EuBiologics: Phase III Clinical Trial IND Approval of EuCorVac-19, COVID-19 Vaccine Candidate, in South Korea
SEOUL, South Korea–(BUSINESS WIRE)–EuBiologics (KOSDAQ: 206650, CEO, Dr. Baik YoungOk, Mr. Seukkeun Choi), a South Korean biotech company, announced on Jan 28th that EuCorVac-19, a COVID-19 vaccine candidate developed by EuBiologics, obtained approval to conduct Phase III comparison clinical trials (Phase III IND Approval) from the Ministry of Food and Drug Safety in South Korea.
Eubiologics is able to commence Phase III comparison trial for 4,000 healthy participants including the Philippines, Bangladesh and other countries based on the standard comparison clinical trial guideline by the Ministry of Food and Drug Safety in Korea.
Eubiologics will work closely with the global CROs for recruiting the participants to expedite the entire process in low vaccination rate countries and will also expedite the trial result analysis to advance EuCorVac-19’s regulatory approval and commercialization.
Eubiologics is developing EuCorVac-19, its vaccine platform, which consists of owned antigen, EulMT in-licensed from Korea Institute of Science and Technology and SNAP technology of POP Biotechnologies that EuBiologics has invested. The company has announced Phase I/II trial interim results in December 2021.
On the other hand, as EuCorVac-19 has alre ady proved its safety and efficacy through Phase I/II clinical trial, the company expects to expedite the development of Omicron variant vaccine based on the same platform used for EuCorVac-19. Currently, the pre-clinical trial of Mouse immunogenicity test and TG mouse which is transformed from human gene are under progress and the company plans to proceed with the human trial within the 1st half of 2022. In addition, a booster vaccine is necessary due to the dominance of the Omicron variant, and thus the company will commence its trial to prove efficacy as a booster vaccine.
Eubiologics has 2 main animal-based bioreactors (1,000L) to produce recombinant protein antigens at Chuncheon Plant 1 and EcML which is adjuvant at Chuncheon Plant 2. The total capacity of COVID-19 vaccine is from 100M to 200M doses per year. EuCorVac-19 vaccine uses the same type of cell line which is for antibody treatment, so if the company uses these facilities, its manufacturing capacity can be further expanded.
A company official said, “The company has already had product supply MOUs with partners in the Philippines and Saudi Arabia, and many Asian, CIS, Latin American partners have shown a great interest in EuCorVac-19. Once the product is launched, the company will target the overseas markets that have high population and middle-income based on the product’s safety, efficacy and logistics convenience.”
Eubiologics has already received funds for Phase I/II (9.4billion KRW) March 2021 from the new drug development committee of the Ministry of Health and Welfare in Korea and recently submitted the application for phase III trial to get additional financial assistance.
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