CEPI funds Phase 3 trial of UW Medicine COVID-19 vaccine
Korea’s SK bioscience will receive up to $173.4 million to assess the efficacy of a new COVID-19 vaccine from Institute for Protein Design.
Leila Gray, 206.475.9809, firstname.lastname@example.org
A COVID-19 nanoparticle vaccine candidate, named GPB510, has received significant additional funding from the Coalition for Epidemic Preparedness Innovations (CEPI). The funding, which will go to SK bioscience, will enable multi-national Phase 3 clinical trials, and also support additional research and development on emerging coronavirus variants of concern. It will also fund further scale-up of SK bioscience manufacturing to full commercial scale, potentially enabling the annual production of hundreds of millions of doses. If proven safe and effective, doses of this vaccine candidate will be made available to the COVAX Facility for procurement and equitable allocation worldwide.
CEPI will provide up to $173.4 million to SK bioscience for these activities. SK bioscience, which is based in South Korea, and the UW Medicine Institute for Protein Design in Seattle jointly developed the nanoparticle vaccine candidate.
The scientists working on this vaccine seek to create an ultrapotent “second-generation” COVID-19 vaccine that is safe, effective at low doses, simple to manufacture, and stable without deep freezing. These attributes would enable vaccination against COVID-19 at a global scale by reaching people in areas where medical, transport, and storage resources are limited. The same qualities would also make such a vaccine in high demand in other parts of the world.
Within the next month, SK bioscience aims to submit an investigational new drug application to the Ministry of Food and Drug Safety, and other regulatory authorities, for a multi-national Phase 3 clinical trial. The GBP510 vaccine candidate entered into a phase 1/2 clinical study near the end of 2020 and is currently in the second stage.
The vaccine candidate was created with structure-based vaccine design techniques invented at UW Medicine. It is based on a computationally designed self-assembling protein nanoparticle that displays 60 copies of a key region of the viral Spike protein.
The molecular structure of this vaccine candidate roughly resembles that of a virus, which may contribute to its enhanced recognition by the immune system.
In preclinical studies reported last year in Cell, GBP510 produced high levels of virus-neutralizing antibodies at low doses. These antibodies target several different sites on the coronavirus Spike protein, a quality which may enhance protection against coronavirus variants.
Further preclinical studies, published in Nature, also showed that the vaccine conferred robust protection and produced a strong B-cell response, which may improve how long the protective effects of the vaccine last. Later lab studies conducted at SK bioscience offered additional evidence that the nanoparticle vaccine blocked proliferation of the COVID-19 virus.
SK bioscience Co., LTD, is among the biotechnology companies advancing its own studies to support manufacturing, clinical development, and commercialization.
Before this funding commitment, SK bioscience received support from the Bill & Melinda Gates Foundation for preclinical laboratory studies, and from CEPI for preliminary clinical trials, variants research, and manufacturing process development. The latest CEPI funding brings its total investment in SK bioscience to $210.1 million, potentially the most extensive international funding ever for vaccine development in Korea. This large-scale support follows promising results from safety and immune response studies in the Phase 1/2 trials, which began last year.
SK bioscience is working toward commercialization within the first half of 2022 through an expedited approval process, such as an emergency use license. Their eventual goal would be to build up to a manufacturing scale of hundreds of millions of doses per year.
GBP510 was selected for the first program of the Wave 2 (Next Generation COVID-19 Vaccine) project, which CEPI launched last year to support various COVID-19 vaccine candidates. If GBP510 proves safe and effective, and becomes commercialized, it will be supplied globally through the COVAX Facility.
SK bioscience vaccine manufacturing credentials include a recent EU-GMP certification of the COVID-19 Vaccine manufacturing facility at Andong.
Jae-Yong Ahn, CEO of SK bioscience, said, “It is a great pleasure to expand collaboration with CEPI to advance the GBP510 development, including against variants. The wholehearted support of CEPI and the Gates Foundation reflects the technological level and potential value of our vaccine candidate.”
He added, “We are also pursuing the development by cooperating closely with relevant international regulatory agencies, as well as the Korean pan-government support group and MFDS [Ministry of Food and Drug Safety]. To achieve the goals against the pandemic, we will continue our highest efforts for the successful development and enlarged access to a COVID-19 vaccine, that can also be preventive against variants, by utilizing our expanded manufacturing capabilities.”
The work on COVID-19 nanoparticle vaccines at the UW Institute for Protein Design has been supported by the Bill & Melinda Gates Foundation, the National Institutes of Health, gifts from The Audacious Project, from Jodi Green and Mike Halperin, from Nicolas and Leslie Hanauer, from anonymous donors, and from other granting agencies.
In addition to Neil King, head of vaccine design at the Institute of Protein Design and inventor of the computational design technology used in developing this COVID-19 nanoparticle vaccine candidate, other lead investigators are research scientists Alexandra Walls and Brooke Fiala, and David Veesler, associate professor, all in the University of Washington School of Medicine Department of Biochemistry, who conducted the work along with numerous collaborators.