# US 11,299,545 B2 · Anti-HLA-C antibodies and uses thereof

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- Number: US 11,299,545 B2
- Document ID: US11299545B2
- Status: Granted
- Kind: B2
- Application number: 16/839,179
- Filed: 2020-04-03
- Published: 2020-10-08
- Granted: 2022-04-12
- Earliest claimed: 2019-04-04
- Assignees: Janssen Biotech, Inc.
- Applicants: Janssen Biotech, Inc.
- Inventors: Ryan Eberwine; Anne Fourie; Paul H. Kim; Carl L. Manthey; Hong Zhou
- Web page: https://patentgrep.com/patent/US11299545B2

## CPC

- C07K 16/2833: {against MHC-molecules, e.g. HLA-molecules}
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- C07K 2317/21: from primates, e.g. man
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- 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
- 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

Anti-HLA-C6 antibodies and antigen-binding fragments thereof are described. Also described are nucleic acids encoding the antibodies, compositions comprising the antibodies, methods of producing the antibodies, and methods of using the antibodies for treating or preventing diseases, such as autoimmune diseases.

## Claims

### Claim 1

An isolated monoclonal antibody or antigen-binding fragment thereof comprising a heavy chain variable region and a light chain variable region, the heavy chain variable region comprising a heavy chain complementarity determining region 1 (HCDR1), HCDR2, and a HCDR3, the light chain variable region comprising a light chain complementarity determining region 1 (LCDR1), LCDR2, and LCDR3, wherein the HCDR1, HCDR2, HCDR3, LCDR1, LCDR2 and LCDR3 comprise the amino acid sequences of:
a. SEQ ID NOs: 37, 38, 39, 64, 65, and 66, respectively;
b. SEQ ID NOs: 40, 41, 42, 67, 68, and 69, respectively;
c. SEQ ID NOs: 43, 44, 45, 70, 71, and 72, respectively;
d. SEQ ID NOs: 46, 47, 48, 73, 74, and 75, respectively;
e. SEQ ID NOs: 49, 50, 51, 76, 77, and 78, respectively;
f. SEQ ID NOs: 52, 53, 54, 79, 80, and 81, respectively;
g. SEQ ID NOs: 55, 56, 57, 82, 83, and 84, respectively;
h. SEQ ID NOs: 58, 59, 60, 85, 86, and 87, respectively; or
i. SEQ ID NOs: 61, 62, 63, 88, 89, and 90, respectively;
wherein the antibody or antigen-binding fragment thereof binds HLA-C.

### Claim 2

An isolated monoclonal antibody or antigen-binding fragment thereof comprising a heavy chain variable region and a light chain variable region, the heavy chain variable region comprising a heavy chain complementarity determining region 1 (HCDR1), HCDR2, and a HCDR3, the light chain variable region comprising a light chain complementarity determining region 1 (LCDR1), LCDR2, and LCDR3, wherein the HCDR1, HCDR2, HCDR3, LCDR1, LCDR2 and LCDR3 comprise the amino acid sequences of:
a. SEQ ID NOs: 91, 92, 93, 118, 119, and 120, respectively;
b. SEQ ID NOs: 94, 95, 96, 121, 122, and 123, respectively;
c. SEQ ID NOs: 97, 98, 99, 124, 125, and 126, respectively;
d. SEQ ID NOs: 100, 101, 102, 127, 128, and 129, respectively;
e. SEQ ID NOs: 103, 104, 105, 130, 131, and 132, respectively;
f. SEQ ID NOs: 106, 107, 108, 133, 134, and 135, respectively;
g. SEQ ID NOs: 109, 110, 111, 136, 137, and 138, respectively;
h. SEQ ID NOs: 112, 113, 114, 139, 140, and 141, respectively; or
i. SEQ ID NOs: 115, 116, 117, 142, 143, and 144, respectively;
wherein the antibody or antigen-binding fragment thereof specifically binds HLA-Cw6.

### Claim 3

An isolated monoclonal antibody or antigen-binding fragment thereof comprising a heavy chain variable region and a light chain variable region, the heavy chain variable region comprising a heavy chain complementarity determining region 1 (HCDR1), HCDR2, and a HCDR3, the light chain variable region comprising a light chain complementarity determining region 1 (LCDR1), LCDR2, and LCDR3, wherein the HCDR1, HCDR2, HCDR3, LCDR1, LCDR2 and LCDR3 comprise the amino acid sequences of:
a. SEQ ID NOs: 145, 146, 147, 172, 173, and 174, respectively;
b. SEQ ID NOs: 148, 149, 150, 175, 176, and 177, respectively;
c. SEQ ID NOs: 151, 152, 153, 178, 179, and 180, respectively;
d. SEQ ID NOs: 154, 155, 156, 181, 182, and 183, respectively;
e. SEQ ID NOs: 157, 158, 159, 184, 185, and 186, respectively;
f. SEQ ID NOs: 160, 161, 162, 187, 188, and 189, respectively;
g. SEQ ID NOs: 163, 164, 165, 190, 191, and 192, respectively;
h. SEQ ID NOs: 166, 167, 168, 193, 194, and 195, respectively; or
i. SEQ ID NOs: 169, 170, 171, 196, 197, and 198, respectively;
wherein the antibody or antigen-binding fragment thereof binds HLA-C.

