# US 2019/0169259 A1 · Btnl3 proteins, nucleic acids and antibodies and uses thereof

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- Number: US 2019/0169259 A1
- Document ID: US20190169259A1
- Status: Published application
- Kind: A1
- Application number: 16/256,951
- Filed: 2019-01-24
- Published: 2019-06-06
- Earliest claimed: 2012-07-19
- Assignees: Amgen Inc.
- Applicants: Amgen Inc.
- Inventors: Heather ARNETT; Sabine Schadow ESCOBAR; Ryan Michael SWANSON; Joanne Louise VINEY
- Web page: https://patentgrep.com/patent/US20190169259A1

## CPC

- C07K 14/705: Receptors; Cell surface antigens; Cell surface determinants {(tumour specific antigens C07K14/4748)}
- A61K 39/0013: {Therapeutic immunisation against small organic molecules, e.g. cocaine, nicotine}
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 11/06: Antiasthmatics
- A61P 17/06: Antipsoriatics
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 35/00: Antineoplastic agents
- A61P 37/02: Immunomodulators
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- C07K 14/70503: {Immunoglobulin superfamily}
- C07K 16/46: Hybrid immunoglobulins (hybrids of an immunoglobulin with a peptide not being an immunoglobulin C07K19/00)
- 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 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

## Abstract

The invention provides novel BTNL3 proteins, including multimers, fragments, fusion proteins, and variants. In addition, antibodies that can bind to BTNL3 proteins and nucleic acids encoding BTNL3 proteins are provided. Methods of making BTNL3 proteins using such nucleic acids are also provided. Uses for BTNL3 proteins, and agonists or antagonists thereof, are described.

## Claims

### Claim at position 1

1-52. (canceled)

### Claim 53

A method of treating a patient having an autoimmune or inflammatory disease comprising administering to the patient a therapeutically effective dose of a BTNL3 protein comprising
(a) the amino acid sequence of amino acids 18-236 of SEQ ID NO:2 or the amino acid sequence of amino acids 18-166 of SEQ ID NO:9,
(b) an amino acid sequence at least 90% identical to amino acids 18-236 of SEQ ID NO:2 or amino acids 18-166 of SEQ ID NO:9, wherein the alignment window of the amino acid sequence with amino acids 18-236 of SEQ ID NO:2 or amino acids 18-166 of SEQ ID NO:9 is at least 80 amino acids long, or
(c) an amino acid sequence that has no more than 20 insertions, deletions, or substitutions of a single amino acid relative to the sequence of amino acids 18-236 of SEQ ID NO:2 or amino acids 18-166 of SEQ ID NO:9,
wherein the BTNL3 protein can inhibit the proliferation of a T cell stimulated by an immobilized anti-CD3 antibody.

### Claim 54 (depends on 53)

The method of claim 53, wherein the autoimmune or inflammatory disease is selected from the group consisting of systemic lupus erythematosus, rheumatoid arthritis, an inflammatory bowel disease, a transplantation-related condition, Crohn's disease, ulcerative colitis, psoriasis, sarcoidosis, asthma, or a fibrotic disease.

### Claim 55 (depends on 54)

The method of claim 54, wherein the autoimmune or inflammatory disease is Crohn's disease.

### Claim 56 (depends on 54)

The method of claim 54, wherein the autoimmune or inflammatory disease is ulcerative colitis.

### Claim 57 (depends on 54)

The method of claim 54, wherein the autoimmune or inflammatory disease is a fibrotic disease.

### Claim 58

A method for inhibiting T cell proliferation comprising adding to the T cell a BTNL3 protein comprising
(a) the amino acid sequence of amino acids 18-236 of SEQ ID NO:2 or amino acids 18-166 of SEQ ID NO:9,
(b) an amino acid sequence at least 90% identical to amino acids 18-236 of SEQ ID NO:2 or amino acids 18-166 of SEQ ID NO:9, wherein the alignment window of the amino acid sequence with amino acids amino acids 18-236 of SEQ ID NO:2 or amino acids 18-166 of SEQ ID NO:9 is at least 80 amino acids long, or
(c) an amino acid sequence that has no more than 20 insertions, deletions, or substitutions of a single amino acid relative to the sequence of amino acids 18-236 of SEQ ID NO:2 or amino acids 18-166 of SEQ ID NO:9,
wherein the BTNL3 protein can inhibit the proliferation of a T cell stimulated by an immobilized anti-CD3 antibody.

### Claim 59 (depends on 58)

The method of claim 58, wherein the inhibition occurs in vitro or ex vivo.

### Claim 60 (depends on 58)

The method of claim 58, wherein the inhibition occurs in vivo.

### Claim at position 10

61-72. (canceled)

### Claim 73

A method for treating a patient having an autoimmune or inflammatory condition comprising the following steps:
(a) removing T cells from the patient;
(b) stimulating the T cells with a combination of proteins comprising an anti-CD3 antibody and a BTNL3 protein, wherein the BTNL3 protein comprises
(i) the amino acid sequence of amino acids 18-236 of SEQ ID NO:2 or amino acids 18-166 of SEQ ID NO:9,
(ii) an amino acid sequence at least 90% identical to amino acids 18-236 of SEQ ID NO:2 or amino acids 18-166 of SEQ ID NO:9, wherein the alignment window of the amino acid sequence with amino acids 18-236 of SEQ ID NO:2 or amino acids 18-166 of SEQ ID NO:9 is at least 80 amino acids long, or
(iii) an amino acid sequence that has no more than 20 insertions, deletions, or substitutions of a single amino acid relative to the sequence of amino acids 18-236 of SEQ ID NO:2 or amino acids 18-166 of SEQ ID NO:9,
(c) harvesting the stimulated T cells; and
(d) returning the harvested T cells to the patient,
wherein the BTNL3 protein can inhibit the proliferation of a T cell stimulated by an immobilized anti-CD3 antibody.

### Claim 74 (depends on 73)

The method of claim 73, wherein the BTNL3 protein is the BTNL3 protein of (b)(iii), wherein the amino acid sequence has no more than 10 insertions, deletions, or substitutions of a single amino acid relative to the sequence of amino acids 18-236 of SEQ ID NO:2 or amino acids 18-166 of SEQ ID NO:9.

### Claim 75 (depends on 74)

The method of claim 74, wherein the amino acid sequence has no more than 5 insertions, deletions, or substitutions of a single amino acid relative to the sequence of amino acids 18-236 of SEQ ID NO:2 or amino acids 18-166 of SEQ ID NO:9.

### Claim 76 (depends on 73)

The method of claim 73, wherein the BTNL3 protein is the BTNL3 protein of (b)(i).

### Claim 77 (depends on 73)

The method of claim 73, wherein the autoimmune or inflammatory condition is selected from the group consisting of systemic lupus erythematosus, rheumatoid arthritis, an inflammatory bowel disease, Crohn's disease, ulcerative colitis, psoriasis, sarcoidosis, asthma, a transplantation-related condition, types 1 or 2 diabetes, or a fibrotic disease.