# US 2013/0156783 A1 · Immunotherapy targeting of the shared abnormal conformational state of amyloidogenic peptides/proteins

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- Number: US 2013/0156783 A1
- Document ID: US20130156783A1
- Status: Published application
- Kind: A1
- Application number: 13/773,264
- Filed: 2013-02-21
- Published: 2013-06-20
- Earliest claimed: 2009-05-05
- Assignees: New York University
- Inventors: Thomas M. Wisniewski; Fernando Goni
- Web page: https://patentgrep.com/patent/US20130156783A1

## CPC

- C07K 7/08: having 12 to 20 amino acids (gastrins C07K14/595; somatostatins C07K14/655; melanotropins C07K14/68)
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 38/10: Peptides having 12 to 20 amino acids {(A61K38/043 - A61K38/046 take precedence)}
- A61K 39/0007: {Nervous system antigens; Prions}
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/16: Anti-Parkinson drugs
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 35/00: Antineoplastic agents
- C07K 16/18: against material from animals or humans
- A61K 2039/55505: {Inorganic adjuvants}
- 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 2319/70: containing domain for protein-protein interaction
- 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 is directed to pharmaceutical agents and compositions useful for the treatment and prevention of amyloid disease in a subject. The invention further relates to isolated antibodies that recognize a common conformational epitope of amyloidogenic proteins or peptides that are useful for the diagnosis, treatment, and prevention of amyloid disease.

## Claims

### Claim at position 1

-24. (canceled)

### Claim 25

An isolated antibody or binding portion thereof having antigenic specificity for an epitope of a polymerized peptide, wherein the polymerized peptide is selected from the group consisting of:
a polymer of a first peptide comprising the amino acid sequence X1aX2aX3aX4aX5aX6aX7aX8aX9aX10aX11aX12aX13a (SEQ ID NO: 19), wherein X1a is C, M, S, or G; X2a is T, S, or C; X3a is K, R, or H; X4a is S, T, or C; X5a is V, I, or L; X6a is R, K, or H; X7a is R, K, or H; X8a is Q or N; X9a is L, I, or V; X10a is L, I, or V; X11a is D or E; X12a is D or E; X13a is Q or N;
a polymer of a second peptide comprising the amino acid sequence X1bX2bX3bX4bX5bX6bX7bX8bX9bX10bX11bX12bX13b (SEQ ID NO: 20), wherein X1b is C, M, S, or G; X2b is F, Y, or W; X3b is Q or N; X4b is I, L, or V; X5b is F, Y, or W; X6b is I, L, or V; X7b is Q Or N; X8b is T, S, or C; X9b is N or Q; X10b is D or E; X11b is R, K, or H; X12b is H, R, or K; X13b is Y, W, or F; and
a polymer of a fusion peptide comprising the first and/or second peptides.

### Claim 26 (depends on 25)

The isolated antibody or binding portion thereof of claim 25, wherein the epitope is a conformational epitope.

### Claim 27 (depends on 25)

A pharmaceutical composition comprising:
the antibody or binding portion thereof of claim 25 and
a pharmaceutically acceptable carrier.

### Claim 28 (depends on 25)

A method of treating a condition mediated by an amyloidogenic protein or peptide in a subject, said method comprising:
administering to the subject the antibody or binding portion thereof of claim 25 in an amount effective to treat the condition mediated by the amyloidogenic protein or peptide in the subject.

### Claim 29 (depends on 28)

A method according to claim 28 further comprising:
selecting a subject having a condition mediated by an amyloidogenic protein or peptide prior to said administering the antibody to the subject.

### Claim 30 (depends on 28)

The method according to claim 28, wherein the condition is selected from the group consisting of Alzheimer's disease, Down syndrome, fronto-temporal dementia, Parkinson's disease, hereditary cerebral hemorrhage with amyloidosis, kuru, Creutzfeldt-Jakob disease, Gerstmann-Straussler-Scheinker disease, fatal familial insomnia, British familial dementia, Danish familial dementia, familial corneal amyloidosis, Familial corneal dystrophies, medullary thyroid carcinoma, insulinoma, type 2 diabetes, isolated atrial amyloidosis, pituitary amyloidosis, aortic amyloidosis, plasma cell disorders, familial amyloidosis, senile cardiac amyloidosis, inflammation-associated amyloidosis, familial Mediterranean fever, dialysis-associated amyloidosis, systemic amyloidosis, and familial systemic amyloidosis.

### Claim 31 (depends on 25)

A method of diagnosing an amyloid disease in a subject, said method comprising:
detecting, in the subject, the presence of an amyloidogenic protein or peptide using a diagnostic reagent, wherein the diagnostic reagent comprises the antibody or binding fragment thereof of claim 25, and
diagnosing an amyloid disease in the subject based on said detecting.

### Claim 32 (depends on 31)

The method according to claim 31, wherein said detecting comprising:
obtaining a biological sample from the subject;
contacting the biological sample from the subject with the diagnostic reagent under conditions effective for the diagnostic reagent to bind to an amyloidogenic protein or peptide in the sample; and
detecting binding of the diagnostic reagent to an amyloidogenic protein or peptide in the sample.

### Claim 33 (depends on 31)

The method according to claim 31, wherein the diagnostic reagent contains a detectable label and said detecting is carried out using an in vivo imaging device to detect the labeled diagnostic reagent in the subject.

### Claim 34 (depends on 25)

A diagnostic kit comprising:
the isolated antibody or binding fragment thereof of claim 25 and
a detectable label.

### Claim at position 12

-51. (canceled)