AavantiBio and Resilience Announce Strategic Collaboration for Gene Therapy Development and Manufacturing

• Collaboration to Support AavantiBio’s Diverse Gene Therapy Pipeline; Development and Supply of GMP Cell Lines and Viral Banks

• Agreement to Include Manufacture and Supply of Material for GLP Tox Studies and Clinical Trial for Friedreich’s Ataxia Patients

CAMBRIDGE, Mass. & SAN DIEGO, Calif.--(BUSINESS WIRE)--AavantiBio, a gene therapy company focused on transforming the lives of patients with rare genetic diseases, and National Resilience, Inc. (“Resilience”), a company building the world’s most advanced biopharmaceutical manufacturing ecosystem, today announced a strategic collaboration to support the development and manufacturing of AavantiBio’s pipeline of therapies, including its lead program in Friedreich’s Ataxia (FA).

Resilience will provide process development and GMP manufacturing services including cell lines and viral banks for AavantiBio’s adeno-associated viral (AAV) vector-based therapeutic FA candidate for use in both pre-clinical studies, and Phase I/II clinical trials in the U.S. and Europe. Resilience will assist in the development and optimization of the manufacturing processes for GLP Tox and first-in human material at its 183,000-square-foot, state-of-the-art facility in Alachua, Florida.

"This partnership supports our immediate and long-term objectives in developing and ultimately commercializing our diverse pipeline of gene therapies, beginning with our lead FA program,” said Bo Cumbo, President and Chief Executive Officer of AavantiBio. “With an emphasis on Chemistry, Manufacturing and Controls (CMC) for gene therapies, we are committed to ensuring the quality of manufacturing processes along with analytical development. We look forward to a lasting collaboration with Resilience as we execute on our mission of bringing new therapies to patient populations."

“We are excited to work with an innovative development-stage company like AavantiBio who is utilizing a unique AAV approach to address the underlying causes of rare genetic diseases,” said Rahul Singhvi, Sc.D, Chief Executive Officer of Resilience. “Our highly-experienced team will work collaboratively with AavantiBio on process development and analytical testing to enable a seamless transition from development to manufacturing.”

FA is a rare inherited neuromuscular disease that causes progressive nervous system damage and movement problems. The multisymptomatic disease usually begins in childhood and leads to degeneration in the spinal cord, peripheral nerves and cerebellum (the part of the brain that controls synchronization and balance) and causes impaired muscle coordination (ataxia) that worsens over time. The neurological degeneration caused by the disease results in unsteady movements, impaired sensory function, and even the loss of speech. Affected individuals can also develop heart problems, diabetes, or curvature of the spine. Though rare, FA affects 1 in every 40,000-50,000 people and is the most common form of hereditary ataxia in the United States.

About AavantiBio, Inc.

AavantiBio is a gene therapy company backed by a premier syndicate of life sciences investors including Perceptive Advisors, Bain Capital Life Sciences, and RA Capital Management, who led the company’s recent $107 million Series A financing. Headquartered in Cambridge, Massachusetts, AavantiBio is advancing a diversified gene therapy pipeline in areas of high unmet medical need, including a lead program in Friedreich’s Ataxia, a rare inherited genetic disease that causes cardiac and central nervous system dysfunction. The company benefits from strategic partnerships with the University of Florida’s renowned Powell Gene Therapy Center and the MDA Care Center at UF Health where AavantiBio’s co-founders and renowned gene therapy researchers Barry Byrne, M.D., Ph.D. and Manuela Corti, P.T., Ph.D. maintain their research and clinical practices. Learn more at www.aavantibio.com.

About Resilience

Resilience (National Resilience, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. Resilience offers the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience frees partners to focus on the discoveries that improve patients’ lives. For more information, visit www.Resilience.com.