SK Bioscience‘s COVID-19 vaccine to begin phase 3 trial

SK Bioscience has been given the green light to proceed with a late stage clinical trial of its COVID-19 vaccine candidate, heightening expectations for a homegrown vaccine becoming available next year.

The Ministry of Food and Drug Safety announced Tuesday that it has given approval to the SK Group company’s plan for the final-stage Phase 3 study of GBP510, based on interim data from the company’s phase 1clinical trial.

Developed in collaboration with the University of Washington Antigen Design Research Institute, GBP510 is a recombinant protein vaccine, as opposed to the messenger RNA types produced by Pfizer and Moderna doses.

The phase 2 clinical trial involving over 240 participants is still ongoing. The firm plans to launch the final stage study next year and produce an interim result during the first quarter of next year, before seeking final approval. It aims for a commercial launch within the first half of 2022.

The drugmaker is the only local company that has received South Korean approval to enter a phase 3 trial.

President Moon Jae-in on Tuesday expressed hopes for the rollout of the country’s first COVID-vaccine, while promising all possible support for local vaccine developers.

“The government will provide full-fledged support to ensure swift and prompt clinical studies,” President Moon was quoted as saying at a meeting arranged by the presidential office.

South Korea has major drug manufacturers who produce COVID-19 vaccines developed by global companies like AstraZeneca. Beyond the position of the region’s vaccine production and distribution hub, it aims to develop its own shots both for local and global consumption.

SK Bioscience’s advancement came as the government said it would lodge a formal complaint to the US vaccine firm Moderna for its repeated delays in shipping COVID-19 shots here, which affected vaccine rollout plans.

The firm’s planned phase 3 study will involve 3,990 participants aged over 18, recruited from countries in Southeast Asia and Eastern Europe, as well as South Korea.

SK Bioscience will recruit 10 percent of clinical study participants in South Korea. The company will cooperate with the International Vaccine Institute to gather participants abroad, it said.

GBP510 will be compared to the AstraZeneca vaccine in the trial, which will measure its safety and effectiveness, the Drug Ministry said.

SK Bioscience will give its experimental vaccine to 3,000 adults, while the remaining 990 will receive the AstraZeneca vaccine, with an interval of four weeks.

According to the ministry, SK Bioscience will collect and analyze clinical data during the phase 3 study to see if the vaccine candidate is effective against the COVID-19 variants.

GBP510 will be the world’s second COVID-19 vaccine candidate to be tested against another authorized vaccine.

Previously, French biotech company Valneva announced that its phase 3 trial will compare its COVID-19 vaccine candidate to the AstraZeneca vaccine.

The government said it was also considering purchasing homegrown COVID-19 vaccines upon the interim findings of second phase clinical trials or approval of phase three clinical trials.

There are currently seven local companies, including SK Bioscience, that are developing multiple types of COVID-19 vaccines.

Genexine‘s DNA-based vaccine is in a phase two trial, and Geneone Life Science is in a phase one trial for its DNA-based vaccine.

By Shim Woo-hyun (ws@heraldcorp.com)