Genexine Advances Global Clinical Trials for COVID-19 Vaccine 'GX-19N'

Clinical trial drug GX-19, a DNA vaccine by Genexine, exhibited at the 'COVID-19 Vaccine and Therapeutics Development Field Meeting' held last October at SK Bioscience in Seongnam, Gyeonggi Province.
[Image source=Yonhap News]

[Asia Economy Reporter Lee Chun-hee] Genexine announced on the 18th that it has submitted the global Phase 2/3 clinical trial plan for its COVID-19 vaccine candidate 'GX-19N' to the Indonesian Food and Drug Authority (BPOM).

Genexine stated that through this plan, it will recruit 1,000 participants in Indonesia and conduct clinical trials at five hospitals. In addition, it plans to conduct clinical trials involving a total of 30,000 participants across several countries. Phases 2 and 3 will be conducted simultaneously to evaluate efficacy, safety, and immunogenicity.

According to Genexine, GX-19N is a vaccine candidate that carries both the spike antigen of the COVID-19 virus and the nucleocapsid antigen, which has a high sequence conservation. This suggests the potential to defend against variants of the COVID-19 virus.

Genexine is currently conducting a Phase 2a clinical trial of GX-19N with 150 participants in South Korea. Based on domestic and international clinical results, the company plans to apply for emergency use authorization within this year.