ROKOTE Laboratories licenses CEVEC’s CAP® Ad Technology for vaccine manufacturing

• ROKOTE Laboratories Finland Ltd to use CEVEC’s CAP® Ad viral vector technology for manufacturing therapeutic and prophylactic vaccines for COVID-19 and other respiratory diseases
• By eliminating the risk of RCA contaminations, CAP® Ad-derived viral vectors provide highest safety, addressing one of the major challenges in vector-based vaccine production

Cologne, Germany and Helsinki and Kuopio, Finland – September 20, 2022

CEVEC Pharmaceuticals GmbH (CEVEC) and ROKOTE Laboratories Finland Ltd today announced the signing of an agreement on the use of CEVEC’s proprietary CAP® Ad Technology for the manufacturing of vaccines in various indications.

Under the agreement, CEVEC has granted ROKOTE Laboratories Finland Ltd non-exclusive rights to use the CAP® Ad platform for the manufacturing of adeno-based vaccines for prophylactic and therapeutic use in infectious diseases such as COVID-19, influenza and RSV infections. CEVEC in return is eligible to receive license fees, milestone payments, and royalties on net sales. Further financial details were not disclosed.

“We are very pleased that ROKOTE Laboratories Finland Ltd will build on the CAP® Ad Technology and we are proud that we can contribute to combating the ongoing COVID-19 pandemic with a technology that makes a real difference in vaccine safety,” said Dr. Nicole Faust, Chief Executive Officer of CEVEC. “The quality and safety of vaccines is crucial, given the fact that they are administered prophylactically. Our CAP® Ad Technology ensures that the risk of potential adverse effects due to contaminating replication-competent adenovirus is as low as possible.”

“Ease of scalability, high production yields, and most importantly, elimination of the risk of RCA contamination were key points why we chose CEVEC’s CAP® Ad Technology for our adenovirus vector-based large-scale vaccine production,” said Dr. Erkko Ylösmäki, Director, Research and Development of ROKOTE Laboratories Finland. “This technology allows us to rapidly address the global need for a safe and easy-to-administer variant-proof COVID-19 intranasal vaccine that can not only prevent the disease but can also prevent those vaccinated from further transmitting the SARS-CoV-2 virus.”

About CAP® Ad Technology

The CAP® Ad Technology is an innovative technology platform developed by CEVEC for the scalable production of RCA-free adenoviral vectors for gene therapy applications and vaccines.

Recombinant adenoviral vectors 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 adenoviral vectors have the inherent risk of generating certain levels of replication-competent adenovirus (RCA). The presence of RCA in adenoviral vector preparations 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 RCA.

CEVEC’s CAP® cell line is based on an engineered human suspension cell line of non-tumor origin, derived from human amniocytes. CAP® cells can be grown in all formats and sizes of bioreactors, providing a robust, fully scalable production platform for the manufacturing of adenoviral vectors from research grade and smaller amounts up to industrial scales. The CAP® cell line has been fully documented and was positively reviewed by various regulatory authorities. Since 2016, a Biologics Master File has been available for reference with the U.S. FDA and fully tested GMP cell banks are available for licensing.

About CEVEC

CEVEC is a leading provider of high-performance cell technology for the manufacturing of advanced biotherapeutics.

With the ELEVECTA® Technology, CEVEC offers a unique solution for large-scale production of AAV vectors using helper virus-free inducible 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 or cGMP-grade plasmids. CEVEC’s CAP® Ad Technology is the ideal production platform for RCA-free adenoviral vectors. Based on human suspension cells, it allows for a robust manufacturing process, easy scale-up from research grade to industrial volumes and thus opens the way for various applications, from gene therapy to vaccine production.

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About ROKOTE Laboratories Finland Ltd

ROKOTE Laboratories Finland Ltd is a Finnish vaccine development company established in 2020 and located in Helsinki and Kuopio. The Company's operations were founded on research cooperation based on the competence of the University of Helsinki and the University of Eastern Finland. In 2021, ROKOTE Laboratories Finland Ltd received EUR 9 million in funding (Ferring Ventures SA, Jenny and Antti Wihuri Fund, Finnish Cultural Fund, and Business Finland) for the development, manufacture, and implementation of FINCoVac coronavirus vaccine, as well as for the first and second phases of clinical trials.

Website: www.rokote.com

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