GenSight Biologics to Partner with Catalent on Gene Therapy Candidate
GenSight Biologics recently announced the successful transfer of the upstream phase of the manufacturing process for LUMEVOQ, the Company’s gene therapy candidate product for the rare mitochondrial disease Leber Hereditary Optic Neuropathy (LHON), to CDMO Catalent.
Catalent is the only contract development and manufacturing organization (CDMO) with a successfully commercialized gene therapy produced in its facility. It offers gene therapy companies both production and in-house testing capabilities, and the GMP capacity at the facility used for LUMEVOQ will provide GenSight Biologics greater flexibility in the manufacture of the gene therapy.
Catalent successfully manufactured the drug product batch that was released as safe for human use in November 2024, which will be the source of product supply for the named patient early access program (AAC) and dose-ranging study in France. After the tech transfer is completed, Catalent will also manufacture the drug for the planned global Phase III trial RECOVER and the regulatory submissions.
“Our partnership with a manufacturing powerhouse like Catalent is a critical enabler of our global strategy,” explained Laurence Rodriguez, CEO of GenSight Biologics. “The outputs from their work with our team will allow us to reassure regulators that we have surmounted the challenges we faced in the past and, ultimately, to fulfill our mission to provide LHON patients a safe and effective treatment for their urgent unmet need.”
