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

'STP2104' Applies the Same LNP Technology as Moderna and Pfizer

[Asia Economy Reporter Lee Gwan-joo] The K-mRNA Consortium announced on the 25th that ST Pharm has received approval from the Ministry of Food and Drug Safety for the clinical phase 1 trial plan (IND) of the COVID-19 mRNA vaccine candidate 'STP2104'.

ST Pharm plans to start a multinational phase 1 clinical trial by dividing 30 healthy adult subjects aged 19 to 55 into two dosage groups of 25㎍ and 50㎍, administering STP2104 twice in a stepwise manner. In particular, the trial will also be conducted in South Africa, where COVID-19 vaccination rates are low, aiming to quickly complete phase 1 to verify safety and immunogenicity.

The approval of the STP2104 phase 1 clinical trial plan was achieved through rapid and close cooperation with Hanmi Pharmaceutical, GC Green Cross, and Dong-A ST via the K-mRNA Consortium, which was formed together with the Korea Innovative Medicines Consortium. The K-mRNA Consortium plans to pursue a global vaccine hub strategy based on domestic and international licensing rights, overseas expansion, and mass production.

ST Pharm currently holds two candidate substances targeting Omicron and stealth Omicron variants and is conducting efficacy evaluations and non-clinical toxicity tests. The company is establishing phase 2 and 3 clinical strategies for booster shot development against variants.

All vaccine candidates developed by ST Pharm use SMARTCAP®, a proprietary 5’-Capping reagent (five prime capping analog). Additionally, STP2104 uses lipid nanoparticles (LNPs) as delivery vehicles, which have been proven safe through global clinical trials.

ST Pharm possesses mRNA platform technologies essential for vaccine development, including capping and LNP formulation technologies, as well as GMP production facilities, enabling response to future emerging pandemic infectious diseases.

An ST Pharm official stated, “Future vaccine development will be divided between countries with mRNA platform technology and those without. It is highly significant in securing vaccine sovereignty by building core capabilities to respond swiftly to new pandemics that may arise again.”

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