# US 12,216,120 B2 · Human monoclonal antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

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- Number: US 12,216,120 B2
- Document ID: US12216120B2
- Status: Granted
- Kind: B2
- Application number: 17/655,503
- Filed: 2022-03-18
- Published: 2022-09-08
- Granted: 2025-02-04
- Earliest claimed: 2020-03-26
- Assignees: Vanderbilt University
- Applicants: Vanderbilt University
- Inventors: James E. Crowe, Jr.; Seth Zost; Robert Carnahan; Pavlo Gilchuk
- Web page: https://patentgrep.com/patent/US12216120B2

## CPC

- G01N 33/56983: {Viruses}
- A61P 31/14: for RNA viruses
- C07K 16/102: Coronaviridae (F)
- C07K 16/104: Severe acute respiratory syndrome coronavirus 2 [SARS‐CoV‐2]
- A61K 2039/505: {comprising antibodies}
- A61K 2039/507: {Comprising a combination of two or more separate antibodies}
- C07K 2317/35: Valency
- C07K 2317/52: Constant or Fc region; Isotype
- C07K 2317/55: Fab or Fab'
- C07K 2317/56: variable (Fv) region, i.e. VH and/or VL
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C07K 2317/94: Stability, e.g. half-life, pH, temperature or enzyme-resistance
- G01N 2333/165: Coronaviridae, e.g. avian infectious bronchitis virus
- G01N 2469/10: Detection of antigens from microorganism in sample from host
- 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

The present disclosure is directed to antibodies binding to and neutralizing the coronavirus designated SARS-CoV-2 and methods for use thereof.

## Claims

### Claim 1

A method of treating a subject infected with SARS-COV-2 or reducing the likelihood of infection of a subject at risk of contracting SARS-COV-2, comprising administering to the subject a first antibody or antibody fragment comprising:
(a) a CDRH1 comprising the amino acid sequence of SEQ ID NO:59, a CDRH2 comprising the amino acid sequence of SEQ ID NO:60, a CDRH3 comprising the amino acid sequence of SEQ ID NO:61, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 89, a CDRL2 comprising the amino acid sequence of SEQ ID NO:90, a CDRL3 comprising the amino acid sequence of SEQ ID NO:91;
(b) a CDRH1 comprising the amino acid sequence of SEQ ID NO:68, a CDRH2 comprising the amino acid sequence of SEQ ID NO:69, a CDRH3 comprising the amino acid sequence of SEQ ID NO:70, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 98, a CDRL2 comprising the amino acid sequence of SEQ ID NO:99, a CDRL3 comprising the amino acid sequence of SEQ ID NO:100;
(c) a CDRH1 comprising the amino acid sequence of SEQ ID NO:41, a CDRH2 comprising the amino acid sequence of SEQ ID NO:42, a CDRH3 comprising the amino acid sequence of SEQ ID NO:43, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 71, a CDRL2 comprising the amino acid sequence of SEQ ID NO:72, a CDRL3 comprising the amino acid sequence of SEQ ID NO:73;
(d) a CDRH1 comprising the amino acid sequence of SEQ ID NO:44, a CDRH2 comprising the amino acid sequence of SEQ ID NO:45, a CDRH3 comprising the amino acid sequence of SEQ ID NO:46, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 74, a CDRL2 comprising the amino acid sequence of SEQ ID NO:75, a CDRL3 comprising the amino acid sequence of SEQ ID NO:76;
(e) a CDRH1 comprising the amino acid sequence of SEQ ID NO:47, a CDRH2 comprising the amino acid sequence of SEQ ID NO:48, a CDRH3 comprising the amino acid sequence of SEQ ID NO:49, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 77, a CDRL2 comprising the amino acid sequence of SEQ ID NO:78, a CDRL3 comprising the amino acid sequence of SEQ ID NO:79;
(f) a CDRH1 comprising the amino acid sequence of SEQ ID NO:50, a CDRH2 comprising the amino acid sequence of SEQ ID NO:51, a CDRH3 comprising the amino acid sequence of SEQ ID NO:52, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 80, a CDRL2 comprising the amino acid sequence of SEQ ID NO:81, a CDRL3 comprising the amino acid sequence of SEQ ID NO:82;
(g) a CDRH1 comprising the amino acid sequence of SEQ ID NO:53, a CDRH2 comprising the amino acid sequence of SEQ ID NO:54, a CDRH3 comprising the amino acid sequence of SEQ ID NO:55, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 83, a CDRL2 comprising the amino acid sequence of SEQ ID NO:84, a CDRL3 comprising the amino acid sequence of SEQ ID NO:85;
(h) a CDRH1 comprising the amino acid sequence of SEQ ID NO:56, a CDRH2 comprising the amino acid sequence of SEQ ID NO:57 a CDRH3 comprising the amino acid sequence of SEQ ID NO:58, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 86, a CDRL2 comprising the amino acid sequence of SEQ ID NO:87, a CDRL3 comprising the amino acid sequence of SEQ ID NO:88;
(i) a CDRH1 comprising the amino acid sequence of SEQ ID NO:62, a CDRH2 comprising the amino acid sequence of SEQ ID NO:63 a CDRH3 comprising the amino acid sequence of SEQ ID NO:64, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 65, a CDRL2 comprising the amino acid sequence of SEQ ID NO:66, a CDRL3 comprising the amino acid sequence of SEQ ID NO:67; or
(j) a CDRH1 comprising the amino acid sequence of SEQ ID NO:65, a CDRH2 comprising the amino acid sequence of SEQ ID NO:66, a CDRH3 comprising the amino acid sequence of SEQ ID NO:67, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 95, a CDRL2 comprising the amino acid sequence of SEQ ID NO:96, a CDRL3 comprising the amino acid sequence of SEQ ID NO:97.

