Junshi Biosciences is carrying out the development of the investigational medicine in Greater China, while Lilly is leading development in the other parts of the world
Eli Lilly and Company's Corporate Center in Indianapolis, Indiana. (Credit: Momoneymoproblemz/Wikipedia.)
Eli Lilly and Company (Lilly) in partnership with Junshi Biosciences, a biopharmaceutical company, has dosed the first healthy volunteer in a Phase 1 study evaluating potential Covid-19 antibody therapy, dubbed JS016.
JS016 is jointly developed by Junshi Biosciences and Institute of Microbiology, Chinese Academy of Science. Junshi Biosciences is carrying out development in Greater China, while Lilly is leading development in the other parts of the world.
Lilly chief scientific officer and Lilly Research Laboratories president Daniel Skovronsky said: “There is much we still don’t know about COVID-19.
“The best path to learn more about the potential for neutralizing antibodies, either as monotherapy or in combination, is through carefully controlled randomized trials. We look forward to the results of such trials in the coming months.”
JS016 specifically binds to the SARS-CoV-2 surface spike protein receptor binding domain
The investigational medicine JS016 is a recombinant fully human monoclonal neutralizing antibody that has been modified to eliminate effector function.
JS016 specifically binds to the SARS-CoV-2 surface spike protein receptor binding domain and blocks the binding of viruses to the ACE2 host cell surface receptor.
Lilly will hold exclusive global rights to the drug, except in china, and intends to start dosing patients in a complementary Phase 1 study in the US in the future.
The clinical studies are aimed at evaluating the safety, tolerability, pharmacokinetics and immunogenicity of JS016 in healthy participants who have not been diagnosed with Covid-19.
Lilly said that JS016 is its second neutralising antibody to reach clinical trials, after LY-CoV555 that recently evaluated in Phase 1 trials and currently being tested in hospitalised Covid-19 patients.
The investigational medicine LY-CoV555 is a neutralising IgG1 monoclonal antibody (mAb), developed under collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of Covid-19.
According to the company, as JS016 and LY-CoV555 bind different epitopes on the spike protein, their use would expand the diversity of options for achieving efficacy and avoiding resistance.