Precigen begins Phase 1 PRGN-3005 study

GERMANTOWN, Md.—Precigen, Inc., a wholly-owned subsidiary of Intrexon Corporation, is a biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients. Today the company has announced that the first patient has been dosed with PRGN-3005, a first-in-class investigational therapy using Precigen’s UltraCAR-T therapeutic platform.

PRGN-3005 UltraCAR-T is an autologous chimeric antigen receptor T (CAR-T) cell therapy manufactured using non-viral gene delivery. The cell therapy is under investigation for the treatment of patients with advanced recurrent platinum-resistant ovarian, fallopian tube or primary peritoneal cancer.

According to Precigen, the UltraCAR-T platform brings several advancements: non-viral gene transfer using multigenic vectors for expression of multiple effector genes leads to better precision and control of tumor targeting and eliminates the need for virus; sustained persistence and desired phenotype of infused UltraCAR-T helps address T-cell exhaustion, a common issue with current CAR-T therapies; T-cell control by incorporation of kill switch technology to potentially improve the safety profile; and rapid manufacturing of UltraCAR-T cells using the Precigen’s proprietary non-viral gene transfer process, which eliminates the need for ex vivo propagation and reduces wait times for patients from weeks to one day after gene transfer.

PRGN-3005 utilizes Precigen’s UltraCAR-T therapeutic platform, which eliminates ex vivo expansion and reduces manufacturing time to allow for rapid next day administration of UltraCAR-T cells following non-viral gene transfer. PRGN-3005 UltraCAR-T is a multigenic CAR-T cell investigational therapy utilizing Precigen’s advanced non-viral gene delivery system to co-express a chimeric antigen receptor, membrane-bound interleukin‐15 (mbIL15), and a kill switch for better precision and control.

“This is an important milestone in our efforts to develop a new treatment option for patients with ovarian cancer,” said Helen Sabzevari, Ph.D., president of Precigen. “With the first ovarian cancer patient dosed with Precigen’s PRGN-3005 UltraCAR-T investigational therapy, we remain steadfast in our goal of delivering critical new therapies to solid tumor patients with high unmet need.”

Conducted in collaboration with the University of Washington and Fred Hutchinson Cancer Research Center, the PRGN-3005 UltraCAR-T clinical study is an open-label, first-in-human Phase 1 dose escalation study to evaluate the safety and maximal tolerated dose of PRGN‐3005 UltraCAR-T delivered by intraperitoneal infusion or intravenous infusion. The study population includes patients with advanced stage (III/IV) recurrent ovarian, fallopian tube and primary peritoneal cancer who are platinum-resistant and have progressed after receiving standard-of-care therapies, or who are not eligible to receive available therapies with known clinical benefit.

“Many women with ovarian, fallopian tube and primary peritoneal cancer have historically poor outcomes. Dosing the first patient with the PRGN-3005 UltraCAR-T represents a potentially significant development for the use of CAR-T cell therapies in solid tumors,” noted Mary L. (Nora) Disis, M.D., faculty member at the University of Washington and Fred Hutchinson Cancer Research Center and one of the lead investigators for the PRGN-3005 study.