Lexeo Therapeutics, a fully integrated clinical-stage gene therapy company advancing adeno-associated virus (AAV)-mediated treatments for genetic conditions, and Fujifilm Diosynth Biotechnologies, a contract development and manufacturing organization (CDMO) for biologics, viral vaccines and viral vectors, formed a collaboration to support the development and manufacturing of Lexeo’s AAV-mediated gene therapies.
 
Fujifilm Diosynth Biotechnologies will provide good manufacturing practice (GMP) production, analytical development, process optimization, and chemistry, manufacturing and controls (CMC) for Lexeo’s clinical-stage programs, with an initial focus on the upcoming pivotal study for LX1004, an AAV-mediated gene therapy for potential treatment of CLN2 Batten disease. Production of clinical and commercial supply for Lexeo’s pipeline will utilize single-use suspension bioreactor technology, creating a common manufacturing platform and technology base that will support vector demand across all pipeline programs.
 
“This partnership provides us with the basis for an integrated supply chain, complementing internal CMC capabilities and will position Lexeo to advance multiple late-stage clinical programs simultaneously,” said R. Nolan Townsend, CEO, Lexeo Therapeutics.
 
Gerry Farrell, chief operating officer, Fujifilm Diosynth Biotechnologies, Texas, said, “This synergistic partnership combines our world-class technical expertise in gene therapy manufacturing with Lexeo’s cutting-edge pipeline to accelerate the development of transformative medicines for patients.”