### Claim 2

A method of protecting the health of a subject of age 60 or older, an immunocompromised subject, or a subject suffering from a respiratory and/or cardiovascular disorder that is infected with or at risk of infection with SARS-COV-2 comprising administering to the subject a first antibody or antibody fragment comprising:
(a) a CDRH1 comprising the amino acid sequence of SEQ ID NO:59, a CDRH2 comprising the amino acid sequence of SEQ ID NO:60, a CDRH3 comprising the amino acid sequence of SEQ ID NO:61, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 89, a CDRL2 comprising the amino acid sequence of SEQ ID NO:90, a CDRL3 comprising the amino acid sequence of SEQ ID NO:91;
(b) a CDRH1 comprising the amino acid sequence of SEQ ID NO:68, a CDRH2 comprising the amino acid sequence of SEQ ID NO:69, a CDRH3 comprising the amino acid sequence of SEQ ID NO:70, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 98, a CDRL2 comprising the amino acid sequence of SEQ ID NO:99, a CDRL3 comprising the amino acid sequence of SEQ ID NO: 100;
(c) a CDRH1 comprising the amino acid sequence of SEQ ID NO:41, a CDRH2 comprising the amino acid sequence of SEQ ID NO:42, a CDRH3 comprising the amino acid sequence of SEQ ID NO:43, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 71, a CDRL2 comprising the amino acid sequence of SEQ ID NO:72, a CDRL3 comprising the amino acid sequence of SEQ ID NO:73;
(d) a CDRH1 comprising the amino acid sequence of SEQ ID NO:44, a CDRH2 comprising the amino acid sequence of SEQ ID NO:45, a CDRH3 comprising the amino acid sequence of SEQ ID NO:46, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 74, a CDRL2 comprising the amino acid sequence of SEQ ID NO:75, a CDRL3 comprising the amino acid sequence of SEQ ID NO:76;
(e) a CDRH1 comprising the amino acid sequence of SEQ ID NO:47, a CDRH2 comprising the amino acid sequence of SEQ ID NO:48, a CDRH3 comprising the amino acid sequence of SEQ ID NO:49, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 77, a CDRL2 comprising the amino acid sequence of SEQ ID NO:78, a CDRL3 comprising the amino acid sequence of SEQ ID NO:79;
(f) a CDRH1 comprising the amino acid sequence of SEQ ID NO:50, a CDRH2 comprising the amino acid sequence of SEQ ID NO:51, a CDRH3 comprising the amino acid sequence of SEQ ID NO:52, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 80, a CDRL2 comprising the amino acid sequence of SEQ ID NO:81, a CDRL3 comprising the amino acid sequence of SEQ ID NO:82;
(g) a CDRH1 comprising the amino acid sequence of SEQ ID NO:53, a CDRH2 comprising the amino acid sequence of SEQ ID NO:54, a CDRH3 comprising the amino acid sequence of SEQ ID NO:55, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 83, a CDRL2 comprising the amino acid sequence of SEQ ID NO:84, a CDRL3 comprising the amino acid sequence of SEQ ID NO:85;
(h) a CDRH1 comprising the amino acid sequence of SEQ ID NO:56, a CDRH2 comprising the amino acid sequence of SEQ ID NO:57 a CDRH3 comprising the amino acid sequence of SEQ ID NO:58, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 86, a CDRL2 comprising the amino acid sequence of SEQ ID NO:87, a CDRL3 comprising the amino acid sequence of SEQ ID NO:88;
(i) a CDRH1 comprising the amino acid sequence of SEQ ID NO:62, a CDRH2 comprising the amino acid sequence of SEQ ID NO:63 a CDRH3 comprising the amino acid sequence of SEQ ID NO:64, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 65, a CDRL2 comprising the amino acid sequence of SEQ ID NO:66, a CDRL3 comprising the amino acid sequence of SEQ ID NO:67; or
(j) a CDRH1 comprising the amino acid sequence of SEQ ID NO:65, a CDRH2 comprising the amino acid sequence of SEQ ID NO:66, a CDRH3 comprising the amino acid sequence of SEQ ID NO:67, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 95, a CDRL2 comprising the amino acid sequence of SEQ ID NO:96, a CDRL3 comprising the amino acid sequence of SEQ ID NO:97.

