- GenSight Biologics has completed the upstream tech transfer of its gene therapy candidate LUMEVOQ® to Catalent.
- Catalent will supply clinical batches and support regulatory and Phase III trial preparations.
GenSight Biologics has announced the successful transfer of the upstream phase of LUMEVOQ® manufacturing to Catalent, Inc., marking a pivotal milestone in its gene therapy programme for Leber Hereditary Optic Neuropathy (LHON). The collaboration forms part of GenSight’s broader strategy to stabilise production and prepare for global regulatory submissions and a Phase III clinical trial.
Catalent, a global contract development and manufacturing organisation (CDMO), is the only CDMO with a commercialised gene therapy produced in-house. The company’s capabilities include both production and testing under GMP conditions, providing GenSight with added flexibility and control over the supply of LUMEVOQ®.
The partnership has already yielded tangible results. In November 2024, Catalent successfully produced a batch of LUMEVOQ® that was cleared for human use. This batch will supply both the named patient early access programme in France and an upcoming dose-ranging study.
The transition to Catalent is part of GenSight’s wider operational plan, which also includes regulatory consultations in the US and EU, MHRA submission in the UK, and preparations for the global Phase III trial scheduled for 2026.
“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,” said Scott Jeffers, Chief Technical Officer at GenSight Biologics.
“Our partnership with Catalent is key to our global strategy,” said Laurence Rodriguez, CEO of GenSight Biologics. “Their work supports our efforts to show regulators we’ve overcome past challenges and are ready to deliver a safe, effective treatment for LHON patients.”
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