China-based Luye Pharma Group (HKG: 2186) announced that its subsidiary Shandong BoAn Biotechnology Co., Ltd’s BA-CovMab, a broad-spectrum neutralizing antibody against COVID-19, has obtained clinical trial approval from the National Medical Products Administration (NMPA).
Mechanism of Action
BA-CovMab is a recombinant fully human monoclonal neutralizing antibody obtained through sequential immunization and screening of surface spike protein (Spike)/receptor domain (RBD) proteins of various mutants. It binds to the RBD region of the SARS-CoV-2 virus Spike protein, effectively blocking the virus’s binding to the host cell surface receptor ACE2 to inhibit infection. The antibody targets the conserved epitope of RBD, avoiding most mutation-sensitive sites, giving it broad neutralization ability against various SARS-CoV-2 variants and reducing resistance to future variants.
In Vitro and In Vivo Results
In vitro pseudovirus neutralization activity results showed that BA-CovMab could efficiently and broadly neutralize 18 SARS-CoV-2 variant strains, including Omicron BA.1, BA.2, BA.2.12.1, and BA.2.13. The pseudovirus neutralizing activity IC50 values for BA.3, BA.4, and BA.5 ranged from 1.24 to 5.52 ng/mL. True virus neutralizing activity results demonstrated excellent activity against Omicron BA.1 and BA.2 mutants, with IC50 values of 53.20 and 18.17 ng/mL, respectively. BA-CovMab has high affinity for the RBD of nine new coronavirus strains and high resistance to the other eight strains except B.1.621. Pharmacodynamic studies in mice showed that BA-CovMab can effectively prevent and treat Omicron BA.1 and BA.2 infections, significantly reducing the pulmonary live virus titer in animal infection models by 2 to 3.5 log10 (p<0.005), demonstrating an excellent protective effect.-Fineline Info & Tech
