# US 11,299,540 B2 · IL17A antibodies and antagonists for veterinary use

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- Number: US 11,299,540 B2
- Document ID: US11299540B2
- Status: Granted
- Kind: B2
- Application number: 16/621,012
- Filed: 2018-06-18
- Published: 2020-06-25
- Granted: 2022-04-12
- Earliest claimed: 2017-06-18
- Assignees: Kindred Biosciences, Inc.
- Applicants: Kindred Biosciences, Inc.
- Inventors: Shyr Jiann Li; Lam Nguyen; Lan Yang; Hangjun Zhan
- Web page: https://patentgrep.com/patent/US11299540B2

## CPC

- C07K 14/7155: {for interleukins [IL]}
- C07K 16/244: {Interleukins [IL]}
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61P 37/00: Drugs for immunological or allergic disorders
- C12N 15/63: Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
- A61K 2039/505: {comprising antibodies}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/31: multispecific
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/34: Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
- C07K 2317/524: CH2 domain
- C07K 2317/56: variable (Fv) region, i.e. VH and/or VL
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/71: Decreased effector function due to an Fc-modification
- C07K 2317/734: Complement-dependent cytotoxicity [CDC]
- 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
- C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

Provided are various embodiments relating to anti-IL17A antibodies and IL17Ra ECD polypeptides that bind to IL17A. In various embodiments, such anti-IL17A antibodies or IL17Ra ECD polypeptides can be used in methods to treat IL17-induced conditions in subjects, such as humans or companion animals, such as canines, felines, and equines. Also provided are various embodiments relating to IgG Fc variant polypeptides having one or more amino acid substitutions for reducing binding to C1q and/or CD16. In some embodiments, the IgG Fc variants and/or polypeptides comprising the IgG Fc variants (e.g., fusion polypeptides comprising the IgG Fc variants and the anti-IL17A antibodies and/or IL17Ra ECD polypeptides described herein) may have reduced complement-mediated immune responses and/or antibody-dependent cell-mediated cytotoxicity.

## Claims

### Claim 1

An isolated antibody that binds to canine IL17A, wherein the antibody comprises:
(i) a CDR-H1 comprising the amino acid sequence of SEQ ID NO: 1, a CDR-H2 comprising the amino acid sequence of SEQ ID NO: 2, and a CDR-H3 comprising the amino acid sequence of SEQ ID NO: 3, and
(ii) a CDR-L1 comprising the amino acid sequence of SEQ ID NO: 8, a CDR-L2 comprising the amino acid sequence of SEQ ID NO: 9 or SEQ ID NO: 108, and a CDR-L3 comprising the amino acid sequence of SEQ ID NO: 10.

### Claim 2 (depends on 1)

The antibody of claim 1, wherein the antibody binds to canine IL17A with a dissociation constant (Kd) of less than 1×10−8M, as measured by biolayer interferometry.

### Claim 3 (depends on 1)

The antibody of claim 1, wherein the antibody is a monoclonal antibody.

### Claim 4 (depends on 1)

The antibody of claim 1, wherein the antibody is a caninized, a felinized, an equinized, or a chimeric antibody.

### Claim 5 (depends on 1)

The antibody of claim 1, wherein the antibody comprises:
(a) (i) a variable light chain sequence having at least 95% sequence identity to the amino acid sequence of SEQ ID NO: 24; (ii) a variable heavy chain sequence having at least 95% sequence identity to the amino acid sequence of SEQ ID NO: 25; or (iii) a variable light chain sequence as in (i) and a variable heavy chain sequence as in (ii); or
(b) (iv) a variable light chain sequence having at least 95% sequence identity to the amino acid sequence of SEQ ID NO: 16; (11 v) a variable heavy chain sequence having at least 95% sequence identity to the amino acid sequence of SEQ ID NO: 15; or (vi) a variable light chain sequence as in (14 iv) and a variable heavy chain sequence as in (V).

### Claim 6 (depends on 1)

The antibody of claim 1, wherein the antibody comprises:
(a) a variable light chain sequence of SEQ ID NO: 24 and a variable heavy chain sequence of SEQ ID NO: 25; or
(b) a variable light chain sequence of SEQ ID NO: 16 and a variable heavy chain sequence of SEQ ID NO: 15.

### Claim 7 (depends on 1)

The antibody of claim 1, wherein the antibody comprises (a) a canine heavy chain constant region selected from an IgG-A, IgG-B, IgG-C, and IgG-D constant region; (b) a feline heavy chain constant region selected from an IgG-1a, IgG-1b, and IgG-2 constant region; or (c) an equine heavy chain constant region selected from an IgG-1, IgG-2, IgG-3, IgG-4, IgG-5, IgG-6, and IgG-7 constant region.

### Claim 8 (depends on 1)

The antibody of claim 1, wherein the antibody comprises a heavy chain amino acid sequence of SEQ ID NO: 17, SEQ ID NO: 18, SEQ ID NO: 19, SEQ ID NO: 20, or SEQ ID NO: 27.

### Claim 9 (depends on 1)

The antibody of claim 1, wherein the antibody comprises a light chain amino acid sequence of SEQ ID NO: 21 or SEQ ID NO: 26.

### Claim 10 (depends on 1)

The antibody of claim 1, wherein the antibody is an antibody fragment, selected from an Fv, scFv, Fab, Fab′, F(ab′)2, and Fab′-SH fragment.

### Claim 11 (depends on 1)

An isolated nucleic acid encoding the antibody of claim 1.

### Claim 12 (depends on 11)

A host cell comprising the nucleic acid of claim 11.

### Claim 13 (depends on 12)

A method of producing an antibody comprising culturing the host cell of claim 12 and isolating the antibody.

### Claim 14 (depends on 1)

A pharmaceutical composition comprising the antibody of claim 1 and a pharmaceutically acceptable carrier.

