Anti-SARS-Cov-2 antibodies derived from 2GHW
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-11021531-B1
Publication Date
2021-06-01
Expiration Date
2040-05-14
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Abstract
This disclosure provides antibodies and antigen-binding fragments that are derived from 2ghw and that can be administered to an individual that is infected or suspected of being infected with a virus. Antibodies and antigen-binding fragments provided 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 provided herein can be used to diagnose a SARS-Cov-2 infection.
Core Innovation
The invention provides antibodies and antigen-binding fragments derived from 2ghw that selectively bind to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). These antibodies or fragments include specific variable heavy chain (VH) and variable light chain (VL) complementarity determining regions (CDRs), with certain sequence identities to representative SEQ ID numbers. The antibodies can exhibit high binding affinity to SARS-CoV-2, with affinities less than 50 nanomolar, and are capable of neutralizing the virus. These antibodies and fragments can bind specifically to the receptor binding domain (RBD) of SARS-CoV-2.
The problem addressed by this invention is the urgent need for compositions that can be used for treating or preventing SARS-CoV-2 infection and for diagnosing exposure to the SARS-CoV-2 virus, especially given the absence of effective vaccines or treatments for COVID-19 at the time of the invention. Current strategies such as social distancing are insufficient to completely control the spread of the virus, and effective therapeutics or diagnostics are lacking.
The invention also discloses methods for using these 2ghw-derived antibodies or antigen-binding fragments in the prevention, treatment, and diagnosis of SARS-CoV-2 infection. Administration of these antibodies or fragments can be achieved through various routes and in combination with other therapies. The antibodies and antigen-binding fragments can be formulated into pharmaceutical compositions and included in kits for clinical use.
Claims Coverage
The patent contains multiple independent claims highlighting several inventive features regarding 2ghw-derived antibodies or antigen-binding fragments and their use.
Antibody or antigen-binding fragment comprising specific CDRs
An antibody or antigen-binding fragment that selectively binds to SARS-CoV-2, comprising: - Variable heavy chain (VH) CDR1: SEQ ID NO: 39 - VH CDR2: SEQ ID NO: 53 - VH CDR3: SEQ ID NO: 68 - Variable light chain (VL) CDR1: SEQ ID NO: 7 - VL CDR2: SEQ ID NO: 15 - VL CDR3: SEQ ID NO: 25 These components define the unique specificity and binding characteristics of the antibody or fragment.
Antibody or fragment with defined VH and VL chain sequence identity
An antibody or antigen-binding fragment that comprises a VH having at least 90% identity to SEQ ID NO: 81 and a VL having at least 90% identity to SEQ ID NO: 93. This defines the molecular identity and ensures the antibody or fragment maintains both specificity and high-affinity binding to SARS-CoV-2.
Antibody or fragment with specified binding affinity
An antibody or antigen-binding fragment in which the binding affinity to SARS-CoV-2 is less than 50 nanomolar (nM), ensuring high specificity and strong interaction with the virus.
Antigen-binding fragment includes multiple fragment types
An antigen-binding fragment that may be selected from Fab, Fab′, F(ab′)2, Fv, triabody, tetrabody, minibody, bispecific F(ab′)2, trispecific F(ab′)2, diabody, bispecific diabody, single chain variable fragment (scFv), scFv-Fc, Fab-Fc, VHH, or bispecific scFv. This provides flexibility for different molecular formats.
Use of antibody or fragment for prevention or treatment of SARS-CoV-2 infection
A method of preventing or treating a SARS-CoV-2 viral infection or COVID19 in a subject by administering the defined antibody or antigen-binding fragment. The method can include co-administration with one or more additional therapies or drugs.
Use of antibody or fragment for diagnostic purposes
A method of diagnosing SARS-CoV-2 infection in a subject, comprising: 1. Contacting a sample from the subject (e.g., nasal swab, tissue sample, saliva, blood) with the antibody or antigen-binding fragment; 2. Detecting the presence or absence of an antibody/SARS-CoV-2 virus complex or antigen-binding fragment/SARS-CoV-2 virus complex; and 3. Diagnosing infection when such a complex is detected. Detection can involve assays such as ELISA, immunospot, lateral flow, flow cytometry, immunohistochemistry, or western blot.
Antibody or antigen-binding fragment with alternative CDR combinations
An antibody or antigen-binding fragment that selectively binds SARS-CoV-2 and comprises specific alternative sets of VH and VL CDR1, CDR2, and CDR3 sequences, as defined in the claim, such as: - VH CDR1: SEQ ID NO: 41, VH CDR2: SEQ ID NO: 55, VH CDR3: SEQ ID NO: 70, VL CDR1: SEQ ID NO: 9, VL CDR2: SEQ ID NO: 14, VL CDR3: SEQ ID NO: 23; - Or other specific combinations as detailed in the claim.
The claims cover antibodies and antigen-binding fragments with highly defined structural features, sequence identities, binding affinities, multiple molecular formats, and specified uses in both therapeutic and diagnostic applications for SARS-CoV-2.
Stated Advantages
The antibodies and antigen-binding fragments can be capable of treating or curing the virus and may provide protection against the virus for up to several weeks.
The antibodies and antigen-binding fragments can be used to diagnose a SARS-CoV-2 infection.
Administration of these antibodies or fragments can result in reduction of COVID-19 symptoms, shortened recovery time, decreased infection rates, and reduced mortality rate.
Antibodies or fragments can provide prophylactic treatment, protecting individuals at high risk of infection.
Antibody compositions can be formatted in multiple molecular types (such as monoclonal, chimeric, humanized, or fragment forms), offering versatility for various clinical or diagnostic needs.
Documented Applications
Treatment and prevention of SARS-CoV-2 viral infection or COVID-19 in a subject in need thereof through administration of the disclosed antibody or antigen-binding fragment.
Diagnosis of SARS-CoV-2 infection by detecting the presence of the antibody or antigen-binding fragment bound to virus in samples such as nasal swab, tissue sample, saliva, or blood, using assays like ELISA, lateral flow, flow cytometry, immunohistochemistry, or western blot.
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