Charles River and Navega announce an AAV9 production program agreement

Charles River Laboratories and Navega Therapeutics announced an AAV9 production program agreement. As part of Charles River’s Cell and Gene Therapy, CGT, Accelerator Program, CAP, Navega will have access to established contract development and manufacturing or CDMO, capabilities and advisory services to produce an adeno-associated virus, AAV-based gene therapy, NT-Z001, for Phase I clinical trials.Navega is pursuing an approach for treatment of chronic pain associated with rare diseases such as small fiber neuropathy and primary erythromelalgia by harnessing the precision of its AI-enabled zinc-finger epigenome regulation platform. Navega’s epigenetic therapy addresses a gain-of-function mutation in the Nav 1.7 gene, linked to inherited erythromelalgia, small fiber neuropathy and other chronic, debilitating pain disorders. With over 17 million Americans living with high-impact chronic pain, Navega’s non-opioid gene therapy for chronic pain may also be used in other intractable pain indications, including neuropathic and inflammatory pain. Plasmid and Viral Vector CDMO Solutions To bring NT-Z001 to clinic, Navega will leverage Charles River’s off-the-shelf plasmid products, custom plasmid capabilities, and Good Manufacturing Practice or GMP-grade AAV production. “The collaboration with Navega will tap into our premier gene therapy CDMO capabilities and robust AAV offerings. We are thrilled that our expertise will help bring Navega’s gene therapy closer to patients suffering with chronic pain.” – Kerstin Dolph, Corporate Senior Vice President, Biologics Solutions, Charles River