# US 10,308,715 B2 · Antibody targeting osteoclast-related protein Siglec-15

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- Number: US 10,308,715 B2
- Document ID: US10308715B2
- Status: Granted
- Kind: B2
- Application number: 15/729,947
- Filed: 2017-10-11
- Published: 2018-02-08
- Granted: 2019-06-04
- Earliest claimed: 2007-10-11
- Assignees: Daiichi Sankyo Company, Limited
- Applicants: Daiichi Sankyo Company, Limited
- Inventors: Yoshiharu Hiruma; Eisuke Tsuda
- Web page: https://patentgrep.com/patent/US10308715B2

## CPC

- C07K 16/2851: {against the lectin superfamily, e.g. CD23, CD72}
- A61K 31/593: 9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
- A61K 31/663: Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid
- A61K 39/395: Antibodies (agglutinins A61K38/36 {; as drug carriers A61K47/50}); Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 1/02: Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
- A61P 3/14: for calcium homeostasis (vitamin D A61P3/02; parathyroid hormones A61P5/18; calcitonin A61P5/22; osteoporosis A61P19/10; bone metastasis A61P35/04)
- A61P 7/00: Drugs for disorders of the blood or the extracellular fluid
- A61P 13/12: of the kidneys
- A61P 19/00: Drugs for skeletal disorders
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 19/08: for bone diseases, e.g. rachitism, Paget's disease
- A61P 19/10: for osteoporosis
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 35/00: Antineoplastic agents
- A61P 35/04: specific for metastasis
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 16/2803: {against the immunoglobulin superfamily}
- A61K 2039/505: {comprising antibodies}
- C07K 2317/14: Specific host cells or culture conditions, e.g. components, pH or temperature
- 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 2317/76: 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

To provide a method of detecting abnormal bone metabolism by using a gene strongly expressed in an osteoclast; a method of screening a compound having a therapeutic and/or preventive effect on abnormal bone metabolism; and a pharmaceutical composition for treating and/or preventing abnormal bone metabolism. Provision of a method of detecting abnormal bone metabolism by using the expression of human Siglec-15 gene as an index; a pharmaceutical composition containing an antibody which specifically recognizes human Siglec-15 and has an activity of inhibiting osteoclast formation; and the like.

## Claims

### Claim 1

An antibody or an antigen binding fragment thereof, comprising the same Complementarity Determining Regions (CDRs) as a monoclonal antibody produced by hybridoma #32A1, wherein the antibody or antigen binding fragment thereof specifically binds to any one of the following polypeptides (a)-(h), or any combination thereof, and inhibits osteoclast formation and/or osteoclastic bone resorption:
(a) the amino acid sequence of SEQ ID NO: 2;
(b) amino acid residues 21 to 328 of the amino acid sequence of SEQ ID NO: 2;
(c) amino acid residues 1 to 260 of the amino acid sequence of SEQ ID NO: 2;
(d) amino acid residues 21 to 260 of the amino acid sequence of SEQ ID NO: 2;
(e) the amino acid sequence of SEQ ID NO: 4;
(f) amino acid residues 21 to 341 of the amino acid sequence of SEQ ID NO: 4;
(g) amino acid residues 1 to 258 of the amino acid sequence of SEQ ID NO: 4; or
(h) amino acid residues 21 to 258 of the amino acid sequence of SEQ ID NO: 4.

### Claim 2 (depends on 1)

The antibody or antigen binding fragment of claim 1, wherein the antibody is a monoclonal antibody.

### Claim 3 (depends on 1)

The antibody or antigen binding fragment of claim 1, wherein the antibody is an IgG antibody.

### Claim 4 (depends on 1)

A pharmaceutical composition comprising an antibody or antigen binding fragment according to claim 1, wherein the pharmaceutical composition further comprises a pharmaceutically acceptable diluent or carrier.

### Claim 5 (depends on 4)

The pharmaceutical composition of claim 4, wherein the pharmaceutical composition further comprises at least one agent selected from the group consisting of bisphosphonate, active vitamin D3, calcitonin, hormones, ipriflavone, vitamin K2 (menatetrenone), calcium, PTH (parathyroid hormone), nonsteroidal anti-inflammatory agent, soluble TNF receptor, anti-TNF-α antibody or an antigen binding fragment thereof, anti-PTHrP (parathyroid hormone-related protein) antibody or an antigen binding fragment thereof, anti-IL-6 receptor antibody or an antigen binding fragment thereof, anti-RANKL antibody or an antigen binding fragment thereof, and OCIF (osteoclastogenesis inhibitory factor).