Precigen, Inc. announced that the FDA has granted Fast Track designation for PRGN-3006 UltraCAR-T® in patients with relapsed or refractory (r/r) AML (clinical trial identifier: NCT03927261). PRGN-3006 was previously granted FDA Orphan Drug Designation.
PRGN-3006 UltraCAR-T is a multigenic autologous chimeric antigen receptor (CAR)-T cell treatment utilizing Precigen's non-viral Sleeping Beauty system to simultaneously express a CAR specifically targeting CD33, which is over expressed on AML blasts; membrane bound IL-15 for enhanced in vivo expansion and persistence; and a kill switch to conditionally eliminate CAR-T cells for an improved safety profile.
Precigen's UltraCAR-T platform is designed to overcome limitations of currently available CAR-T therapies by utilizing an advanced overnight non-viral gene delivery manufacturing process at a medical center's cGMP facility without the need for ex vivo expansion. Current CAR-T cell therapies are limited due to, inter alia, the prolonged interval between apheresis to product infusion and an exhausted phenotype of T cells resulting from lengthy ex vivo expansion. UltraCAR-T cells for the PRGN-3006 study are manufactured overnight using Precigen's proprietary UltraPorator™ system.
"We are very pleased to receive the FDA's Fast Track designation, which facilitates development and expedites the review process of drugs that address serious conditions and high unmet medical needs," said Helen Sabzevari, PhD, President and CEO of Precigen. "AML is a rapidly progressing disease with a very poor prognosis. The Fast Track designation will help facilitate the timely development of this program and we look forward to working more closely with the FDA to potentially bring this new and highly differentiated overnight UltraCAR-T therapy to patients."
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