SK Bioscience Begins Phase 1 Clinical Trial for COVID-19 Vaccine

[Asia Economy Reporter Cho Hyun-ui] SK Bioscience announced on the 24th that it has received approval from the Ministry of Food and Drug Safety for the clinical trial plan (IND) of its COVID-19 vaccine candidate 'NBP2001' and will immediately begin clinical trials.

The clinical trial will be conducted on healthy adults at Seoul National University Hospital and Bundang Seoul National University Hospital. It will focus on evaluating in vivo safety and immunogenicity.

Previously, SK Bioscience induced neutralizing antibodies approximately 10 times higher than those in the serum of recovered COVID-19 patients in efficacy tests on primates. When the COVID-19 virus was directly administered to primates, virus replication in the respiratory tract was blocked compared to the placebo group, and safety was confirmed in preclinical toxicity tests on rodents.

SK Bioscience stated, "Since NBP2001 is a stabilized synthetic antigen vaccine produced through protein culture and purification processes, we expect to secure high safety." They added, "Once development is completed, it can be mass-produced at the L House of the Andong vaccine factory."

SK Bioscience has also succeeded in developing a cervical cancer vaccine candidate using the same synthetic antigen method, completed phase 2 clinical trials, and is preparing to enter global phase 3 clinical trials next year.

Jaeyong Ahn, CEO of SK Bioscience, said, "Our goal is to develop a COVID-19 vaccine with confirmed safety and efficacy, even if it is somewhat later than global vaccines," adding, "We are increasing the chances of success with full government support."

In addition to NBP2001, SK Bioscience is conducting preclinical trials for an additional COVID-19 vaccine 'GBP510' supported by the Bill & Melinda Gates Foundation since May. The company aims to enter clinical trials within this year. In July, it signed a contract to manufacture the bulk and finished products of a COVID-19 vaccine candidate developed by AstraZeneca and the University of Oxford, which is in phase 3 clinical trials, as a contract manufacturing organization (CMO).

In August, under a facility use agreement with the international private organization CEPI (Coalition for Epidemic Preparedness Innovations), SK Bioscience signed a contract development and manufacturing organization (CDMO) agreement with the U.S. biotech company Novavax for antigen development, production, and global supply of the COVID-19 vaccine candidate, and began process development and bulk production.