Saturday, August 01, 2020
Oxford Biomedica plc, a leading gene and cell therapy group, announced that it has signed a three year Clinical Supply Agreement (“CSA”) with a wholly-owned subsidiary of Axovant Gene Therapies Ltd.. 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.
Under the terms of the CSA, 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 Oxford Biomedica’s LentiVector® platform. Axovant is currently conducting a Phase 2 SUNRISE-PD 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. OXB expects to manufacture AXO-Lenti-PD in its commercial-scale GMP manufacturing facilities including Oxbox in the UK, and additionally in other OXB GMP facilities as required to ensure security of supply.
John Dawson, Chief Executive Officer of Oxford Biomedica, said: “This new Agreement builds upon our existing worldwide licensing agreement with Axovant and highlights the strengths of Oxford Biomedica's commercial GMP manufacturing capabilities. We are pleased with how the partnership is progressing and excited by the clinical progress to date. The agreement today signals our commitment to the efficient ongoing development of this much needed product for patients with Parkinson’s disease.
“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 and we look forward to this next phase of our partnership.”
Pavan Cheruvu, Chief Executive Officer at Axovant Gene Therapies, said: “This Agreement with Oxford Biomedica means that together we can continue to advance the development of AXO-Lenti-PD in Parkinson’s disease. We are pleased to extend our partnership with Oxford Biomedica, a world leader in lentiviral vector development and manufacturing, as we scale-up AXO-Lenti-PD production to support our Phase 2 and Phase 3 clinical studies and enable commercialization of the product. This marks another mutual accomplishment for our Parkinson’s disease program where we expect to enroll the first subject in a randomized, sham-controlled trial in 2021.”