The consortium consisting of Eyegene, BMI Korea, MicroUni, and MediciBio announced on Thursday that they received approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for the Phase 1 clinical trial plan (IND) of their next-generation mRNA-based COVID-19 variant prevention vaccine, BMI2012.
This clinical trial is supported by the Pandemic Preparedness mRNA Vaccine Development Support Project, overseen by the Korea Disease Control and Prevention Agency’s National Institute of Health and the Korea Health Industry Development Institute. The consortium has already completed preclinical studies for BMI2012.
The Phase 1 trial will evaluate the vaccine’s safety, tolerability, and immunogenicity in 72 healthy adults aged 19 to 55, while also determining the optimal dosage for Phase 2. Immunogenicity refers to the vaccine’s ability to stimulate an immune response, such as antibody production, in the body.
Trials will be conducted at Korea University Guro Hospital, Hallym University Kangnam Sacred Heart Hospital, and Ajou University Hospital, with the first doses planned for mid-October. Participants will receive a single intramuscular injection of the vaccine, followed by a 28-day priority analysis of safety and immune response, and a total follow-up period of 52 weeks.
According to the consortium, BMI2012 demonstrated immunogenicity equal to or better than existing vaccines in preclinical animal studies. It also showed superior protective effects compared to current vaccines when vaccinated hamsters were exposed to the virus.
The consortium is developing BMI2012 by combining mRNA vaccine technologies from various domestic companies. Eyegene is handling vaccine prototype production, manufacturing and quality control (CMC) research, and toxicity and efficacy evaluations. BMI Korea is overseeing clinical management and production of clinical trial materials.
MicroUni is developing a self-amplifying RNA (saRNA) platform that allows RNA to multiply within the body, producing antigen proteins with smaller doses. MediciBio is responsible for developing lipid nanoparticles (LNP) to protect and deliver RNA into cells. The consortium has also completed a freedom-to-operate (FTO) analysis to assess potential patent infringement risks during vaccine development.
Choi Seok-geun, Chief Executive Officer (CEO) of Eyegene, stated that BMI2012 is significant as it’s a vaccine developed entirely with domestic technology. This clinical trial approval marks a crucial step in proving the clinical effectiveness of the proprietary mRNA platform technology.
Meanwhile, the South Korean government aims to secure approval for domestically produced COVID-19 mRNA vaccines and establish its own mRNA vaccine platform by 2028. To achieve this, it plans to invest approximately 505.2 billion KRW (about 357 million USD) over four years starting in 2025. The ultimate goal is to develop a system capable of producing a vaccine within 200 days in the event of a new infectious disease outbreak, leveraging the technology acquired through COVID-19 vaccine development.