Inovio gets green light for Covid-19 clinical trials in Korea
The Plymouth Meeting, Pennsylvania-based company, Seoul National University Hospital (SNUH) and the International Vaccine Institute (IVI) signed a partnership agreement Thursday to conduct Phase 1 and Phase 2 clinical trials of Inovio’s vaccine candidate, INO-4800.
On Tuesday, Korea’s Ministry of Food and Drug Safety cleared the IVI's request to conduct the tests.
Headquartered in Seoul, the IVI is a non-profit under the United Nations Development Programme aimed to make vaccines available in all parts of the world. For this project, the organization helped design the clinical trial alongside SNUH, and will take part in analyzing the test results.
Exactly when clinical trials will start depends on how quickly enough people register to take part, said a spokesman from SNUH, which is in charge of carrying out the tests.
Phase 1 clinical trials will test the safety of the vaccine candidate on 40 healthy adults aged between 19 and 50, while Phase 2 tests will assess the tolerability — which measures how tolerable adverse affects of the drug are — and immunogenicity — the ability of the vaccine to provoke an immune response in the body — on a larger group of 120, aged between 19 and 64 years.
“If the proceedings are smooth, we’ll be able to publish the full trial results by August. I’m expecting a vaccine to roll out by December,” said SNUH President Kim Yon-su Thursday after a signing ceremony at the hospital in Jongno District, central Seoul.
The clinical trials in Korea received $6.9 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI), an international organization that supports efforts around the world to develop Covid-19 treatments and vaccines. The vaccine candidate is already undergoing Phase 1 clinical trials in the United States, after receiving a nod from the Food and Drug Administration in April.
“We will soon have Phase 1 data from the U.S. trial of INO-4800 and plan to begin Phase 2 or 3 trials in the mid-summer,” said Inovio President and CEO Dr. J. Joseph Kim. “We thank IVI and SNUH for their work to speed up the Korean trial of INO-4800.”
Clinical trials for a vaccine typically take years. Obtaining a permit to conduct the tests alone is a lengthy process that requires a long list of documents. The approval for the INO-4800, however, came only 12 working days after the IVI first submitted the documents, thanks to a “fast-track” approval process launched in April for clinical trials of Covid-19 vaccine candidates.
What also sped up the process was Inovio’s existing vaccine platform — which refers to the mechanism used to produce various types of infectious disease vaccines from a single system. INO-4800 was developed on the same DNA medicine platform on which the company had formerly produced a vaccine against the Middle East respiratory syndrome (MERS). This added credibility to INO-4800’s safety in the screening process, explained a statement from the IVI and SNUH.
BY SONG KYOUNG-SON [firstname.lastname@example.org]