Date: 2021-10-13

Type of information: Production agreement

Compound: AAV-mediated gene therapies

Company: Lexeo Therapeutics (USA-NY) Fujifilm Diosynth (USA-TX)

Therapeutic area: Rare diseases - Genetic diseases -Neurodegenerative diseases - Cardiovascular diseases

Type agreement: manufacturing bioproduction

Action mechanism: gene therapy



• On October 13, 2021, 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 world leading contract development and manufacturing organization (CDMO) for biologics, viral vaccines and viral vectors, announced a strategic 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.

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