# US 9,040,246 B2 · Methods of making antibodies that bind polypeptides involved in the process of bone remodeling

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- Number: US 9,040,246 B2
- Document ID: US9040246B2
- Status: Granted
- Kind: B2
- Application number: 13/950,490
- Filed: 2013-07-25
- Published: 2013-11-14
- Granted: 2015-05-26
- Earliest claimed: 2006-02-13
- Assignees: Alethia Biotherapeutics Inc.
- Applicants: Alethia Biotherapeutics Inc.
- Inventors: Roy Rabindranauth Sooknanan; Gilles Bernard Tremblay; Mario Filion
- Web page: https://patentgrep.com/patent/US9040246B2

## CPC

- C07K 14/51: Bone morphogenetic factor; Osteogenins; Osteogenic factor; Bone-inducing factor
- A61K 39/39533: {against materials from animals}
- A61P 1/02: Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
- A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00)
- A61P 3/04: Anorexiants; Antiobesity agents
- 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 5/14: of the thyroid hormones, e.g. T3, T4
- A61P 5/18: of the parathyroid hormones
- A61P 5/24: of the sex hormones
- A61P 5/38: of the suprarenal hormones
- A61P 13/12: of the kidneys
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- A61P 15/08: for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
- 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 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 14/47: from mammals
- C07K 16/18: against material from animals or humans
- C12N 15/113: Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; {Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing (when used in plants C12N15/8218)}
- C12Q 1/6883: for diseases caused by alterations of genetic material
- G01N 33/5044: {involving specific cell types}
- 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 2317/54: F(ab')2
- C07K 2317/55: Fab or Fab'
- C12N 2310/11: Antisense
- C12N 2310/12: catalytic nucleic acids, e.g. ribozymes
- C12N 2310/14: interfering nucleic acids [NA]
- C12Q 2600/136: Screening for pharmacological compounds
- C12Q 2600/158: Expression markers
- C12Q 2600/178: miRNA, siRNA or ncRNA
- G01N 2500/00: Screening for compounds of potential therapeutic value
- G01N 2800/10: Musculoskeletal or connective tissue disorders
- G01N 2800/108: Osteoporosis
- 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)
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

This invention relates, in part, to unique and newly identified genetic polynucleotides involved in the process of bone remodeling, variants and derivatives of the polynucleotides and corresponding polypeptides, uses of the polynucleotides, polypeptides, variants and derivatives, and methods and compositions for the amelioration of symptoms caused by bone remodeling disorders. Disclosed in particular are the isolation and identification of polynucleotides polypeptides variants and derivatives involved in osteoclast activity, validation of the identified polynucleotides for their potential as therapeutic targets and use of the polynucleotides, polypeptides, variants and derivatives for the amelioration of disease states and research purposes.

## Claims

### Claim 1

A process of providing an antibody or antigen binding fragment thereof, comprising characterizing an antibody or antigen binding fragment which specifically binds to a polypeptide consisting of SEQ ID NO:48 or SEQ ID NO:82 in an in vitro assay indicative of an ability of the antibody or antigen binding fragment thereof to inhibit osteoclast differentiation activity.

### Claim 2 (depends on 1)

The process of claim 1, wherein the in vitro assay is indicative of the ability of the antibody or antigen binding fragment thereof to inhibit the osteoclast differentiation activity at a nanomolar concentration.

### Claim 3 (depends on 1)

The process of claim 1, wherein the in vitro assay comprises characterizing the ability of the antibody or antigen binding fragment thereof to inhibit the differentiation of osteoclast precursors into differentiated osteoclasts.

### Claim 4

A method of making an antibody or an antigen binding fragment thereof, the method comprising obtaining an antibody or antigen binding fragment thereof which specifically binds to a polypeptide consisting of SEQ ID NO:48 or SEQ ID NO:82 from cultured cells, wherein said antibody or antigen binding fragment thereof is characterized by its ability to inhibit osteoclast differentiation.

### Claim 5 (depends on 4)

The method of claim 4, wherein the antibody or antigen binding fragment thereof inhibits osteoclast differentiation at a nanomolar concentration.

### Claim 6

A method of making an antibody or an antigen binding fragment thereof which specifically binds to a polypeptide consisting of SEQ ID NO:48 or SEQ ID NO:82, the method comprising culturing a host cell under conditions that allow production of the antibody or antigen binding fragment thereof, wherein said antibody or antigen binding fragment thereof is characterized by an ability to inhibit osteoclast differentiation.

### Claim 7 (depends on 6)

The method of claim 6, wherein the antibody or antigen binding fragment thereof is characterized by the ability to inhibit osteoclast differentiation in an in vitro assay.

### Claim 8 (depends on 7)

The method of claim 7, wherein the in vitro assay is indicative of the ability of the antibody or antigen binding fragment thereof to inhibit the osteoclast differentiation activity at a nanomolar concentration.

### Claim 9 (depends on 7)

The method of claim 7, wherein the in vitro assay comprises characterizing the ability of the antibody or antigen binding fragment thereof to inhibit differentiation of osteoclast precursors into differentiated osteoclasts.