Boan Biotech Completes Enrollment of Subjects in Phase I Clinical Trial for Its Neutralizing Antibody Against SARS-CoV-2

Luye Pharma Group today announced that all subjects have been enrolled for the phase I clinical trial in China for LY-CovMab, an innovative antibody product developed by Shandong Boan Biotechnology Co. Ltd (Boan Biotech), a subsidiary of the Group. Boan Biotech is one of the first innovative biopharmaceutical companies in China to develop a neutralizing antibody against SARS-CoV-2.

The 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 fully human monoclonal neutralizing antibody, which specifically binds to the SARS-CoV-2 surface spike protein receptor binding domain with high affinity, and can effectively block the binding of the virus to the ACE2 host cell surface receptor.

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).

Neutralizing Antibody Therapy has both prophylactic and therapeutic value; LY-CovMab is included in MST’s Emergency Project

In contrast to COVID-19 vaccines and antiviral drugs, neutralizing antibody therapy has both prophylactic and therapeutic value. Since the protection rate of current COVID-19 vaccines cannot reach 100%, neutralizing antibody therapy will still be a useful treatment for COVID-19 patients after the vaccines become available.

One of the major advantages of neutralizing antibody therapy is its rapid effect. Compared to most COVID-19 vaccines that require two injections and take two months to produce a stable immune response, neutralizing antibodies for prophylaxis can produce rapid passive immunity and are expected to provide excellent protection for some high-risk groups unsuited for vaccination, or for those who come into close contact with COVID-19 patients or SARS-CoV-2 positive non-symptomatic people.

After the initial COVID-19 outbreak, Luye Pharma immediately donated money and supplies, and contributed its expertise to the battle against the virus through drug R&D and public welfare activities. Boan Biotech is one of the first innovative biopharmaceutical companies in China to develop a neutralizing antibody against SARS-CoV-2. China’s Ministry of Science and Technology included LY-CovMab in its COVID-19 Neutralizing Antibody Emergency Project. This will speed up the research and development process and future launch, offering a potential therapeutic option for patients. Outside China, Boan Biotech will also carry out clinical research on patients in the United States to support the launch of LY-CovMab in global markets.

Boan Biotech’s Patented Tech Platform Boosts Antibody Development

LY-CovMab was developed using Boan Biotech’s Fully-human Antibody Transgenic Mouse Technology and Phage Display Technology. These patented technologies lead the field in China.

The antibody screened out by BA-hMab, Boan Biotech's own fully human antibody transgenic mice, does not need to go through the conventional humanization process. It took less than 50 days from immunization to obtaining blocking antibodies. This represents a significant acceleration of overall antibody development process. In addition, LY-CovMab employs a special design for the Fc region, which can avoid or reduce ADE and the exacerbation of cytokine storm. This improves the safety profile of the antibody drug candidate and increases the prospects of its final approval.

Dr. Dou Changlin, Chief Operating Officer of Boan Biotech said: “Since the outbreak of the COVID-19 disease, Boan Biotech’s rapid development of LY-CovMab represents a race against the threat of the virus. Thanks to our superior patented technology platforms – the fruit of many years’ work – together with our exceptional in-house innovation capabilities, we were able to develop this high-affinity candidate antibody in a very short period of time. We are now working on process characterization and preparations for process validation to meet Biologic License Application filing requirements for China and overseas markets. We expect to be able to supply millions of patients around the world with this product– this will be our ‘Luye Wisdom’ contribution to the global fight against the virus.”

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About Boan Biotech

Established in 2013 as a 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 four technology platforms: Human Antibody Transgenic Mouse and Phage Display Technology, Bispecific T-cell Engager Technology, ADC Technology, and Nanobody Platform. 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. In addition, the company is investing in further cutting-edge technologies.  Outside of China, Boan Biotech also conducts biopharmaceutical development in the US and European markets.

Thanks to its exceptional in-house innovation capability, Boan Biotech has developed more than 10 innovative antibody product candidates with international intellectual property protection, and eight biosimilar products. One of the innovative antibody products is undergoing phase I clinical trial in China, while 4 others are expected to enter clinical trials soon. Among the company’s biosimilar products, a Biologic License Application has been submitted for LY01008 (biosimilar to Avastin®) in China. LY06006 (biosimilar to Prolia®) is undergoing comparative clinical studies (phase III clinical trials) in China and phase I clinical trials in Europe and the United States. Meanwhile, LY01011 (biosimilar to Xgeva®) and LY09004 (biosimilar to Eylea®) are also in comparative clinical studies (phase III clinical trials) in China.