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Charles River, Navega Therapeutics Enter Gene Therapy Mfg. Pact

Will leverage Charles River’s off-the-shelf plasmid products, custom plasmid capabilities, and GMP-grade AAV production.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Charles River Laboratories International, Inc. and Navega Therapeutics, Inc., a biotechnology company developing epigenetic gene therapies, entered an AAV9 production program agreement. As part of Charles River’s Cell and Gene Therapy (CGT) Accelerator Program (CAP), Navega will have access to CDMO capabilities and advisory services to produce an adeno-associated virus (AAV)-based gene therapy, NT-Z001, for Phase I trials.
 
Navega is developing a non-opioid gene therapy treatment for chronic pain associated with rare diseases using its AI-enabled zinc-finger epigenome regulation platform. The 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. The gene therapy for chronic pain may also be used in other intractable pain indications, including neuropathic and inflammatory pain.
 
To bring NT-Z001 to clinic, Navega will leverage Charles River’s off-the-shelf plasmid products, custom plasmid capabilities, and 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,” said Kerstin Dolph, Corporate Senior Vice President, Biologics Solutions, Charles River.

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