# US 12,570,725 B2 · ZIKA antibodies and their use

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- Number: US 12,570,725 B2
- Document ID: US12570725B2
- Status: Granted
- Kind: B2
- Application number: 17/642,674
- Filed: 2020-09-11
- Published: 2022-10-06
- Granted: 2026-03-10
- Earliest claimed: 2019-09-13
- Assignees: Duke University
- Applicants: Duke University
- Inventors: Sallie Permar; Mattia Bonsignori; Tulika Singh; Kwan-Ki Hwang
- Web page: https://patentgrep.com/patent/US12570725B2

## CPC

- C07K 16/10: RNA viruses
- A61P 31/14: for RNA viruses
- A61K 2039/505: {comprising antibodies}
- A61K 2039/55: {characterised by the host/recipient, e.g. newborn with maternal antibodies}
- C07K 2317/10: characterized by their source of isolation or production
- C07K 2317/21: from primates, e.g. man
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/52: Constant or Fc region; Isotype
- C07K 2317/71: Decreased effector function due to an Fc-modification
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C12N 2770/24122: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The invention is directed to antibodies, and antigen-binding fragments thereof, that potently neutralize infection of ZIKV. The invention also relates to antigenic sites to which the antibodies and antigen-binding fragments bind, as well as to nucleic acids that encode the antibodies of the invention, and immortalized B cells that produce such antibodies and antibody fragments. In addition, the invention relates to the use of the antibodies and antibody fragments of the invention in screening methods as well as in the diagnosis, prophylaxis and treatment of ZIKV infection.

## Claims

### Claim 1

A recombinant Zika antibody or the antigen-binding fragment thereof, as selected from the group consisting of: 119-4-D6.01 having a VH consisting of H621098 with the amino acid sequence of SEQ ID NO: 30 and a VL consisting of K620748 with the amino acid sequence of SEQ ID NO: 40, 119-4-D6.02 having a VH consisting of H621098 with the amino acid sequence of SEQ ID NO: 30 and a VL consisting of L620584 with the amino acid sequence of SEQ ID NO: 47, 119-4-D6.03 having a VH consisting of H621098 with the amino acid sequence of SEQ ID NO: 30 and a VL consisting of L620585 with the amino acid sequence of SEQ ID NO: 48, DH1017.IgM having a VH consisting of H592679 with the amino acid sequence of SEQ ID NO: 35 and a VL consisting of L590920 with the amino acid sequence of SEQ ID NO: 50, and DH1017.IgG, having a VH consisting of H592679 with the amino acid sequence of SEQ ID NO: 35 and a VL consisting of L590920 with the amino acid sequence of SEQ ID NO: 50.

### Claim 2 (depends on 1)

The antibody, or the antigen-binding fragment thereof, according to claim 1, wherein the antibody or antigen-binding fragment thereof, comprises a heavy chain comprising CDRH1, CDRH2 and CDRH3 and a light chain comprising CDRL1, CDRL2 and CDRL3, wherein the CDR comprises an amino acid sequence according to any of the CDR sequences in VH H592679 with the amino acid sequence of SEQ ID NO: 35 and a VL L590920 with the amino acid sequence of SEQ ID NO: 50.

### Claim 3 (depends on 1)

The antibody, or the antigen-binding fragment thereof, according to claim 1, wherein the antibody is the antibody DH1017.IgM or DH1017.IgG.

### Claim 4 (depends on 3)

The antibody, or the antigen-binding fragment thereof, according to claim 3, wherein the antibody, or the antigen-binding fragment thereof, is a purified antibody, a single chain antibody, Fab, Fab′, F (ab) 2, Fv or scFv.

### Claim 5 (depends on 1)

The antibody of claim 1, wherein the antibody is IgM or IgG isotype.

### Claim 6 (depends on 1)

A pharmaceutical composition comprising the antibody, or the antigen-binding fragment thereof, of claim 1, and a pharmaceutically acceptable carrier.

### Claim 7 (depends on 6)

A method for the treatment of Zika virus infection in a subject comprising administering to the subject a therapeutically effective amount of the pharmaceutical composition of claim 6.

### Claim 8 (depends on 1)

A nucleic acid molecule comprising a polynucleotide encoding the antibody, or the antigen-binding fragment thereof, according to claim 1.

### Claim 9 (depends on 8)

The nucleic acid of claim 8 wherein the nucleic acid is an mRNA, wherein the mRNA is suitable for use and delivery as a therapeutic mRNA.

### Claim 10 (depends on 9)

A vector comprising the nucleic acid molecule according to claim 9.

### Claim 11 (depends on 10)

A cell expressing the antibody, or the antigen-binding fragment thereof, comprising the vector according to claim 10.

### Claim 12 (depends on 10)

A pharmaceutical composition comprising the vector according to claim 10.

### Claim 13 (depends on 12)

The pharmaceutical composition according to claim 12 further comprising a pharmaceutically acceptable excipient, diluent or carrier.

### Claim 14 (depends on 9)

A method of treating Zika infection in a subject in need thereof, comprising administering to the subject, the nucleic acid of claim 9 in an amount suitable to effect treatment of Zika infection.

### Claim 15 (depends on 14)

The method of claim 14, wherein the subject is pregnant or expected to become pregnant.
