Type: Telecombinant fully human-monoclonal neutralizing antibody, modified to diminish effector function. JS016 is designed to specifically bind to the SARS-CoV-2 surface spike protein receptor binding domain, effectively blocking the binding of viruses to the ACE2 host cell surface receptor.
Status: Junshi Biosciences said July 12 that it completed enrollment in a Phase I trial (NCT04441918) of JS016, which according to the company is the first COVID-19 neutralizing antibody to enter clinical trials in China, and the first neutralizing antibody entering clinical trial in healthy subjects in the world. During the second quarter, JS016 entered into U.S. clinical trials that were overseen by Eli Lilly.
The Phase I trial is a randomized, double-blind, placebo-controlled study designed to investigate the safety and tolerability of a single dose JS016 intravenous injection in 40 healthy subjects in four dosing groups. The first patient was enrolled on June 7 at Huashan Hospital Affiliated to Fudan University in China. Junshi said no dose-limiting events had been observed as of July 12.
Junshi said it plans to initiate a Phase Ib trial in non-severe COVID-19 patients and Phase II/III trials in severe and critical patients “soon.” Simultaneously, the company disclosed plans to investigate the prophylactic potential of JS016 in high-risk populations.
The antibody treatment is being co-developed by the companies, with Junshi leading development in Greater China, and Lilly holding rights in the rest of the world—including the U.S., where it plans to begin dosing the first patient in a complementary clinical trial. Both studies aim to assess the safety, tolerability, pharmacokinetics, and immunogenicity of JS016 in healthy participants not been diagnosed with COVID-19.
JS016 is part of Lilly’s COVID-19 clinical development program, through which the pharma is creating a portfolio of monotherapy and combination or “cocktail” antibody regimens that could combine JS016 with LY-CoV555, being codeveloped with AbCellera, and additional antibodies now in preclinical development.
JS016 was jointly developed by Junshi with the Institute of Microbiology, Chinese Academy of Science (IMCAS). According to Junshi, preclinical research has shown JS016 to express extremely high specific affinity (on a level of nM) to the SARS-CoV-2 receptor-binding domain on the spike protein blocking the virus from invading host cells. A study published in Nature showed JS016 protected rhesus monkeys from COVID-19 infection, suggesting a potential for prophylactic use in humans.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: