Pharma Focus Europe

Charles River and Navega Therapeutics Announce Comprehensive Collaboration for Gene Therapy Manufacturing

Friday, March 15, 2024

Charles River Laboratories International, Inc. (NYSE: CRL) and Navega Therapeutics, Inc., a biotech company specializing in epigenetic gene therapies, have recently unveiled a collaborative agreement for an AAV9 production program. This collaboration falls under Charles River’s Cell and Gene Therapy (CGT) Accelerator Program (CAP), granting Navega access to established contract development and manufacturing (CDMO) capabilities along with advisory services for producing NT-Z001, an adeno-associated virus (AAV)-based gene therapy slated for Phase I clinical trials.

The primary focus of Navega is to develop a non-opioid treatment for chronic pain associated with rare conditions like small fiber neuropathy and primary erythromelalgia. Their approach hinges on utilizing an AI-enabled zinc-finger epigenome regulation platform, aiming to target a gain-of-function mutation in the Nav 1.7 gene, known to be associated with inherited erythromelalgia, small fiber neuropathy, and other chronic pain disorders. Given the substantial number of Americans living with high-impact chronic pain, Navega’s non-opioid gene therapy could potentially address various intractable pain conditions, including neuropathic and inflammatory pain.

To facilitate the development of NT-Z001, Navega will leverage Charles River’s plasmid products, customized plasmid capabilities, and Good Manufacturing Practice (GMP)-grade AAV production.

Charles River is committed to simplifying complex supply chains while maintaining high quality, offering phase-appropriate solutions to meet the increasing global demand for plasmid DNA, viral vectors, and cell therapy services. Through strategic acquisitions, capacity expansions, and the establishment of manufacturing platforms such as eXpDNA™ (plasmid), nAAVigation™ (AAV), and Lentivation™ (lentiviral vector), Charles River aims to provide a comprehensive "concept to cure" solution for advanced therapies, aiding developers throughout the journey from concept to clinic and beyond.



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