CEPI to Support Phase 3 Clinical Trials
The nanoparticle technology applied to SK Bioscience's COVID-19 vaccine GBP510, which is under development, is drawing attention. Nanoparticles applied to GBP510 were jointly developed by researchers at SK Bioscience and the University of Washington. The university’s nanoparticle technology is known to be highly advanced.
The Coalition for Epidemic Preparedness Innovations (CEPI), an international private organization, is continuing to invest in SK Bioscience’s GBP510, the first WAVE 2 (2nd-generation) vaccine it has chosen for investment. GBP510 is the only Korean vaccine supported by the CEPI and the Bill and Melinda Gates Foundation (BMGF) throughout the process of clinical tests. SK Bioscience secured a total of 240 billion won in supporting funds for GBP510. The funds included US$210.1 million (234 billion won) from the CEPI and US$3.6 million (4 billion won) from the Bill and Melinda Gates Foundation.
GBP510 is a vaccine based on a synthetic antigen platform technology that artificially synthesizes antigens and puts them into the body. It is a traditional platform technology that has been used in vaccines for various diseases including flu vaccines for about 70 years. Its safety and efficacy have been verified.
GBP510 was loaded with receptor-binding domains (RBDs), which induce neutralizing antibody responses, and the nanoparticle self-assembly technology from the Antigen Design Institute of the University of Washington. Among them, the University of Washington’s self-assembly of nanoparticles are receiving a lot of global attention. A paper that verified its efficacy in a preclinical stage was published in Cell, one of the world’s most prestigious academic journals, in the second half of 2020.
The paper says that in animal experiments, B cells that make antibodies become active when nanoparticles designed for the COVID-19 virus are injected. Production of neutralizing antibodies was strongly promoted by RBD nanoparticles. In particular, despite the administration of a dose five times lower than the previous one, neutralizing antibodies were produced 10 times higher than those in their recovery periods.
"The vaccine’s production process is easy, the vaccine can be effective in small quantities and can be stored even if it is not frozen," said Alexandra Walls, a professor of medicine at the University of Washington, who led the study. University of Washington's nanoparticle design was also introduced as a candidate for the Corona vaccine by Icosavax, an American biotechnology company. Icosavax is a bio-company spun off from the University of Washington. The company has key scientists who developed nanoparticles at the University of Washington. Currently, a clinical test has begun on Icosavax's candidate substance for the COVID-19 vaccine in accordance with FDA standards.
"mRNA vaccines, first-generation vaccines for COVID-19, were developed based on a platform technology that are not yet verified," said an official at SK Bioscience. “They are difficult to distribute. The CEPI chose SK Bioscience’s vaccine for the first time among second-generation vaccines because it understands that the vaccine is developed through a safe synthetic antigen method and show stronger effects. GBP510 is still in Phase 1/2 of clinical trials, but the CEPI has decided to provide additional support for Phase 3 clinical trials as it thinks that SK Bioscience’s vaccine development will be successful."
GBP510 will enter Phase 3 clinical trials in July and be released in the first half of next year, according to SK Bioscience’s schedule. Although SK Bioscience is a latecomer in COVID-19 vaccine development, it has secured a strong supply chain. The vaccine will be supplied not only to the Korean government but to the world through COVAX Facility supported by the CEPI. However, SK Bioscience has to pay the University of Washington running royalties per dose and the contract amount is kept under wraps.