GSK, SK Bioscience Submit BLA for SKYCovione for COVID-19

Study shows that the vaccine candidate demonstrated superior neutralizing antibody titers over the control, Vaxzevria from AstraZeneca.

GSK and SK Bioscience announced the submission of a biologics license application for SKYCovione, a recombinant protein-based COVID-19 vaccine candidate adjuvanted with the GSK’s pandemic adjuvant, to the Korean Ministry of Food and Drug Safety, following positive phase 3 clinical data.

The results of the trial showed a superior neutralizing antibody response of the vaccine candidate against SARS-CoV-2 parental strain at 2.93 times than the control vaccine, Vaxzevria (AstraZeneca), an authorized COVID-19 vaccine, 2 weeks after the second dose.

“As the COVID-19 pandemic continues to evolve, a variety of vaccines will be needed to meet the health needs across the globe, including temperature stable vaccines like the SK/GSK vaccine candidate. These immunogenicity and safety data confirm the important role that our adjuvant technologies play in vaccine development,” Roger Connor, president of vaccines at GSK, said in a statement.

Additionally, the proportion of individuals who seroconverted was 98.06% in the vaccine candidate group and 87.3% in the control group. The vaccine candidate also had a greater than 4-fold increase in neutralizing antibody titers compared to baseline.

Both the immunological superiority and non-inferiority of SKYCovione was demonstrated compared with the control vaccine.

“At this point in time, when countries around the world are developing strategies to respond to the endemic phase of the COVID-19 global health crisis, SK bioscience has reached the final stage of developing Korea's first COVID-19 vaccine for the benefit of Korea and the world,” Jae-Yong Ahn, CEO of SK Bioscience, said in the statement.

Individuals aged 65 years or older had an antibody conversion rate of more than 95% when vaccinated with the vaccine candidate compared with the control vaccine, which was at approximately 79% for the same age group.

In the phase 3 trial, investigators included 4037 adults across New Zealand, the Philippines, South Korea, Thailand, Ukraine, and Vietnam. It was also conducted in cooperation with 16 institutions, including the International Vaccine Institute and Korea University Guro Hospital.

The vaccine candidate showed a clinically favorable safety profile. Most of the adverse events that occurred after injection were mild or moderate in severity.

SKYCovione is a self-assembled nanoparticle vaccine candidate targeting the binding domain of the SARS-CoV-2 spike protein for the parental SARS-CoV-2, jointly developed with the Institute for Protein Design at the University of Washington School of Medicine with combination of GSK’s pandemic adjuvant.

In March, SK Bioscience signed an advance purchase agreement with the Korea Centers for Disease Control and Prevention for 10 million doses.

Additionally, the company will apply for an emergency use listing to the World Health Organization and authorization at individual regulatory agencies around the world. If authorized, the vaccine could be made available to the COVAX Facility for procurement and allocation worldwide.

SK Bioscience is conducting a homologous booster clinical trial of the vaccine in South Korea and a heterologous booster trial in both South Korea and abroad.

Reference

SK bioscience and GSK’s adjuvanted COVID-19 vaccine candidate meets coprimary objectives in a phase III study; biologics license application submitted for SKYCovione (GBP510/GSK adjuvant) in South Korea. GSK. News release. April 29, 2022. Accessed April 29, 2022. https://www.gsk.com/en-gb/media/press-releases/sk-bioscience-and-gsk-s-adjuvanted-covid-19-vaccine-candidate-meets-coprimary-objectives-in-a-phase-iii-study/