On June 5, 2020, China’s National Medical Products Administration (NMPA) officially approved the clinical trials for a fully human monoclonal antibodiy (mAb) against COVID-19 developed by a research team at the Institute of Microbiology of the Chinese Academy of Sciences (IMCAS).
Phase I clinical trials will be carried out to test safety and appropriate doses in healthy human beings. This is also the first clinical trial of therapeutic mAb in healthy people after evaluating in non-human primate model around the world, indicating that the SARS-CoV-2 specific mAb with independent intellectual property rights in China has entered clinical evaluation on the human beings.
Since the mid-January, IMCAS has organized a number of research and technical teams to fight against COVID-19, including Prof. YAN Jinghua, and GAO Fu (George Fu Gao).
Dozens of fully human mAbs genes were isolated and identified from convalescent patients of COVID-19. After repeated tests and comparisons, two ideally specific mAbs were screened out with highly effective neutralization of SARS-CoV-2 in late-February.
The researchers assessed the potencies of the mAbs by using the rhesus monkey model. The results showed that the neutralizing mAbs effectively blocked the infection of SARS-CoV-2, significantly reduced the load of the new coronavirus in the respiratory tract of rhesus monkey, and protected lung damage caused by virus infection.
COVID-19 has spread rapidly in the world, and the number of infected people has exceeded 6.6 million. Scientists all over the world are making efforts to find drugs effective against the virus, but there is still no specific drug approved.
Neutralizing antibody is a specific immunoglobulin that targets pathogens and blocks pathogens from invading cells. It is an innovative specific drug developed for SARS-CoV-2. The clinical trials of mAbs have brought new hope to curb the spread of the virus.
The research was supported by China’s State Council, Chinese Academy of Sciences, China’s Ministry of Science and Technology, China’s National Health and Safety Commission, and Beijing Municipal Science and Technology Commission.
The development of therapeutic mAbs is based on breakthroughs in the basic research on virus-host interaction. Prof. YAN and GAO, together with the researchers from Wuhan Institute Of Virology of CAS, PLA General Hospital, Center for Disease Control and Prevention, Capital Medical University, Beijing Ditan hospital, and the others, published a research paper on the fully human monoclonal neutralizing antibody against SARS-CoV-2 online in Nature, on May 26, 2020.
There is still a long way to go from entering the human clinical trial stage to the final use of antibody drugs in the future.
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