The UK-based cell and gene therapy CDMO eXmoor Pharma has entered into a strategic partnership with Belgium's KU Leuven to accelerate the development of adeno-associated virus (AAV) gene therapies. The collaboration will support a newly established cell and gene therapy hub created by KU Leuven and university hospitals Leuven (UZ Leuven) as a translational vehicle for their most promising gene therapy assets.
The partnership brings together complementary capabilities: KU Leuven's academic innovation and scientific expertise with eXmoor's regulatory knowledge and manufacturing infrastructure. This integration aims to streamline the path from laboratory discovery to first-in-human clinical trials for advanced cell and gene therapies.
Strategic Focus on AAV Technology
A central element of the collaboration is the development of AAV gene therapy programs utilizing intellectual property from KU Leuven. The university's Trellis Research Group, led by Principal Investigator Els Henckaerts, will serve as the AAV innovation partner, providing scientific leadership in vector development.
"Over the years, our lab has worked tirelessly to bridge the gap between academic innovation and real-world therapeutic applications," said Henckaerts. "This partnership represents the final critical step in our mission to streamline the path from discovery to clinical impact, ensuring that our advanced AAV vector technologies can reach patients more efficiently and effectively."
Four Key Collaboration Areas
The partnership encompasses four strategic areas designed to overcome common bottlenecks in gene therapy development:
Joint AAV Cell Line Development
eXmoor and the Trellis Research Group will co-develop a proprietary AAV producer cell line, which will be jointly owned and deployed for both KU Leuven and eXmoor clients. This initiative addresses one of the most significant challenges in gene therapy manufacturing: creating scalable and cost-effective vector production systems.
Strategic CMC Consultancy
eXmoor will function as the venture's in-house Chemistry, Manufacturing, and Controls (CMC) partner. This role includes asset assessment through eXmoor's proprietary Health Check Questionnaire, regulatory and manufacturing strategy development, and cost of goods analysis. The company's integrated consultancy team will support all translational and technical planning activities, ensuring early scientific decisions align with future Good Manufacturing Practice (GMP) requirements.
AAV Platform Process Development
The partners will collaborate to build a scalable AAV platform process incorporating KU Leuven's licensed intellectual property. Quality and regulatory elements will be embedded from the beginning, enabling eXmoor to manage process development, manufacturing science and technology (MSAT), technology transfer, and GMP production from its UK-based facility.
Process Development and GMP Manufacturing Support
eXmoor will provide the new hub with process development expertise and GMP manufacturing capabilities, ensuring access to the technical infrastructure needed as programs advance toward clinical trials.
Industry Impact and Patient Benefits
Angela Osborne, CEO of eXmoor Pharma, emphasized the transformative potential of the partnership: "By uniting KU Leuven's academic leadership, Trellis' scientific innovation and eXmoor's development and manufacturing expertise, we are creating a launchpad for next-generation therapies. Our aim is to give this new cell and gene therapy hub the best possible start by aligning strategy, science and scalability from day one."
The collaboration addresses several persistent challenges in the gene therapy field, including manufacturing scalability, regulatory complexity, and the translation gap between academic innovation and clinical application. By combining KU Leuven's research excellence with eXmoor's regulatory and manufacturing expertise, the partnership aims to accelerate promising therapies from the laboratory to early clinical trials with greater speed, rigor, and efficiency.
For patients awaiting gene therapies for rare and serious conditions, this partnership represents a potential acceleration in the development timeline, potentially bringing innovative treatments to the clinic more rapidly while maintaining scientific rigor and manufacturing quality.
Market Context
The partnership comes at a critical time for the gene therapy sector, which has seen significant investment but also faces challenges in manufacturing scale-up and cost control. AAV vectors remain one of the most promising delivery systems for gene therapies, with several AAV-based products already approved by regulatory agencies worldwide.
The collaboration between eXmoor and KU Leuven exemplifies a growing trend of strategic partnerships between academic institutions and specialized CDMOs to bridge the "valley of death" that often prevents promising academic discoveries from reaching clinical development.
By establishing this comprehensive partnership model, eXmoor and KU Leuven are positioning themselves at the forefront of efforts to make gene therapy development more efficient, cost-effective, and ultimately more accessible to patients with unmet medical needs.
