SK Bioscience to start Covid-19 vaccine clinical trials

[SK BIOSCIENCE]

SK Bioscience’s Covid-19 vaccine candidate NBP2001 has received permission to begin Phase 1 clinical trials, the company said Tuesday.

Following the approval from Korea’s Ministry of Food and Drug Safety, Phase 1 trials will be conducted on healthy adults to verify safety and observe immune responses to the vaccine.

SK will start planning Phase 2 clinical trials at the same time as starting Phase 1 tests, the company said in a statement.

A vaccine affiliate under SK Chemicals, SK Bioscience was one of the three companies selected in August to receive government funding to support developing a coronavirus vaccine. It is also the contract manufacturing partner to British biopharmaceutical firm AstraZeneca and U.S. Novavax for Covid-19 vaccine candidates.

SK Bioscience’s NBP2001 is a recombinant vaccine that uses protein antigens. It is the result of recombinant DNA technology which involves inserting the antigen onto the surface of a protein. Inside the body, that antigen stimulates an immune response that would create antibodies to fight off the virus in case of infection.

U.S. pharmaceutical company Novavax is also developing a similar recombinant vaccine. Its vaccine candidate NVX-CoV2373 is undergoing Phase 3 clinical trials in Britain, the United States and Mexico.

“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 Ahn Jae-yong in a Tuesday statement.

SK Bioscience’s NBP2001 is the third coronavirus vaccine candidate to receive approval for clinical trials from local authorities. Inovio’s INO-4800 and Genexine’s GX-19 both received the nod for Phase 1 and 2a trials in June. NBP2001 is the only recombinant drug among the three, with the other two being DNA vaccines.

Through preclinical trials conducted on monkeys, SK said it found that NBP2001 induced 10 times more antibodies than existed in blood recovered from coronavirus patients. The candidate was also effective in preventing the virus spreading in the lungs and throat, it added, as opposed to the placebo group that was 100 percent infected by the coronavirus after injection.

Along with SK’s NBP2001, the Ministry of Food and Drug Safety also gave the green light to Phase 2 clinical trials for Dong Wha Pharm’s Covid-19 treatment candidate, DW2008S. Originally developed as an asthma treatment, DW2008S has already been through Phase 1 clinical trials and is already undergoing Phase 2 clinical trials as a drug for asthma.

As of Tuesday, the Korean government has granted clinical trials for 30 coronavirus-related projects, among which 27 are treatments and three are vaccines.

BY SONG KYOUNG-SON [song.kyoungson@joongang.co.kr]