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.”
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About Boan Biotech
Established in 2013 as a holding subsidiary of Luye Pharma Group, Boan Biotech is a fully integrated biopharmaceutical company. It specializes in therapeutic antibody development with a focus on oncology, immunology, pain, and endocrine diseases. Boan Biotech’s antibody discovery work is based on three technology platforms: Human Antibody Transgenic Mouse and Phage Display Technology, Bispecific T-cell Engager Technology, and ADC Technology. Through leveraging its efficient innovative capabilities, the company has developed more than 10 innovative antibody product candidates with international intellectual property protection, and 8 biosimilar products.
Boan Biotech has expertise in the full industry chain: antibody generation, lead optimization, cell line development, upstream and downstream process development, analytical development, technology transfer, pilot production, and commercial manufacturing. Outside of China, Boan Biotech also pursues biopharmaceutical development in the US and European markets.
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.”
###
About Boan Biotech
Established in 2013 as a holding subsidiary of Luye Pharma Group, Boan Biotech is a fully integrated biopharmaceutical company. It specializes in therapeutic antibody development with a focus on oncology, immunology, pain, and endocrine diseases. Boan Biotech’s antibody discovery work is based on three technology platforms: Human Antibody Transgenic Mouse and Phage Display Technology, Bispecific T-cell Engager Technology, and ADC Technology. Through leveraging its efficient innovative capabilities, the company has developed more than 10 innovative antibody product candidates with international intellectual property protection, and 8 biosimilar products.
Boan Biotech has expertise in the full industry chain: antibody generation, lead optimization, cell line development, upstream and downstream process development, analytical development, technology transfer, pilot production, and commercial manufacturing. Outside of China, Boan Biotech also pursues biopharmaceutical development in the US and European markets.
