Shanghai's Junshi Biosciences (HK: 1877) dosed the first subject in a China Phase I trial of JS016, a SARS-CoV-2 neutralizing antibody. Two months ago, Junshi formed a collaboration with the Institute of Microbiology, Chinese Academy of Sciences (IMCAS) to partner development of the candidate. It then out-licensed ex-China development of JS016 to Eli Lilly (NYSE: LLY), which is close to starting US trials. JS016 was identified by screening blood from recovered COVID-19 patients. In preclinical tests, the candidate showed very high specific affinity to the SARS-CoV-2 receptor-binding domain, blocking the virus from invading host cells.

According to Junshi, JS016 is the first mAb to start China trials for COVID-19.

The trial is a randomized, double-blind and placebo-controlled study to evaluate JS016 in healthy subjects. If the results show the antibody can be administered safely, the Phase II trial will test the antibody’s ability to prevent and treat Covid-19.

Junshi said previous clinical trials for Ebola have shown that monoclonal neutralizing antibodies can substantially improve clinical symptoms and reduce the mortality of those infected. In an article published in the journal Nature, preclinical tests showed the candidate protected rhesus monkeys from Covid-19 infection.

Professor Zhang Wenhong from Huashan Hospital said: “Neutralizing antibodies can precisely target the SARS-CoV-2 virus, which may quickly prevent the virus from replicating in the human body. We hope to demonstrate the safety and tolerability of JS016 in Phase I and provide supporting data for additional clinical trials.”

Lilly is planning a clinical development program for JS016 that includes monotherapy and combination antibody regimen. The combinations will include JS016 and LY-CoV555, Lilly's other COVID-19 mAb, plus other proposed therapies. Lilly says JS016 and LY-CoV555 bind different epitopes on the spike protein, increasing the options for providing efficacy and avoiding resistance. The company has already begun Phase I testing of LY-CoV555.

See our other articles on Junshi and Lilly.

Disclosure: none.