ST Pharm Receives Approval for Phase 1 Clinical Trial of mRNA COVID-19 Vaccine

[Asia Economy Reporter Chunhee Lee] ST Pharm announced on the 24th that it has received approval for the Phase 1 clinical trial of its messenger ribonucleic acid (mRNA)-lipid nanoparticle (LNP)-based COVID-19 vaccine 'STP2104.'

ST Pharm plans to conduct the clinical trial at multiple international institutions, including Korea University Guro Hospital, after receiving approval for the Phase 1 clinical trial plan (IND) from the Ministry of Food and Drug Safety. The trial will involve at least 30 patients aged 19 to 55, who will be administered STP2104 to evaluate safety and immunogenicity, and to determine the appropriate dosage for the Phase 2 clinical trial. For this purpose, participants will be divided into two groups receiving mRNA-based ST2104 doses of 25 μg and 50 μg, respectively, with a total of two doses administered stepwise.

STP2104 is a COVID-19 preventive vaccine containing mRNA designed based on modified nucleosides. It uses a proprietary 5'-capping analog called 'SmartCap,' which is said to enhance capping efficiency and transcriptional activity. ST Pharm also added that it utilizes LNPs, which have been proven safe through global clinical trials, as the mRNA delivery vehicle.