours to manufacture a single dose. In contrast, UltraPorator is capable of handling the electroporation of billions of T-cells in minutes and further streamlines the UltraCAR-T overnight manufacturing process. "UltraPorator represents a pivotal advance in the field of personalized gene and cell therapy, allowing us to bring the drug manufacturing process as close as possible to patients in a commercially viable and expedient way,"
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Some of the statements made in this press release are forward-looking statements. These forward-looking statements are based upon the Company's current expectations and projections about future events and generally relate to plans, objectives, and expectations for the development of the Company's business, including the timing and progress of preclinical studies, clinical trials, discovery programs and related milestones, the promise of the Company's portfolio of therapies, and in particular its CAR-T therapies, and the Company's refocus to a healthcare-oriented business. Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties, including the possibility that the timeline for the Company's clinical trials might be impacted by the COVID-19 pandemic, and actual future results may be materially different from the plans, objectives and expectations expressed in this press release. The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For further information on potential risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in the Company's most recent Annual Report on Form 10-K and subsequent reports filed with the
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