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Precigen Doses First Patients With Cell Therapies Manufactured Using UltraPorator System

NEW YORK – Germantown, Maryland-based Precigen on Monday announced that the first patients had been dosed with autologous cell therapies manufactured using its UltraPorator system, a technology that the company says will allow for rapid, decentralized production of its UltraCAR-T cell therapies.

The UltraPorator technology is a semi-closed system that uses Precigen's non-viral gene transfer technology, dubbed Sleeping Beauty, to reprogram patients' own T cells through electroporation. According to Precigen, the system can be implemented within medical centers' own facilities and reduce turnaround times and manual handling of samples, as well as allow next-day administration of the treatments due to the speed of its electroporation.

The UltraPorator system was used to manufacture products in two ongoing Phase I clinical trials. One study is evaluating Precigen's PRGN-3005 cell therapy in patients with advanced, recurrent platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer, and another study is evaluating Precigen's PRGN-3006 cell therapy for patients with relapsed or refractory acute myeloid leukemia or high-risk myelodysplastic syndromes.

Both PRGN-3005 and PRGN-3006 are what Precigen calls UltraCAR-T cells, which are multigenic autologous CAR T-cell treatments that use Precigen's Sleeping Beauty system to express chimeric antigen receptors targeting select proteins expressed on cancer cells — MUC16 for ovarian tumors and CD33 for AML and MDS. The therapies also include membrane-bound IL-15 to allow for in vivo expansion, and a "kill switch" to improve safety by eliminating CAR T cells conditionally. The Phase I studies for both PRGN-3005 and PRGN-3006 are assessing the treatments' safety and maximum tolerated doses while also looking at evidence of early efficacy as secondary endpoints.

"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," Precigen CEO Helen Sabzevari said in a statement. "This milestone positions UltraPorator as the essential go-to platform for cell therapy manufacturing. 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."