- SK bioscience signs an agreement with Novavax to manufacture and supply COVID-19 vaccines globally under the support of CEPI

SK bioscience announced on the 13th that the company has signed a CDMO (contract development and manufacturing organization) agreement with Novavax, a U.S. biotechnology company specializing in next-generation vaccines, for the development, production, and global supply of the antigen ‘NVX-CoV2373,’ a COVID-19 vaccine candidate.

Under the CDMO contract, Novavax’s antigen manufacturing technologies will be transferred to SK bioscience, where further developments will be made and added for the production of the COVID-19 vaccine candidate NVX-CoV2373. The antigen will undergo manufacturing at the vaccine manufacturing plant in Andong, L HOUSE.

On the 13th, SK bioscience and Novavax signed a trilateral letter of intent(LOI) with the Ministry of Health and Welfare at the SK bioscience R&D Center, agreeing to cooperate in the △effort to improve both domestic and global health by ensuring the quick and stable production and △fair distribution of NVX-CoV2373.

Attending the signing ceremony were Neung-hoo Park, the Minister of Health and Welfare, Andrey Chey, Vice Chairman of SK discovery, Jaeyong Ahn, CEO of SK bioscience, and via video conference, Stanley Erck, CEO of Novavax.

NVX-CoV2373 takes the COVID-19 spike protein expressed in the cells of insects and utilizes recombinant technology to convert into nanoparticles, and combined with Novavax’s proprietary adjuvant ‘Matrix-M,’ it has shown to possess superior immunogenicity and excellent formation of neutralizing antibodies. NVX-CoV2373 is currently undergoing Phase II clinical trials, with plans to enter Phase III clinical trials as early as October.

In the first phase of clinical trials revealed by Novavax on the 4th, all 131 healthy adults who had received two injections of NVX-CoV2373 were immunized from the disease. Neutralizing antibodies necessary for immunity were detected and antigen concentrations were significantly higher than those shown from blood samples of recovering COVID-19 patients.

Under this agreement, SK biosciences, having both the synthetic antibody technologies used for the creation NVX-CoV2373 and the manufacturing capacities for cell culture, will begin the process of its development and production in the L HOUSE, a vaccine plant located in Andong.

SK bioscience has also signed a Capacity Reservation contract with the Coalition for Epidemic Preparedness Innovations (CEPI), delegating a portion of the production facilities in L HOUSE to companies supported by CEPI for the production of COVID-19 vaccines. CEPI is an international organization launched at the Davos Forum in 2017 with the mission of countering new infectious diseases, more recently taking the lead in the development of safe and effective COVID-19 vaccines as well as their equal distribution globally.

Novavax is a pharmaceutical company which has acquired a 388 million USD deal from CEPI in R&D support for the quick development and production of NVX-CoV2373. SK biosciences will be utilizing a segment of the manufacturing facilities under the CDMO contract with CEPI.

SK bioscience has tripled its annual L HOUSE production of 150 million doses through its advancement in the CMO and CDMO businesses, securing a contract to manage the production of a COVID-19 vaccine candidate developed by AstraZeneca and Oxford University in the UK.

Stanley Erck, CEO of Novavax said “We are pleased with our partnership with SK bioscience to keep our promise of supplying NVX-CoV2373 to the world, SK bioscience will be sharing our commitment to giving the world access to the COVID-19 vaccine without discrimination.”

Jaeyong Ahn, CEO of SK bioscience, “Not only global companies are paying attention to our technological capacity, but so is CEPI, a leading international player in the development and distribution of COVID-19 vaccines. As a Korean company, we will do our best to keep pace with the government´s two-track strategy of domestic development and foreign import.”

Separately, SK bioscience is developing its own COVID-19 vaccine.

Last March, SK bioscience successfully conceived a candidate substance for the COVID-19 vaccine in March, which is currently undergoing preclinical trials.

With support from the Bill & Melinda Gates Foundation, the company is also working to develop more COVID-19 vaccine candidates to find the most suitable antigens, and move them into clinical trials.