Medigen Vaccine Biologics (MVC) and Dynavax Technologies announced the first participant has been dosed in the Phase 2 clinical trial evaluating MVC's COVID-19 vaccine candidate, MVC-COV1901. MVC-COV1901 is a subunit vaccine with recombinant S-2P antigen adjuvanted with CpG 1018 supplied by Dynavax.

MVC's Phase 2 clinical trial is a randomized, double-blinded, multi-center clinical trial, expecting to enroll 3,700 healthy subjects, 20 years of age and above. The trial will evaluate MVC-COV1901 safety and endurance of immunogenicity. The proposed dosing regimen is two doses administered intramuscularly one month apart. Based on MVC's Phase 1 interim data, MVC-COV1901 has demonstrated a good safety profile and encouraging immunogenicity performance.

"MVC is delighted to receive the Phase 2 clinical trial IND approval by Taiwan, China FDA for MVC-COV1901 vaccine" said Charles Chen, Chief Executive Officer at Medigen. "We would like to express our deepest gratitude to all the volunteers, partners and Dynavax for the continued support. MVC will continue with our best efforts to bring MVC-COV1901 vaccine to market to meet our commitment to help the global community in the fight against COVID-19."

"Dynavax is proud to collaborate with MVC and support their commitment to help the global fight against COVID-19," commented Ryan Spencer, Chief Executive Officer of Dynavax. "We are pleased with the results of Phase 1 clinical testing, where the combination of S-2P and CpG 1018 plus alum induced neutralizing antibody levels higher than human convalescent sera and was well tolerated, allowing for the continued development on the path to bringing this product to market to address the global demand for coronavirus vaccines."

MVC-COV1901 is a subunit vaccine with recombinant S-2P antigen adjuvanted with CpG 1018 supplied by Dynavax plus aluminum hydroxide. The S-2P antigen is a trimeric and prefusion-stable recombinant spike protein developed by U.S. NIH. MVC has obtained a global technology license for S-2P from the U.S. Vaccine Research Center at National Institutes of Health (NIH). Building upon the S-2P platform, MVC conducted large-scale screenings of various adjuvants and finalized the compositions of MVC-COV1901 vaccine to optimize safety and desired immunogenicity properties. MVC established the production platform of MVC-COV1901 and based on MVC's preclinical and phase 1 clinical study data, MVC-COV1901 showed robust safety and promising immunogenicity responses and as a result entered Phase 2 clinical trial in 2020.