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Next-generation AAV gene therapy to target debilitating pain disorders
Charles River Laboratories International, Inc. (NYSE:CRL) and Navega Therapeutics, Inc., a biotechnology company developing epigenetic gene therapies, today 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 (CDMO) capabilities and advisory services to produce an adeno-associated virus (AAV)-based gene therapy, NT-Z001, for Phase I clinical trials.
Developing a Non-Opioid Treatment for Chronic Pain
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 (GMP)-grade AAV production.
Simplifying complex supply chains, without compromising on quality, Charles River provides phase-appropriate solutions to meet the growing global demand for plasmid DNA, viral vector, and cell therapy services. Through several acquisitions, capacity expansions, and the establishment of manufacturing platforms including eXpDNA™ (plasmid), nAAVigation™ (AAV), and Lentivation™ (lentiviral vector) to expedite and standardize supply, Charles River's CGT portfolio has been significantly enhanced. Combined with the company's legacy testing services, Charles River offers an industry-leading "concept to cure" solution for advanced therapies, helping developers to navigate the path to clinic and beyond.
New for the 2024 Charles River Cell & Gene Therapy Summit, the Company Pitches session showcases the "who, what, why, and how," highlighting technologies, milestones, path to clinic, and patient outcomes. Join Ana Moreno, CEO, Navega Therapeutics on March 19 in San Francisco – see the full agenda and save your seat: https://bit.ly/3SW3VOV
Posted In: CRL
