- The result of preclinical trial of a recombinant protein-based vaccine candidate, ‘NBP2001,’ is confirmed its safety and immune response against SARS CoV-2

- The IND approval was based on acceptable nonclinical trial results. SK bioscience plans to quickly verify its safety and efficacy

SK bioscience announced on the 24th that the company’s COVID-19 vaccine candidate ‘NBP2001’ has obtained a final approval from the Ministry of Food and Drug Safety(KMFDS) for an Investigational New Drug(IND) Phase I clinical trial.

NBP2001 will enter clinical trials immediately upon the IND approval under acceptable safety and efficacy results in preclinical trial.

Last August, SK bioscience cooperated with Dr. Jeong-Ju Hong’s research team at the Korea Research Institute of Bioscience & Biotechnology´s National Primate Research Center, successfully induced 10 times more neutralizing antibodies than what was found in the serum of fully recovered COVID-19 subjects. 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 preclinical 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 preclinical assessments, such results of NBP2001 will be used as a cornerstone for SK bioscience to initiate a Phase I clinical trials while preparing for subsequent clinical trials.

The Phase I clinical trial of NBP2001 will be conducted 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 recombinant protein-based 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 II clinical trials and is expected to enter Phase III clinical trials in the next year.

SK bioscience plans to mass produce NBP2001 L-HOUSE, a vaccine manufacturing plant in Andong.

Jaeyong Ahn, CEO of SK bioscience said, “Our goal is to develop a COVID-19 vaccine that ensures safety and efficacy even if it risks being a little late. We are steadily increasing our chances of success with active support from the pan-government level.”

Separately, SK bioscience is also conducting preclinical trials of another COVID-19 vaccine candidate, ‘GBP510,’ with support from the Bill & Melinda Gates Foundation. Clinical trials are expected to be initiated in this year.

In July, SK bioscience signed a CMO agreement of drug substance and drug product of a COVID-19 vaccine candidate developed by AstraZeneca and Oxford University which currently is in Phase 3 clinical trials. In August, SK bioscience signed a CDMO agreement with Novavax for global supply of ‘NVX-CoV2373,’ a COVID-19 vaccine candidate, beginning its manufacturing and development according to the manufacturing capacity reservation contract with the Coalition for Epidemic Preparedness Innovations(CEPI).