SK Bioscience Vaccine, 'World's 2nd' Comparative Clinical Trial... "A Rain in the Vaccine Drought"

Recombinant Vaccine 'GBP510' Expectations
"Targeting Regulatory Approval Application in Q1 Next Year"

[Image source=Yonhap News]

[Asia Economy Reporter Kim Ji-hee] SK Bioscience's ‘GBP510’ is the domestically developed COVID-19 vaccine expected to be commercialized first among those currently under development. Recently, the government also expressed high expectations for GBP510 at the announcement of the K-Global Vaccine Hub strategy, stating, "We will ensure that the protein subunit vaccine can be commercialized by the first half of next year."

Amid recent supply issues with the Moderna vaccine, the need for a domestic vaccine has become even more urgent. In particular, this clinical approval not only marks the first Phase 3 entry for a domestically developed COVID-19 vaccine but also represents the world's second case of conducting a Phase 3 trial using a comparative clinical trial method. Earlier in April, France's Valneva received approval for a comparative Phase 3 trial using the AstraZeneca vaccine as a control group and began clinical trials in the UK, the first in the world.

GBP510, developed by SK Bioscience, is a ‘recombinant vaccine’ that induces an immune response by injecting the surface antigen protein of the COVID-19 virus created using genetic recombination technology. On the 10th, Kim Gang-rip, Commissioner of the Ministry of Food and Drug Safety, explained the background of this approval during a briefing, saying, "Although GBP510 is currently in Phase 2 clinical trials, Phase 1 showed sufficient safety and immunogenicity, indicating the possibility of entering Phase 3."

According to SK Bioscience, GBP510, co-developed with the Institute for Protein Design (IPD) at the University of Washington, showed positive immune responses and safety in the Stage 1 analysis of Phase 1 and 2 clinical trials. Notably, this vaccine includes GSK's pandemic adjuvant technology. In clinical trials conducted on 80 adults at Korea University Guro Hospital and others, all participants in the group administered the vaccine with the adjuvant developed antibodies, showing a 100% neutralizing antibody formation rate. The level of neutralizing antibody induction was 5 to 8 times higher than the serum panel of recovered COVID-19 patients. Regarding safety, no serious adverse reactions related to GBP510 administration were reported.

The target commercialization period for GBP510 is the first half of next year. Commissioner Kim stated, "SK Bioscience aims to apply for product approval with interim analysis results of the Phase 3 clinical trial in the first quarter of next year, and the government will support to ensure that this goal is achieved without delay."

With SK Bioscience's entry into Phase 3, it is expected that the development of other domestic vaccines will gain momentum. Genexine, which was the first in the country to enter Phase 2, received approval last month from Indonesia's Food and Drug Monitoring Agency (BPOM) for Phase 2 and 3 clinical trial plans. Curetis is conducting clinical trials for a messenger RNA (mRNA) vaccine, and Celltrion has also announced plans to develop an mRNA vaccine. The ‘Next-generation mRNA Vaccine Platform Technology Consortium’ consisting of Hanmi Pharmaceutical, GC Green Cross, and ST Pharm plans to produce 100 million doses of mRNA-based COVID-19 vaccines capable of one-time nationwide vaccination by next year.

This content was produced with the assistance of AI translation services.