- Will enter clinical trials upon IND approval from the Ministry of Food and Drug Safety on the 23rd. Preparing for subsequent clinical trials in tandem
- Infectious Internal Medicine Professor Myoung-Don Oh participating as head of clinical research for thorough evaluation of safety and immunogenicity
SK bioscience and Seoul National University Hospital will be cooperating in the development of the COVID-19 vaccine.
SK bioscience (CEO: Jae-Yong Ahn) announced on December 2nd that it has signed a business agreement with Seoul National University Hospital to conduct Phase 1 clinical trials of “NBP2001,” a COVID-19 vaccine candidate self-developed by SK bioscience. This is in response to the Ministry of Food and Drug Safety's IND approval on November 23rd to carry out Phase 1 clinical trials, followed by 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 Phase 1 clinical trials evaluating the 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 head of clinical research.
SK bioscience expects a successful outcome for the Phase 1 clinical trials 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 in Jongno-gu, Seoul, 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.”
SK bioscience CEO Jae-Yong Ahn 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 nonclinical 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. Hong Jeong Ju 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 patients. 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 synthetic antigen vaccine stabilized through protein culture and purification.
In addition to “NBP2001,” SK bioscience is conducting nonclinical trials for another COVID-19 vaccine candidate, “GBP510,” with aims to begin clinical trials within this year, having received support from the Bill & Melinda Gates Foundation last May.