SK Bioscience Announces Commencement of Booster Trial of Adjuvanted COVID-19 Vaccine Candidate 'GBP510(AS03)' in South Korea

A homologous booster trial of GBP510 will be initiated

* A heterologous booster trial is being conducted by the KDCA

* SK bioscience will evaluate efficacy against variants including Omicron through the trial

* Clinical trial for booster vaccine in children and adolescents will be initiated soon

Sungnam, South Korea--SK bioscience will explore expanding the scope of use for its COVID-19 vaccine candidate. The company plans to commercialize 'Korea's First Adjuvanted Recombinant Protein-Based COVID-19 Vaccine' following initiation of a new clinical trial evaluating its use as a booster and for vaccination of adolescents in the first half of 2022.

SK bioscience announced that the company has submitted an investigational new drug (IND) application for a homologous booster trial of 'GBP510, a COVID-19 vaccine candidate to South Korea's Ministry of Food and Drug Safety (KMFDS).

GBP510 is a self-assembled nanoparticle vaccine candidate targeting the receptor binding domain of the SARS-CoV-2 Spike protein, jointly developed with the Institute for Protein Design (IPD) at School of Medicine the University of Washington with combination of GSK's pandemic adjuvant, AS03. The development of GBP510 has been supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

SK bioscience plans to recruit 750 participants over the age of 18 who have received two shots of GBP510 in the Phase III clinical trial before. The participants will receive an additional booster shot 6 months after the initial shots in the previous trial. Safety and efficacy of the booster shot will be evaluated at 16 clinical institutions including Korea University Guro Hospital.

In addition, an investigative heterologous booster trial of GBP510 is also being conducted in adults who have received other authorized COVID-19 vaccines. The trial led by the Korea Centers for Disease Control and Prevention (KDCA) is currently being conducted with 550 adults between the ages of 19 and 50 at 9 clinical institutions including Korea University Guro Hospital since December 2021.

SK bioscience has also initiated a research study to confirm the preventive effect of GBP510 against COVID-19 variants such as Omicron and establish a vaccine platform to respond the 'Next Pandemic' era by utilizing the GBP510 technology. Recently, SK bioscience confirmed that the booster shot showed a preventive effect against Omicron variant to subjects who participated in the Phase I/II clinical trials. The extended research regarding the effect is underway. In addition, in collaboration with CEPI, SK bioscience initiated the development of a vaccine candidate effective for the entire Sarbecovirus group to establish a broader protection system against COVID-19 variants and SARS in the future.

SK bioscience also plans clinical trials of GBP510 for children and adolescents in the first half of 2022.

SK bioscience will accelerate applications for authorization including a biologics license application in South Korea, application for emergency use listing (EUL) to the World Health Organization (WHO) and authorizations at individual regulatory agencies around the world once finishing the trial.

Recombinant protein vaccine technology has been used for development of current vaccines including influenza (flu), hepatitis B, and HPV. GBP510 is stored in normal refrigeration conditions from 2 to 8 degrees Celsius, so it can be distributed through the current vaccine supply network without thawing at inoculation stage.

Jae-Yong Ahn, CEO of SK bioscience said, “We will expand the scope of use of GBP510 by establishing it as a platform to with the goal to preemptively prevent the next potential viral threat. As our vaccine technology has grown to a global level, we also plan to grow to become a leading company in the vaccine industry.”

About SK bioscience

SK bioscience is an innovative biopharmaceutical company, standing committed to global pandemic preparedness in vaccine development and manufacturing to create more equitable access to vaccines. In leveraging strengths on cutting-edge vaccine development technologies, SK bioscience has been dedicated to improving healthcare from prevention to cure across the globe. Under collaborations of domestic and international governments, regulatory agencies, healthcare providers, doctors and medical experts, SKBS has firmly established globally certified R&D and manufacturing technologies. All of SK colleagues are passionately committed to providing high-quality vaccines to those who need them and better public healthcare solutions.

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