GeneOne Life Science to start phase 2a clinical study of DNA vaccine

South Korean drug firm GeneOne Life Science announced Thursday that the company will begin a phase 2a clinical trial of the company‘s self-developed DNA-based COVID-19 vaccine candidate GLS-5310.

The phase 1 clinical trial, conducted at Korea University Guro Hospital with 45 participants, has produced positive results and was reviewed and confirmed by a data safety monitoring board, the firm said.

A DSMB is a group of independent experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.

Data from the phase 1 trial showed that the vaccine candidate was safe with no serious adverse reactions reported.

Nine out of 10 participants administered with the DNA-based COVID-19 vaccine candidate, also showed T cell responses, GeneOne Life Science noted.

Whether the vaccine could elicit enough neutralizing antibody responses against the coronavirus, however, has not been confirmed yet. GeneOne Life Science said an external institution is analyzing the clinical data and the company will reveal the results as soon as possible.

GeneOne Life Science plans to speed up the clinical development for phase 2 and 3 trials with an aim of receiving emergency use authorization early 2022.

The company received an approval for phase 1 and 2a clinical trials from the Ministry of Food and Drug Safety in December last year.


By Shim Woo-hyun (ws@heraldcorp.com)