Medigen, Dynavax start Phase 2 for Covid vax candidate

 Medigen Vaccine Biologics Corporation (MVC) (TPEx: 6547.TWO) a biopharmaceutical company focusing on the development and production of vaccines and biologics, and Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing vaccines, today announced that 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 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."

https://www.prnewswire.com/news-releases/medigen-vaccine-biologics-covid-19-vaccine-adjuvanted-with-dynavaxs-cpg-1018-announces-first-participant-dosed-in-phase-2-clinical-trial-in-taiwan-301213721.html