# US 2014/0154715 A1 · Monoclonal antibodies specific for beta-amyloid x-37 and uses thereof

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- Number: US 2014/0154715 A1
- Document ID: US20140154715A1
- Status: Published application
- Kind: A1
- Application number: 14/233,068
- Filed: 2012-07-06
- Published: 2014-06-05
- Earliest claimed: 2011-07-15
- Assignees: Janssen Pharmaceutica NV
- Inventors: Marc Hubert Mercken; Marianne Borgers; Marc, Maria, Pierre, Pelagie Vandermeeren; Bianca Julia J Van Broeck
- Web page: https://patentgrep.com/patent/US20140154715A1

## CPC

- G01N 33/577: involving monoclonal antibodies {binding reaction mechanisms characterised by the use of monoclonal antibodies (G01N33/5302 - G01N33/576 take precedence)}
- C07K 16/18: against material from animals or humans
- 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)
- 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 provides monoclonal antibodies which specifically recognize the shorter Aβ peptides obtained after cleavage of the APP protein mediated by γ-secretase, i.e. the Aβ-peptide fragments Aβ1-37, Aβ3-37, Aβ3p-37, Aβ1-37 and Aβ11p-37, and other like fragments ending at the 37th amino acid of APP, hereinafter also referred to as the Aβx-37 peptides. It further provides hybridoma cells producing the monoclonal antibodies as well as methods for producing the antibodies and the hybridoma cells; and an immunoassay for an Aβx-37 peptide by a competitive method or a sandwich method using the antibody of the present invention; and methods for measuring the level of Aβx-37 peptides in a sample, such as a biological sample.

## Claims

### Claim 1

A monoclonal antibody which specifically recognizes Aβx-37 peptide.

### Claim 2 (depends on 1)

The monoclonal antibody as in claim 1, wherein said Aβx-37 peptide is selected from the group consisting of the Aβ-peptide fragments Aβ1-37, Aβ3-37, Aβ3p-37, Aβ11-37 and Aβ11p-37.

### Claim 3 (depends on 1)

The monoclonal antibody of claim 1 wherein the monoclonal antibody is detectably labeled.

### Claim 4 (depends on 3)

The monoclonal antibody of claim 3 wherein the detectable label is a radiolabel, an enzyme label, a luminescent label or a fluorescent label.

### Claim 5 (depends on 4)

The monoclonal antibody of claim 4 wherein the monoclonal antibody is immobilized on a carrier.

### Claim 6 (depends on 1)

The monoclonal antibody according to claim 1, wherein the monoclonal antibody is selected from the group consisting of monoclonal antibodies produced by any of the hybridoma cells JRD/Ab37/3 sc11 deposited at the Belgian coordinated collection of microorganisms on Feb. 1, 2011 with accession numbers LMBP 8062CB, JRD/Ab37/4 sc11 deposited at the Belgian coordinated collection of microorganisms on Feb. 1, 2011 with accession numbers LMBP 8063CB, or the hybridoma JRD/Ab37/10 sc11 deposited at the Belgian Coordinated Collections of Microorganisms on Mar. 30, 2011 with accession number LMBP 8064CB.

### Claim 7

Method for the determination or detection of the presence of Aβx-37 peptides in a sample, comprising contacting the sample with the a monoclonal antibody which specifically recognizes Aβx-37 peptide and determining whether an immune complex is formed between said monoclonal antibody and said Aβx-37 peptide.

### Claim 8 (depends on 7)

The method of claim 7, wherein said sample is selected from the group consisting of a tissue sample and a body fluid sample from a mammal.

### Claim 9

(canceled)

### Claim 10

A method for monitoring treatment of β-amyloid-related diseases, comprising the steps of:
determining the amount of Aβx-37 peptide and the amount Aβ42 peptide in a biological sample of a patient undergoing treatment at regular time intervals, and
determining the relative change of said amount of Aβx-37 peptide and said amount Aβ42 peptide over time.

### Claim 11 (depends on 10)

The method of claim 10, wherein said step of determining the amount of Aβx-37 peptide is performed using a monoclonal antibody which specifically recognizes Aβx-37 peptide.

### Claim 12

An immunoassay kit for the diagnosis, progression monitoring or treatment monitoring of β-amyloid-related diseases comprising the monoclonal antibody which specifically recognizes Aβx-37 peptide which is detectable labeled and a carrier means for the monoclonal antibody.

### Claim 13 (depends on 2)

The monoclonal antibody of claim 2 wherein the monoclonal antibody is detectably labeled.

### Claim 14 (depends on 13)

The monoclonal antibody of claim 13 wherein the detectable label is a radio-label, an enzyme label, a luminescent label or a fluorescent label.

### Claim 15 (depends on 14)

The monoclonal antibody of claim 14 that is immobilized on a carrier.
