Yposkesi enters into agreement for strategic partnership to expand Axovant gene therapy manufacturing capacity
In the framework of a preferred partnership, Yposkesi plans to grant Axovant access to dedicated cGMP capacity and manufacturing resources to further support the global development and commercialization of Axovant’s AAV-based gene therapy programs.
Corbeil-Essonnes, France, November 28, 2018 – Yposkesi, a leading CDMO for gene therapy viral vector manufacturing, today announces an agreement in principle governing the terms of a strategic partnership with Axovant Sciences, a company developing innovative gene therapies for neurologic and neuromuscular diseases. Upon execution of the definitive agreement, the partnership would grant Axovant reserved capacity for cGMP-grade Adeno-Associated Virus (AAV) production. It will provide dedicated suite space with ongoing prioritized access to manufacturing resources for Axovant’s AAV-based gene therapy programs through development and commercialization.
Yposkesi brings to the partnership extensive gene therapy manufacturing capabilities for AAV and lentiviral vector production. This includes its current 50,000 ft2 (approx. 5,000 m2) state-of-the-art facility, housing multiple independent manufacturing suites for bulk drug substance and fill and finish, and the company’s’ expertise in vector development and manufacturing. As a spin-off of the gene therapy pioneer Genethon, Yposkesi benefits from Genethon’s 25 years of experience in the field. Axovant will have access to Yposkesi’s manufacturing processes, complying with both European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) manufacturing requirements for phase I-III clinical trials. By 2019 Yposkesi will extend its capacity to further support commercial production, and by 2021 will increase its global footprint to 100,000 ft2 (approx. 10,000 m2).
In addition to the dedicated cGMP production capacity, the long-term, strategic collaboration between Yposkesi and Axovant would provide dedicated expertise in process development, technology transfer, manufacturing scale up, quality control and assurance.
“We are very pleased to partner with Axovant to support the manufacture and delivery of its innovative gene therapies on a large scale,” said Alain Lamproye, CEO of Yposkesi. “Leaders in gene therapy, such as Axovant, are drawn to our state-of-the-art facilities, robust manufacturing capacity and years of expertise in producing cGMP-grade material. We look forward to contributing to advancing Axovant’s innovative and robust gene therapy pipeline.”