The trial will enroll about 4,000 people worldwide to confirm the drug’s safety and immunogenicity profiles.
Korean biopharmaceutical firm SK bioscience and U.K. pharma giant GlaxoSmithKline are launching a Phase III clinical trial on a potential COVID-19 vaccine following positive interim results from its Phase I/II studies.
In a statement, the firms in collaboration said that the Phase I/II trial of its GBP510 vaccine candidate fared well in immunogenicity and safety data when combined with GSK’s pandemic adjuvant. The trial will enroll about 4,000 people worldwide to confirm the drug’s safety and immunogenicity profiles, specifically when compared to rival AstraZeneca/Oxford University’s vaccine product.
The advance to Phase III follows strong interim results from the previous studies, showing that those who received the adjuvanted vaccine developed a strong antibody response with a 100 percent seroconversion rate. Neutralizing antibody titers figured at around 5 to 8 times higher than the sera of people who recovered from the illness. The researchers also did not observe any possible safety issues.
GBP510 is a self-assembled vaccine candidate that targets the receptor binding domain of SARS-CoV-2 Spike protein, plus GSK’s adjuvant. SK is developing the antigen alongside the Institute for Protein Design (IPD) at the University of Washington, with support from the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Initiative.
“While many countries have made good progress with vaccination, there remains a need for accessible and affordable COVID-19 vaccines to ensure equitable access and to protect people across the world. We are pleased to contribute with GSK’s pandemic adjuvant and to be working with SK to deliver the vaccine at scale via COVAX if it is approved,” said Thomas Breuer, chief global health officer for GSK in a press release.
Results are expected to be released in the first half of 2022. If successful, the drug will then apply for regulatory approval to be supplied worldwide through the COVAX facility.
“We are grateful that we were able to advance to the Phase III study with the unprecedented support of global initiatives, including GSK, Coalition for Epidemic Preparedness Initiative (CEPI), and the Bill & Melinda Gates Foundation (BMGF). Taking this important step towards overcoming the global pandemic situation, SK and GSK will bring our technical expertise together for the development of an adjuvanted protein-based vaccine candidate, GBP510,” commented Jaeyong Ahn, the chief executive of SK.
Aside from the GBP510 vaccine, GSK is also working with mRNA specialist facility CureVac to create optimized mRNA vaccines against COVID-19. In addition, it is collaborating with Vir Biotechnology to develop existing and identify new anti-viral antibodies that could also treat or prevent COVID-19 symptoms. GSK received Emergency Use Authorization from the US Food and Drug Administration for Sotrovimab, which has shown promise in the early treatment of the illness in adults at high risk of being hospitalized.
