# US 2009/0275084 A1 · Long-acting epo polypeptides and derivatives thereof and methods thereof

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 2009/0275084 A1
- Document ID: US20090275084A1
- Status: Published application
- Kind: A1
- Application number: 12/401,737
- Filed: 2009-03-11
- Published: 2009-11-05
- Earliest claimed: 2006-02-03
- Assignees: Prolor Biotech Ltd.
- Inventors: FUAD FARES; UDI EYAL FIMA
- Web page: https://patentgrep.com/patent/US20090275084A1

## CPC

- C07K 14/505: Erythropoietin [EPO]
- A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00)
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 5/06: of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
- A61P 7/00: Drugs for disorders of the blood or the extracellular fluid
- A61P 7/06: Antianaemics
- A61P 31/12: Antivirals
- A61P 35/00: Antineoplastic agents
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 14/555: Interferons [IFN]
- C07K 14/59: Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g.hCG [human chorionic gonadotropin]; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
- C07K 14/61: Growth hormone [GH], i.e. somatotropin
- 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 2319/00: Fusion polypeptide
- C07K 2319/31: fusions, other than Fc, for prolonged plasma life, e.g. albumin
- 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

A polypeptide and polynucleotides encoding same comprising at least two carboxy-terminal peptides (CTP) of chorionic gonadotrophin attached to an EPO peptide are disclosed. Pharmaceutical compositions comprising the polypeptide and polynucleotides of the invention and methods of using same are also disclosed.

## Claims

### Claim 1

A polynucleotide molecule comprising a DNA sequence, wherein said a DNA sequence consists a coding portion encoding a polypeptide, said polypeptide consists of an EPO polypeptide, one chorionic gonadotrophin carboxy terminal peptide attached to the amino terminus of said EPO polypeptide, and two chorionic gonadotrophin carboxy terminal peptides attached to the carboxy terminus of said EPO polypeptide.

### Claim 2

A polynucleotide molecule comprising a DNA sequence, wherein said a DNA sequence consists a coding portion encoding a polypeptide, said polypeptide consists of an EPO polypeptide, one chorionic gonadotrophin carboxy terminal peptide attached to the amino terminus of said EPO polypeptide, two chorionic gonadotrophin carboxy terminal peptides attached to the carboxy terminus of said EPO polypeptide, and a signal peptide attached to the amino terminus of said one chorionic gonadotrophin carboxy terminal peptide.

### Claim 3 (depends on 2)

The polynucleotide of claim 2, wherein the sequence of said signal peptide is as set forth in SEQ ID NO: 19.

### Claim 4 (depends on 1)

The polynucleotide of claim 1, wherein said DNA sequence is selected from the group consisting of SEQ ID NO: 20 and SEQ ID NO: 21.

### Claim 5 (depends on 1)

An expression vector comprising the polynucleotide of claim 1.

### Claim 6 (depends on 2)

An expression vector comprising the polynucleotide of claim 2.

### Claim 7 (depends on 5)

A cell comprising the expression vector of claim 5.

### Claim 8 (depends on 6)

A cell comprising the expression vector of claim 6.

### Claim 9 (depends on 5)

A composition comprising the expression vector of claim 5.

### Claim 10 (depends on 6)

A composition comprising the expression vector of claim 6.

### Claim 11 (depends on 5, 6)

A method of producing an EPO polypeptide with an improved biological half life in a cell, comprising the step of transfecting said cell with an expression vector of claim 5 or claim 6, thereby producing an EPO polypeptide with an improved biological half life in a cell.

### Claim 12

A method of producing an EPO polypeptide with an improved biological activity in a cell, comprising the step of transfecting said cell with an expression vector comprising a coding portion encoding a polypeptide, said polypeptide comprises an EPO polypeptide and at least two chorionic gonadotrophin carboxy terminal peptides, wherein a first chorionic gonadotrophin carboxy terminal peptide of said at least two chorionic gonadotrophin carboxy terminal peptides is attached to an amino terminus of said EPO polypeptide, and a second chorionic gonadotrophin carboxy terminal peptide of said at least two chorionic gonadotrophin carboxy terminal peptides is attached to the carboxy terminus of said EPO polypeptide, thereby producing an EPO polypeptide with an improved biological activity in a cell.

### Claim 13 (depends on 12)

The method of claim 12, wherein said polypeptide further comprises a third chorionic gonadotrophin carboxy terminal peptide attached in tandem to said second chorionic gonadotrophin carboxy terminal peptide.

### Claim 14 (depends on 12)

The method of claim 12, wherein said coding portion further comprises a signal peptide.

### Claim 15 (depends on 14)

The method of claim 14, wherein the sequence of said signal peptide is as set forth in SEQ ID NO: 19.

### Claim 16 (depends on 12)

The method of claim 12, wherein said DNA sequence is selected from the group consisting of SEQ ID NO: 20 and SEQ ID NO: 21.

### Claim 17 (depends on 12)

The method of claim 12, wherein said biological activity is stimulation of erythropoiesis.

### Claim 18

A method of producing an EPO polypeptide with an improved biological half life and an improved biological activity in a cell, comprising the step of transfecting said cell with an expression vector comprising a coding portion encoding a polypeptide, said polypeptide comprises an EPO polypeptide and at least two chorionic gonadotrophin carboxy terminal peptides, wherein a first chorionic gonadotrophin carboxy terminal peptide of said at least two chorionic gonadotrophin carboxy terminal peptides is attached to an amino terminus of said EPO polypeptide, and a second chorionic gonadotrophin carboxy terminal peptide of said at least two chorionic gonadotrophin carboxy terminal peptides is attached to the carboxy terminus of said EPO polypeptide, thereby producing an EPO polypeptide with an improved biological half life and an improved biological activity in a cell.

### Claim 19 (depends on 18)

The method of claim 18, wherein said polypeptide further comprises a third chorionic gonadotrophin carboxy terminal peptide attached in tandem to said second chorionic gonadotrophin carboxy terminal peptide.

### Claim 20 (depends on 18)

The method of claim 18, wherein said coding portion further comprises a signal peptide.

### Claim 21 (depends on 20)

The method of claim 20, wherein the sequence of said signal peptide is as set forth in SEQ ID NO: 19.

### Claim 22 (depends on 18)

The method of claim 18, wherein said DNA sequence is selected from the group consisting of SEQ ID NO: 20 and SEQ ID NO: 21.
