GenSight Biologics, a biopharma company focused on developing and commercializing innovative gene therapies, has transferred the upstream phase of the manufacturing process for LUMEVOQ, its gene therapy candidate product for the rare mitochondrial disease Leber Hereditary Optic Neuropathy (LHON), to its new manufacturing partner, Catalent Inc.

Catalent Inc. is the only CDMO with a successfully commercialized gene therapy produced in its facility. Catalent 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 and 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.

“This outstanding result is a significant milestone in GenSight’s strategy for securing the supply of LUMEVOQ for clinical use and for supporting the planned regulatory submissions,” commented Scott Jeffers, Chief Technical Officer of GenSight Biologics. “Our new partnership is proving to be highly effective, not just in completing the tech transfer process successfully, but also in improving the yield and upgrading the analytical methods used to reinforce control over the safety and quality of each batch.”