Anti-SARS-Cov-2 antibodies derived from CR3022
Inventors
Glanville, Jacob • Daraeikia, Shahrad • Wang, I-Chieh • Liao Chan, Sindy Andrea • Bürckert, Jean-Philippe • Youssef, Sawsan
Assignees
Distributed Bio Inc • Centivax Inc
Publication Number
US-11034762-B1
Publication Date
2021-06-15
Expiration Date
2040-05-14
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Abstract
This disclosure provides antibodies that are derived from CFR3022 and that can be administered to an individual that is infected with a virus. Antibodies herein can be capable of treating or curing the virus, and which may provide protection against the virus for up to several weeks. Antibodies herein can be used to diagnose a SARS CoV 2 infection.
Core Innovation
The invention provides antibodies and antigen-binding fragments that are derived from the CR3022 antibody and selectively bind to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). These CR3022-derived antibodies are specified by defined complementarity-determining region (CDR) sequences for both the variable heavy (VH) and variable light (VL) chains, enabling selective binding to the receptor-binding domain (RBD) of SARS-CoV-2 with high affinity, often less than 50 nanomolar.
The invention addresses the urgent need for new therapeutic and diagnostic compositions to treat, prevent, and diagnose SARS-CoV-2 infection (COVID-19), especially in the absence of vaccines or effective treatments. The CR3022-derived antibodies not only have high sequence similarity to CR3022 but differ in ways that allow selective and potentially improved recognition and neutralization of SARS-CoV-2 compared to previously known antibodies.
In addition to direct virus neutralization, the invention discloses methods for treatment and prevention of SARS-CoV-2 infection utilizing administration of these antibodies or antigen-binding fragments, as well as diagnostic methods where these antibodies are used in assays to detect SARS-CoV-2 infection in biological samples from subjects. The CR3022-derived antibodies are also adaptable as various isotype forms and functional fragments, providing flexibility for therapeutic and diagnostic uses.
Claims Coverage
The patent includes three independent claim groups, each focusing on specific inventive features relating to CR3022-derived anti-SARS-CoV-2 antibodies and their sequences, as well as therapeutic, preventative, and diagnostic applications.
CR3022-derived antibody with specific CDR sequences for selective binding to SARS-CoV-2
An antibody or antigen-binding fragment that selectively binds to SARS-CoV-2 and comprises: - A variable heavy chain (VH) CDR1 with the amino acid sequence of SEQ ID NO: 176 - A VH CDR2 with the sequence of SEQ ID NO: 225 - A VH CDR3 with the sequence of SEQ ID NO: 291 - A variable light chain (VL) CDR1 with the sequence of SEQ ID NO: 37 - A VL CDR2 with the sequence of SEQ ID NO: 444 - A VL CDR3 with the sequence of SEQ ID NO: 126. This structure ensures selective and high affinity binding to SARS-CoV-2.
Method for preventing or treating SARS-CoV-2 viral infection using the CR3022-derived antibody
A method comprising administering to a subject in need thereof the CR3022-derived antibody or antigen-binding fragment that is defined by the specific VH and VL CDR sequences as described above, for the purpose of preventing or treating a SARS-CoV-2 viral infection or COVID-19.
Diagnostic method using CR3022-derived antibody to detect SARS-CoV-2 infection
A method of diagnosing a subject as being infected or suspected of being infected with SARS-CoV-2. The method involves: - Contacting a biological sample from the subject with a CR3022-derived antibody or antigen-binding fragment as defined by claim 1 - Detecting the presence or absence of an antibody/SARS-CoV-2 complex (or antigen-binding fragment/SARS-CoV-2 complex) - Diagnosing infection when the complex is detected The method is applicable to samples such as nasal swab, tissue, saliva, or blood, and detection methods include ELISA, immunospot assays, lateral flow assay, flow cytometry, immunohistochemistry, or western blot.
CR3022-derived antibody with specified full variable region sequences
An antibody or antigen-binding fragment that selectively binds to SARS-CoV-2, comprising: - A VH having an amino acid sequence of SEQ ID NO: 352 - A VL having an amino acid sequence of SEQ ID NO: 412. This claim covers the antibody with defined full variable region sequences, not just CDRs.
CR3022-derived antibody defined by alternative CDR combinations for SARS-CoV-2 binding
An antibody or antigen-binding fragment comprising combinations of CDR sequences as follows: - Alternative 1: VH CDR1 SEQ ID NO: 155; VH CDR2 SEQ ID NO: 193; VH CDR3 SEQ ID NO: 259; VL CDR1 SEQ ID NO: 5; VL CDR2 SEQ ID NO: 65; VL CDR3 SEQ ID NO: 94. - Alternative 2: VH CDR1 SEQ ID NO: 157; VH CDR2 SEQ ID NO: 195; VH CDR3 SEQ ID NO: 261; VL CDR1 SEQ ID NO: 7; VL CDR2 SEQ ID NO: 66; VL CDR3 SEQ ID NO: 96. These combinations define additional sequence variants of the antibody for selective binding to SARS-CoV-2.
The inventive features focus on specific monoclonal antibody and antigen-binding fragment compositions, defined by explicit CDR and variable region sequences for selective binding to SARS-CoV-2, methods for their use in prevention, treatment, and diagnosis of infection, and variant CDR combinations covering a breadth of sequence-defined anti-SARS-CoV-2 antibody formats.
Stated Advantages
The CR3022-derived antibodies can selectively bind to SARS-CoV-2 with high affinity, enabling neutralization of the virus and providing therapeutic and prophylactic utility.
These antibodies can be used to diagnose SARS-CoV-2 infection by binding the virus in biological samples.
The CR3022-derived antibodies may provide protection against SARS-CoV-2 for up to several weeks after administration.
Documented Applications
Prevention or treatment of SARS-CoV-2 viral infection or COVID-19 by administration of the antibody or antigen-binding fragment to a subject in need thereof.
Diagnosis of subjects as being infected with SARS-CoV-2 by detecting an antibody/SARS-CoV-2 complex or an antigen-binding fragment/SARS-CoV-2 complex in samples such as nasal swab, tissue, saliva, or blood.
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