The International Vaccine Institute (IVI) is partnering with SK bioscience of South Korea to conduct Phase III clinical trials of SK bioscience’s COVID-19 vaccine candidate in multiple countries in an effort to accelerate the development of much-needed “Wave 2” vaccines. Funding for this Phase III study has been provided by the Coalition for Epidemic Preparedness Innovations (CEPI). Additionally, IVI, SK, and the Korea National Institute of Health (KNIH) under the Korea Disease Control and Prevention Agency (KDCA) signed an agreement to jointly conduct antibody testing for the global Phase III trials.
These moves follow SK bioscience’s announcement on August 10 confirming the safety and robust immunogenic response of its GBP510 vaccine candidate, co-developed with the Institute for Protein Design (IPD) at the University of Washington and adjuvanted with GlaxoSmithKline’s (GSK) AS03, in an interim analysis of the stage 1 segment in a Phase I/II study.
In that study 80 healthy Korean adults received the GBP510 recombinant protein vaccine, and the trial confirmed the generation of neutralizing antibodies against the SARS-CoV-2 virus in 100% of vaccine recipients. In terms of safety, no serious adverse events were detected in relation to the vaccine, suggesting a beneficial safety profile.
Based on the promising interim data from Phase I/II clinical trials, SK bioscience has formed the COVID vaccine Clinical and Operational Alliance (COCOA) and is working with IVI on global Phase 3 trials of the vaccine. The aim of this consortium is to make the GBP510 vaccine available worldwide with WHO prequalification (PQ) / WHO Emergency Use Listing (EUL). IVI and SK bioscience will jointly conduct the clinical trials, while SK proceeds with preparations to achieve WHO PQ and emergency use authorization (EUA) in individual countries.
SK bioscience has also received approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for its Phase III investigational new drug (IND) application. This is the first Phase III IND approval by the MFDS for a COVID-19 vaccine developed domestically.
As a non-profit international organization devoted to the discovery, development and delivery of vaccines for global health, IVI is conducting or supporting clinical trials of COVID-19 vaccine candidates in various stages of pre-clinical and clinical development in a number of countries. IVI and SK will aim to complete the Phase 3 trial of GBP510 in Europe and Southeast Asia and bring the vaccine to market by the first half of 2022.
“IVI is excited to partner with SK in Phase 3 clinical trials, which is a crucial step towards the development and WHO approval of their COVID-19 vaccine,” said Dr. Sushant Sahastrabuddhe, IVI Principal Investigator and Director, COCOA. “We will build on our successful partnership with SK in Vi-DT typhoid conjugate vaccine development to accelerate the development of a much-needed vaccine to tackle COVID-19 including variants.”
Dr. Hoon Kim, CTO of SK bioscience said, “The trials will demonstrate the vaccine’s safety and immunogenicity in comparison to currently licensed vaccines in multiple countries. We expect IVI’s global network, formed through its strong international engagement with companies and organizations for COVID-19 vaccine development around the world, will help accelerate the trials and ultimately approval and use of the GBP510 vaccine.”
SK bioscience, IVI and KNIH further agreed to collaborate on the analysis of GBP510’s ability to generate antibody that neutralizes COVID-19 and its mutants. Under this agreement, they will jointly participate in analysis of neutralizing antibodies in test subjects across global Phase III trials to secure accurate results within a shortened timeframe.
GBP510 was the first COVID-19 vaccine candidate selected for “Wave 2” vaccines, an investment initiated by CEPI in 2020 to support promising vaccine candidates. Once marketed, hundreds of millions of GBP510 doses will be supplied across the world, including developing nations, through the COVAX Facility.
The recombinant protein antigen vaccine platform applied to GBP510 offers advantages in terms of storage conditions (2-8 degrees Celsius) and shelf life compared to COVID-19 vaccines using other platforms, which will help the developing world secure more equitable access to vaccines.
“The world still faces severe vaccine shortages, and we need sufficient vaccine supply to bring this pandemic to a close. SK’s vaccine could be part of Wave 2 vaccines, which will be crucial in the control of COVID-19 and its variants,” said Dr. Jerome Kim, Director General of IVI. “Testing the vaccine in different populations is essential to its eventual approval and global use, and IVI is privileged to contribute to this effort in collaboration with SK and KNIH.”
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About the International Vaccine Institute (IVI)
The International Vaccine Institute (IVI) is a nonprofit inter-governmental organization established in 1997 at the initiative of the United Nations Development Programme (UNDP). IVI has 36 countries and the World Health Organization (WHO) on its treaty, including the Republic of Korea, Sweden, India, and Finland as state funders.
Our mandate is to make vaccines available and accessible for the world’s most vulnerable people. We focus on infectious diseases of global health importance such as cholera, typhoid, shigella, salmonella, schistosomiasis, chikungunya, group A strep, Hepatitis A, HPV, TB, HIV, MERS, COVID-19, as well as antimicrobial resistance. For more information, please visit https://www.ivi.int
About SK bioscience
SK bioscience is an innovative South Korean biopharmaceutical company specialized in the vaccine area. SK bioscience developed the cell-culture based influenza vaccine named SKYCellFlu™ prequalified by WHO in 2019, SKYZoster™, the world’s second vaccine for shingles, and SKYVaricella™, the world’s second WHO prequalified varicella vaccine for chickenpox. By leveraging the company’s strengths on cutting-edge vaccine development technologies, SK bioscience has been expanding its R&D portfolio including pneumococcal conjugate vaccine, human papillomavirus vaccine, typhoid conjugate vaccine and non-replicating rotavirus vaccine through in-house development or external partnership with public and private institutions around the globe pursuing global health. For the COVID-19 vaccine response, SK bioscience is undergoing development for its vaccine candidate against SARS-CoV-2 with support from the Bill & Melinda Gates Foundation and CEPI, and using its established development and manufacturing capabilities, it has been cooperating to develop and manufacture AstraZeneca’s and Novavax’s COVID-19 vaccine candidates.