Junshi Biosciences of China has inked a licensing deal with Switzerland’s Lonza Group to secure their contract drug manufacturing technology to help produce a neutralizing antibody targeting COVID-19. The first neutralizing antibody against COVID-19 was created using Lonza’s GS Xceed, a gene expression system. Known as JS016, the antibody has entered clinical trials in China. The first volunteer was dosed on June 8th in a Phase 1 safety study. The investigational JS016 product is the result of a collaboration between Junshi Bioscience and American multinational Eli Lilly: Junshi sponsors the clinical trials in China and Lilly the rest of the world.
Lonza Business Booming
Lonza reports that due to its sophisticated facilities or its ability to license its technology, it has received dozens of inquiries to partner with biotech firms developing medicines targeting COVID-19. Large deals have already been executed, such as the one with Moderna to make up to one billion doses of its investigational vaccine targeting COVID-19.
On May 4th, 2020, both Eli Lily and Shanghai Junshi Biosciences announced the co-development partnership. Lilly sought to target the development Junshi undertook during the height of the pandemic in China. Junshi identified and engineered multiple neutralizing antibodies.
The Chinese Study Targeting JS016
Called Shanghai Junshi Biosciences, they are sponsoring a study, NCT04441918, a randomized, double-blind, placebo-controlled, Phase 1 clinical trial evaluating the tolerability, safety, pharmacokinetic profile and immunogenicity of JS016 (anti-SARS-CoV-2 monoclonal antibody) injections in healthy Chinese subjects after intravenous infusions of a single dose. Eligible patients will be injected with JS016.
The study commenced June 5th, 2020, and will run through December 2020. The principal investigational site is Huashan Hospital affiliated to Fudan University. Wenhong Zhang from Fudan University serves as the Principal Investigator.
Founded in 2012, Junshi Biosciences commits to the development of first-in-class and best-in-class drugs through original innovation and seeks to become a pioneer in translational medicine to provide patients with more effective and affordable treatment options. By December 24th, 2018, Junshi was listed on the Main Board of the Stock Exchange of Hong Kong with the stock code: 1877.HK. They have established a diversified pipeline of candidates, including 21 drug candidates and therapeutic areas covering cancer, metabolic diseases, autoimmune diseases, neurologic diseases, and infectious diseases.
Call to Action: TrialSite monitors the JS016 clinical trial—hopefully, results in the fall. This product could be similar to the REGV-COV2 monoclonal antibody developed by Regeneron.