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Precigen Announces Positive Phase 1 Dose Escalation Data for Autologous PRGN-3006 UltraCAR-T® Manufactured Overnight for Next Day Infusion in Relapsed or Refractory Acute Myeloid Leukemia Patients
– Single infusion of UltraCAR-T cells with or without lymphodepletion demonstrated robust expansion and persistence in blood and bone marrow – – PRGN-3006
About this update from Precigen, Inc.
[{"type":"text","content":"– Single infusion of UltraCAR-T cells with or without lymphodepletion demonstrated robust expansion and persistence in blood and bone marrow –\n– PRGN-3006 infusion with lymphodepletion resulted in a decrease in bone marrow blasts in 60% of heavily pre-treated patients –\n– Single infusion of autologous PRGN-3006 cells resulted in 27% objective response rate (ORR) in heavily pre-treated relapsed or refractory (r/r) acute myeloid leukemia (AML) patients infused following lymphodepletion –\n– PRGN-3006 was well-tolerated with no dose-limiting toxicities (DLTs) reported to date –\nGERMANTOWN, Md., Dec. 12, 2022 /PRNewswire/ -- Precigen, Inc., a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today 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 (MDS) (clinical trial identifier: NCT03927261) at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract# 4633). 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 (Moffitt) and a lead investigator for the PRGN-3006 clinical trial.\nPRGN-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® 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 (US FDA).\nThe Phase 1/1b c...