EuBiologics to file for phase 3 trial of homegrown COVID-19 vaccine

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EuBiologics, the South Korea-headquartered biopharmaceutical company, has reportedly sought the approval of the Ministry of Food and Drug Safety to conduct the phase 3 clinical trial of its homegrown COVID-19 vaccine candidate.

As per EuBiologics’ regulatory filing, the clinical trial of its vaccine candidate, dubbed EuCorVac-19, would include 4,000 participants. The company would compare EuCorVac-19 with AstraZeneca’s vaccine to assess its safety and efficacy, as per reports.

EuCorVac-19 is a recombinant protein vaccine that has been developed by leveraging genetic recombination technology, reports suggest. The vaccine’s surface antigen supposedly induces the immune cells to produce neutralizing antibodies in order to combat COVID-19.

For the uninitiated, EuBiologics has been working on EuCorVac-19 since July 2020. The vaccine, which uses synthetic antigens, takes a specific RBD site as an antigen and works by using liposomes as carriers, the company explained.

Baik Yeong-ok, the CEO of EuBiologics, stated that they added immunologic adjuvant “EcML” to the vaccine and optimized the antibody production rate. The company then used the antigen delivery platform through joint venture POPBio and utilized liposomes as antigen carriers, Baik added.

Evidently, in June this year, EuBiologics completed the phase 1 clinical study and commenced the phase 2 clinical trial for EuCorVac-19. The company has administered the drug candidate to 230 healthy adults until now, according to its statement.

As per reliable sources, results for the phase 2 clinical study are slated for release in November 2021.

If the Vaccine Bio Research Institutes and the International Vaccine Institutes publish the interim results for the phase 2 clinical trials, EuBiologics would apply for the phase 3 study this week, Baik stated.

It is worth noting that, upon approval, EuBiologics would become the second company after SK Bioscience to venture into a phase 3 clinical trial of a self-developed COVID-19 vaccine. Reportedly, EuBiologics also plans on seeking regulatory approval for phase 3 clinical trials of EuCorVac-19 in foreign countries.

Additionally, EuBiologics has apparently revealed its plans to add a 1,000-liter culture line in its second plant situated in Chuncheon, Gangwon Province. Following this expansion, the firm would have a production capacity of about 100 to 200 million EuCorVac-19 doses, according to reports.

Source credits: http://www.koreaherald.com/view.php?ud=20211013000976&np=1&mp=1