Boan Biotech to Start Phase II Clinical Trial in U.S. for Neutralizing Antibody Against SARS-CoV-2

Luye Pharma Group today announced that its subsidiary Boan Biotech has submitted the investigational new drug (IND) application for a self-developed drug LY-CovMab to the U.S. Food and Drug Administration. LY-CovMab is an innovative investigational biological antibody for the treatment of COVID-19. 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. Since February 2021 Boan Biotech has been working flat out on the development of LY-CovMab, in the hope of contributing its expertise to the global battle against the virus.

Preliminary Validation as Effective, Safe and Capable of Coping with Viral Mutations

LY-CovMab is a human monoclonal neutralizing antibody that specifically binds to the SARS-CoV-2 surface spike protein receptor binding domain with high affinity, and can effectively block the attachment of the virus to the host cell surface receptor ACE2. The preclinical pharmacodynamics study of LY-CovMab shows that it is effective for both therapeutic and prophylactic venues against SARS-CoV-2 infection, and can effectively cope with multiple viral mutations. In addition, LY-CovMab can effectively reduce the antibody-dependent enhancement effect (ADE), due to a special design for its Fc region. Phase I clinical study completed in China demonstrated LY-CovMab has a good safety and tolerability profile.

This submission in the U.S. is to start a phase II study evaluating the efficacy, safety, tolerability, pharmacokinetics and immunogenicity of the LY-CovMab injection in patients with mild to moderate COVID-19. It is designed to further validate LY-CovMab’s safety and efficacy and will enroll 150 subjects.

A research paper on LY-CovMab has been published in ‘Communications Biology’, a sub-journal of international authoritative journal ‘Nature’. In addition, based on the demonstrated high potential of its therapeutic and prophylactic effects, LY-CovMab has been included in the COVID-19 Neutralizing Antibody Emergency Projects by the Ministry of Science and Technology of China.  

According to a report by the U.S. Consumer News and Business Channel (CNBC) on 3 May 2021, the World Health Organization recently stated that it is closely following 10 new coronavirus variants around the world. These variants are regarded as significant potential threats to global public health. Among them, the B.1.1.7 variant which was first detected in the U.K. in December 2020 occurs at a relatively high frequency. The recent research show that LY-CovMab has good neutralization potency against the B.1.1.7 variant.

Highly Efficient Technology Platform Aids Global Fight Against Virus  

To date, there have been more than 170 million infections and 3.8 million deaths from COVID-19 worldwide. There is an urgent need for the global development of new prevention and treatment drugs to address the clinical needs of the pandemic.

In comparison with COVID-19 vaccines and antiviral drugs, neutralizing antibody therapy has both prophylactic and therapeutic value. In addition, neutralizing antibodies for prophylaxis can produce immediate passive immunity and are expected to provide 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 carriers.

Dr. Dou Changlin, R&D President and Chief Operating Officer of Boan Biotech, said, “The COVID-19 pandemic is a tremendous threat to global public health. Since the outbreak, Boan Biotech’s rapid development of neutralizing antibody has been a race against the threat. Thanks to our own Human Antibody Transgenic Mouse and Phage Display Technology platform, we were able to develop this high-activity candidate antibody in merely 50 days. Antibodies derived from BA-hMab™, the company's human antibody transgenic mice, do not need to go through the antibody humanization process. This represents a significant acceleration in the overall antibody development process. We will accelerate the international multi-center clinical study of LY-CovMab for the early global launch of the drug. This will be our contribution to the global fight against the virus and the protection of human health.”

In addition to the U.S., phase II clinical studies for LY-CovMab will be conducted in China and Europe, to provide an effective treatment to patients around the globe.