Policy & Regulation
EuBiologics Receives IND Approval for Phase I/II Clinical Trial of 'EuCorVac-19' in Korea
21 January 2021 - - South Korea-based biotechnology company EuBiologics's (KOSDAQ: 206650) EuCorVac-19, a COVID-19 vaccine candidate developed by EuBiologics, has been approved to conduct Phase I/II clinical trials by the Ministry of Food and Drug Safety, immediately entering into the Phase I trial, the company said.

The Phase I trial is designed for 50 healthy adults aged from 19 to 50 years old and will be conducted at 'the Catholic University of Korea Eunpyeong St. Mary's Hospital' evaluating safety, tolerance and immunogenicity.

The Phase II trial will be subsequently carried out for 230 adults aged from 19 to 75 years old in four hospitals located in Seoul metropolitan area in order to evaluate dosage and vaccine immunogenicity.

EuCorVac-19 under development by EuBiologics is a safe vaccine formulated with the coronavirus spike protein using the recombinant protein technology and with a potent adjuvant, similar to the other virus vaccines already licensed in the world.

EuCorVac-19 is a liquid injection in glass vials and can be stored and distributed at refrigerated temperatures which can take advantage of the general distribution system for biopharmaceuticals.

EuBiologics plans to consult with the Korean Ministry of Food and Drug Safety in order to progress the Phase III clinical trial later this year based on the interim results of the Phase I/II trial available no later than June 2021 and receive an emergency use approval of EuCorVac-19, as early as possible.

EuBiologics also has a GMP accredited facility which can manufacture recombinant protein antigens and adjuvants.


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