### Claim 3 (depends on 1)

The method of claim 1, wherein the method further comprises administering to the subject a second antibody or antibody fragment that binds to a SARS-COV-2 surface spike protein, wherein the second antibody or antibody fragment comprises:
(a) a CDRH1 comprising the amino acid sequence of SEQ ID NO:59, a CDRH2 comprising the amino acid sequence of SEQ ID NO:60, a CDRH3 comprising the amino acid sequence of SEQ ID NO:61, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 89, a CDRL2 comprising the amino acid sequence of SEQ ID NO:90, a CDRL3 comprising the amino acid sequence of SEQ ID NO:91;
(b) a CDRH1 comprising the amino acid sequence of SEQ ID NO:68, a CDRH2 comprising the amino acid sequence of SEQ ID NO:69, a CDRH3 comprising the amino acid sequence of SEQ ID NO:70, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 98, a CDRL2 comprising the amino acid sequence of SEQ ID NO:99, a CDRL3 comprising the amino acid sequence of SEQ ID NO:100;
(c) a CDRH1 comprising the amino acid sequence of SEQ ID NO:41, a CDRH2 comprising the amino acid sequence of SEQ ID NO:42, a CDRH3 comprising the amino acid sequence of SEQ ID NO:43, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 71, a CDRL2 comprising the amino acid sequence of SEQ ID NO:72, a CDRL3 comprising the amino acid sequence of SEQ ID NO:73;
(d) a CDRH1 comprising the amino acid sequence of SEQ ID NO:44, a CDRH2 comprising the amino acid sequence of SEQ ID NO:45, a CDRH3 comprising the amino acid sequence of SEQ ID NO:46, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 74, a CDRL2 comprising the amino acid sequence of SEQ ID NO:75, a CDRL3 comprising the amino acid sequence of SEQ ID NO:76;
(e) a CDRH1 comprising the amino acid sequence of SEQ ID NO:47, a CDRH2 comprising the amino acid sequence of SEQ ID NO:48, a CDRH3 comprising the amino acid sequence of SEQ ID NO:49, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 77, a CDRL2 comprising the amino acid sequence of SEQ ID NO:78, a CDRL3 comprising the amino acid sequence of SEQ ID NO:79;
(f) a CDRH1 comprising the amino acid sequence of SEQ ID NO:50, a CDRH2 comprising the amino acid sequence of SEQ ID NO:51, a CDRH3 comprising the amino acid sequence of SEQ ID NO:52, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 80, a CDRL2 comprising the amino acid sequence of SEQ ID NO:81, a CDRL3 comprising the amino acid sequence of SEQ ID NO:82;
(g) a CDRH1 comprising the amino acid sequence of SEQ ID NO:53, a CDRH2 comprising the amino acid sequence of SEQ ID NO:54, a CDRH3 comprising the amino acid sequence of SEQ ID NO:55, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 83, a CDRL2 comprising the amino acid sequence of SEQ ID NO:84, a CDRL3 comprising the amino acid sequence of SEQ ID NO:85;
(h) a CDRH1 comprising the amino acid sequence of SEQ ID NO:56, a CDRH2 comprising the amino acid sequence of SEQ ID NO:57 a CDRH3 comprising the amino acid sequence of SEQ ID NO:58, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 86, a CDRL2 comprising the amino acid sequence of SEQ ID NO:87, a CDRL3 comprising the amino acid sequence of SEQ ID NO:88;
(i) a CDRH1 comprising the amino acid sequence of SEQ ID NO:62, a CDRH2 comprising the amino acid sequence of SEQ ID NO:63 a CDRH3 comprising the amino acid sequence of SEQ ID NO:64, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 65, a CDRL2 comprising the amino acid sequence of SEQ ID NO:66, a CDRL3 comprising the amino acid sequence of SEQ ID NO:67; or
(j) a CDRH1 comprising the amino acid sequence of SEQ ID NO:65, a CDRH2 comprising the amino acid sequence of SEQ ID NO:66, a CDRH3 comprising the amino acid sequence of SEQ ID NO:67, a CDRL1 comprising the amino acid sequence of SEQ ID NO: 95, a CDRL2 comprising the amino acid sequence of SEQ ID NO:96, a CDRL3 comprising the amino acid sequence of SEQ ID NO:97.

