Shanghai, September 12, 2022 – BA-CovMab injection, the broad-spectrum neutralizing antibody developed by Luye Pharma Group subsidiary Boan Biotech for use against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has been approved for clinical trials by China’s National Medical Products Administration. BA-CovMab is highly potent in neutralizing 18 variants of the virus, including D614G, Alpha, Beta, Delta, and Omicron BA.1 through BA.5. It is expected to become a potent agent against the current and future variants of the virus.
BA-CovMab is highly potent in neutralizing diverse variants and shows excellent efficacy in the mouse model of SARS-CoV-2 infection
The coronavirus (CoV) disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has posed a serious threat to public health and global economy. BA-CovMab is a recombinant human monoclonal neutralizing antibody identified through the sequential immunization and sequential screening with the Spike ectodomain proteins or Receptor-Binding Domain (RBD) proteins from multiple SARS-CoV-2 variants. The antibody can specifically bind to the RBD in Spike proteins and effectively block the virus from binding to the host cell’s ACE2 receptor, thereby preventing the SARS-CoV-2 virus from entering the host cells. Cryo-electron microscopy studies show that BA-CovMab avoids most mutation-sensitive sites in the RBD of SARS-Cov-2 spike protein and can broadly and effectively neutralize diverse SARS-CoV-2 variants with a lower risk for loss of neutralizing activity against future variants.
Based on the results of preclinical pharmacodynamic studies there were several findings - 1) an in vitro pseudovirus-based neutralization assay shows that BA-CovMab could effectively neutralize 18 SARS-CoV-2 variants, and the IC50 values for Omicron BA.1, BA.2, BA.2.12.1, BA.2.13, BA.2.75, BA.3, BA.4 and BA.5 were 1.24-5.52 ng/mL; 2) an in vitro authentic-based neutralization assay shows that BA-CovMab was excellent in neutralizing Omicron BA.1 and BA.2, with the IC50 values as 53.20 ng/mL and 18.17 ng/mL respectively; 3) BA-CovMab had high affinity to the RBD proteins of 9 SARS-CoV-2 variants, including the wild-type(WT) strain, B.1.1.7, B.1.351, P.1, B.1.617.2, as well as Omicron B.1.1.529, C.37, B.1.621 and B.1.617.1, and maintained high blocking activity against 8 out of 9 SARS-CoV-2 variants tested apart from B.1.621; 4) an efficacy study against authentic viruses in mice shows that BA-CovMab could effectively prevent and treat infection by Omicron BA.1 and BA.2, as it significantly reduced lung virus titers by 2-3.5 log10 (p<0.005) in the infected animal models, indicating that the viruses were basically eliminated from the lung and the antibody provided excellent protection.
BA-CovMab’s rapid development was due to Boan Biotech’s Technology Platform
It has been over two years since the emergence of COVID-19 pandemic in 2019. Although multiple vaccines and therapeutic drugs have been granted Emergency Use Authorization (EUA) or approval for therapeutic or preventive use, the continuous mutation in the virus enhances its infectivity and escape ability, which has compromised the effects of approved vaccines and impaired the efficacy of neutralizing antibody treatments, resulting in high infection rate. The Omicron variant, which has spread rapidly, is currently the dominant variant around the world. Compared with previous variants, approved vaccines and most neutralizing antibodies have lost their neutralizing activities against Omicron, either partially or completely. The emergence of SARS-CoV-2 variants has underscored the urgent need for next-generation mAb therapeutics able to broadly neutralize current and future variants.
Using its human antibody transgenic mouse and phage display platforms, Boan Biotech completed neutralizing antibody screening and identified an excellent candidate, BA-CovMab within a short time period, which further confirms its efficient and innovative capabilities for novel drug development.
Dr. Dou Changlin, R&D President and Chief Operating Officer of Boan Biotech, said: "Since the start of the COVID-19 pandemic, we responded quickly to calls from the government to discover and develop neutralizing antibodies against SARS-CoV-2, using the company’s proprietary Human Antibody Transgenic Mouse and Phase Display Technology Platform. We are delighted to see that R&D progress with BA-CovMab has received recognition from relevant authorities and experts. Given the excellent preclinical research data for BA-CovMab, we are accelerating clinical research and development for the drug and doing our utmost to make the greatest possible contribution to COVID-19 prevention and treatment efforts in China.”
About Boan Biotech
As a subsidiary of Luye Pharma Group, Boan Biotech is a fully integrated biopharmaceutical company that specializes in developing, manufacturing and commercializing therapeutic antibodies with a focus on key therapeutic areas including oncology, autoimmune diseases, ophthalmology, and metabolism. The company’s antibody discovery is based on three technology platforms: Human Antibody Transgenic Mouse and Phage Display Technology Platform, Bispecific T-cell Engager Technology Platform and ADC Technology Platform. The company has built a robust pipeline including multiple innovative antibodies protected internationally for intellectual property rights as well as biosimilars. Its first biologic product Boyounuo® (Bevacizumab Injection) has been launched in China.
Boan Biotech operates across the entire value chain of the industry from antibody discovery, cell line development, upstream and downstream process development, analytical and bio-analytical method development, technology transfer to pilot and commercial scale production. In addition to China, the company is also developing biopharmaceutical products in the U.S. and the EU countries.