### Claim 15 (depends on 1)

A method of treating a companion animal species having an IL17A-induced condition, the method comprising administering to the companion animal species a therapeutically effective amount of the antibody of claim 1, wherein the IL17A-induced condition is plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, airway inflammation, asthma, osteoarthritis, inflammatory bowel disorder, Crohn's disease, ankylosing spondylitis, atopic dermatitis, degenerative myelopathy, multiple sclerosis, or uveitis.

### Claim 16 (depends on 1)

The antibody of claim 1, comprising (i) a variable light chain sequence having at least 95% sequence identity to the amino acid sequence of SEQ ID NO: 16; (ii) a variable heavy chain sequence having at least 95% sequence identity to the amino acid sequence of SEQ ID NO: 15; or (iii) a variable light chain sequence as in (i) and a variable heavy chain sequence as in (ii).

### Claim 17 (depends on 1)

The antibody of claim 1, comprising a variable light chain sequence having the amino acid sequence of SEQ ID NO: 16; (ii) a variable heavy chain sequence having the amino acid sequence of SEQ ID NO: 15; or (iii) a variable light chain sequence as in (i) and a variable heavy chain sequence as in (ii).

### Claim 18

An isolated antibody that binds to canine IL17A, comprising a variable light chain sequence having the amino acid sequence of SEQ ID NO: 16 and a variable heavy chain sequence having the amino acid sequence of SEQ ID NO: 15.

### Claim 19 (depends on 18)

The antibody of claim 18, wherein the antibody comprises a constant heavy chain region or constant light chain region derived from a companion animal.

### Claim 20 (depends on 18)

The antibody of claim 18, wherein the antibody comprises (a) a canine heavy chain constant region selected from an IgG-A, IgG-B, IgG-C, and IgG-D constant region; (b) a feline heavy chain constant region selected from an IgG-1a, IgG-1b, and IgG-2 constant region; or (c) an equine heavy chain constant region selected from an IgG-1, IgG-2, IgG-3, IgG-4, IgG-5, IgG-6, and IgG-7 constant region.

### Claim 21 (depends on 18)

The antibody of claim 18, wherein the antibody is an antibody fragment, selected from an Fv, scFv, Fab, Fab′, F(ab′)2, and Fab′-SH fragment.

### Claim 22 (depends on 18)

An isolated nucleic acid encoding the antibody of claim 18.

### Claim 23 (depends on 22)

A host cell comprising the nucleic acid of claim 22.

### Claim 24 (depends on 23)

A method of producing an antibody comprising culturing the host cell of claim 23 and isolating the antibody.

### Claim 25 (depends on 18)

A pharmaceutical composition comprising the antibody of claim 18 and a pharmaceutically acceptable carrier.

### Claim 26 (depends on 18)

A method of treating a companion animal species having an IL17A-induced condition, the method comprising administering to the companion animal species a therapeutically effective amount of the antibody of claim 18, wherein the IL17A-induced condition is plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, airway inflammation, asthma, osteoarthritis, inflammatory bowel disorder, Crohn's disease, ankylosing spondylitis, atopic dermatitis, degenerative myelopathy, multiple sclerosis, or uveitis.

### Claim 27

An isolated antibody that binds to canine IL17A, comprising
(i) a CDR-H1 comprising the amino acid sequence of SEQ ID NO: 1, a CDR H2 comprising the amino acid sequence of SEQ ID NO: 2, and a CDR-H3 comprising the amino acid sequence of SEQ ID NO: 3, and
(ii) a CDR-L1 comprising the amino acid sequence of SEQ ID NO: 8, a CDR-L2 comprising the amino acid sequence of SEQ ID NO: 9 or SEQ ID NO: 108, and a CDR-L3 comprising the amino acid sequence of SEQ ID NO: 10;
and comprising a variable light chain sequence having at least 95% sequence identity to the amino acid sequence of SEQ ID NO: 16 and a variable heavy chain sequence having at least 95% sequence identity to the amino acid sequence of SEQ ID NO: 15.

### Claim 28 (depends on 27)

The antibody of claim 27, wherein the antibody comprises a constant heavy chain region or constant light chain region derived from a companion animal.

### Claim 29 (depends on 27)

The antibody of claim 27, wherein the antibody comprises (a) a canine heavy chain constant region selected from an IgG-A, IgG-B, IgG-C, and IgG-D constant region; (b) a feline heavy chain constant region selected from an IgG-1a, IgG-1b, and IgG-2 constant region; or (c) an equine heavy chain constant region selected from an IgG-1, IgG-2, IgG-3, IgG-4, IgG-5, IgG-6, and IgG-7 constant region.

### Claim 30 (depends on 27)

The antibody of claim 27, wherein the antibody is an antibody fragment, selected from an Fv, scFv, Fab, Fab′, F(ab′)2, and Fab′-SH fragment.

### Claim 31 (depends on 27)

An isolated nucleic acid encoding the antibody of claim 27.

### Claim 32 (depends on 31)

A host cell comprising the nucleic acid of claim 31.

### Claim 33 (depends on 32)

A method of producing an antibody comprising culturing the host cell of claim 32 and isolating the antibody.

### Claim 34 (depends on 27)

A pharmaceutical composition comprising the antibody of claim 27 and a pharmaceutically acceptable carrier.

### Claim 35 (depends on 27)

A method of treating a companion animal species having an IL17A-induced condition, the method comprising administering to the companion animal species a therapeutically effective amount of the antibody of claim 27, wherein the IL17A-induced condition is plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, airway inflammation, asthma, osteoarthritis, inflammatory bowel disorder, Crohn's disease, ankylosing spondylitis, atopic dermatitis, degenerative myelopathy, multiple sclerosis, or uveitis.