### Claim 4

A method of reducing the likelihood of infection of a subject at risk of contracting SARS-COV-2, comprising administering to the subject a first antibody or antibody fragment and a second antibody or antibody fragment, wherein the first antibody or antibody fragment comprises a CDRH1 comprising the amino acid sequence of SEQ ID NO: 59, a CDRH2 comprising the amino acid sequence of SEQ ID NO:60, a CDRH3 comprising the amino acid sequence of SEQ ID NO:61, a CDRL1 comprising the amino acid sequence of SEQ ID NO:89, a CDRL2 comprising the amino acid sequence of SEQ ID NO: 90, a CDRL3 comprising the amino acid sequence of SEQ ID NO:91, and wherein the second antibody or antibody fragment comprises a CDRH1 comprising the amino acid sequence of SEQ ID NO:68, a CDRH2 comprising the amino acid sequence of SEQ ID NO: 69, a CDRH3 comprising the amino acid sequence of SEQ ID NO:70, a CDRL1 comprising the amino acid sequence of SEQ ID NO:98, a CDRL2 comprising the amino acid sequence of SEQ ID NO:99, a CDRL3 comprising the amino acid sequence of SEQ ID NO: 100.

### Claim 5 (depends on 3)

The method of claim 3, wherein the first antibody or antibody fragment comprises a CDRH1 comprising the amino acid sequence of SEQ ID NO:59, a CDRH2 comprising the amino acid sequence of SEQ ID NO:60, a CDRH3 comprising the amino acid sequence of SEQ ID NO:61, a CDRL1 comprising the amino acid sequence of SEQ ID NO:89, a CDRL2 comprising the amino acid sequence of SEQ ID NO: 90, a CDRL3 comprising the amino acid sequence of SEQ ID NO:91 and wherein the second antibody or antibody fragment comprises a CDRH1 comprising the amino acid sequence of SEQ ID NO:68, a CDRH2 comprising the amino acid sequence of SEQ ID NO:69, a CDRH3 comprising the amino acid sequence of SEQ ID NO: 70, a CDRL1 comprising the amino acid sequence of SEQ ID NO:98, a CDRL2 comprising the amino acid sequence of SEQ ID NO:99, a CDRL3 comprising the amino acid sequence of SEQ ID NO:100.

### Claim 6 (depends on 4)

The method of claim 4, wherein the subject is is immunocompromised.

### Claim 7 (depends on 5)

The method of claim 5, wherein (i) the first antibody or antibody fragment comprises a heavy chain variable sequence comprising the amino acid sequence of SEQ ID NO:33 and a light chain variable sequence comprising the amino acid sequence of SEQ ID NO:34 and/or (ii) the second antibody comprises a heavy chain variable sequence comprising the amino acid sequence of SEQ ID NO:39 and a light chain variable sequence comprising the amino acid sequence of SEQ ID NO:40.

### Claim 8 (depends on 4)

The method of claim 4, wherein the first antibody comprises a YTE mutation, and wherein the second antibody comprises a YTE mutation.

### Claim 9 (depends on 4)

The method of claim 4, wherein the first antibody is an IgG1, and wherein the second antibody is an IgG1.

### Claim 10 (depends on 9)

The method of claim 9, wherein the first antibody comprises a YTE mutation, and wherein the second antibody comprises a YTE mutation.

### Claim 11 (depends on 4)

The method of claim 4, wherein the first antibody and the second antibody are administered via intramuscular injection.

### Claim 12 (depends on 4)

The method of claim 4, wherein (i) the first antibody or antibody fragment comprises a heavy chain variable sequence comprising the amino acid sequence of SEQ ID NO: 33 and a light chain variable sequence comprising the amino acid sequence of SEQ ID NO: 34 and (ii) the second antibody comprises a heavy chain variable sequence comprising the amino acid sequence of SEQ ID NO:39 and a light chain variable sequence comprising the amino acid sequence of SEQ ID NO:40.

### Claim 13 (depends on 12)

The method of claim 12, wherein the first antibody comprises a YTE mutation, and wherein the second antibody comprises a YTE mutation.

### Claim 14 (depends on 12)

The method of claim 12, wherein the first antibody is an IgG1, and wherein the second antibody is an IgG1.

### Claim 15 (depends on 12)

The method of claim 12, wherein the first antibody is an IgG1 comprising a YTE mutation, and wherein the second antibody is an IgG1 comprising a YTE mutation.

### Claim 16 (depends on 15)

The method of claim 15, wherein the first antibody and the second antibody are administered via intramuscular injection.

### Claim 17 (depends on 15)

The method of claim 15, wherein the subject is immunocompromised.

### Claim 18 (depends on 16)

The method of claim 16, wherein the subject is immunocompromised.

### Claim 19 (depends on 12)

The method of claim 12, wherein the first antibody and the second antibody are administered via intramuscular injection.

### Claim 20 (depends on 12)

The method of claim 12, wherein the subject is immunocompromised.