보도일시: 2020. 10. 20.(화)
CEVEC AND RZNOMICS SIGN LICENSE AGREEMENT
FOR THE USE OF CAP® TECHNOLOGY IN MANUFACTURING OF ADENOVIRAL VECTORS
* Rznomics will use the technology for gene therapies based on their proprietary trans-splicing ribozyme technology targeting various cancer indications
* CEVEC’s unique CAP® cell line enables by design the efficient production of high-quality adenoviral vectors
CEVEC Pharmaceuticals GmbH (CEVEC) and Rznomics Inc. (Rznomics) today announced the signing of a clinical and commercial license agreement for the use of CEVEC’s proprietary CAP® Technology for the manufacturing of adenoviruses for gene therapy applications. Under the terms of the agreement, Rznomics will use CEVEC’s cell line technology in combination with Rznomics’ proprietary trans-splicing ribozyme technology for manufacturing of gene therapies targeting various cancer indications. Financial details of the agreement were not disclosed.
“We are delighted about the agreement with Rznomics that again demonstrates the potential of our CAP® technology for adenoviral vector-based gene therapies. In addition, it marks a next step in our geographic reach”, said Dr. Nicole Faust, CEO of CEVEC. “With our unique cell line technology, we are addressing one of the major challenges in the manufacturing of adenoviral vectors, the elimination of RCAs. We very much look forward to working with Rznomics and support them in their development of gene therapy programs through clinical development and to the market.”
“We are excited about the partnership with CEVEC,” said Seong-Wook Lee, Ph.D., CEO of Rznomics. “We strongly believe that establishing an efficient, reliable and robust production process helps to accelerate clinical development at later stages. The advantages of the CAP® Cell Line in terms of safety and scale up convinced us to select it as the technology of choice for the production of our adenoviral vector-based gene therapy portfolio.”
About CAP® Technology – Cell lines specifically designed for scalable, RCA-free AV-production
CEVEC’s CAP® cell line is based on an engineered human suspension cell line of non-tumor origin, derived from human amniocyte cells. CAP® cells can be grown in all formats and all sizes of bioreactors providing a robust, fully scalable production platform for the manufacturing of AV vectors from research grade and smaller amounts up to industrial volumes. The CAP® cell line is fully documented and reviewed by regulatory authorities. Since 2016, a Biologics Master File (BMP) is available for reference with the US FDA. GMP Master Cell Banks are available and ready for licensing.
RCA-free adenoviral vectors – One of the biggest challenges in vector manufacturing
Recombinant adenoviral vectors (AVs) are among the most efficient vectors for gene therapy purposes and have become the vehicle of choice in many human gene therapies. Today, many cell lines used for production of AVs generate certain levels of replication-competent adenovirus (RCAs). The presence of RCAs in AV preparations which are intended for use in humans is increasingly considered to be a potential risk, especially for immuno-compromised patients. The CAP® cell line is specifically designed to avoid the production of RCAs.
CEVEC is a leading provider of high-performance cell technology for the manufacturing of advanced bio-therapeutics from R&D to manufacturing scale. The company’s product portfolio comprises platform technologies for gene therapy viral vectors and complex recombinant proteins. 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 ELEVECTA® CEVEC has developed the first stable AAV Producer Cell Line Technology which stably incorporates the sequences of the serotype-specific capsid and the gene of interest into the genome of the cell. The helper virus-free platform based on suspension cells delivers a consistent quality of AAV vectors over time through the elimination of any transfection step. With CAP® Go 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.
For more information, please visit www.cevec.com or follow CEVEC on LinkedIn
Rznomics is a biopharmaceutical company founded in 2017 dedicated to the development of gene therapies for cancers, degenerative diseases, and genetic diseases based on cutting-edge RNA technology. Core platform technology of Rznomics is based on RNA replacement enzyme called ‘trans-splicing ribozyme’, which can edit target RNAs via simultaneous destruction and repair (and/or reprograming) to yield the desired therapeutic RNAs, thus selectively inducing therapeutic gene activity in cells expressing the target RNAs. Rznomics has developed and optimized the ribozymes to be applied as therapeutics for intractable human disease by developing them to have high target specificity and efficacy, target accuracy and minimal off-target ability. Rznomics has established pipelines targeting indications with high unmet medical demand for which the unique properties of the ribozymes can be the most competitive. The leading candidate is treatment for hepatocellular carcinoma, and treatments for glioblastoma, Alzheimer’s disease and hereditary retinal dystrophy are also under development. For more information, please visit www.rznomics.com
CEVEC Pharmaceuticals GmbH
Dr. Ulrich Kettling
Chief Business Officer
T.:+49 221 46020800
Chief Development Officer
T.: +82 31 8018 8730
MC Services AG
Dr. Solveigh Mähler
T.: +49 211 52925219