Boan Biotech’s Neutralizing Antibody against SARS-CoV-2 Completes Phase I Clinical Trial in China, With Good Results in Safety and Tolerance

Luye Pharma Group today announced that the phase I clinical trial for LY-CovMab, an innovative antibody for the treatment of COVID-19, has been completed in China, with good results in safety and tolerance observed. LY-CovMab was developed by Boan Biotech, a holding subsidiary of the Group. Phase II clinical studies for the antibody are soon to start in China the U.S. and Europe, accelerating the R&D process in global markets to provide an effective treatment to patients as early as possible.

The COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) poses a tremendous threat to human health and the global economy. LY-CovMab is a human monoclonal neutralizing antibody that binds specifically to the receptor-binding domain in SARS-CoV-2 spike protein with high affinity, and can effectively block the attachment of the virus to the host cell surface receptor ACE2.

The clinical trial completed in China is a phase I clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and immunogenicity of a single dose LY-CovMab injection. The trial involved a total of 42 healthy Chinese subjects, with results showing that LY-CovMab has good safety and tolerance profiles, providing a clear reference and basis for future studies.

LY-CovMab shows high potential clinical value, with research results published in a sub-journal of Nature magazine

The results of a preclinical pharmacodynamics study show that LY-CovMab has good effects for both therapeutic and prophylactic venues against SARS-CoV-2 infection. LY-CovMab shows efficient neutralizing activities, and could effectively cope with multiple viral mutations. In addition, LY-CovMab could effectively avoid or reduce the antibody-dependent enhancement effect (ADE).

Based on the high potential clinical value of both therapeutic and prophylactic effects observed in the studies, LY-CovMab has been included in the COVID-19 Neutralizing Antibody Emergency Projects by the Ministry of Science and Technology of China. A research paper on the drug candidate was recently published in Communications Biology, a sub-journal of Nature magazine.

Boan Biotech’s patented technology platform boosts antibody development

LY-CovMab was developed using Boan Biotech’s human antibody transgenic mouse technology and phage display technology. These patented technologies lead the field in China. 

Antibodies derived from BA-huMab™, Boan Biotech's own human antibody transgenic mice, do not require the antibody humanization process. Through this platform, Boan Biotech was able to obtain the lead antibody against SARS-CoV-2 in less than 50 days. This represents a significant acceleration of overall antibody development process. In addition, LY-CovMab adopted a special design for the Fc region, which reduced the risk of ADE and improved the safety profile of the antibody.

Jiang Hua, Chief Executive Officer of Boan Biotech said: “Thanks to our patented technology platforms, which are the result of many years’ work, together with our in-house innovation capabilities, we were able to develop this high-affinity candidate antibody in a very short period of time. Boan Biotech is one of the first innovative biopharmaceutical companies in China to develop neutralizing antibodies against SARS-CoV-2. By accelerating the R&D and launch process of LY-CovMab, we aim to leverage our expertise to fight against COVID-19 and support public health needs.”