Charles River and Navega Therapeutics Announce Comprehensive Gene Therapy Manufacturing Collaboration
14 Marzo 2024 - 6:00AM
Business Wire
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
Approved Quotes
- “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.
About Charles River
Charles River provides essential products and services to help
pharmaceutical and biotechnology companies, government agencies and
leading academic institutions around the globe accelerate their
research and drug development efforts. Our dedicated employees are
focused on providing clients with exactly what they need to improve
and expedite the discovery, early-stage development and safe
manufacture of new therapies for the patients who need them. To
learn more about our unique portfolio and breadth of services,
visit www.criver.com.
About Navega Therapeutics Inc.
Navega is a preclinical stage company developing
epigenetic-regulation gene therapies to tackle common and complex
diseases via a proprietary AI-enabled zinc finger platform. Due to
the involvement of NaV1.7 in multiple chronic pain states, Navega
is harnessing the power of the epigenome to modify its expression
and treat multiple chronic pain indications, including
chemotherapy-induced peripheral neuropathy. Other indications in
Navega’s pipeline include neurological and ophthalmic diseases.
To learn more visit https://navegatx.com/.
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Charles River Investor Contact: Todd Spencer Corporate
Vice President, Investor Relations 781.222.6455
todd.spencer@crl.com Charles River Media Contact: Amy
Cianciaruso Corporate Vice President, Chief Communications Officer
781.222.6168 amy.cianciaruso@crl.com
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