Oxford Biomedica signs 3-year CSA for Parkinson’s disease gene therapy program

The company expects to manufacture the clinical-stage gene therapy product in its commercial-scale GMP manufacturing facilities.

The CSA builds on the worldwide license agreement signed between the two companies in June 2018 for the Parkinson’s disease gene therapy program OXB-102, now called AXO-Lenti-PD.

Oxford Biomedica will manufacture GMP batches for Axovant to support the ongoing and future clinical development of AXO-Lenti-PD, a clinical-stage gene therapy product to treat moderate to severe Parkinson’s Disease based on their vector delivery platform, LentiVector.

Axovant is currently conducting a Phase II trial with AXO-Lenti-PD. Dosing of all patients in the second cohort is completed with 6-month safety and efficacy data expected in the fourth quarter of 2020.

Oxford Biomedic expects to manufacture AXO-Lenti-PD in its commercial-scale GMP manufacturing facilities including Oxbox in the UK, and in the company's other GMP facilities as required to ensure security of supply.

John Dawson, CEO of Oxford Biomedica, said: “We are now at a stage in the partnership where we can determine the manufacturing activities and infrastructure required to support the mid- and late-stage development of AXO-Lenti-PD in a way which is compatible with later commercialisation.”

Pavan Cheruvu, CEO at Axovant Gene Therapies, said that they expect to enroll the first subject in a randomized, sham-controlled trial in 2021.