EuBiologics said it has completed the administration of its Covid-19 vaccine candidate EuCorVac-19 in a local phase 2 study. The company plans to apply for a phase 3 trial in October, it said.
The phase 2 trial involved 230 healthy adults aged between 19 and 75. The study took place at the Catholic University of Korea St. Mary's Hospital, the Catholic University of Korea Bucheon St. Mary's Hospital, Soonchunhyang University Bucheon Hospital, Hanyang University Guri Hospital, and Ewha Womans University Seoul Hospital.
EuBiologics assigned 100 participants to the low-dose group, another 100 to the high-dose group, and the remaining 30 to the placebo group and checked EuCorVac-19’s safety and immunogenicity. The trial participants received two doses of vaccination at a three-week interval.
EuBiologics had a follow-up for eight or nine weeks after vaccination. The company expects to have the phase 2 trial results in November.
“We will apply for a phase 3 study at least by October,” an official at EuBiologics said.
Normally, a phase 3 trial application comes after getting the phase 2 trial results, but the company aims to speed up the phase 3 study, he added.
“We are discussing using AstraZeneca’s Covid-19 vaccine as the control vaccine in our trial.”
The official went on to say that Eubiologics has been working with Korea National Enterprise for Clinical Trials (KoNECT) for patient enrollment since the phase 2 study.
In January, the Ministry of Food and Drug Safety allowed EuBiologics to conduct a phase 1/2 trial. In February, the company tested the Covid-19 vaccine candidate in 50 healthy adults at the Catholic University of Korea Eunpyeong St. Mary’s Hospital.
EuCorVac-19 is a recombinant protein vaccine that induces an immune response by directly injecting the surface antigen protein of the Covid-19 virus. It is the same platform technology that SK Bioscience adopted for its vaccine candidate GBP510 in a phase 3 study.
In August. EuBiologics was selected as the final winner for the state project to support Covid-19 treatment and vaccine production facility under the Korea Innovative Medicines Consortium (KIMCo).
The company is adding a 1,000-liter culture line in its second plant in Chuncheon, Gangwon Province, with state support.
The company expects to manufacture 100 million to 200 million doses of vaccines annually if EuCorVac-19 gets commercialized.
EuBiologics is also developing a new vaccine candidate to fight variants of the Covid-19 virus.
The company discovered the new Covid-19 vaccine candidate, EuCorVac-19-SA, through the Ministry of Health and Welfare’s support program for non-clinical trials of Covid-19 treatments and vaccines in July.
The company tests the candidate’s effect in animal models with Seoul National University and Yonsei University under the Korea Mouse Phenotyping Center’s (KMPC) support and has nearly completed the non-clinical trial.