# US 11,028,150 B1 · Anti-SARS-CoV-2 antibodies derived from 2DD8

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- Number: US 11,028,150 B1
- Document ID: US11028150B1
- Status: Granted
- Kind: B1
- Application number: 15/931,642
- Filed: 2020-05-14
- Granted: 2021-06-08
- Earliest claimed: 2020-03-23
- Assignees: Centivax, Inc.
- Applicants: Centivax, Inc.
- Inventors: Jacob Glanville; Shahrad Daraeikia; I-Chieh Wang; Sindy Andrea Liao Chan; Jean-Philippe Bürckert; Sawsan Youssef
- Web page: https://patentgrep.com/patent/US11028150B1

## CPC

- G01N 33/56983: {Viruses}
- A61P 31/14: for RNA viruses
- C07K 16/104: Severe acute respiratory syndrome coronavirus 2 [SARS‐CoV‐2]
- A61K 2039/505: {comprising antibodies}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- G01N 2333/165: Coronaviridae, e.g. avian infectious bronchitis virus
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## 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.

## Claims

### Claim 1

An antibody or an antigen-binding fragment that selectively binds to a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that comprises a variable heavy chain (VH) complementarity determining region 1 (CDR1) having an amino acid sequence of SEQ ID NO: 70; a VH CDR2 having an amino acid sequence of SEQ ID NO: 116; a VH CDR3 having an amino acid sequence of SEQ ID NO: 165; a variable light chain (VL) CDR1 having an amino acid sequence of SEQ ID NO: 3; a VL CDR2 having an amino acid sequence of SEQ ID NO: 6; and a VL CDR3 having an amino acid sequence of SEQ ID NO: 26.

### Claim 2 (depends on 1)

An antibody or an antigen-binding fragment that selectively binds to a SARS-CoV-2, that comprises the CDRs of claim 1, and that comprises a VH having an amino acid sequence that is at least 90% identical to SEQ ID NO: 207 and a VL having an amino acid sequence that is at least 90% identical to SEQ ID NO: 248.

### Claim 3 (depends on 1)

The antibody or the antigen-binding fragment of claim 1, that selectively binds to a receptor binding domain (RBD) of SARS-CoV-2.

### Claim 4 (depends on 2)

The antibody or the antigen-binding fragment of claim 2, that selectively binds to a receptor binding domain (RBD) of SARS-CoV-2.

### Claim 5 (depends on 1)

The antibody or the antigen-binding fragment of claim 1, wherein the antibody is an IgG, an IgM, an IgE, an IgA, or an IgD, or is derived therefrom.

### Claim 6 (depends on 5)

The antibody or the antigen-binding fragment of claim 5, wherein the antibody is an IgG selected from the group consisting of an IgG1, an IgG2a, an IgG2b, an IgG3, and an IgG4.

### Claim 7 (depends on 2)

The antibody or the antigen-binding fragment of claim 2, wherein the antibody is an IgG, an IgM, an IgE, an IgA, or an IgD, or is derived therefrom.

### Claim 8 (depends on 7)

The antibody or the antigen-binding fragment of claim 7, wherein the antibody is an IgG selected from the group consisting of an IgG1, an IgG2a, an IgG2b, an IgG3, and an IgG4.

### Claim 9 (depends on 1)

The antibody or the antigen-binding fragment of claim 1, wherein the antibody comprises a monoclonal antibody, a grafted antibody, a chimeric antibody, a human antibody, or a humanized antibody.

### Claim 10 (depends on 2)

The antibody or the antigen-binding fragment of claim 2, wherein the antibody comprises a monoclonal antibody, a grafted antibody, a chimeric antibody, a human antibody, or a humanized antibody.

### Claim 11 (depends on 1)

The antibody or the antigen-binding fragment of claim 1, that comprises a binding affinity of less than 50 nM.

### Claim 12 (depends on 2)

The antibody or the antigen-binding fragment of claim 2, that comprises a binding affinity of less than 50 nM.

### Claim 13 (depends on 1)

The antibody or the antigen-binding fragment of claim 1, wherein the antigen-binding fragment comprises a Fab, a Fab′, a F(ab′)2, a variable fragment (Fv), a triabody, a tetrabody, a minibody, a bispecific F(ab′)2, a trispecific F(ab′)2, a diabody, a bispecific diabody, a single chain variable fragment (scFv), a scFv-Fc, a Fab-Fc, a VHH, or a bispecific scFv.

### Claim 14 (depends on 2)

The antibody or the antigen-binding fragment of claim 2, wherein the antigen-binding fragment comprises a Fab, a Fab′, a F(ab′)2, a variable fragment (Fv), a triabody, a tetrabody, a minibody, a bispecific F(ab′)2, a trispecific F(ab′)2, a diabody, a bispecific diabody, a single chain variable fragment (scFv), a scFv-Fc, a Fab-Fc, a VHH, or a bispecific scFv.

### Claim 15

An antibody or an antigen-binding fragment that selectively binds to a SARS-CoV-2, wherein the antibody or the antigen-binding fragment comprises a VH chain having an amino acid sequence of SEQ ID NO: 207 and a VL chain having an amino acid sequence of SEQ ID NO: 248.

### Claim 16

An antibody or an antigen-binding fragment that selectively binds to a SARS-CoV-2, that comprises:
(i) a VH CDR1 having an amino acid sequence of SEQ ID NO: 58, a VH CDR2 having an amino acid sequence of SEQ ID NO: 104, a VH CDR3 having an amino acid sequence of SEQ ID NO: 153, a VL CDR1 having an amino acid sequence of SEQ ID NO: 3, a VL CDR2 having an amino acid sequence of SEQ ID NO: 6, and a VL CDR3 having an amino acid sequence of SEQ ID NO: 14;
(ii) a VH CDR1 having an amino acid sequence of SEQ ID NO: 83, a VH CDR2 having an amino acid sequence of SEQ ID NO: 129, a VH CDR3 having an amino acid sequence of SEQ ID NO: 178, a VL CDR1 having an amino acid sequence of SEQ ID NO: 3, a VL CDR2 having an amino acid sequence of SEQ ID NO: 6, and a VL CDR3 having an amino acid sequence of SEQ ID NO: 39;
(iii) a VH CDR1 having an amino acid sequence of SEQ ID NO: 57, a VH CDR2 having an amino acid sequence of SEQ ID NO: 103, a VH CDR3 having an amino acid sequence of SEQ ID NO: 152, a VL CDR1 having an amino acid sequence of SEQ ID NO: 3, a VL CDR2 having an amino acid sequence of SEQ ID NO: 8, and a VL CDR3 having an amino acid sequence of SEQ ID NO: 13; or
(iv) a VH CDR1 having an amino acid sequence of SEQ ID NO: 76, a VH CDR2 having an amino acid sequence of SEQ ID NO: 122, a VH CDR3 having an amino acid sequence of SEQ ID NO: 171, a VL CDR1 having an amino acid sequence of SEQ ID NO: 3, a VL CDR2 having an amino acid sequence of SEQ ID NO: 6, and a VL CDR3 having an amino acid sequence of SEQ ID NO: 32.

### Claim 17 (depends on 1)

A method of preventing or treating a SARS-CoV-2 viral infection or COVID19 in a subject in need thereof, comprising administering to the subject the antibody or the antigen-binding fragment of claim 1.

### Claim 18 (depends on 17)

The method of claim 17, that further comprises administering one or more additional therapies or drugs to the subject.

### Claim 19 (depends on 1)

A method of diagnosing a subject as being infected with a SARS-CoV-2 virus or suspected of being infected with a SARS-CoV-2 virus, the method comprising contacting a sample obtained from the subject with the antibody or the antigen-binding fragment of claim 1; detecting the presence or absence of the antibody or the antigen-binding fragment; and diagnosing the subject as being infected with a SARS-CoV-2 virus when the presence of the antibody or the antigen-binding fragment is detected.

### Claim 20 (depends on 19)

The method of claim 19, wherein the sample comprises a nasal swab, a tissue sample, saliva, or blood.

### Claim 21 (depends on 19)

The method of claim 19, wherein detecting the presence or absence of the antibody or the antigen-binding fragment comprises an enzyme linked immunosorbent assay (ELISA), an immunospot assay, a lateral flow assay, flow cytometry, immunohistochemistry, or a western blot.
