LEXEO Therapeutics & FUJIFILM Diosynth Biotechnologies Announce Collaboration to Support Development & Manufacturing of Gene Therapies for Genetic Diseases

LEXEO Therapeutics and FUJIFILM Diosynth Biotechnologies recently 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.

“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, Chief Executive Officer 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 programs 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.”

LEXEO Therapeutics is a New York City-based fully integrated clinical-stage gene therapy company advancing disease-modifying treatments for genetic cardiovascular conditions and genetic conditions of the central nervous system (CNS). The company aims to apply cutting-edge science to target the underlying causes of both rare monogenic diseases and diseases affecting large patient populations. LEXEO’s current pipeline consists of adeno-associated virus (AAV)- mediated gene therapies in rare cardiac diseases, CLN2 Batten disease, and APOE4-associated Alzheimer’s disease. In addition, the company has more than 15 AAV-mediated gene therapy programs in research and development. LEXEO was founded based on a well-established gene therapy research legacy at Weill Cornell Medicine’s Department of Genetic Medicine by a team of pioneering scientists, clinicians, and business leaders with deep expertise in gene therapy. For more information, visit www.lexeotx.com.

FUJIFILM Diosynth Biotechnologies is an industry-leading biologics Contract Development and Manufacturing Organization (CDMO) with locations in Teesside, UK, RTP, North Carolina, College Station, Texas and Hillerød, Denmark. FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ microbial and Apollo™X cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing. FUJIFILM Diosynth Biotechnologies is a partnership between FUJIFILM Corporation and Mitsubishi Corporation. For more information, visit www.fujifilmdiosynth.com.

FUJIFILM Corporation is an operating company of FUJIFILM Holdings Corporation. FUJIFILM Holdings Corporation, Tokyo, Japan, brings cutting edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to the various fields including healthcare, highly functional materials, document solutions and imaging products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2021, the company had global revenues of $21 billion, at an exchange rate of 106 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship. For more information, visit www.fujifilmholdings.com.