Precigen announces ‘positive’ Phase 1 dose escalation data from PRGN-3006 study

Precigen presented positive Phase 1 dose escalation data from the ongoing Phase 1/1b clinical study of PRGN-3006 UltraCAR-T in patients with r/r AML and higher risk myelodysplastic syndromes at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition. The presentation was delivered by David A. Sallman, MD, Assistant Member in the Department of Malignant Hematology at the H. Lee Moffitt Cancer Center & Research Institute and a lead investigator for the PRGN-3006 clinical trial. PRGN-3006 UltraCAR-T is a multigenic autologous chimeric antigen receptor (CAR)-T simultaneously expressing a CAR specifically targeting CD33; membrane bound IL-15 (mbIL15) for enhanced in vivo expansion and persistence; and a kill switch to conditionally eliminate CAR-T cells for an improved safety profile. CD33 is over-expressed on AML blasts with lesser expression on normal hematopoietic stem cells. PRGN-3006 UltraCAR-T drug product is manufactured via an overnight process at medical centers using the Company’s proprietary non-viral and UltraPorator(R) systems and released for infusion in patients the next day. The decentralized, overnight UltraCAR-T manufacturing process, which does not use viral vectors or ex vivo activation and expansion of T cells, has the potential to address major limitations of current T cell therapies. PRGN-3006 UltraCAR-T has been granted Orphan Drug Designation and Fast Track Designation in patients with AML by the US Food and Drug Administration.