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Charles River Laboratories to Manufacture AAV9 Vectors for Navega Therapeutics' Pain Gene Therapy

NEW YORK – Navega Therapeutics has entered into an agreement with Charles River Laboratories to support manufacturing of its chronic pain gene therapy candidate as it moves into Phase I trials, the firms said Thursday.

As part of Wilmington, Massachusetts-based Charles River's cell and gene therapy accelerator program, Navega will have access to the lab's contract development and manufacturing capabilities and advisory services to produce adeno-associated virus serotype 9 (AAV9) vectors for use in its NT-Z001 gene therapy.

San Diego-based Navega is developing NT-Z001 as a treatment for chronic pain by targeting a gain-of-function mutation in the SCN9A gene that codes for Nav 1.7, a sodium channel implicated in pain sensation that's been linked to pain disorders, including small fiber neuropathy and primary erythromelalgia. NT-Z001 is an epigenetic gene therapy that uses Navega's zinc-finger epigenome regulation platform to modulate SCN9A expression.

"The selection of Charles River as our CDMO resulted from the additional benefits of its CGT Accelerator Program, including manufacturing prioritization for Nav 1.7, introduction to key industry players, scientific advisory and consulting services, plus comarketing efforts,” Navega CEO Ana Moreno said in a statement.