SK bioscience has secured approval for phase 3 trials pitting its COVID-19 vaccine candidate GBP510 against AstraZeneca’s Vaxzevria.
The South Korean company reported “promising interim data” from its phase 1/2 trial. In the first stage of the trial, 80 healthy adults received the adjuvanted vaccine, showing a 100% seroconversion rate, while in the second stage, no adverse events were reported by the 247 participants, which included elderly people.
The phase 3 trial will see 3,990 adults receive the experimental vaccine versus 990 who will receive Vaxzevria.
GBP510 is a frontrunner in the Wave 2 vaccine programme run by CEPI – the Coalition for Epidemic Preparedness Innovations – a global partnership between public, private, philanthropic and civil society organisations launched in Davos in 2017 to develop vaccines to stop future epidemics.
SK bioscience has received more than $200m from the Bill & Melinda Gates Foundation and CEPI, the majority of which will fund the phase 3 trial.
As part of Wave 2, if successful, GBP510 will be made available across the world as part of the COVAX initiative.
The vaccine candidate is being co-developed with the Institute for Protein Design at the University of Washington. It is adjuvanted with GSK’s pandemic adjuvant system, which is designed to enhance a vaccine’s immunological profile and potential immune response.
SK bioscience hopes GBP510 will boost South Korea’s domestic COVID-19 vaccine supply once it becomes available in the first half of 2022.
Not only will the vaccine be manufactured inside South Korea, it also has the advantage being able to produce hundreds of millions of vaccine doses quickly, said the company.
SK bioscience is also continuing its research on COVID-19 variants, and clinical trials for variant antigens are scheduled to start later this year.
Shares in the company shot up at the news of the trial, rising nearly 30% to a record high.
Like many countries, South Korea’s vaccination programme has experienced supply problems and only 15.4% of its population of 52 million are fully vaccinated. The country has suffered more than 2,000 deaths from the pandemic.
In April, French biotech, Valneva, reported it would move into phase 3 to test its COVID-19 vaccine candidate against AstraZeneca’s Vaxzevria. More recently it announced the start of a second trial to test its vaccine in older people and against new variants.