Lexeo Therapeutics and FUJIFILM announce partnership to co-develop gene therapies

pharmafile | October 14, 2021 | News story | Business Services  

LEXEO Therapeutics, clinical-stage gene therapy company, and FUJIFILM Diosynth Biotechnologies, world leading CDMO for biologics, viral vaccines and viral vectors, have announced a strategic collaboration to boost the development and manufacturing of LEXEO’s AAV-mediated gene therapies for genetic conditions.

With over 30 years of experience in the development and manufacturing of recombinant proteins and other molecules, FUJIFILM Diosynth Biotechnologies will offer support in the form of good manufacturing practice (GMP), and analytical development. They will also provide chemistry, manufacturing and controls (CMC) for LEXEO’s clinical-stage programmes, with a focus on the upcoming pivotal study for LX1004, which is an AAV-mediated gene therapy for the potential treatment of CLN2 Batten Disease, a disorder characterised by loss of muscle control and early onset dementia.

Based in New York City, LEXEO Therapeutics is focused on advancing disease-modifying treatments for genetic cardiovascular conditions and genetic conditions of the central nervous system. Their current pipeline consists of adeno-associated virus (AAV)-mediated gene therapies in rare cardiac diseases.

As part of this collaboration, production of clinical and commercial supply for LEXEO’s pipeline will use single-use suspension bioreactor technology, creating a common manufacturing platform and technology bass tosupport vector demand across al pipeline programmes.

“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 programmes simultaneously,” said R Nolan Townsend, CEO of LEXEO Therapeutics.

“We’re confident that FUJIFILM Diosynth Biotechnologies’ industry leading technology expertise and experience in gene therapy manufacturing will help position LEXEO for long-term success as we advance programmes from early to late clinical studies,” said Paul McCormac, Senior Vice President, Technical Operations of LEXEO Therapeutics.

Gerry Farrell, Chief Operating Officer of FUJIFILM Diosynth Biotechnologies, Texas, added, “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.”

Lina Adams

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