# US 8,569,233 B2 · Modified animal erythropoietin polypeptides and their uses

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- Number: US 8,569,233 B2
- Document ID: US8569233B2
- Status: Granted
- Kind: B2
- Application number: 13/556,754
- Filed: 2012-07-24
- Published: 2013-01-17
- Granted: 2013-10-29
- Earliest claimed: 2008-09-26
- Assignees: Eli Lilly and Company; Ambrx, Inc.
- Applicants: Feng Tian; Anna-Maria A. Hays Putnam; Frank Song; Stephanie Chu; Joseph Sheffer; Richard S. Barnett; Marc Siladi; Kyle Atkinson; Darin Lee; Peter C. Canning
- Inventors: Feng Tian; Anna-Maria A. Hays Putnam; Frank Song; Stephanie Chu; Joseph Sheffer; Richard S. Barnett; Marc Siladi; Kyle Atkinson; Darin Lee; Peter C. Canning
- Web page: https://patentgrep.com/patent/US8569233B2

## CPC

- C07K 14/505: Erythropoietin [EPO]
- 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)
- A61K 38/1816: {Erythropoietin [EPO]}
- A61K 47/60: the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
- A61P 7/06: Antianaemics
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C12N 15/102: {Mutagenizing nucleic acids}
- 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
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

Modified animal erythropoietin polypeptides and uses thereof are provide.

## Claims

### Claim 1

A method of treating a feline with anemia comprising administering to the patient a therapeutically-effective amount of a feline erythropoietin (fEPO) polypeptide comprising a non-naturally encoded amino acid substituted at position 1 of SEQ ID NO: 2, wherein the non-naturally encoded amino acid is para-acetylphenylalanine, and wherein the non-naturally encoded amino acid is linked to a water soluble polymer comprising a poly(ethylene) glycol moiety.

### Claim 2 (depends on 1)

The method of claim 1, wherein the anemia is non-regenerative anemia.

### Claim 3 (depends on 1)

The method of claim 1, wherein the water soluble polymer has a molecular weight of between about 0.1 kDa and about 100 kDa.

### Claim 4 (depends on 3)

The method of claim 3, wherein the water soluble polymer has a molecular weight of between about 0.1 kDa and about 50 kDa.

### Claim 5 (depends on 4)

The method of claim 4, wherein the water soluble polymer has a molecular weight of about 20 kDa.

### Claim 6 (depends on 4)

The method of claim 4, wherein the water soluble polymer has a molecular weight of about 30 kDa.

### Claim 7 (depends on 4)

The method of claim 4, wherein the water soluble polymer has a molecular weight of about 40 kDa.

### Claim 8

A method of treating a feline patient having anemia comprising administering to said feline patient a therapeutically-effective amount of a pharmaceutical composition comprising a feline erythropoietin (fEPO) polypeptide comprising a non-naturally encoded amino acid substituted at position 1 of SEQ ID NO: 2, wherein the non-naturally encoded amino acid is para-acetylphenylalanine, and wherein the non-naturally encoded amino acid is linked to a water soluble polymer comprising a poly(ethylene) glycol moiety, wherein the water soluble polymer has a molecular weight of between about 0.1 kDa and about 50 kDa; and a pharmaceutically acceptable carrier.

### Claim 9 (depends on 8)

The method of claim 8, wherein the water soluble polymer has a molecular weight of about 20 kDa.

### Claim 10 (depends on 9)

The method of claim 9, wherein the anemia is non-regenerative anemia.

### Claim 11 (depends on 8)

The method of claim 8, wherein the water soluble polymer has a molecular weight of about 30 kDa.

### Claim 12 (depends on 11)

The method of claim 11, wherein the anemia is non-regenerative anemia.

### Claim 13 (depends on 8)

The method of claim 8, wherein the water soluble polymer has a molecular weight of about 40 kDa.

### Claim 14 (depends on 13)

The method of claim 13, wherein the anemia is non-regenerative anemia.

### Claim 15 (depends on 8)

The method of claim 8, wherein the anemia is non-regenerative anemia.