Anti-SARS-Cov-2 antibodies derived from 6nb6
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-11053304-B1
Publication Date
2021-07-06
Expiration Date
2040-05-14
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Abstract
This disclosure provides antibodies and antigen-binding fragments that are derived from 6nb6 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
This invention provides antibodies and antigen-binding fragments derived from 6nb6 that selectively bind to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). These antibodies and fragments are engineered or selected to have high specificity for SARS-CoV-2, including the receptor binding domain (RBD), and can possess a binding affinity of less than 50 nanomolar (nM). The antibodies are characterized by variable regions, particularly complementarity determining regions (CDRs), with specified amino acid sequences or sequence identities to defined sequences.
The invention addresses a critical need due to the lack of a vaccine or effective treatment for COVID19 at the time of invention. There is an urgent requirement for new compositions that can be used in treating or preventing SARS-CoV-2 infection, as well as diagnosing exposure to the virus. Existing measures such as social distancing were insufficient to control the pandemic, motivating the development of novel therapeutics and diagnostics.
The provided 6nb6-derived antibodies and antigen-binding fragments can neutralize SARS-CoV-2 and may be formulated as monoclonal, human, humanized, chimeric, or grafted antibodies. They include specific combinations of CDRs and framework sequences, as well as modifications to optimize activity, specificity, or pharmacological properties. The invention further covers methods for using these antibodies in the prevention, treatment, or diagnosis of SARS-CoV-2 infection, including use in ELISA, immunospot, lateral flow, and other immunoassays.
Claims Coverage
There are four independent claims, each focused on inventive features related to specific 6nb6-derived antibodies/antigen-binding fragments or their use in diagnostics or therapeutics.
Antibody or antigen-binding fragment with specified CDRs selectively binding SARS-CoV-2
An antibody or antigen-binding fragment that selectively binds to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), comprising: - VH CDR1: SEQ ID NO: 136 - VH CDR2: SEQ ID NO: 190 - VH CDR3: SEQ ID NO: 223 - VL CDR1: SEQ ID NO: 8 - VL CDR2: SEQ ID NO: 38 - VL CDR3: SEQ ID NO: 120 This combination confers selective binding to SARS-CoV-2.
Method of preventing or treating SARS-CoV-2 infection or COVID19 using the 6nb6-derived antibody or fragment
A method involving administering to a subject in need thereof the antibody or antigen-binding fragment defined above for the prevention or treatment of a SARS-CoV-2 viral infection or COVID19.
Diagnostic method for SARS-CoV-2 infection using the specified antibody or fragment
A method of diagnosing a subject as being infected or suspected of infection with SARS-CoV-2, comprising: 1. Contacting a sample from the subject with the antibody or antigen-binding fragment as defined above. 2. Detecting the presence or absence of the antibody or fragment. 3. Diagnosing infection if the antibody or fragment is detected.
Antibody or antigen-binding fragment with variable regions at least 90% identical to reference sequences
An antibody or antigen-binding fragment that selectively binds SARS-CoV-2 and contains: - The CDRs as defined above - A VH amino acid sequence at least 90% identical to SEQ ID NO: 428 - A VL amino acid sequence at least 90% identical to SEQ ID NO: 490 This inventive feature also encompasses binding to the RBD, a variety of antibody forms (monoclonal, chimeric, humanized, etc.), a binding affinity of less than 50 nM, and fragment forms such as Fab, scFv, or VHH.
The inventive features collectively cover 6nb6-derived antibodies or fragments with specific CDR and variable region sequences for selective binding to SARS-CoV-2, methods of treatment, and diagnostic use based on the defined antibody constructs.
Stated Advantages
The antibodies and antigen-binding fragments can be capable of treating or curing SARS-CoV-2 infection and may provide protection against the virus for up to several weeks.
The invention enables the diagnosis of SARS-CoV-2 infection using antibodies or antigen-binding fragments.
The compositions allow for prevention or treatment of COVID-19 in subjects, including those at increased or high risk of infection.
The methods can reduce infection rates, shorten recovery time, reduce symptoms, lower death rates, or slow/reduce viral reproduction in subjects infected with SARS-CoV-2.
Administration of the polynucleotide encoding the antibody or fragment can induce protective immune responses, such as T cell activation, T cell proliferation, and memory T cell response.
Documented Applications
Treatment and prevention of SARS-CoV-2 infection or COVID-19 in subjects, including those who are symptomatic or asymptomatic.
Diagnosis of SARS-CoV-2 infection in a subject by contacting a biological sample with the antibody or fragment and detecting its presence in assays such as ELISA, immunospot, lateral flow assay, flow cytometry, immunohistochemistry, or western blot.
Use in antibody compositions and medicaments formulated for human or animal administration for preventing or treating COVID-19.
Use of polynucleotides encoding the antibody or antigen-binding fragment for in vivo expression to prevent or treat SARS-CoV-2 infection.
Reduction of viral replication and viral titers as demonstrated in in vivo animal models such as Syrian golden hamsters.
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