- SK bioscience and the Coalition for Epidemic Preparedness Innovations (CEPI) cooperate in developing a COVID-19 vaccine candidate

- SK bioscience secured 10 million USD in R&D expenses for ‘GBP510,’ a recombinant protein-based COVID-19 vaccine candidate

- SK bioscience submitted an application for Investigational New Drug (IND)of GBP510 to the Ministry of Food and Drug Safety(KMFDS) on the 9th. Once the vaccine candidate is approved, it will be supplied globally through COVAX facility

Photo description: An SK bioscience researcher is conducting R&D for vaccine development.

SK bioscience announced on the 9th that the company’s COVID-19 vaccine candidate, ‘GBP510,’ which is currently under development, was chosen as a first candidate for the ‘Wave 2’ project by the Coalition for Epidemic Preparedness Innovations (CEPI).

Wave2 is a project operated by CEPI to support a group of differentiated COVID-19 vaccine candidates.

The project specifically aims to discover additional vaccine candidates having universal and economic technology that can respond to global demand in terms of storage, administration, productivity, and immune response.

SK bioscience will receive R&D expenses of 10 million USD from CEPI for Phase I/II clinical trials of GBP510.

In addition, GBP510 will be supplied worldwide through the COVAX facility, where more than 180 countries including Korea participate under the leadership of international organizations such as CEPI, Global Alliance for Vaccines and Immunization (GAVI), and World Health Organization (WHO) once the development is completed.

GBP510 is a COVID-19 vaccine candidate that SK bioscience is developing with a grant from the Bill & Melinda Gates Foundation. The candidate is being jointly developed with Institute for Protein Design of the University of Washington School of Medicine. It is characterized by being designed as an antigen with a structure that can maximize the immune effect.

The SK’ bioscience’s gene recombination technology and the University of Washington’s self-assembly nanoparticle design technology were applied to the “receptor-binding protein” (RBD), which is the key to inducing immunity by GBP510.

SK bioscience has confirmed the preventive effect of blocking the proliferation of neutralizing antibodies and viruses through the efficacy testing of GBP510 on rodents’ and primates’ trials, which have entered the final stage of testing.

SK bioscience submitted an application for the investigational new drug (IND) of GBP510 to the KMFDS on the 9th, aiming to initiate clinical trials within this year.

Richard Hatchett, CEO of CEPI said,“We are pleased to have entered into a partnership with SK bioscience to develop the COVID-19 vaccine candidate GBP510. This is our first investment for a Wave2 vaccine, which would be a good option to overcome the COVID-19 through higher accessibility by developing a better form of COVID-19 vaccine.”

Jaeyong Ahn, CEO of SK bioscience said, “Using our differentiated vaccine platform, we are discovering many COVID-19 vaccine candidates which will lead to the development of the best vaccines. Our goal is to create a COVID-19 vaccine with proven safety and effectiveness.”

To secure a COVID-19 vaccine, SK bioscience is developing a variety of vaccines with its own platform technology and adopting a two-track strategy for CMO/CDMO of COVID-19 vaccines developed globally at the same time.

SK bioscience received the approval from the KMFDS on the 23rd of last month for its investigational new drug of ‘NBP2001,’ another COVID-19 vaccine candidate. NBP2001 induced induced 10 times more neutralizing antibodies than what was found in the serum of fully recovered COVID-19 subjects

Also, SK bioscience signed a Capacity Reservation with CEPI in June. SK bioscience’s vaccine plant, L HOUSE will be utilized as manufacturing facilities to produce COVID-19 vaccines for companies supported by CEPI. Through this, in August, the company signed a CDMO agreement with Novavax, a U.S. biotechnology company, for process development, production, and global supply of Novavax’ COVID-19 vaccine candidates.

In July, SK bioscience signed a CMO agreement to produce drug substance and drug product of a COVID-19 vaccine candidate developed by AstraZeneca and Oxford University in the UK which is in Phase III clinical trials.