Jinwon Life Sciences "Plan to Develop Phase 3 Clinical Trial for COVID-19 Booster-Specific Vaccine"

[Asia Economy Reporter Jang Hyowon] GeneOne Life Science announced on the 1st that it received approval from the Ministry of Food and Drug Safety to change the clinical trial plan for GLS-5310, its COVID-19 vaccine under development, reducing the enrollment for the Phase 2a clinical trial from 300 to 120 participants, allowing for early completion.

According to the company, currently 126 participants have been enrolled, 122 of whom have received their second dose, and the remaining 4 participants will complete all vaccinations within one month.

The company explained that after confirming safety and vaccine immune response efficacy through the Phase 1/2a trial results, they plan to conduct Phase 2b/3 clinical trials as a booster-only vaccine targeting individuals who have completed the primary vaccination series with existing COVID-19 vaccines.

A company representative stated, “Due to the high vaccination rate of domestic COVID-19 vaccines, there were difficulties in recruiting participants for the GLS-5310 Phase 2a trial. After consultation with the Ministry of Food and Drug Safety, the number of participants was reduced to a level that does not affect the clinical study evaluation objectives. Once the participants complete GLS-5310 vaccination, we will begin interim analysis in the first half of the year, review the interim analysis results in the second half, and by utilizing the interim results of the ongoing Phase 1 clinical trial of the booster vaccine in the United States, we expect to be able to apply for Phase 2b/3 trials as a booster-only vaccine in the second half of the year.”

Park Young-geun, CEO of GeneOne Life Science, said, “Despite the high domestic COVID-19 vaccination rate of over 85%, the dedication of participating research institutions allowed us to recruit more than 120 participants. Due to the high vaccination rates domestically and internationally, recruiting thousands of participants for Phase 3 clinical trials is difficult. Moreover, limitations in preventive efficacy upon re-vaccination with existing COVID-19 vaccines have been reported, and there is a possibility that annual vaccinations will be necessary. Therefore, we aim to develop GLS-5310 as a booster-only vaccine.”

He added, “In particular, the interim analysis results of the Phase 1 trial showed that T-cell immune responses, which are not affected by viral mutations, were maintained at a high level continuously. We expect GLS-5310 to have differentiation and strengths as a booster-only vaccine responding to viral variants.”

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