Intrexon’s Precigen Starts Phase 1/1b Study for Leukemia Med

Precigen, Inc., a wholly-owned subsidiary of Intrexon Corporation (NASDAQ: XON), and a biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for PRGN-3006, a first-in-class investigational therapy using Precigen’s UltraCAR-T™ platform. PRGN-3006 UltraCAR-T is an autologous chimeric antigen receptor T-cell (CAR-T) therapy for treatment of patients with relapsed or refractory acute myeloid leukemia (AML) and higher risk myelodysplastic syndrome (MDS). PRGN-3006 utilizes Precigen’s transformative UltraCAR-T platform, which reduces manufacturing time to less than two days following non-viral gene transfer.

PRGN-3006 UltraCAR-T is a multigenic CAR-T cell treatment utilizing Precigen’s clinically-validated Sleeping Beauty system to co-express chimeric antigen receptor, membrane-bound interleukin‐15 (mbIL15), and a kill switch for better precision and control in targeting relapsed or refractory AML and higher risk MDS. This first-in-human Phase 1 dose escalation study to evaluate the safety and maximal tolerated dose of PRGN‐3006 UltraCAR-T will be conducted in collaboration with Moffitt Cancer Center.

https://www.biospace.com/article/releases/precigen-announces-clearance-of-ind-to-initiate-phase-1-1b-study-for-first-in-class-prgn-3006-ultracar-t-therapy-in-patients-with-relapsed-or-refractory-acute-myeloid-leukemia-aml-and-higher-risk-myelodysplastic-syndrome-mds-/