Anti-coronavirus antibodies and methods of use
Inventors
WESTENDORF, Kathryn • ZENTELIS, Stefanie • MUTHURAMAN, Krithika • JEPSON, Kevin • FALCONER, Ester • Mascola, John • Graham, Barney • Corbett, Kizzmekia • Ledgerwood, Julie • Wang, Lingshu • ABIONA, Olubukola • Shi, Wei • Kong, Wing-pui • Zhang, Yi • Jones, Bryan Edward • FOSTER, Denisa • Davies, Julian • Chai, Qing • Frye, Christopher Carl • Gopalrathnam, Ganapathy • HENDLE, Jörg • SAUDER, John Michael • Boyles, Jeffrey Streetman • PUSTILNIK, Anna
Assignees
AbCellera Biologics Inc • United States, REPRESENTED BY SECRETARY Department Of Health And Human Svcs AS • Eli Lilly and Co • US Department of Health and Human Services
Publication Number
US-12172038-B2
Publication Date
2024-12-24
Expiration Date
2040-12-09
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Abstract
Antibodies that bind SARS-CoV spike protein, SARS-CoV-2 spike protein, and methods of using same for treating or preventing conditions associated with SARS or COVID-19 and for detecting SARS-CoV or SARS-CoV-2.
Core Innovation
The invention provides a large library of fully human anti-coronavirus antibodies, specifically targeting the spike protein of SARS-CoV-2, including antibodies that cross-react with SARS-CoV spike protein. These antibodies are recombinant in nature, derived from convalescent patient B cells, and formatted as full-length human IgG1 isotypes. The invention encompasses compositions of these antibodies, antigen-binding fragments, nucleic acid sequences encoding the antibodies, expression vectors, and host cells producing these antibodies, along with methods for diagnosing, treating, and preventing SARS and COVID-19.
The problem addressed arises from the urgent need to respond rapidly to pandemic viral outbreaks such as SARS-CoV-2. Traditional vaccine development and hybridoma methods for antibody discovery are limited by slow response times and manufacturing challenges, while antiviral monoclonal antibodies offer a viable strategy but with obstacles including high production costs and the rarity of potent neutralizing antibodies. This invention offers a high-throughput process to discover neutralizing, cross-reactive, and manufacturable antibodies suitable for therapeutic, prophylactic, and diagnostic applications, facilitating rapid pandemic response.
Claims Coverage
The patent claims focus on an antibody specifically binding to SARS-CoV-2 spike protein, detailing its variable region complementarity determining regions (CDRs), isotype, conjugates, pharmaceutical compositions, nucleic acids encoding the antibody, expression vectors, host cells, production methods, diagnostic and therapeutic uses.
Specific antibody binding to SARS-CoV-2 spike protein with defined CDRs and IgG1m3 allotype
Claims an antibody or antigen-binding fragment specifically binding SARS-CoV-2 spike protein comprising three heavy chain CDRs set forth in SEQ ID NO: 3325 and three light chain CDRs set forth in SEQ ID NO: 3326, with IgG1m3 allotype, and CDRs defined by Kabat, Chothia, or MacCallum numbering.
Defined CDR composition according to Kabat, Chothia or MacCallum
Claims specific CDR residue ranges according to Kabat, Chothia or MacCallum systems for heavy and light chains that configure the antibody's antigen recognition site.
Antibody sequence identity and exact sequence coverage
Claims include antibodies having heavy and light chain variable regions at least 90% identical to SEQ ID NOs: 3325 and 3326 respectively, including exact sequences thereof.
Conjugation to therapeutic or diagnostic agents
Claims antibodies conjugated to immunomodulators, cytokines, cytotoxic, chemotherapeutic, diagnostic, antiviral, antimicrobial agents, or drugs.
Pharmaceutical compositions comprising the antibody
Claims formulations comprising the antibody with pharmaceutically acceptable carriers, optionally including additional antibodies, excipients such as histidine, sodium chloride, sucrose, and polysorbate 80, having defined pH and concentrations.
Nucleic acids, vectors, and host cells encoding the antibody
Claims isolated nucleic acids encoding the heavy and/or light chains, vectors comprising said nucleic acids, and host cells containing the nucleic acids or vectors.
Antibody production process
Claims a method for producing the antibody by cultivating host cells expressing the antibody and recovering the product.
Article of manufacture for diagnosis or treatment
Claims kits or products comprising the antibody and instructional materials for use in diagnosing or treating SARS-COV or SARS-COV-2-linked diseases.
Methods for identifying infected cells and diagnosis
Claims diagnostic methods involving antibody binding conjugated to a detectable agent to identify SARS-COV or SARS-COV-2 infected cells or diagnose infection in patient samples.
Methods for treating SARS-COV or SARS-CoV-2-linked diseases
Claims therapeutic methods administering a therapeutically effective amount of the antibody to treat diseases including COVID-19, including specified dosing regimens and combination with other antibodies.
The claims comprehensively cover the composition, structure, production, diagnostic use, and therapeutic application of a specific anti-SARS-CoV-2 spike protein antibody characterized by defined CDR sequences and IgG1m3 isotype, including variants, conjugates, formulations, nucleic acids, expression systems, and methods of use.
Stated Advantages
Provides rapid discovery and manufacture of fully human antibodies with specificity for SARS-CoV-2 spike protein, suitable for therapeutic, prophylactic, and diagnostic purposes.
Offers high-affinity neutralizing antibodies capable of inhibiting SARS-CoV-2 infection and reducing viral loads in vivo at low doses.
Addresses challenges of virus antigenic variation by providing a diverse library of cross-reactive antibodies facilitating rapid response to emerging variants.
Enables alternative nucleic acid-based delivery formats that can reduce production costs and ease scalability for global deployment.
Exhibits therapeutic efficacy in non-human primate models, demonstrating dose-responsive protection against SARS-CoV-2 infection.
Documented Applications
Treatment and prevention of SARS-CoV and SARS-CoV-2 linked diseases including COVID-19.
Diagnostic detection of SARS-CoV or SARS-CoV-2 infections in patient samples using antibody binding assays.
Identification of SARS-CoV-2 infected cells via antibody binding with detectable labels.
Prophylaxis in at-risk populations to reduce progression or hospitalization due to COVID-19.
Use in vaccine development testing and evaluation.
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