Boan Biotech has announced significant progress with LY-CovMab, a neutralizing antibody independently developed for the treatment of COVID-19. LY-CovMab has been preliminarily validated for effectively inhibiting infections of Alpha (B.1.1.7),Delta (B.1.617.2), Gamma (P.1), Lambda (C.37) and other SARS‑CoV‑2 strains, and is expected to be a powerful weapon against these strains. The investigational drug has been approved for phase II clinical trials in China.
Since the outbreak of the pandemic, multiple variants of the virus have emerged worldwide. Among them, the Alpha variant, first discovered in the UK, the Gamma variant, first discovered in Brazil, and the Delta variant, first discovered in India, are included on the WHO’s list of “Variants of Concern”, while the Lambda variant, first discovered in Peru, is listed among “Variants of Interest”. The Lambda variant is rapidly spreading in dozens of countries, while the Delta variant is currently the main variant sweeping in China and around the world. There is an urgent need for the fast development of SARS-CoV-2 prevention and treatment drugs to address the clinical needs arising from the COVID-19 pandemic.
LY-CovMab is a type of human monoclonal neutralizing antibody that binds specifically to the SARS-CoV-2 spike protein receptor binding domain with high affinity, and can effectively prevent the virus from entering human cells by blocking its attachment to ACE2 receptors on the host cell surface. According to research done on in vitro virus neutralization activity and human serum drug concentration at different blood collection time points in phase I clinical trials, preliminary results showed that LYCovMab is able to inhibit infections of Alpha, Delta, Gamma, Lambda and other strains.
Demonstrating Good Efficacy, Phase II Trials for LY-CovMab are Planned in Multiple Countries
Neutralizing antibody therapy has both prophylactic and therapeutic value. In contrast to small-molecule drugs and plasma therapy, neutralizing antibodies have higher specificity and better safety profiles, and are expected to become a “silver bullet” for treating coronavirus infection. Working full steam ahead on development of LY-CovMab since the outbreak of the pandemic, Boan Biotech is one of the first innovative biopharmaceutical companies in China to develop a neutralizing antibody against SARS-CoV-2. The company plans to conduct phase II clinical trials for LY-CovMab in multiple countries around the world.
The preclinical pharmacodynamics study of LY-CovMab shows that it is effective for both therapeutic and prophylactic use against SARS-CoV-2 infection, and can effectively cope with multiple variants. In addition, LY-CovMab can reduce the antibody-dependent enhancement effect (ADE) due to the special design of its Fc region. The Phase I clinical study completed in China demonstrated LY-CovMab has a good safety and tolerability profile.
Based on its demonstrated high potential for 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. In addition, a research paper on LY-CovMab has been published in Communications Biology, a sub-journal of the international authoritative journal Nature.
Boan Biotech's Patented Technology Platform Boosts Antibody Development
LY-CovMab was developed using Boan Biotech’s Human Antibody Transgenic Mouse and Phage Display Technology platform. The Human Antibody Transgenic Mouse, BA-hMab, is a proprietary technology of Boan Biotech and leads the field in China. Antibodies derived from BA-huMab do not require antibody humanization process. The high activity candidate antibody LY-CovMab was obtained within50 days via this platform, representing a significant acceleration of the overall antibody development process.
Dr. Dou Changlin, R&D President and Chief Operating Officer of Boan Biotech said, “The COVID-19 pandemic poses a tremendous threat to global public health. Since the outbreak, we have been racing the clock to help combat the virus with a neutralizing antibody in a bid to contribute to its prevention and control. We are now rapidly advancing with the international multi-center clinical study of LY-CovMab, aiming to accelerate the product’s global development and launch to help guard human health in the global fight against the virus.”