Jinwon Life Sciences Decides to Enter Phase 2a Clinical Trial Based on Interim Results of COVID-19 Vaccine Phase 1 Trial

[Asia Economy Reporter Jang Hyowon] GeneOne Life Science announced on the 8th that it has entered clinical phase 2a after confirming the positive interim analysis results of the COVID-19 DNA vaccine (GLS-5310) conducted on 45 subjects at Korea University Guro Hospital and passing the review of the Data and Safety Monitoring Board (DSMB).

According to the company, the phase 1 clinical trial of GLS-5310 was divided into three groups: low dose 0.6mg with two injections at 8-week intervals, high dose 1.2mg with two injections at 8-week intervals, and high dose 1.2mg with two injections at 12-week intervals. After intradermal injection using a suction medical device, the safety and immunogenicity of the vaccine were evaluated.

Safety was assessed through multiple hospital visits before and after vaccination, confirming excellent tolerability with no serious adverse events reported. The most common side effect was itching.

The company stated, “The seroconversion rates for the spike antigen among the three dosing groups were 93%, 93%, and 80%, respectively, and the average antibody titers after completion of vaccination were 1673, 3160, and 2923, with no statistically significant differences between groups.” They added, “Neutralizing antibody responses are currently being analyzed by an external biosafety level 3 (BL3) certified specialized laboratory, and the results will be announced once secured.”

Furthermore, “T-cell immune responses were confirmed in 91.1% of vaccine recipients, with average analysis values per one million peripheral blood mononuclear cells after vaccination being 476, 705, and 465 in the three dosing groups, respectively. T-cell immune responses were observed across broad regions of the spike antigen and ORF3a antigen,” and “Notably, all five subjects who did not show detectable antibody titers against the spike antigen exhibited strong T-cell immune responses ranging from 442 to 795.”

Dr. Joel Meslo, Chief Medical Officer of GeneOne Life Science, said, “The interim analysis results of phase 1 confirmed that strong vaccine immune responses were induced by intradermal injection using suction.” He added, “We have already confirmed through animal experiments that excellent binding antibody immune responses and neutralizing antibody immune responses appear together.”

He continued, “This suction injection device is painless, easy to use, inexpensive, and allows rapid mass production. Therefore, if combined with the advantages of DNA vaccines, such as long-term storage in refrigeration and stability at room temperature, vaccine distribution and administration will be possible even in countries with challenging geographic conditions and economic difficulties.”

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