- ProBio has supplied GMP AAV6 materials to support IND-enabling studies for GlyTR Therapeutics and the University of California, Irvine’s next-generation AAV-mediated CAR-T platform targeting tumor-associated carbohydrate antigens.
- The collaboration utilizes ProBio’s integrated CDMO capabilities in plasmid DNA development, GMP manufacturing, and CMC to support preclinical development and preparation for IND submission.
ProBio has supported the development of a next-generation AAV-mediated CAR-T platform created by the University of California, Irvine School of Medicine and GlyTR Therapeutics by supplying GMP AAV6 scale-up materials for IND-enabling studies. The collaboration leverages the company’s integrated CDMO and contract manufacturing capabilities, including plasmid DNA development, GMP manufacturing, and scalable chemistry, manufacturing and controls (CMC) expertise.
The GlyTR platform is designed to target tumor-associated carbohydrate antigens expressed across multiple cancers using a lectin-based binding mechanism intended to improve selectivity and reduce off-tumor toxicity. According to the announcement, the technology is being developed as a first-in-class pan-cancer immunotherapy platform and has been licensed by the University of California, Irvine to GlyTR Therapeutics for commercialization.
ProBio said its manufacturing support is intended to reduce development risk and accelerate the program toward clinical evaluation. Preclinical findings will inform upcoming toxicology studies and clinical strategy, with the program now advancing toward clinical trial preparation and an investigational new drug (IND) submission. Clinical studies are planned through collaboration between the UC Irvine Chao Family Comprehensive Cancer Center and the UC Irvine Alpha Clinic.
“ProBio’s GMP AAV6 product demonstrated robust on-target CAR gene insertion of ~80%, greatly surpassing the ~40% insertion efficiency with previous research grade material.”
Dr. Ani Grigorian, Associate Project Scientist at the UC Irvine School of Medicine and lead scientist for the study
The program has received approximately US$30 million in development support, including a recent US$4.6 million grant from the California Institute for Regenerative Medicine, according to the announcement.
