U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Science & Research
  3. FDA Technology Transfer Program
  4. Licensing and Collaboration Opportunities
  5. Computationally Engineered Anti-SARS-CoV-2 Monoclonal Antibodies with High Binding Affinities
  1. Licensing and Collaboration Opportunities

Computationally Engineered Anti-SARS-CoV-2 Monoclonal Antibodies with High Binding Affinities

Download the Abstract (PDF - 123KB)

Technology Summary

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 Competitive Advantages
  • Immunoassays – diagnostic testing or as a research tool
  • Vaccine development
  • Therapeutic molecule to treat SARS-Cov-2 infection
  • Monoclonal antibodies specific to different SARS-CoV-2 variants’ spike proteins
  • Monoclonal antibodies with broad specificity to multiple SARS-CoV-2 variants’ Spike proteins

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)

Publications:

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

Licensing Contact:
FDA Technology Transfer Program
Email: FDAInventionlicensing@fda.hhs.gov

 

 

Back to Top