The collaboration will enable production of gene therapies for LEXEO’s upcoming clinical trials, future IND-enabling studies and commercialization, according to the parties.
FBD is to provide good manufacturing practice (GMP) production, analytical development, process optimization, and chemistry, manufacturing and controls (CMC) for LEXEO’s clinical-stage programs.
Gerry Farrell, COO, FBD, Texas, called the alliance a "synergistic partnership" that combines its technical expertise in gene therapy manufacturing with the New York city based company's "cutting-edge" pipeline.
R Nolan Townsend, CEO of LEXEO, outlined how the partnership would help it advance multiple late-stage clinical programs simultaneously.
The partners will initially focus on the supply of LX1004, an adeno-associated virus (AAV)-mediated gene therapy for potential treatment of CLN2 Batten disease, in an upcoming pivotal study.
LEXEO will utilize single-use suspension bioreactor technology, creating a common manufacturing platform and technology base to support vector demand across its pipeline.
The company's portfolio targets rare and non-rare disease indications; it also has an APOE2+ Alzheimer’s Disease program.
Founded on the basis of a gene therapy research legacy at Weill Cornell Medicine’s Department of Genetic Medicine with the goal of developing disease-modifying treatments for genetic cardiovascular conditions and genetic conditions of the central nervous system (CNS), it now has more than 15 AAV-mediated gene therapy programs in research and development.
Gene therapy focus
Parent company, Fujifilm Corporation, has spent US$5.5bm since 2011 to support the CDMO business of Fujifilm Diosynth Biotechnologies.
With an US$850m investment announced in June this year, the CDMO is expanding its manufacturing capabilities to support an increased capacity for biologics and gene therapies. The cash infusion is aimed at growing FBD’s contract manufacturing capabilities in the US and the UK. Those expansion projects will be fully realized in 2023.
In January 2021, the company invested US$40m to establish its third viral vector contract development operation in Boston. The third site, it said, would enable it to respond to customers’ needs for the viral vector manufacturing process from the early clinical stage through commercialization.