### Claim 4 (depends on 1)

The isolated monoclonal antibody or antigen-binding fragment thereof of claim 1, wherein the antibody or antigen-binding fragment comprises (i) the heavy and light chain CDRs as set forth in subsection a., and wherein either the heavy chain variable region is at least 95% identical to SEO ID NO:1, the light chain variable region is at least 95% identical to SEO ID NO:2, or both;
(ii) the heavy and light chain CDRs as set forth in subsection b., and wherein either the heavy chain variable region is at least 95% identical to SEO ID NO:3, the light chain variable region is at least 95% identical to SEQ ID NO:4, or both;
(iii) the heavy and light chain CDRs as set forth in subsection c., and wherein either the heavy chain variable region is at least 95% identical to SEO ID NO:5, the light chain variable region is at least 95% identical to SEQ ID NO:6, or both;
(iv) the heavy and light chain CDRs as set forth in subsection d., and wherein either the heavy chain variable region is at least 95% identical to SEQ ID NO:7, the light chain variable region is at least 95% identical to SEO ID NO:8, or both;
(v) the heavy and light chain CDRs as set forth in subsection e., and wherein either the heavy chain variable region is at least 95% identical to SEQ ID NO:9, the light chain variable region is at least 95% identical to SEO ID NO: 10, or both;
(vi) the heavy and light chain CDRs as set forth in subsection f., and wherein either the heavy chain variable region is at least 95% identical to SEO ID NO:11, the light chain variable region is at least 95% identical to SEO ID NO: 12, or both;
(vii) the heavy and light chain CDRs as set forth in subsection g., and wherein either the heavy chain variable region is at least 95% identical to SEO ID NO: 13, the light chain variable region is at least 95% identical to SEQ ID NO: 14, or both;
(viii) the heavy and light chain CDRs as set forth in subsection h., and wherein either the heavy chain variable region is at least 95% identical to SEO ID NO: 15, the light chain variable region is at least 95% identical to SEO ID NO: 16, or both: or
(ix) the heavy and light chain CDRs as set forth in subsection i., and wherein either the heavy chain variable region is at least 95% identical to SEQ ID NO: 17, the light chain variable region is at least 95% identical to SEO ID NO:18, or both.

### Claim 5 (depends on 1)

The isolated monoclonal antibody or antigen-binding fragment thereof of claim 1, wherein the antibody or antigen-binding fragment thereof is chimeric.

### Claim 6 (depends on 1)

The isolated monoclonal antibody or antigen-binding fragment thereof of claim 1, wherein the antibody or antigen-binding fragment thereof is humanized.

### Claim 7 (depends on 1)

The isolated monoclonal antibody or antigen-binding fragment thereof of claim 1, wherein the antibody or antigen-binding fragment thereof blocks development and activation of T cells, through binding and inhibition of antigen presentation by HLA-Cw6.

### Claim 8 (depends on 1)

An isolated nucleic acid encoding the monoclonal antibody or antigen-binding fragment thereof of claim 1.

### Claim 9 (depends on 8)

A vector comprising the isolated nucleic acid of claim 8.

### Claim 10 (depends on 9)

A host cell comprising the vector of claim 9.

### Claim 11 (depends on 1)

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

### Claim 12 (depends on 11)

A method of treating or preventing an autoimmune disease selected from the group consisting of psoriasis, plaque psoriasis, guttate psoriasis, and psoriatic arthritis in a subject in need thereof, comprising administering to the subject the pharmaceutical composition of claim 11.

### Claim 13 (depends on 1)

A method of producing the monoclonal antibody or antigen-binding fragment thereof of claim 1, comprising culturing a cell comprising a nucleic acid encoding the monoclonal antibody or antigen-binding fragment thereof under conditions to produce the monoclonal antibody or antigen-binding fragment thereof, and recovering the antibody or antigen-binding fragment thereof from the cell or culture.

### Claim 14 (depends on 1)

A method of producing a pharmaceutical composition comprising the monoclonal antibody or antigen-binding fragment of claim 1, comprising combining the monoclonal antibody or antigen-binding fragment thereof with a pharmaceutically acceptable carrier to obtain the pharmaceutical composition.