Computational engineering of the anti-SARS-CoV-1 antibody 80R (Hwang et al, 2006) was done to produce monoclonal antibodies that bind specifically to the SARS-CoV-2 spike (S) protein and to SARS-CoV-2 variants, but not to SARS-Cov-1. These new monoclonal antibodies were selected based on their specificity to different variants of SARS-Cov-2, and several monoclonal antibodies with broad specificity were made. These novel monoclonal antibodies have been tested against wild-type, Wuhan S6P, Delta, South African SP6, and Omicron variants. One monoclonal antibody binds strongly to all tested variants and one monoclonal antibody binds to 4 of 5 tested variants.
The plasmids for expressing the various monoclonal antibodies are available for licensing. Theses anti-SARS-CoV-2 monoclonal antibodies may be useful for diagnostic tests, research, quality control, therapeutics, and vaccine development. In addition, the antibodies may be useful for identifying antigens or epitopes specific for a spike protein subtype of a SARS-CoV-2 variant virus responsible for infection, and for validating the conformation of antigenic proteins.
|Potential Commercial Applications
Development Stage: Monoclonal antibodies, expression plasmids, and in vitro characterization data
Inventors: Zuben Sauna, Wojciech Jankowski, and Nancy Hernandez (FDA); Jeffrey Gray and Rahel Frick (Johns Hopkins University); and Roland Dunbrack and Simon Kelow (Fox Chase Cancer Center)
New manuscript in preparation; unpublished as of August 2022
Intellectual Property: U.S. provisional application 63/351,312 was filed June 10, 2022
Product Area: Research tools, diagnostic assays, vaccine development, and therapeutic antibodies
FDA Reference No: E-2022-006
FDA Technology Transfer Program