China Commences Phase I Clinical Trials of Neutralizing Monoclonal Antibody-based Treatment for COVID-19

China Commences Phase I Clinical Trials of Neutralizing Monoclonal Antibody-based Treatment for COVID-19

The Institute of Microbiology at the Chinese Academy of Sciences (IMCAS) announced that its application for fully human monoclonal antibody clinical trials targeting COVID-19 has been approved by China’s drug regulatory authority called the National Medical Produts Administration. A domestically developed SARS-CoV-2 antibody-based investigational product now enters the Phase I clinical trials stage. Based on a recent press release, the information has some stealth appeal as the authors don’t share who they interviewed, and it isn’t clear if a commercial entity will ultimately become involved.  

Background

The Phase I clinical trial is designed so that the sponsor can test the safety and dosage of the neutralizing antibody among healthy participants; in the recent press release, IMCAS reports that this represents the world’s first neutralizing antibody treatment against COVID-19 among healthy people after non-primate experiments. Interestingly, the Global Times reported that an unnamed, Beijing-based immunologist told the press that this marks a breakthrough in the treatment of COVID-19 around the world. But why would the immunologists request to be anonymous?

More from the “Anonymous” Scientist

This “anonymous” scientists told the Global Times, “Monoclonal antibodies are generally very rarely used in the treatment of infectious diseases. Antibodies are sometimes used in the treatment of diphtheria, tetanus, even Ebola, but they either are antiserum or the plasma from recovered patients, not monoclonal.”

Stuck on IP

Moreover, the expert continued that both monoclonal antibodies “have their own unique structure and sequence in which the antibody binds to the antigen, and that uniqueness represents its intellectual property right.”

On to more IP discussion, the anonymous source suggested that this particular candidate’s intellectual property was secured in China as it was developed by research teams in that country. 

A Clue to the Source?

Then the story mentions on May 26, the journal Nature released research on antibodies of COVID-19 led by teams of experts form the Institute of Microbiology at the Chinese Academy of Sciences, Wuhan Virology institute, some top hospitals in Beijing, pharma companies and China’s Center for Disease Control and Prevention. The intellectual property, it would appear, emanates out of this research.

The Study

The May 26 study was titled “A Human Neutralizing Antibody Targets the Receptor Binding Site of SARS-CoV-2” and also lists the authors, so, more than likely, the anonymous source could be one of them—or someone associated with the group. Sounding promising, the researchers identified specific human monoclonal antibodies (MAbs) from a convalescent COVID-19 patient. Identified as CA1 and CB6 both demonstrated strong SARS-CoV-2-specific neutralization activity in vitro against SARS-CoV-2. Moreover, CB6 inhibited SARS-CoV-2 infection in rhesus monkeys at both prophylactic and treatment settings. Additional structural investigation revealed that CB6 recognizes an epitope that overlaps with angiotensin converting enzyme 2(ACE2)-binding sites in SARS-CoV-2 receptor binding domain (RBD), hence interfering with the novel coronavirus and its receptor interactions by both steric hindrance and direct interface-residue competition. Hence, this Chinese study team will more than likely pursue additional preclinical research.

Ready for Clinical Trials?

The Global Times piece suggests that the clinical research is further along, proposing that the neutralizing antibodies’ industrialization process is “smooth” with high confidence this intellectual property (IP) will contribute to global COVID-19 prevention. Note, however, that the institute stresses that the MAbs have “still a long way to go between entering into clinical trials to finally making the antibodies a usable medicine.”

This part of the press release read a bit awkward but TrialSite News will monitor this group for updates and more clarity.

Study Authors

Trial Site News includes the corresponding authors.

·         Fu-sheng Wang, Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing,

·         Qihui Wang, CAS Key Laboratory of Microbial Physiological and Metabolic Engineering, Institute of Microbiology, Chinese Academy of Sciences, Beijing

·         George Fu Gao, CAS Key Laboratory of Pathogenic Microbiology and Immunology, Institute of Microbiology, Chinese Academy of Sciences, Beijing, 

·         Zhiming Yuan. Center for Biosafety Mega-Science, Wuhan Institute of Virology, Chinese Academy of Sciences, Wuhan, Hubei 

·         Jinghua Yan, CAS Key Laboratory of Microbial Physiological and Metabolic Engineering, Institute of Microbiology, Chinese Academy of Sciences, Beijing

Call to ActionTrialSite News monitors COVID-19 and other interesting research in China via the TrialSite Network. For updates on this effort, sign up for the daily newsletter. We will monitor the Chinese Clinical Trial Registry as well for this study.

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