CEVEC Pharmaceuticals GmbH announced the signing of an agreement with UCB S.A. on the evaluation and use of CEVEC’s proprietary ELEVECTA® Technology for the research, development, and manufacturing of Adeno-Associated Virus (AAV) vectors for gene therapy applications.
According to the agreement, CEVEC grants UCB non-exclusive rights for research and development using ELEVECTA® producer cell lines for specific transgenes selected by UCB. The agreement also grants UCB options to obtain licenses for use of the ELEVECTA® producer cell lines in commercial manufacturing of potential AAV gene therapy products, and for the internal use of the ELEVECTA® Technology at UCB to generate new producer cell lines. Under the terms of the license, CEVEC is eligible for license fees, clinical and regulatory milestone payments, as well as royalties on potential future net sales. Financial details of the agreement were not disclosed.
“We are very pleased to have UCB embarking on the ELEVECTA® Technology enabling them to use the platform for scalable, robust and efficient manufacturing of gene therapy vectors,” said Dr. Nicole Faust, Chief Executive Officer of CEVEC. “This license agreement represents a further step towards establishing ELEVECTA® as the future AAV manufacturing standard. With more and more gene therapies in development, we see an increasing need in the industry for scalable manufacturing technologies to enable production of AAV vectors at large scale.”
The ELEVECTA® Technology is an innovative technology platform developed by CEVEC for the production of AAV gene therapy vectors. The technology is based on stable, helper virus-free producer cell lines which have all functions required for AAV production stably integrated into the genome of a producer cell, including the capsid and the transgene. Unlike other technologies, neither transient transfection nor helper virus is needed for production, enabling low batch-to-batch variations. ELEVECTA® is fully compatible with standard processes and methods for purification and analysis. Custom-made producer cell lines can serve as research cell banks or as fully tested cGMP Master Cell Banks for manufacturing of clinical and commercial material. The technology is patent protected by CEVEC and is designed to overcome the limitations of current manufacturing methods.
CEVEC is a leading provider of high-performance cell technology for the manufacturing of advanced biotherapeutics from R&D to manufacturing scale. The company’s product portfolio comprises platform technologies for gene therapy viral vectors, vaccines and complex recombinant proteins. With the ELEVECTA® Technology, CEVEC offers a unique solution for large-scale production of AAV vectors using helper virus-free producer cell lines with all necessary components stably integrated into the cell. The technology is based on suspension cells and does not require any expensive transfection reagents and cGMP plasmids. CEVEC’s CAP® Technology based on human suspension cells is the ideal production platform for RCA-free Adenoviral vectors, Lentiviral vectors, viral vaccines and exosomes. With the CAP-Go® Technology CEVEC provides a solution to the increasing need for recombinant production of complex and highly glycosylated protein molecules, including laminins, coagulation factors and plasma proteins.