Genexine Enters Phase 2a Clinical Trial for COVID-19 Vaccine... "Effective Against Variants"

Clinical Trial with 150 Participants... First Subject Dosed Completed

[Image source=Yonhap News]

[Asia Economy Reporter Seo So-jeong] Genexine announced on the 2nd that it has started the Phase 2a clinical trial of its COVID-19 vaccine under development, 'GX-19N,' and completed the first subject administration on the 26th of last month.

Genexine is the first to advance a domestically developed vaccine to Phase 2a clinical trials. This vaccine includes the nucleocapsid antigen, which can respond to variants.

The Phase 2a trial of GX-19N is being conducted at six institutions, including Yonsei University Severance Hospital, Gangnam Severance Hospital, Hanyang University Hospital, Kyung Hee University Hospital, Ajou University Hospital, and Wonju Severance Christian Hospital, targeting a total of 150 healthy adults, including 50 placebo group participants.

Among these, the first administration to a subject was carried out at Gangnam Severance Hospital. It will take about 10 weeks from the completion of subject recruitment to interim analysis, followed by follow-up observation for long-term safety evaluation.

GX-19N is a vaccine that contains both the spike antigen of the COVID-19 virus and the nucleocapsid antigen with high sequence conservation, increasing the potential to defend against coronavirus variants. The company explained that it induces a broad T-cell immune response, enabling long-term protective efficacy against COVID-19.

Genexine is currently conducting an additional Phase 1 clinical trial targeting elderly individuals aged 55 to 85. Based on the interim analysis results of Phase 2a, the company plans to conduct large-scale clinical trials simultaneously in Korea and overseas and then apply for emergency use authorization.

Along with the COVID-19 vaccine, Genexine is developing therapeutics. In Indonesia, it is conducting a Phase 2 clinical trial of 'GX-I7' as a COVID-19 treatment, and in Korea and the United States, it is conducting Phase 1b and Phase 1 clinical trials, respectively.