Charles River will manufacture both plasmid DNA and viral vectors for late phase clinical trials targeting degenerative ocular diseases with no known cure

Charles River Laboratories International, Inc. (NYSE: CRL) and Nanoscope Therapeutics, Inc., a clinical-stage biotechnology company developing gene therapies for retinal degenerative diseases, today announced a comprehensive manufacturing collaboration utilizing Charles River’s extensive contract development and manufacturing (CDMO) services in both plasmid DNA and viral vectors.

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A Robust Manufacturing Collaboration

Through this partnership, Nanoscope will have access to established manufacturing platforms and multiple Charles River CDMO centers of excellence, leveraging a comprehensive range of services including, 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 comprehensive cell and gene therapy (C&GT) portfolio to span each of the major CDMO platforms – cell therapy, viral vector, and plasmid DNA production.

Treating Degenerative Retinal Diseases

Nanoscope Therapeutics 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.

Approved Quotes

• “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.” – Kerstin Dolph, Corporate Senior Vice President, Biologics Solutions, Charles River
• “Nanoscope looks forward to working with Charles River to support our accelerated development program. We have high expectations for our program and are counting on Charles River leadership, resources and scale to deliver in this partnership.” - Anil Lalwani, Vice President, CMC, Nanoscope Therapeutics, Inc.

About Charles River

Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.

About Nanoscope Therapeutics Inc.

Nanoscope Therapeutics is developing gene-agnostic, sight restoring optogenetic therapies for the millions of patients blinded by retinal degenerative diseases, for which no cure exists. The company’s lead asset, MCO-010, is presently in Phase 2b multicenter, randomized, double-masked, sham-controlled clinical trials in the U.S. for retinitis pigmentosa (NCT04945772) with top line data expected H1 2023. The company has also fully enrolled a Phase 2 trial of MCO-010 therapy in Stargardt patients (NCT05417126). 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.

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