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Precigen Announces Clearance of IND to Initiate Phase 1/1b Study for PRGN-3007 UltraCAR-T® in Advanced ROR1+ Hematological and Solid Tumors
- PRGN-3007 is the first of the next generation UltraCAR-T, incorporating intrinsic PD-1 checkpoint inhibition in addition to the three effector genes used in
About this update from Precigen, Inc.
[{"type":"text","content":"- PRGN-3007 is the first of the next generation UltraCAR-T, incorporating intrinsic PD-1 checkpoint inhibition in addition to the three effector genes used in the first generation UltraCAR-T technology -\n - Proprietary technology for checkpoint blockade intrinsic to UltraCAR-T avoids the need for combination with a secondary therapeutic -\n - ROR1 is an attractive target for treatment of multiple hematological and solid tumors due to its high expression in cancer and minimal expression in healthy adult tissues -\n\n\nGERMANTOWN, Md., Oct. 26, 2021 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell 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 to initiate the Phase 1/1b clinical trial of PRGN-3007 in advanced receptor tyrosine kinase-like orphan receptor 1-positive (ROR1+) hematological and solid tumors. PRGN-3007 is a first-in-class investigational therapy based on the next generation of Precigen's UltraCAR-T® platform and incorporates intrinsic programmed cell death protein 1 (PD-1) blockade. This first-in-human investigator-initiated study of PRGN–3007 will be conducted in collaboration with the H. Lee Moffitt Cancer Center & Research Institute.\n\n \n \n \n \n \n \n\n \nROR1 is overexpressed in various cancers with minimal expression in healthy adult tissues. ROR1 is aberrantly expressed in multiple hematological tumors, including chronic lymphocytic leukemia (CLL), mantle cell leukemia (MCL), acute lymphoblastic leukemia (ALL), and diffuse large B-cell lymphoma (DLBCL) and solid tumors, including breast adenocarcinomas encompassing triple negative breast cancer (TNBC), pancreatic cancer, ovarian cancer, and lung adenocarcinoma.\nPRGN-3007 UltraCAR-T is an investigational multigenic, autologous CAR-T cell therapy utilizing Precigen's clinically validated advanced non-viral gene delivery system and the well-established overnight, decentralized manufacturing process. Precigen has further advanced the UltraCAR-T platform to address the inhibitory tumor microenvironment by incorporating intrinsic checkpoint blockade without the need for complex and costly gene editing techniques. PRGN-3007 is engineered using a single multicistr...