# US 7,407,653 B2 · Treatment of IgA1 deposition diseases

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- Number: US 7,407,653 B2
- Document ID: US7407653B2
- Status: Granted
- Kind: B2
- Application number: 10/921,676
- Filed: 2004-08-19
- Published: 2005-06-23
- Granted: 2008-08-05
- Earliest claimed: 2003-03-07
- Assignees: Tufts Medical Center, Inc.
- Inventors: Andrew G. Plaut; Jiazhou Qiu
- Web page: https://patentgrep.com/patent/US7407653B2

## CPC

- C12N 9/52: derived from bacteria {or Archaea}
- A61P 7/04: Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 13/12: of the kidneys
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 37/00: Drugs for immunological or allergic disorders
- A61P 37/02: Immunomodulators
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 2319/21: containing a His-tag
- C07K 2319/40: containing a tag for immunodetection, or an epitope for immunisation
- C07K 2319/42: containing a HA(hemagglutinin)-tag
- C07K 2319/43: containing a FLAG-tag
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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)

## Abstract

The present invention discloses the use of bacterial IgA1 proteases to treat IgA1 deposition in tissue and organs. Bacterial IgA1 proteases specifically cleave IgA1 molecules and thus provide a means to specifically cleave and remove IgA1 depositions. Accordingly, therapeutic agents for the treatment of diseases characterized by IgA deposition are provided. In particular, therapeutic agents to treat IgA nephropathy, Dermatitis herpetiformis (DH), and Henoch-Schoenlein purpura (HS) are disclosed.

## Claims

### Claim 1

A method comprising a step of administering to an individual having deposits of human IgA1 an IgA1 protease selected from the group consisting of Streptococcus pneumoniae IgA1 protease, Streptococcus sanguis IgA1 protease, Clostridium ramosum IgA1 protease, Haemophilus influenzae IgA1 protease, Haemophilus aegyptius IgA1 protease, Neisseria meningitidis IgA1 protease, and Neisseria gonorrhoeae IgA1 protease, such that the deposits of human IgA1 are reduced.

### Claim 2

A method comprising a step of administering to an individual having deposits of human IgA1 a therapeutically effective amount of an isolated polypeptide molecule comprising a first amino acid sequence comprising an IgA1 protease selected from the group consisting of Streptococcus pneumoniae IgA1 protease, Streptococcus sanguis IgA1 protease, Clostridium ramosum IgA1 protease, Haemophilus influenzae IgA1 protease, Haemophilus aegyptius IgA1 protease, Neisseria meningitidis protease, and Neisseria gonorrhoeae IgA1 protease, and a second amino acid sequence comprising a tag, such that the deposits of human IgA1 are reduced.

### Claim 3 (depends on 1, 2)

The method of claim 1 or 2, wherein said IgA1 protease is selected from the group consisting of Haemophilus influenzae IgA1 protease, Neisseria gonorrhoeae IgA1 protease, Clostridium ramosum IgA1 protease, and Streptococcus sanguis IgA1 protease.

### Claim 4 (depends on 1, 2)

The method of claim 1 or 2, wherein said IgA1 protease is Haemophilus influenzae IgA1 protease.

### Claim 5 (depends on 1)

The method of claim 1 2 or , wherein said IgA1 protease cleaves at the hinge region of IgA1.

### Claim 6 (depends on 1, 2)

The method of claim 1 or 2, wherein said Haemophilus influenzae IgA1 protease is selected from the group consisting of Haemophilus influenzae type 1 IgA1 protease and Haemophilus influenzae type 2 IgA1 protease.

### Claim 7 (depends on 4)

The method of claim 4, wherein said Haemophilus influenzae IgA1 protease is selected from the group consisting of Haemophilus influenzae type 1 IgA1 protease and Haemophilus influenzae type 2 IgA1 protease.

### Claim 8 (depends on 1, 2)

The method of claim 1 or 2, wherein said Neisseria meningitidis IgA1 protease is selected from the group consisting of Neisseria meningitidis type 1 IgA1 protease and Neisseria meningitidis type 2 IgA1 protease.

### Claim 9 (depends on 1, 2)

The method of claim 1 or 2, wherein said Neisseria gonorrhoeae IgA1 protease is selected from the group consisting of Neisseria gonorrhoeae type 1 IgA1 protease and Neisseria gonorrhoeae type 2 IgA1 protease.