Agreement will allow Roche to use CEVEC’s unique and proprietary ELEVECTA® Technology for AAV vector manufacturing
Cologne, Germany, November 10, 2020 - CEVEC Pharmaceuticals GmbH (CEVEC) today announced the signing of an option and license agreement with Roche for the use of its newly launched ELEVECTA® Technology for large scale manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications.
Under the terms of the agreement, CEVEC will grant Roche, and Spark Therapeutics, a member of the Roche Group, an option for a non-exclusive license for the development of AAV producer cell lines based on CEVEC’s ELEVECTA® Technology. The partnership will provide Roche the rights to use CEVEC’s technology for their portfolio of gene therapy products. Under the license, CEVEC will be eligible for payments based on achievement of certain milestones for products, as well as royalties on sales of potential products using the technology. Financial details of the agreement were not disclosed.
“We are delighted to partner with Roche with the goal to manufacture AAV vector-based gene therapy programs on a large scale by leveraging our novel ELEVECTA® Technology. This agreement represents a major milestone while highlighting ELEVECTA® as the technology of choice for next generation viral vector manufacturing,” said Dr.Nicole Faust, CEO of CEVEC. “Given the enormous progress of gene therapies, manufacturing technologies must keep up with the needs of the industry in terms of volumes, quality, robustness and ease of use. With ELEVECTA® we are paving the way for many more commercial gene therapy applications in the future.”
“Across the Roche Group, we are always looking for new and innovative technologies that provide clear competitive advantages and add significant value to our portfolio,” said James Sabry, Head of Roche Pharma Partnering. “We are excited to use CEVEC’s ELEVECTA®Technology for potential large-scale production of gene therapies and providing them to patients in need.”
The ELEVECTA® Technology is a new technology platform developed and marketed 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. No transient transfection is needed for production, enabling low batch-to-batch variations and superior vector quality. The technology is fully compatible with standard processes and methods for purification and analysis. Custom-made ELEVECTA® 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 overcomes the limitations of current manufacturing methods with its superior scalability, process stability and product quality.
About AAV Gene Therapy Vectors
AAVs are the most common vectors in gene therapy as they provide significant advantages over other vectors. AAV is non-pathogenic, replication-defective and, as the AAV-derived vectors depend on additional functions for replication, safer than other vectors. In addition, AAVs exist in many serotypes or capsid types, varying in their surface properties and tissue selectivity. For gene therapy applications, AAV capsids can further be engineered to improve their tissue-specificity. AAV gene therapy vectors are robust and stable, easy to purify and storage-stable. Therefore, the majority of new gene therapy programs are now using AAV vectors.
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 viralvectors (AAV, Adeno, Oncolytic viruses) and complex recombinant proteins.
With ELEVECTA® CEVEC has developed the first stable AAV Producer Cell Line Technology which stably incorporates all elements required for AAV production into the genome of one producer cell. CEVEC’s CAP® Technology based on human suspension cells is the ideal production platform for RCA-free adenoviral vectors, oncolytic viruses,viral vaccines and exosomes. With CAP®Go CEVEC provides asolution to the increasing need for recombinant production of complex andhighly glycosylated protein molecules, including laminins, coagulation factors,and plasma proteins.
For more information, please visit www.cevec.com
CEVEC Pharmaceuticals GmbH
Dr. Ulrich Kettling
Chief Business Officer
T.:+49 221 46020800
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