- Charles River Laboratories has entered into a partnership with Navega Therapeutics to produce the AAV gene therapy candidate NT-Z001 for phase 1 clinical trials.
- The gene therapy candidate NT-Z001 is being developed to treat chronic pain associated with rare diseases like small fiber neuropathy and primary erythromelalgia.
- Charles River will leverage its off-the-shelf plasmid products, custom plasmid capabilities, and adeno-associated virus (AAV) production to bring NT-Z001 to the clinic.
Charles River Laboratories, a cell therapy contract development and manufacturing organisation (CDMO), has announced a new partnership with Navega Therapeutics. The collaboration is centred on the production of an adeno-associated virus 9 (AAV9) candidate, NT-Z001, a non-opioid alternative for patients living with chronic pain due to rare diseases.
The deal grants Navega access to Charles River’s contract development and manufacturing capabilities as part of the CDMO’s Cell and Gene Therapy Accelerator Program. This will enable the production of the AAV gene therapy candidate NT-Z001 for phase 1 clinical trials.
NT-Z001 is designed to address a gain-of-function mutation in the Nav 1.7 gene, which is linked to inherited erythromelalgia, small fiber neuropathy, and other chronic, debilitating pain disorders. The drug leverages Navega’s artificial intelligence-enabled zinc-finger gene-editing platform.
“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
“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 co-marketing efforts. We are delighted to have been selected from a pool of talented applicants.” – Ana Moreno, PhD, Chief Executive Officer, Navega Therapeutics, Inc.
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