Coronavirus antibody treatment enters clinical stage

The world's first healthy volunteer has been dosed in a phase-1 study of a SARS-CoV-2 neutralizing antibody. It was also the first antibody of this kind to enter the clinical stage in China.

Shanghai-based biopharmaceutical company Junshi Biosciences announced on Sunday its SARS-CoV-2 neutralizing antibody, named JS016, has entered clinical trials at Huashan Hospital Affiliated to Fudan University. Junshi and United States-based Eli Lilly and Co are collaborating to co-develop JS016 globally, with Junshi leading clinical development in China and Lilly leading clinical development in the rest of the world.

Neutralizing antibodies may have the potential to prevent and treat COVID-19. Previous clinical trials of agents developed to treat Ebola have shown monoclonal neutralizing antibodies can reduce viremia, attenuate virulence, substantially improve clinical symptoms and reduce the mortality of those infected.

Should phase-1 results show the antibody can be safely administered, the company intends to move to the next phase of testing to study the antibody’s ability to prevent and treat COVID-19.

Zhang Wenhong, professor at Huashan Hospital and also head researcher of the clinical study, 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-1 and provide supporting data for additional clinical trials.”

On April 28, the Ministry of Science and Technology issued a guideline on the emergency research and development of SARS-CoV-2 neutralizing antibody products, widely soliciting from society those with mature preclinical effectiveness, safety research foundation, high industrial conversion rate and ability to quickly enter clinical research.

JS016 was jointly developed by Junshi Biosciences and the Institute of Microbiology under the Chinese Academy of Sciences. The fully human monoclonal antibody was identified by screening blood samples of patients who recovered from COVID-19. A preclinical study showed JS016 expressed extremely high specific affinity to the SARS-CoV-2 receptor-binding domain on the spike protein blocking the virus from invading host cells.

A recent publication in Nature detailed the findings from a study showing JS016 protected rhesus monkeys from COVID-19 infection, suggesting a potential for prophylactic use in humans.

Li Ning, chief executive officer of Junshi Biosciences, said: "We are very pleased that we have achieved this key milestone through joint efforts. Our R&D and manufacturing teams have been working diligently, aiming to help the infected and the vulnerable as quickly as possible."

"Preclinical studies have shown JS016 has strong neutralizing and blocking ability, as well as prophylactic and treatment effect. We anticipate that JS016 could be further tested in clinical trials,” said Yan Jinghua, a co-developer of JS016 and a researcher at IMCAS.