Single domain antibodies to SARS-CoV-2 nucleocapsid protein
Inventors
Goldman, Ellen R. • Anderson, George P. • Liu, Jinny L. • Esparza, Thomas J.
Assignees
Publication Number
US-11739137-B2
Publication Date
2023-08-29
Expiration Date
2041-10-28
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Abstract
A number of single domain antibodies (sdAb, also known as nanobodies or VHH) were developed that bind nucleocapsid protein of the SARS-CoV-2 virus. They are useful for detecting the virus and could also find application in therapeutics.
Core Innovation
The invention concerns single domain antibodies (sdAb), also known as nanobodies or VHH, that specifically bind to the nucleocapsid protein (N) of the SARS-CoV-2 virus. These sdAbs have been developed to enable detection of SARS-CoV-2 and may also have therapeutic applications.
The problem addressed by this invention is the need for new techniques for detecting and treating SARS-CoV-2 infections. Existing nucleic acid tests for diagnosis are time-consuming, require skilled technicians, and are costly. Antigen detection methods offer advantages including rapidity and ease of use but current assays rely on conventional antibodies which may lack sensitivity and consistency.
The invention provides isolated camelid heavy-chain antibody variable domains directed against the SARS-CoV-2 nucleocapsid protein, with defined amino acid sequences (SEQ ID NOs: 1 through 16) or variants thereof having high identity in the complementarity determining regions. Furthermore, bivalent or multivalent antibodies comprising two or more sdAbs joined by polypeptide linkers are described, to improve detection sensitivity and affinity.
Claims Coverage
The patent includes four claims, covering isolated antibodies, bivalent antibodies, and nucleotide sequences encoding the antibodies, showing coverage of antibody compositions and their genetic encoding.
Isolated antibodies with specific amino acid sequences
An isolated antibody comprising a protein sequence selected from SEQ ID NOs: 1 through 16, including preferred sequences SEQ ID NO: 1, 2, or 3.
Bivalent antibodies formed by linking two sdAbs
An isolated bivalent antibody comprising two antibodies as defined above, connected by a polypeptide linker, where the antibodies can be identical or different.
Nucleotide sequences encoding the antibodies
Isolated nucleotide sequences encoding the antibodies selected from SEQ ID NOs: 1 through 16.
The claims collectively cover the isolated single domain antibodies specific to SARS-CoV-2 nucleocapsid protein, their bivalent fusion constructs via linkers, and the corresponding encoding nucleotide sequences, encompassing composition and genetic constructs for detection and potential therapeutic use.
Stated Advantages
SdAb are small recombinant molecules that can be produced easily and economically.
They can be prepared as fusion constructs to endow additional controlled properties.
SdAb provide consistency and known sequences unlike most monoclonal antibodies derived from cell lines without sequenced antibodies.
They possess high affinity and specificity, making them ideal reagents for SARS-CoV-2 nucleocapsid protein diagnostics and therapeutics.
Documented Applications
Detection of SARS-CoV-2 nucleocapsid protein in samples using antibody-based diagnostic assays including MagPlex® sandwich fluoroimmunoassays.
Use in diagnostic methods such as ELISA, surface plasmon resonance assays, and other immunoassay formats to detect SARS-CoV-2 presence.
Potential development as therapeutic medicaments comprising one or more sdAb administered to patients for treating COVID-19.
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