分享是關懷!


Excerpt

The International Vaccine Institute (IVI) will be conducting Phase 3 clinical trials of SK bioscience’s recombinant protein vaccine candidate (GBP510) in Europe and Southeast Asia, with the aim of bringing it to market in 2022. Additionally, IVI has formed a partnership with SK and the Korean National Institute of Health (KNIH) to jointly conduct antibody testing for the global trials to accelerate the development of “Wave 2” vaccines.

Article Summary

The International Vaccine Institute (IVI) and SK bioscience of South Korea are forming a partnership in view of conducting Phase III clinical trials of SK bioscience’s COVID-19 vaccine candidate (GBP510) to accelerate the development of “Wave 2” vaccines. They are joined by the Korean National Institute of Health (KNIH) under the Korea Disease Control and Prevention Agency (KDCA) in an agreement to jointly conduct antibody testing for the
trials, expected to be completed in Europe and Southeast Asia and brought to market by the first half of 2022.

This comes after SK bioscience’s announcement 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 GSK’s AS03. Promising interim data from Phase I/II clinical trials done on 80 healthy Korean adults
confirmed the generation of neutralizing antibodies against the SARS-CoV-2 virus in 100% of vaccine recipients with no serious adverse events.

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 to make the GBP510 vaccine available worldwide with WHO prequalification (PQ) / WHO Emergency Use Listing (EUL) in individual countries. Funding for this Phase III study has been provided by the Coalition for Epidemic Preparedness Innovations (CEPI).

In a first, 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. 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. Dr. Sushant Sahastrabuddhe, IVI Principal Investigator and Director, COCOA, and Dr. Hoon Kim, CTO of SK bioscience underlined the importance of Phase III clinical trials to the development and WHO approval of a much-needed vaccine to tackle COVID-19 including variants in multiple countries, accelerated by IVI’s global network.

The International Vaccine Institute (IVI) and SK bioscience of South Korea are forming a partnership in view of conducting Phase III clinical trials of SK bioscience’s COVID-19 vaccine candidate (GBP510) to accelerate the development of “Wave 2” vaccines. They are joined by the Korean National Institute of Health (KNIH) under the Korea Disease Control and Prevention Agency (KDCA) in an agreement to jointly conduct antibody testing for the
trials, expected to be completed in Europe and Southeast Asia and brought to market by the first half of 2022.

This comes after SK bioscience’s announcement 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 GSK’s AS03.

Promising interim data from Phase I/II clinical trials done on 80 healthy Korean adults confirmed the generation of neutralizing antibodies against the SARS-CoV-2 virus in 100% of vaccine recipients with no serious adverse events.

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 to make the GBP510 vaccine available worldwide with WHO prequalification (PQ) / WHO Emergency Use Listing (EUL) in individual countries. Funding for this Phase III study has been provided by the Coalition for Epidemic Preparedness Innovations (CEPI).

In a first, 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. 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. Dr. Sushant Sahastrabuddhe, IVI Principal Investigator and Director, COCOA, and Dr. Hoon Kim, CTO of SK bioscience underlined the importance of Phase III clinical trials to the development and WHO approval of a much-needed vaccine to tackle COVID-19 including variants in multiple countries, accelerated by IVI’s global network.

About International Vaccine Institute (IVI)

The International Vaccine Institute (IVI) is a non-profit intergovernmental organization established in 1997 at the initiative of the United Nations Development Programme (UNDP), with a mandate to make vaccines available and accessible for the world’s most vulnerable people. IVI focuses on infectious diseases of global health. It has 36 countries and the World Health Organization (WHO) on its treaty, including the Republic of Korea, Sweden, India,
and Finland as state funders. For more information, visit https://www.ivi.int.

About SK Bioscience

SK Bioscience is an innovative South Korean biopharmaceutical company specialized in the vaccine area. By leveraging the company’s strengths on cutting-edge vaccine development technologies, SK bioscience has been expanding its R&D portfolio through in-house development or external partnership with public and private institutions around the globe pursuing global health. SK bioscience is developing its COVID-19 vaccine 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.

(Source: IVI, 10th August 2021)