EuBiologics, developing a home-grown Covid-19 vaccine, said it would apply for a local phase 3 study of its vaccine candidate in several days.
The company said it would also apply for a global phase 3 trial of EuCorVac-19 to the Ministry of Food and Drug Safety within this week.
EuBiologics plans to use AstraZeneca’s Covid-19 vaccine as a comparative vaccine to evaluate its vaccine’s efficacy and safety.
Soon, the company will release the results of the Korea Mouse Phenotyping Center’s (KMPC) non-clinical trial of the vaccine candidate against Covid-19 virus variants.
“We completed the second administration of EuCorVac-19 in mid-September and blood collection, which came three weeks after the second jab. So we’re analyzing immunogenicity,” an official at EuBiologics said.
“We expect good results from the phase 2 study, and we will apply for a phase 3 study shortly.”
His comments are in line with the remarks of EuBiologics CEO Baik Yeong-ok, who was a speaker at the global pharmaceutical industry exhibition CPhl Korea on Monday.
“We are analyzing immunogenicity including neutralizing antibody at week 6. We recruited 100 participants each in the low-dose and high-dose groups, and plan to select the appropriate dose and reflect it in a phase 3 trial,” Baik said.
If the International Vaccine Institutes and the Vaccine Bio Research Institutes release the interim results of the phase 2 trial, the company will apply for a phase 3 trial within this week, he added. The phase 3 trials will be on 4,000 people in Korea and other countries, under the MFDS’ guidelines.
EuBiologics has been working on EuCorVac-19, a vaccine using synthetic antigens, since July 2020.
EuCorVac-19 took a specific RBD site as an antigen and uses liposomes as carriers, according to EuBiologics.
“We added immunologic adjuvant ‘EcML’ to EuCorVac-19 and maximized the antibody production rate by utilizing the antigen delivery platform by joint venture POPBio and using liposomes as antigen carriers,” Baik said.
While productions of other Covid-19 vaccines have to be consigned, he added that EuBiologics has completed preparing its second plant in Chuncheon, Gangwon Province, to mass-produce EuCorVac-19.