# US 2012/0308513 A1 · Promiscuous her-2/neu cd4 t cell epitopes

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- Number: US 2012/0308513 A1
- Document ID: US20120308513A1
- Status: Published application
- Kind: A1
- Application number: 13/587,619
- Filed: 2012-08-16
- Published: 2012-12-06
- Earliest claimed: 2006-08-11
- Assignees: Dendreon Corporation
- Inventors: Jami B. Wollan; Lori A. Jones
- Web page: https://patentgrep.com/patent/US20120308513A1

## CPC

- C07K 14/71: for growth factors; for growth regulators
- A61P 35/00: Antineoplastic agents
- A61P 37/00: Drugs for immunological or allergic disorders
- A61P 37/04: Immunostimulants
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- 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)
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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)

## Abstract

The present invention relates to the discovery of novel T cell epitopes of the human HER-2/Neu protein that is promiscuous for at least 25 different HLA-DR alleles. The invention also relates to compositions that contain one of the novel epitopes or a fusion peptide of such a epitope and a heterologous polypeptide. Further disclosed herein is the use of the epitopes or their fusion peptides, and compositions containing the epitopes or their fusion peptides.

## Claims

### Claim 1

An isolated peptide consisting of: (a) 12 to 15 contiguous amino acids of residues 3-17 of SEQ ID NO:1; or (b) 16 to 18 contiguous amino acids of SEQ ID NO:1.

### Claim 2 (depends on 1)

A fusion peptide comprising the peptide of claim 1 fused to a heterologous polypeptide.

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

The fusion peptide of claim 2, wherein the peptide of claim 1 is fused to a heterologous polypeptide via a peptide bond.

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

The peptide of claim 1 or 2, which induces a T cell immune response specific to a HER-2/Neu protein when presented by an antigen-presenting cell of at least 15 different HLA-DR alleles.

### Claim 5 (depends on 4)

The peptide of claim 4, which induces a T cell immune response specific to a HER-2/Neu protein when presented by an antigen-presenting cell of at least 25 different HLA-DR alleles.

### Claim 6 (depends on 4)

The peptide of claim 4, wherein the HLA-DR alleles are selected from the group consisting of 0101, 0102, 0103, 1503, 160201, 0301, 0302, 0401, 0402, 040301, 040501, 1101, 1102, 1103, 1104, 110401, 1201, 1301, 1302, 1401, 1402, 0701, 080101, 080201, and 0901.

### Claim 7 (depends on 1)

The peptide of claim 1, which has the amino acid sequence of SEQ ID NO:2.

### Claim 8 (depends on 2)

The peptide of claim 2, wherein the heterologous polypeptide is a granulocyte-macrophage colony-stimulating factor (GM-CSF).

### Claim 9 (depends on 1, 3)

An isolated nucleic acid comprising a polynucleotide sequence encoding the peptide of claim 1 or 3.

### Claim 10 (depends on 7, 9)

The nucleic acid of claim 9, wherein the polynucleotide sequence encodes the peptide of claim 7.

### Claim 11 (depends on 8, 9)

The nucleic acid of claim 9, wherein the polynucleotide sequence encodes the peptide of claim 8.

### Claim 12 (depends on 9)

An expression cassette comprising the nucleic acid of claim 9.

### Claim 13 (depends on 12)

The expression cassette of claim 12, which is a recombinant viral vector.

### Claim 14 (depends on 7, 8, 12)

The expression cassette of claim 12, which directs the expression of the peptide of claim 7 or 8.

### Claim 15 (depends on 12, 13)

A host cell comprising the expression cassette of claim 12 or 13.

### Claim 16 (depends on 1, 2)

A composition comprising the peptide of claim 1 or 2 and a physiologically acceptable excipient.

### Claim 17 (depends on 16)

The composition of claim 16, wherein the peptide has the amino acid sequence of SEQ ID NO:2.

### Claim 18 (depends on 16)

The composition of claim 16, wherein the heterologous polypeptide is a granulocyte-macrophage colony-stimulating factor (GM-CSF).

### Claim 19 (depends on 1, 16)

The composition of claim 16, further comprising an antigen-presenting cell with the peptide of claim 1 forming a complex with a major histocompatibility complex (MHC) molecule on the surface of the cell.

### Claim 20 (depends on 16)

A method for inducing in a patient a T cell immune response specific to a HER-2/Neu protein, the method comprising the step of administering an effective amount of the composition of claim 16 to the patient.

### Claim 21 (depends on 20)

The method of claim 20, wherein the heterologous polypeptide is a granulocyte-macrophage colony-stimulating factor (GM-CSF).

### Claim 22 (depends on 1, 2)

A method for detecting in a patient a T cell immune response specific to a HER-2/Neu protein, the method comprising the steps of (a) obtaining an antigen-presenting cell and a T cell from the patient; (b) contacting the antigen-presenting cell and the T cell with the peptide of claim 1 or 2; and (c) detecting a T cell response, wherein the detection of a T cell response indicates the presence of a T cell immune response specific to a HER-2/Neu protein in the patient.

### Claim 23 (depends on 22)

The method of claim 22, wherein step (c) is performed by ELISPOT, proliferation assay, or flow cytometry.

### Claim 24 (depends on 22)

The method of claim 22, wherein the peptide has the amino acid sequence of SEQ ID NO:2.