Clinical trials begin on neutralizing antibody treatment for coronavirus
Shanghai has begun clinical trials on a home-grown neutralizing antibody treatment for the coronavirus, offering hope to both affected and unaffected people.
The new drug, JS016, co-developed by Shanghai Junshi Biosciences and the Institute of Microbiology under the Chinese Academy of Sciences, was approved by the National Medical Products Administration over the weekend to begin phase-1 clinical trials.
On Sunday morning, the city’s Huashan Hospital gave JS016 to healthy volunteers through veins to test the drug’s safety, immunogenicity, and how the drug moves into, through and out of the body.
The program is the first of its kind to test the neutralizing antibody treatment against the coronavirus in uninfected people.
The test was led by the hospital’s Zhang Jing and Zhang Wenhong, who is also leader of the expert team for coronavirus treatment in Shanghai.
“After receiving the drug, the four recipients are now in good conditions,” professor Zhang Jing said. “We will strictly follow the plan to continue the tests. The results can help us to decide on the proper doses in affected people in following clinical trials.”
She didn’t reveal when the results may come out.
Dr Zhang Wenhong said it is expected to offer a new approach to treating affected people.
The company said it is also expected to protect healthy people with high infection risks, including the elderly and medical workers in ICU, from becoming infected.
“Previous tests showed JS016 can both treat and prevent infection. We are looking forward to seeing its effects further proved in clinical trials,” said researcher Liu Jinghua from the Institute of Microbiology under the Chinese Academy of Sciences.
Neutralizing antibody is produced by B cells lymph, dubbed as natural killer cells, in our immune system. When viruses invade cells, such an antibody will rush to bind to antigens on the virus surface, neutralize any effect it has biologically and prevent the virus from budding.
JS016 was isolated from recovered patients’ blood and engineered through advanced technologies such as single cell sequencing and flow cytometry.
Previous tests on monkeys showed JS016 can block coronavirus entering cells, and decrease the virus in lungs of affected monkeys. Even if excessive doses are given, the monkeys are still safe.