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.
Oxford Biomedica has signed a 3-year clinical supply agreement (CSA) with a wholly-owned subsidiary of Axovant Gene Therapies.
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.
Related News
-
News Pharmapack Awards 2024 Patient-Centric Design Award Winner – Dr Ferrer BioPharma
The 2024 Pharmapack Awards celebrated the best in innovation and design for the pharmaceutical packaging and drug delivery industry on January 24, 2024. -
News Women in Pharma: Minding the Gap at Pharmapack 2024
2024 marks the first year Pharmapack will host a Diversity track dedicated to bridging the gap within the pharmaceutical packaging and drug delivery sector. The track includes a panel discussion on 'Enabling Diversity in the Workplace,' focused... -
News Pharmapack Awards 2024 - Celebrating Packaging and Drug Delivery Innovation
The 2024 Pharmapack Innovation Awards ceremony celebrated the best in pharmaceutical packaging and drug delivery innovation at all levels. The awards were held on January 24, 2024 at the Paris Expo Porte de Versailles. -
News 2024 Pharma Industry Trends Outlook: Collaboration, Market Maturity, and Digital Futures
The annual CPHI Online 2024 Pharma Trends Outlook, in partnership with Arvato Systems, identifies 12 key industry trends shaping the life sciences industry in the coming year. -
News New Novo Nordisk AI hub for drug discovery to open in London, UK
Danish pharmaceutical giant Novo Nordisk will be opening an AI-based research facility in the heart of London to advance drug discovery operations. -
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Women in Pharma: Looking back on 2023 and moving forward to 2024
In this monthly series, we interview women from across the pharmaceutical industry and supply chain to discuss the importance of gender diversity in healthcare, the workplace, and beyond. -
News CPHI Barcelona 2023: Partnering for Success – Managing Outsourcing Relationships to Optimise Manufacturing Operations
During CPHI Barcelona 2023, insightful content sessions offered attendees the chance to explore trending topics with expert speakers and panellists. Here, we summarise what the pharma industry and supply chain are talking about the most.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance