# US 5,702,705 A · Antibody methods for the treatment of a hormone-mediated disease

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- Number: US 5,702,705 A
- Document ID: US5702705A
- Status: Granted
- Kind: A
- Application number: 08/463,892
- Filed: 1995-06-05
- Granted: 1997-12-30
- Earliest claimed: 1995-04-18
- Assignees: Chiron Corporation
- Inventors: Michael Kriegler; Carl Perez
- Web page: https://patentgrep.com/patent/US5702705A

## CPC

- C07K 16/241: {Tumor Necrosis Factors}
- 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)
- A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53)
- C07K 2317/34: Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
- Y10S 530/809: Fused cells, e.g. hybridoma
- 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)
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS

## Abstract

Cleavage site blocking antibody that binds to prohormones, preferable Tumor Necrosis Factor, thereby preventing the formation of prohormone fragment(s) by proteolysis of the prohormone, and uses of the antibody including prophylactic and therapeutic methods to treat disease, and diagnostic assays for determining the amount of the prohormone and prohormone fragments present in a patients body.

## Claims

### Claim 1

A method for prophylactically or therapeutically treating a patient for a disease caused by the presence of a mature hormone in said patient, said mature hormone comprising a 15 kd or a 17 kd TNF and being produced by the protease cleavage of a prohormone form of said mature hormone, said prohormone form comprising a 26 kd TNF, said cleavage being at a prohormone cleavage site, said method comprising administering said patient an effective amount of a monoclonal antibody or an antigen binding fragment thereof that binds to said prohormone TNF at said cleavage site to sterically hinder access of said protease to said cleavage site, thereby preventing or inhibiting formation of said mature hormone TNF.

### Claim 2 (depends on 1)

The method of claim 1, wherein said mature TNF has an approximate molecular weight of about 17,000.

### Claim 3 (depends on 1)

The method of claim 1, wherein said antibody or said antigen binding fragment thereof has specificity for a sequence of amino acid residues in said 26 kd TNF, said sequence being a member of the group consisting of:
Gln-Ala-Val-Arg-Ser-Ser-Ser,
Gln-Ala-Val-Arg-Ser-Ser-Ser-Arg-Thr-Pro-Ser-Asp-Lys-Pro-Val-Ala,
Pro-Leu-Ala-Gln-Ala-Val-Arg-Ser-Ser-Ser-Arg-Thr-Pro-Asp-Lys-Pro-Val-Ala-His -Val-Val-Ala, and
Pro-Leu-Ala-Gln-Ala-Val-Arg-Ser-Ser-Ser-Arg-Thr-Pro.

### Claim 4 (depends on 1, 3)

The method of claim 1 or 3, wherein an antigen binding fragment is administered.

### Claim 5 (depends on 4)

The method of claim 4, wherein said antigen binding fragment is an F(ab').sub.2, an Fab, or an Fv.

### Claim 6 (depends on 5)

The method of claim 5, wherein said antigen binding fragment is humanized.

### Claim 7 (depends on 1, 3)

The method of claim 1 or 3, wherein said antibody is humanized.

### Claim 8 (depends on 1)

The method of claim 1, wherein said antibody or antigen binding fragment thereof is cleavage site specific.