BioLeaders Advances COVID-19 Vaccine Development... Over 10-Fold Increase in Antigen Expression Enhances Variant Response

Development of COVID-19 Vaccine Expressing Nucleocapsid Antigen on Cell Membrane Exterior
Technology Applied to Enhance Both Immune Response and Antigen Expression
Animal Study Results of the Vaccine to Be Presented at Conference Next Month

[Asia Economy Reporter Hyungsoo Park] Biologics developer BioLeaders announced on the 15th that it will unveil the results of animal experiments for a vaccine capable of responding to various COVID-19 variant viruses at the ‘71st Annual Meeting of the Korean Association of Anatomists,’ held over three days from the 13th of next month in Jeju Island.

Recently, with the emergence of new COVID-19 variants such as Alpha, Delta, and Mu, vaccines using a single spike antigen currently administered have seen an increase in infections due to variants as well as breakthrough infections. In particular, because the spike antigen continuously mutates as the virus evolves, the development speed cannot keep up with the emergence of variants.

BioLeaders is developing a novel vaccine based on a strategy that effectively prevents various COVID-19 variants. The company developed a vaccine based on the nucleocapsid antigen, a viral component with almost no mutations and capable of inducing a strong and sustained long-term immune response. The nucleocapsid is a complex of viral nucleic acid and the surrounding protein shell. Due to the advantages of this antigen, companies worldwide are developing nucleocapsid antigen vaccines, but most use systems that express it intracellularly. BioLeaders has established the world’s first system to express the nucleocapsid antigen on the exterior of the cell membrane.

BioLeaders’ COVID-19 vaccine expresses the nucleocapsid antigen on the cell membrane exterior, which not only increases immune responses but also enhances antigen expression by more than tenfold, providing a competitive edge.

Vaccine experts evaluate that the nucleocapsid antigen strategy has a high likelihood of success because multiple variant viruses may emerge in the future. Especially, expressing the antigen on the cell membrane exterior activates MHC class II by immune cells, specifically inducing the important CD4 response in vaccines, which is considered highly valuable technology. According to recent data released by Janssen, the vaccine efficacy decreases if the spike antigen lacks a transmembrane domain that anchors it to the cell membrane.

A company official explained, "The COVID-19 vaccine candidate ‘BLS-A01’ has already shown high antibody titers, neutralizing antibodies, antigen-specific memory T cells, and cytotoxic T cell formation through several animal experiments," adding, "In recently conducted infected animal models, clinical symptoms were significantly improved overall." He further explained, "Comprehensive results regarding vaccine efficacy will be presented by Dr. Sujeong Jeong from Keimyung University School of Medicine at the Korean Association of Anatomists Annual Meeting."

BioLeaders is currently preparing for a Phase 1/2a clinical trial by introducing external antigen labeling technology and applying technology that enhances B and T cell immune responses to secure a strong candidate material capable of responding to various variants.

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