Korea's indigenous coronavirus vaccine enters Phase 2a study

South Korea’s Genexine Inc. has initiated a Phase 2a clinical trial of its investigational coronavirus vaccine GX-19N, marking the country’s first 2a milestone in the development of an indigenous jab for Covid-19.

According to the company on Tuesday, its Covid-19 vaccine candidate includes a coronavirus nucleocapsid (NC) protein that can work against even virus mutants. The company said its vaccine candidate is one of the frontrunners among the global developers of a Covid-19 vaccine that contains the nucleocapsid antigen.

The multi-center Phase 2a study involves 150 healthy adults including 50 in the placebo. Six centers in Korea participate in the study, the company said. The first injection was already carried out at Gangnam Severance Hospital on Feb. 26, and it is expected to take about 10 weeks to reach an interim analysis after subject enrollment and a follow-up monitoring will occur to evaluate the vaccine’s long-term safety.

GX-19N is regarded as a next-generation vaccine equipped with Covid-19’s spike antigen and NC protein that contains highly conserved amino acid sequences, raising the possibility of protecting against even mutants, according to preclinical data. It also induced a wide range of T-cell immune responses.

Genexine is concurrently conducting an additional Phase 1 study of the vaccine candidate in the elderly aged between 55 and 85 years, and it plans to file for emergency use authorization after large clinical trials in Korea and globally based on potential positive interim data from Phase 2a.

The company is also speeding up the development of its Covid-19 cure GX-I7 with a Phase 2a study underway in Indonesia, Phase 1b in Korea and Phase 1 in the U.S.

Genexine shares closed 0.87 percent lower at 102,400 won ($91.36) on Wednesday.

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