# US 9,040,043 B2 · Monoclonal antibodies against GMF-B antigens, and uses therefor

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- Number: US 9,040,043 B2
- Document ID: US9040043B2
- Status: Granted
- Kind: B2
- Application number: 13/949,737
- Filed: 2013-07-24
- Published: 2014-01-30
- Granted: 2015-05-26
- Earliest claimed: 2009-11-12
- Assignees: Alper Biotech, LLC
- Applicants: Özge Alper
- Inventors: Özge Alper
- Web page: https://patentgrep.com/patent/US9040043B2

## CPC

- G01N 33/6854: {Immunoglobulins}
- C07K 16/22: against growth factors {; against growth regulators}
- G01N 33/5758: {involving compounds serving as markers for tumours, cancers or neoplasias, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides or metabolites}
- G01N 33/6896: {Neurological disorders, e.g. Alzheimer's disease}
- C07K 2317/34: Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
- C07K 2317/56: variable (Fv) region, i.e. VH and/or VL
- C07K 2317/565: Complementarity determining region [CDR]
- G01N 2800/2821: Alzheimer
- 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 disclosure relates to anti-glial maturation factor beta (“GMF-B”) monoclonal antibodies (mAbs) and fragments thereof, as well as hybridoma lines that secrete antibodies or fragments. Therapeutic and diagnostic uses of such antibodies, including treatment and detection of cancer and dementia, and methods and kits for detecting cells or samples expressing GMF-B, including soluble GMF-B, are also encompassed.

## Claims

### Claim 1

A method for diagnosing breast cancer in a human subject comprising:
a) contacting a tissue or cell sample from a human with an isolated antibody or antibody fragment specific for glia maturation factor beta (GMF-B), wherein the antibody or antibody fragment comprises a heavy chain variable domain comprising three complementarity determining regions (CDRs) comprising the amino acid sequences of SEQ ID NO: 2, SEQ ID NO: 3, and SEQ ID NO: 4, and a light chain variable domain comprising three CDRs comprising the amino acid sequences of SEQ ID NO: 6, SEQ ID NO: 7, and SEQ ID NO: 8;
b) detecting the antibody; and
c) comparing the detection to a control sample from a healthy subject, wherein the subject is diagnosed with cancer if the antibody is detected at levels that are increased compared to the healthy control.

### Claim 2 (depends on 1)

The method of claim 1, wherein the sample is scored pathologically, wherein a pathology score of 0 indicates negligible staining in the sample, a score of 1+ indicates weak staining in the sample; a score of 2+ indicates intermediate staining in the sample; and a score of 3+ indicates strong staining in the sample, and wherein the subject is diagnosed with breast cancer if the tissue or cell sample is given a score of 2+ or 3+, and wherein the subject is not diagnosed with breast cancer if the tissue or cell sample is given a pathology score of 0 or 1+.

### Claim 3 (depends on 1)

The method of claim 1, wherein the antibody is detected using an immunohistochemistry method.

### Claim 4 (depends on 1)

The method of claim 1, wherein the level of detection correlates with a reduction in expected patient survival time.

### Claim 5 (depends on 2)

The method of claim 2, wherein higher pathology scores correlate with a reduction in expected survival time.

### Claim 6

A method for determining the severity of breast cancer in a patient diagnosed with or suspected of having breast cancer comprising:
a) contacting cell or tissue sample from a human with an isolated antibody or antibody fragment specific for glia maturation factor beta (GMF-B), wherein the antibody or antibody fragment comprises a heavy chain variable domain comprising three complementarity determining regions (CDRs) comprising the amino acid sequences of SEQ ID NO: 2, SEQ ID NO: 3, and SEQ ID NO: 4, and a light chain variable domain comprising three CDRs comprising the amino acid sequences of SEQ ID NO: 6, SEQ ID NO: 7, and SEQ ID NO: 8;
c) detecting the antibody or antibody fragment;
d) scoring the detection pathologically, wherein a pathology score of 0 indicates negligible staining in the sample, a score of 1+ indicates weak staining in the sample; a score of 2+ indicates intermediate staining in the sample; and a score of 3+ indicates strong staining in the sample; and
e) providing a prognosis to the patient, wherein the pathology score correlates with the severity of disease.

### Claim 7

A method for diagnosing early and mid-stage Alzheimer's Disease in a subject, comprising:
a) contacting a blood, serum, or plasma sample from a human with an isolated antibody or antibody fragment specific for glia maturation factor beta (GMF-B), wherein the antibody or antibody fragment comprises a heavy chain variable domain comprising three complementarity determining regions (CDRs) comprising the amino acid sequences of SEQ ID NO: 2, SEQ ID NO: 3, and SEQ ID NO: 4, and a light chain variable domain comprising three CDRs comprising the amino acid sequences of SEQ ID NO: 6, SEQ ID NO: 7, and SEQ ID NO: 8;
b) determining whether the antibody or antibody fragment binds to said specimen, wherein binding that is increased relative to a healthy control indicates that the subject has early or mid-stage Alzheimer's Disease.