Ongoing Domestic mRNA Vaccine Clinical Trials... How Far Have They Progressed?

[Image source=Yonhap News]

[Asia Economy Reporter Chunhee Lee] As clinical trials for domestically produced COVID-19 messenger ribonucleic acid (mRNA) vaccines are gaining momentum, attention is focused on when the actual vaccine release might be possible.

According to the industry on the 27th, ST Pharm recently received approval for the Phase 1 clinical trial plan of the mRNA-lipid nanoparticle (LNP)-based COVID-19 vaccine 'STP2104' and is expected to enter clinical trials soon.

ST Pharm plans to conduct clinical trials at multinational testing institutions, including Korea University Guro Hospital. The patient scale will be at least 30 adults aged 19 to 55, who will be administered STP2104 to evaluate safety and immunogenicity, and to determine the appropriate dosage for Phase 2 clinical trials. For this purpose, subjects will be divided into two groups receiving mRNA-based ST2104 doses of 25 μg and 50 μg, respectively, with a total of two stepwise administrations.

STP2104 is a COVID-19 preventive vaccine containing mRNA designed based on modified nucleosides. It uses a self-developed 5'-capping analog called 'SmartCap' to enhance capping and transcription effects. ST Pharm also added that it utilizes LNPs, which have proven safety through global clinical trials, as mRNA delivery vehicles.

In particular, STP2104 is being developed not only by ST Pharm but also by various domestic pharmaceutical and biotech companies. This is based on the 'K-mRNA Consortium' formed in June last year. Besides ST Pharm, the consortium was formed by the Korea Innovative Medicines Consortium (KIMCo) with Hanmi Pharmaceutical and GC Green Cross. Hanmi Pharmaceutical synthesizes the spike gene (DNA) of the coronavirus, and GC Green Cross is responsible for finished product manufacturing. Additionally, in September last year, Dong-A ST, a specialty pharmaceutical developer, and Icell, a bio raw material supplier, also joined the consortium.

Other companies are also accelerating mRNA vaccine development. Curatis's mRNA COVID-19 vaccine 'TAP104' is currently in Phase 1 clinical trials. IGEN's 'EG-COVID' is also undergoing Phase 1 and 2a clinical trials. Furthermore, to verify the possibility of additional booster shots, Phase 1 and 2a clinical trials have recently been applied for in Australia and South Africa.

Major bio companies are also focusing on mRNA vaccines. They expect that even after COVID-19 ends, mRNA will play a central role in the vaccine industry and are preparing related research and production.

Samsung Biologics is currently producing finished pharmaceutical products (DP) for Moderna's mRNA vaccine and plans to start producing active pharmaceutical ingredients (DS) within this year. To this end, it signed an mRNA vaccine contract manufacturing partnership with Greenlight Biosciences in the U.S. last November. The plan is to complete facility preparations and start vaccine bulk production within the first half of this year. Celltrion has also signed a contract with U.S.-based TriLink Biotechnology and is developing next-generation mRNA vaccine platforms.

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