China-developed monoclonal antibody treatment targeting COVID-19 completes subject dosing in phase 1 trial
By Chen Shasha and Yin Yeping Source: Global Times Published: 2020/7/13 16:53:40
All human participants in a phase 1 clinical trial for a China-produced monoclonal antibody treatment targeting COVID-19 have received the treatment, announced one of its developers, Chinese biopharmaceutical company Junshi Biosciences, on Monday. No dose-limiting event (DLE) has been observed as of Sunday, the company said, indicating good tolerability and safety.
Jointly developed by Junshi Biosciences and the Institute of Microbiology under the Chinese Academy of Sciences, it is believed to be the world's first neutralizing antibody to enter clinical trials with healthy human subjects following trials involving non-human primates. A total of 40 healthy subjects were involved in the clinical trials, according to a statement sent by Junshi to the Global Times.
The phase 1 trial is a randomized, double-blind and placebo-controlled study and is being led by Zhang Wenhong, a prominent Chinese infectious disease expert from Shanghai's Huashan Hospital and leader of the city's COVID-19 expert team, and Zhang Jing, director of Huashan Hospital's phase 1 clinical research center, according to the company's statement.
The company plans to initiate a phase 1b trial involving mild COVID-19 patients, and phase 2 and 3 trials involving severe and critical patients soon. It will also start research into the prophylactic potential of the treatment in the high-risk population.
CEO of Junshi Biosciences Li Ning told the Global Times that the company aims to complete early-stage clinical research as soon as possible in the third quarter of this year, and that subsequent research will be advanced depending on the development of the pandemic.
"The safety and efficacy data obtained in early clinical trials will make it possible for patients to use our medicines through an accelerated review process under special circumstances," Li said.
Clinical trials in the US began in the second quarter. Li told the Global Times that Junshi will also carry out clinical research overseas, including in Southeast Asia and Eastern Europe, so as to complete the treatment's development and bring the product to the market as soon as possible.
Neutralizing antibodies are produced by human B lymphocytes, said Junshi COO Feng Hui. When pathogenic microorganisms invade cells, these antibodies can bind to antigens on the surface of the microorganisms and "neutralize" them.
When the neutralizing antibodies produced by the human immune system are insufficient, the antibody drugs will act as reinforcement to the immune system. These antibody drugs, if they are successfully developed, will not only treat COVID-19 but also prevent infection, according to Feng.
The neutralizing antibodies have captured the world's attention since the early stage of the outbreak due to the possible breakthrough they represent in the treatment of COVID-19. Other medical groups such as the expert teams led by Xie Xiaoliang with Peking University were also among the earliest to study the antibodies after the outbreak.
Several groups are now conducting research into neutralizing antibodies, though the study by the Chinese Academy of Sciences and Junshi was the first to enter clinical trials. Others are following and are expected to see progressive outcomes this year, a source with the China Medicinal Biotech Association told the Global Times on Monday.
"China is leading in the study of the neutralizing antibodies for the prevention and control of COVID-19, and with the successful completion of its early trials, mass production can be expected in the second half of the year," he said.
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