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2021-06-29| Asia-Pacific

SK Bioscience Submits Phase 3 IND for First Korea-Made COVID-19 Vaccine

by Tyler Chen
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South Korea was slow on COVID-19 vaccine development. Until recently, none of the indigenously developed COVID-19 vaccines had reached Phase 3 clinical trials. Genexine’s GX-19 was the fastest in terms of clinical progress, filing a Phase 2/3 clinical trial in Indonesia in March.

On June 28th, SK Bioscience filed an Investigational New Drug (IND) application to South Korea’s Ministry of Food and Drug Safety (MFDS) for Phase 3 clinical trial of its COVID-19 vaccine GBP510. This is the first instance of a locally-made COVID-19 vaccine being submitted for a Phase 3 IND.

 

Commercialization in the First Half of 2022

GBP510 is a protein subunit vaccine suggested for two shots 28 days apart. The Phase 3 trial will be conducted in 14 institutions in Korea and overseas countries in Europe and Southeast Asia. Furthermore, the trial will recruit 4,000 adults and examine the safety, efficacy, and immunogenicity indicators. The plan is to commercialize the vaccine in the first half of 2022.

 

Worldwide Shipping

Along with SK Bioscience, GBP510 is co-developed by the Institute for Protein Design at the University of Washington. The development is supported by Bill & Melinda Gates Foundation and Coalition for Epidemic Preparedness Innovations (CEPI). Once the vaccine is approved, it will join the vaccine pool in COVAX, and millions of shots will be delivered worldwide.

In addition to GBP510, SK Bioscience has another vaccine candidate, a protein subunit vaccine called NBP2001, which is currently in Phase 1 trial.

 

Korea’s Domestic Progress in COVID-19 Vaccine

Korea has approved four COVID-19 vaccines so far, including mRNA-1273 (Moderna), BNT162b2 (Pfizer/BioNTech), Ad26.COV2.S (Janssen), and AZD1222 (Oxford/AstraZeneca). All are developed by overseas companies.

Besides SK Bioscience, four other Korean companies are developing COVID-19 vaccines:

  1. EuBiologics: a protein subunit vaccine EuCorVac-19 (Phase 1/2)
  2. GeneOne Life Science: a DNA vaccine GLS-5310 (Phase 1/2)
  3. Cellid: a viral vector vaccine AdCLD-CoV19 (Phase 1/2)
  4. Genexine: a DNA vaccine GX-19 (Phase 1/2, applied for Phase 2/3 in Indonesia)

Related Article: SK Bioscience Receives EU-GMP Certification for COVID-19 Vaccine Production Plant, Making it Korea’s First

 

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