SK bioscience will enter clinical trials of NBP2001 upon the IND approval from the Ministry of Food and Drug Safety(KMFDS) on the 23rd.

SK bioscience announced on December 2nd that the company has signed an agreement with Seoul National University Hospital to conduct a Phase I clinical trial of ‘NBP2001,’ a COVID-19 vaccine candidate self-developed by SK bioscience.

This is in response to the KMFDS´ IND approval on November 23rd to conduct a Phase I clinical trial, followed by the approval from the Institutional Review Board (IRB) of Seoul National University Hospital on the 27th.

According to the agreement, Seoul National University Hospital will enter a Phase I clinical trial evaluating safety and immunogenicity of NBP2001 in healthy adults. Infectious Internal Medicine Professor Myoung-Don Oh of Seoul National University Hospital and Professor Eu Suk Kim of Infectious Internal Medicine at Bundang Seoul National University Hospital will participate as heads of clinical research.

SK bioscience expects a successful outcome for the Phase I clinical trial in cooperation with Seoul National University Hospital, while already beginning preparation for subsequent clinical trials.

At the agreement ceremony held at the Korean Clinic of Seoul National University Hospital, Seoul National University Hospital Director Yon Su Kim said, “We plan to actively support medical staff so they can totally devote themselves to researching safe and effective vaccines.”

Jaeyong Ahn, CEO of SK bioscience said, “We look forward to cooperating with excellent researchers at Seoul National University Hospital to thoroughly verify the safety and immunogenicity of NBP2001, and to proceed with subsequent clinical trials as soon as possible. In preclinical trials of NBP2001, SK bioscience has secured results exceeding expectations.”

Last August, an efficacy trial targeting primates conducted by a research team led by Dr. Jeong Ju Hong of the Primate Center at the Korea Institute of Bioscience & Biotechnology confirmed that NBP2001 was able to induce 10 times more neutralizing antibodies than what was found in the serum of fully recovered COVID-19 subjects. When primates were directly administered with COVID-19, the control group receiving placebo resulted in 100% infection, while the group with neutralizing antibodies induced by NBP2001 was able to prevent the virus from spreading to the lungs and respiratory system.

SK bioscience expects to secure a high safety profile in clinical trials since NBP2001 is a recombinant protein-based vaccine stabilized through protein culture and purification.

In addition to NBP2001, SK bioscience is conducting preclinical trials for another COVID-19 vaccine candidate, GBP510, with aims to begin clinical trials within this year, with support from the Bill & Melinda Gates Foundation.