Anti-SARS-CoV-2 antibodies derived from 2DD8
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-11028150-B1
Publication Date
2021-06-08
Expiration Date
2040-05-14
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Abstract
This disclosure provides antibodies and antigen-binding fragments that are derived from 2dd8 and that can be administered to an individual that is infected or suspected of being infected with a virus. Antibodies and antigen-binding fragments herein can be capable of treating or curing the virus, and which may provide protection against the virus for up to several weeks. Antibodies and antigen-binding fragments herein can be used to diagnose a SARS CoV-2 infection.
Core Innovation
The invention provides antibodies and antigen-binding fragments derived from 2dd8 that selectively bind to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). These antibodies and fragments possess specific sequence characteristics in their variable heavy and light chains, enabling high-affinity and selective binding to the SARS-CoV-2 receptor binding domain (RBD).
The problem addressed is the lack of effective vaccines, treatments, or diagnostic tools for COVID-19, the disease caused by SARS-CoV-2. There is an urgent need for compositions and methods capable of treating, preventing, or diagnosing SARS-CoV-2 infection, as current public health measures (e.g., social distancing) are only partially effective in controlling spread.
This invention discloses antibodies or antigen-binding fragments that demonstrate binding affinities of less than 50 nanomolar to SARS-CoV-2, with variants able to bind specifically to the RBD and neutralize the virus. The compositions also provide methods for therapeutic, prophylactic, and diagnostic use, including direct administration of the antibodies or nucleic acids encoding them, and their application in various diagnostic assays.
Claims Coverage
The patent contains several independent claims covering main inventive features related to anti-SARS-CoV-2 antibodies and their uses. The following inventive features summarize the independent claim coverage.
Antibody or antigen-binding fragment with specific CDR sequences selectively binding SARS-CoV-2
An antibody or antigen-binding fragment that selectively binds to SARS-CoV-2, comprising: - A variable heavy chain (VH) CDR1 with amino acid sequence SEQ ID NO: 70 - VH CDR2 with SEQ ID NO: 116 - VH CDR3 with SEQ ID NO: 165 - A variable light chain (VL) CDR1 with SEQ ID NO: 3 - VL CDR2 with SEQ ID NO: 6 - VL CDR3 with SEQ ID NO: 26
Antibody or antigen-binding fragment with selective RBD binding and high sequence identity
An antibody or antigen-binding fragment that selectively binds to SARS-CoV-2 and: - Comprises the CDRs listed above - Has a VH sequence at least 90% identical to SEQ ID NO: 207 - Has a VL sequence at least 90% identical to SEQ ID NO: 248
Antibody or antigen-binding fragment targeting the receptor binding domain (RBD) of SARS-CoV-2
An antibody or antigen-binding fragment as described that selectively binds to the receptor binding domain (RBD) of SARS-CoV-2.
Antibody or antigen-binding fragment encompassing full variable region sequences
An antibody or antigen-binding fragment comprising: - A VH chain with amino acid sequence SEQ ID NO: 207 - A VL chain with amino acid sequence SEQ ID NO: 248
Antibody or antigen-binding fragment comprising specified CDR combinations
An antibody or antigen-binding fragment that selectively binds SARS-CoV-2 and comprises one or more of the following CDR combinations: - (i) VH CDR1 SEQ ID NO: 58, VH CDR2 SEQ ID NO: 104, VH CDR3 SEQ ID NO: 153, VL CDR1 SEQ ID NO: 3, VL CDR2 SEQ ID NO: 6, VL CDR3 SEQ ID NO: 14 - (ii) VH CDR1 SEQ ID NO: 83, VH CDR2 SEQ ID NO: 129, VH CDR3 SEQ ID NO: 178, VL CDR1 SEQ ID NO: 3, VL CDR2 SEQ ID NO: 6, VL CDR3 SEQ ID NO: 39 - (iii) VH CDR1 SEQ ID NO: 57, VH CDR2 SEQ ID NO: 103, VH CDR3 SEQ ID NO: 152, VL CDR1 SEQ ID NO: 3, VL CDR2 SEQ ID NO: 8, VL CDR3 SEQ ID NO: 13 - (iv) VH CDR1 SEQ ID NO: 76, VH CDR2 SEQ ID NO: 122, VH CDR3 SEQ ID NO: 171, VL CDR1 SEQ ID NO: 3, VL CDR2 SEQ ID NO: 6, VL CDR3 SEQ ID NO: 32
Method for prevention or treatment of SARS-CoV-2 infection with antibody or antigen-binding fragment
A method of preventing or treating a SARS-CoV-2 viral infection or COVID-19 in a subject in need thereof, comprising administering the disclosed antibody or antigen-binding fragment.
Method for diagnosis of SARS-CoV-2 infection using antibody or antigen-binding fragment
A method of diagnosing a subject as being infected with or suspected of being infected with SARS-CoV-2, comprising: - Contacting a sample obtained from the subject with the antibody or antigen-binding fragment - Detecting the presence or absence of the antibody or antigen-binding fragment - Diagnosing the subject as infected if the antibody or fragment is detected
The inventive features provide antibodies or antigen-binding fragments with defined CDR or variable region sequences, their application to selective binding and neutralization of SARS-CoV-2 (specifically the RBD), and their use in methods for treatment, prevention, and diagnosis of SARS-CoV-2 infection.
Stated Advantages
The antibodies and antigen-binding fragments can treat or cure SARS-CoV-2 infections and may provide protection against the virus for up to several weeks.
These antibodies and fragments are capable of neutralizing SARS-CoV-2 activity with high binding affinity (less than 50 nM), specifically targeting the receptor binding domain.
The invention enables diagnosis of SARS-CoV-2 infection using the described antibodies or antigen-binding fragments in various assay formats.
The antibodies can be used prophylactically to protect high-risk or exposed individuals from SARS-CoV-2 infection.
Documented Applications
Treatment of individuals infected or suspected of being infected with SARS-CoV-2 (COVID-19) using the disclosed antibodies or antigen-binding fragments.
Prophylactic administration to high-risk or exposed individuals to prevent SARS-CoV-2 infection.
Diagnosis of SARS-CoV-2 infection by detecting viral antigen in samples such as nasal swab, tissue, saliva, or blood using assays like ELISA, immunospot, lateral flow assay, flow cytometry, immunohistochemistry, or western blot.
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