EyeGene has initiated Phase 1 clinical trials for its next-generation COVID-19 messenger RNA (mRNA) vaccine, developed in partnership with other domestic companies. The biotech firm aims to validate the safety and immunogenicity of this locally developed vaccine candidate, with plans to advance to Phase 2 trials in the latter half of next year.
EyeGene reported that the consortium, formed with Korea BMI, Micro Uni, and Medici Bio, commenced the first dose administration in the Phase 1 trial of their COVID-19 mRNA vaccine candidate BMI2012 on Wednesday.
The clinical trial is being conducted at three medical centers: Korea University Guro Hospital, Hallym University Gangnam Sacred Heart Hospital, and Ajou University Hospital. This research is backed by the Pandemic Preparedness mRNA Vaccine Development Support Project, spearheaded by the Korea Disease Control Agency’s National Health Research Institute and the Korea Health Industry Development Institute.
The Phase 1 study will assess the vaccine’s safety, tolerability, and immunogenicity in healthy adults aged 19 to 55. A crucial goal is to determine the optimal dosage for subsequent Phase 2 trials.
EyeGene reports that BMI2012 has shown promising immunogenicity and protective effects against viral infection in preclinical animal studies. Building on these results, the consortium plans to evaluate the safety and immune response of the vaccine candidate in early-stage human trials.
The South Korean government previously unveiled plans to invest 505.2 billion KRW (approximately 378 million USD) in research and development (R&D) projects for domestic mRNA vaccine development from 2025 to 2028. This funding includes 337.9 billion KRW (about 253 million USD) from the national budget and 167.3 billion KRW (about 125 million USD) in private sector investments.
Last December 18, the Korea Disease Control Agency announced that the Phase 1 clinical trial protocol for the COVID-19 mRNA vaccine candidate had received approval from the Ministry of Food and Drug Safety.
This May, the National Health Research Institute launched a new initiative to support Phase 1 and 2 studies of the COVID-19 mRNA vaccine candidate. A follow-up call for additional research institutions was issued in June.
The government’s strategic goal is to establish a domestic mRNA vaccine platform capable of developing a vaccine within 200 days in response to potential future pandemics.
EyeGene aims to complete all Phase 1 dosing by December this year and progress to Phase 2 trials in the latter half of 2027.
An EyeGene spokesperson stated that BMI2012 has demonstrated immunogenicity in animals and significant protective effects in animal models against viral challenges. It’s optimistic about achieving positive outcomes in this clinical trial as well.
Meanwhile, market research firm Research and Markets projects that the global mRNA vaccine market will expand from 9.32 billion USD in 2024 to 18.28 billion USD by 2030.
