WILMINGTON, Mass. - Charles River Laboratories International, Inc. (NYSE: CRL) and Navega Therapeutics, Inc. have entered into an agreement to produce an adeno-associated virus (AAV)-based gene therapy, NT-Z001, aimed at treating chronic pain. Announced today, this collaboration is part of Charles River's Cell and Gene Therapy (CGT) Accelerator Program (CAP), which will provide Navega with manufacturing capabilities and advisory services for Phase I clinical trials.
Navega's NT-Z001 targets chronic pain disorders, such as small fiber neuropathy and primary erythromelalgia, which are linked to a mutation in the Nav 1.7 gene. Leveraging artificial intelligence, Navega's zinc-finger epigenome regulation platform aims to provide a non-opioid treatment option for the 17 million Americans dealing with high-impact chronic pain.
Charles River will support Navega's journey to the clinic by supplying off-the-shelf plasmid products, custom plasmid services, and GMP-grade AAV production. This partnership is a move to simplify complex supply chains while maintaining quality, meeting the increasing demand for plasmid DNA, viral vector, and cell therapy services.
Kerstin Dolph, Corporate Senior Vice President, Biologics Solutions at Charles River, expressed enthusiasm about the collaboration, emphasizing that their expertise in gene therapy CDMO capabilities will advance Navega's therapy closer to patients in need.
Ana Moreno, CEO of Navega Therapeutics, highlighted the selection of Charles River as their CDMO for the additional benefits offered by the CGT Accelerator Program. These benefits include manufacturing prioritization, introductions to industry players, and co-marketing efforts, which were decisive factors in their choice.
The partnership will be further discussed during the 2024 Charles River Cell & Gene Therapy Summit, where Moreno is scheduled to present. The summit will take place on March 19 in San Francisco.
Charles River provides a range of products and services that support the development of new therapies, from discovery to manufacture. Navega Therapeutics is a preclinical stage company that focuses on developing gene therapies for various chronic pain conditions, leveraging their proprietary AI-enabled zinc finger platform.
This news is based on a press release statement.
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