- Project will cover the entire process from R&D up to manufacturing and clinical development of adenoviral vectors for medac’s oncology products using CEVEC’s proprietary CAP®GT technology
- Collaboration is next step in setting CAP®GT as global standard in adenoviral gene therapy
Cologne, Wedel and Hamburg, Germany, March 16, 2017 – CEVEC Pharmaceuticals GmbH (CEVEC), the expert in the production of tailor-made recombinant glycoproteins and gene therapy vectors, Provecs Medical GmbH (Provecs), a biopharmaceutical company specialized in the development of cancer microenvironment immunotherapeutics based on adenoviral vector technology , and medac Gesellschaft fuer klinische Spezialpraeparate GmbH (medac), a pharmaceutical company specialized in the diagnosis and treatment of oncological, urological and autoimmune diseases, today announced that the companies have agreed on a broad collaboration for the research, development, manufacture and clinical development of adenoviral vectors for use in oncology indications.
Under the terms of the non-exclusive agreements, CEVEC will grant Provecs a license to further use CEVEC’s proprietary CAP®GT technology for the development and set up of highly efficient, reliable, safe and fully scalable processes for the GMP-compliant production of Provecs’ adenoviral vectors. CEVEC will also license the CAP®GT technology to medac for use in the company’s clinical development, GMP manufacturing and sales of the relevant oncology products. Both companies, Provecs and medac, will perform the CAP®GT-based GMP manufacturing of the adenoviral vectors through a third party. CEVEC will provide regulatory and Chemistry, Manufacturing and Controls (CMC) support to Provecs, medac and the third party GMP-manufacturer.
CEVEC will receive upfront payments, payments for ongoing support, and milestone payments subject to the achievement of pre-defined development and sales targets.
“I am proud that given the excellent results in terms of safety as well as productivity and the easy industrial scale up achieved during three years of intense R&D work, Provecs has now fully implemented our CAP®GT system for the manufacturing of their adenoviral vectors,” Frank Ubags, CEO of CEVEC commented. ”The proven absence of replication-competent adenovirus (RCA), the strong regulatory position based on our FDA Biologics Master File and the consistent and complete documentation of our expression systems are key drivers for CAP®GT to become the world standard for adenoviral vector production.”
Dr. Frank Schnieders, CEO of Provecs, added, ”Already three years ago we opted for CEVEC’s CAP®GT technology as we recognized its outstanding properties even at that early stage. Since then, we successfully further optimized the production process of our adenoviral vectors using the CAP®GT system. Through the combined expertise of medac, CEVEC and ourselves we will be able to move the adenoviral vectors into GMP production in 2017. Based on this positive experience we expect to develop more of these three-party relationships in strong collaboration with CEVEC.”
Nikolaus Graf Stolberg, Managing Director at medac, said, ”Access to Provecs’ adenoviral vector technologies combined with the unique advantages of CEVEC’s CAP®GT expression platform in terms of safety and scalability is an important part of the further development of our portfolio. We are convinced that our research competence and market knowledge will drive the gene therapy concepts developed by Provecs and based on CEVEC technologies to significant market relevance.”
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