-Synthetic antigen vaccine “NBP2001,” non-clinical trials confirm safety and robust immune response
to SARS CoV-2 virus
-IND approval based on excellent nonclinical trial results. Will quickly verify in vivo safety and efficacy

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

SK bioscience’s COVID-19 vaccine is ready to enter clinical trials.

SK bioscience (CEO Jae-Yong Ahn) announced on the 24th that the vaccine candidate “NBP2001” has obtained final approval from the Ministry of Food and Drug Safety for Phase 1 clinical trials as an Investigational New Drug (IND).

SK bioscience’s “NBP2001” will enter clinical trials immediately upon IND approval, having outperformed expectations in nonclinical trials confirming its safety and efficacy.

This past August, SK bioscience teamed up with Dr. Hong Jeong Ju’s research team at the Korea Research Institute of Bioscience & Biotechnology’s National Primate Research Center, successfully inducing ten times the amount of neutralizing antibodies found in a fully recovered COVID-19 patient, in an efficacy trial for “NBP2001” targeting primates. For primates in the control group, direct administration of COVID-19 resulted in 100% infection, while primates with the neutralizing antibodies induced by “NBP2001” demonstrated the ability to prevent the virus from spreading to the lungs and respiratory system.

The safety of “NBP2001” had already been confirmed by SK bioscience in a nonclinical toxicity trial for rodents. In addition, an animal efficacy test by a team led by Professor Jae-Hwan Nam of Catholic University and a team led by Professor Sang-Myung Lee of Chungbuk National University confirmed the vaccine candidate’s immunogenicity, neutralizing antibody production abilities, and immune response against COVID-19.

Having undergone numerous nonclinical assessments, such impressive results of “NBP2001” will be used as a cornerstone for SK bioscience to initiate Phase 1 clinical trials – as soon as possible – while preparing for subsequent clinical trials.

Phase 1 clinical trials of “NBP2001” will be carried out on healthy adults at Seoul National University Hospital and Bundang Seoul National University Hospital, focusing on assessment of in vivo safety and immunogenicity.

SK bioscience expects an advantage in securing high safety since “NBP2001” is a synthetic antigen vaccine stabilized through protein culture and purification.

SK bioscience has already succeeded in developing a cervical cancer vaccine candidate using the same synthetic antigen method. The vaccine candidate has completed Phase 2 clinical trials and is expected to enter Global Phase 3 clinical trials next year.

As soon as development is complete, “NBP2001” will immediately enter mass production at the L-House in Andong—a vaccine manufacturing plant that boasts the world’s top facilities and scale of production. This is considered one of the factors that will contribute to the success of “NBP2001.”

“Our goal is not to be the world’s first, but to develop a COVID-19 vaccine that ensures safety and efficacy even if it risks being a little late,” said SK bioscience CEO Jae-Yong Ahn, “We are steadily increasing our chances of success with active support from the pan-government level.”

In the current battle against the COVID-19 pandemic, SK bioscience is strengthening its position as a global vaccine company.

In addition to “NBP2001,” SK bioscience is conducting nonclinical trials of another COVID-19 vaccine candidate, “GBP510,” with support from the Bill & Melinda Gates Foundation in May. Clinical trials are scheduled to get underway this year.

In July, SK bioscience signed a CMO agreement to consign an undiluted solution and final product of a COVID-19 vaccine candidate developed by AstraZeneca and Oxford University which is in Phase 3 clinical trials. In August, SK bioscience signed a CDMO agreement with Novavax, a U.S. biotechnology company for the development, production, and global supply of the antigen “NVX-CoV2373,” a COVID-19 vaccine candidate, beginning its production and development according to the manufacturing capacity reservation contract with international private organization CEPI (Coalition for Epidemic Preparedness Innovations).

SK bioscience plans to expand cooperation with global public-private organizations based on its core competencies established in the entire vaccine business process, including development, production, and commercialization. In particular, SK bioscience plans to actively respond to the increasing global vaccine demand and intensifying competition for development among individual countries due to COVID-19, and will further strengthen efforts to expand new businesses such as △Securing full-scale overseas operations △ Strengthening R&D pipelines △ Expanding business models.