Charles River Laboratories and Nanoscope Therapeutics signed an agreement based on using Charles River’s contract development and manufacturing (CDMO) services in both plasmid DNA and viral vectors. Nanoscope will have access to manufacturing platforms and multiple Charles River CDMO centers of excellence that will include, but not limited to, Good Manufacturing Practice (GMP) cell banking, High Quality (HQ) and GMP-grade plasmid DNA manufacture, and GMP adeno-associated virus (AAV) production.
This gene therapy manufacturing partnership builds on Charles River’s acquisitions of Cognate BioServices, Cobra Biologics, and Vigene Biosciences in 2021 that expanded its cell and gene therapy portfolio to span each of the major CDMO platforms—cell therapy, viral vector, and plasmid DNA production.
Nanoscope is developing gene-agnostic, sight-restoring Multi-Characteristic Opsin (MCO) optogenetic therapies for the millions of patients blinded by retinal degenerative diseases, for which no cure exists. Nanoscope’s optogenetic therapy uses a proprietary AAV2 vector to deliver MCO genes into retinal cells to enable vision in different color environments. The therapy is administered as a single intravitreal injection for in-office delivery without the need for any other devices or interventions.
Nanoscope’s lead asset, MCO-010, is in Phase IIb multicenter, randomized, double-masked, sham-controlled clinical trials in the United States for retinitis pigmentosa with top-line data expected H1 2023. The company has also fully enrolled a Phase II trial of MCO-010 therapy in Stargardt macular degeneration patients. MCO-010 has received FDA Fast Track designation for RP and FDA orphan drug designations for RP and Stargardt. Preclinical assets include non-viral laser-delivered MCO-020 gene therapy for geographic atrophy.
“We are excited to continue to support Nanoscope Therapeutics’ efforts in the production of gene therapies that are focused on restoring vision for people suffering from retinal degenerative diseases with no known cure. Their work is incredibly important to patients, and we look forward to continuing to serve as a partner,” said Kerstin Dolph, corporate senior vice president, biologics solutions, Charles River.