# US 10,246,513 B2 · Antibodies, compounds and derivatives thereof for use in the treatment of male infertility

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- Number: US 10,246,513 B2
- Document ID: US10246513B2
- Status: Granted
- Kind: B2
- Application number: 14/909,701
- Filed: 2014-08-04
- Published: 2016-06-16
- Granted: 2019-04-02
- Earliest claimed: 2013-08-07
- Assignees: Rigshospitalet Copenhagen University Hospital
- Applicants: Rigshospitalet Copenhagen University Hospital
- Inventors: Martin Blomberg Jensen
- Web page: https://patentgrep.com/patent/US10246513B2

## CPC

- C07K 16/2875: {against the NGF/TNF superfamily, e.g. CD70, CD95L, CD153, CD154 (against NGF C07K16/22, against TNF C07K16/241)}
- A61K 38/1793: {for cytokines; for lymphokines; for interferons}
- A61K 39/395: Antibodies (agglutinins A61K38/36 {; as drug carriers A61K47/50}); Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- 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
- A61K 2039/505: {comprising antibodies}
- C07K 2317/21: from primates, e.g. man
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- 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 present invention relates to antagonists or inhibitors, which bind selectively to RANKL/OPGbp and regulate the interaction between RANKL/OPGbp and RANK/OPG. In particular, the present invention relates to an antibody or antigen binding domain, fragment or derivative thereof, immunoreactive with a RANKL/OPGbppeptide for use in the treatment, prevention or alleviation of male infertility or reduced male fertility such as oligospermia or azospermia.

## Claims

### Claim 1

A method of increasing sperm production in a male subject, comprising:
selecting a male subject with spermatogenic failure; and
administering to said male subject a therapeutically effective amount of a composition comprising Denosumab or an antigen binding domain thereof, or osteoprotegerin (OPG).

### Claim 2 (depends on 1)

The method according to claim 1, wherein the composition comprises Denosumab.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the composition comprises a Denosumab antigen binding domain.

### Claim 4 (depends on 1)

The method according to claim 1, wherein said method includes treating oligospermia.

### Claim 5 (depends on 1)

The method according to claim 1, wherein said method includes treating azoospermia.

### Claim 6 (depends on 1)

The method according to claim 1, wherein said composition is administered intravenously or subcutaneously.

### Claim 7 (depends on 1)

The method according to claim 1, wherein said composition is administered subcutaneously.

### Claim 8 (depends on 1)

The method according to claim 1, wherein said composition, is administered intra-intesticularly or in the genital region.

### Claim 9 (depends on 1)

The method according to claim 1, wherein said composition, is administered in the scrotal region.

### Claim 10 (depends on 1)

The method according to claim 1, wherein the composition is administered to a male subject who does not suffer from testicular cancer at any stage, which is detectable by histological analysis of a tissue sample of the testis from said subject.

### Claim 11 (depends on 1)

The method according to claim 1, wherein said method includes treating oligospermia or azoospermia in male mammals, or increasing sperm production in male mammals.

### Claim 12 (depends on 1)

The method according to claim 1, wherein said composition is in a pharmaceutical composition.

### Claim 13

A method of treating oligospermia or azoospermia in a male mammal, or of increasing sperm production in the male mammal, said method comprising administering a therapeutically effective amount of OPG (osteoprotegerin) or a fusion protein comprising OPG to the male mammal, wherein the male mammal has spermatogenic failure.

### Claim 14

A method of treating oligospermia or azoospermia in a male mammal, or of increasing sperm production in the male mammal, said method comprising administering a therapeutically effective amount of Denosumab to the male mammal, wherein the male mammal has spermatogenic failure.
