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(R)GT Technology
Collaboration is next step in setting CAP(R)GT as global standard in adenoviral gene therapy
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(R)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(R)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(R)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(R)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(R)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(R)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(R)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(R)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.”
CEVEC is a center of expertise for the production of biopharmaceuticals using a unique human cell-based expression system.
CAP(R)GT is a regulatory endorsed expression platform for scalable viral vector production. CEVEC has successfully developed CAP(R)GT suspension cell-derived viral packaging and producer cell lines which enable better scale-up and competitive production costs when compared to adherent cell culture systems. CAP(R)GT suspension cell lines grow to high cell densities and show a broad viral propagation spectrum. Gene therapy vectors such as lentivirus (LV), adenovirus (AV) and adeno-associated virus (AAV) can be produced at industrial scale.
For more information, please visit www.cevec.com.
Follow CEVEC on LinkedIn.
About Provecs Medical:
Provecs Medical is a privately owned biopharmaceutical company founded in 2007 as a spin-out of the University-Medical Center Hamburg-Eppendorf in Hamburg, Germany. Provecs Medical specializes in the development and licensing of a novel class of immunotherapeutics for cancer immunotherapy. Provecs’ lead program termed Immunalon(R) addresses three activating checkpoints in the tumor microenvironment to activate a strong anti-tumor immune response. Provecs runs comprehensive big data technology, bioinformatics and immunology on its human tumor tissue testing platform termed EXVIRO.
For more information, please visit www.provecs.com.
medac Gesellschaft fuer klinische Spezialpraeparate GmbH is a privately owned, global pharmaceutical company specialized in the development, manufacturing and marketing of highly-effective therapeutic and innovative diagnostic products in core areas including oncology, urological and autoimmune diseases. Beside an already established product portfolio, medac is dedicated to the refining of existing and the development of new therapeutic products providing patients with groundbreaking individualized treatments. Founded in 1970, medac today employs 1.000 people in its headquarters in Wedel near Hamburg, Germany.
For more information, please visit www.medac.de
CEVEC Pharmaceuticals GmbH
Dr. Nico Scheer
Chief Business Officer
T.:+49 221 46020800