# US 7,410,779 B2 · Fusion polypeptides of human serum albumin and a therapeutically active polypeptide

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- Number: US 7,410,779 B2
- Document ID: US7410779B2
- Status: Granted
- Kind: B2
- Application number: 11/330,353
- Filed: 2006-01-12
- Published: 2006-05-18
- Granted: 2008-08-12
- Earliest claimed: 1992-01-31
- Assignees: Novozymes Biopharma UK Limited
- Inventors: Reinhard Fleer; Alain Fournier; Jean-Dominique Guitton; Gérard Jung; Patrice Yeh
- Web page: https://patentgrep.com/patent/US7410779B2

## CPC

- B65B 69/00: Unpacking of articles or materials, not otherwise provided for
- A61K 38/21: Interferons {[IFN]}
- A61K 38/38: Albumins
- A61K 47/642: {the peptide or protein in the drug conjugate being a cytokine, e.g. IL2, chemokine, growth factors or interferons being the inactive part of the conjugate}
- A61K 47/643: {Albumins, e.g. HSA, BSA, ovalbumin or a Keyhole Limpet Hemocyanin [KHL]}
- A61P 7/06: Antianaemics
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 14/575: Hormones (derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin C07K14/665, e.g. corticotropin C07K14/695)
- C07K 14/755: Factors VIII {, e.g. factor VIII C (AHF), factor VIII Ag (VWF)}
- C07K 14/76: Albumins
- C07K 14/765: Serum albumin, e.g. HSA
- C12N 9/6456: {Plasminogen activators}
- C07K 2319/00: Fusion polypeptide
- C07K 2319/02: containing a signal sequence
- C07K 2319/31: fusions, other than Fc, for prolonged plasma life, e.g. albumin
- C07K 2319/33: fusions for targeting to specific cell types, e.g. tissue specific targeting, targeting of a bacterial subspecies
- B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00)
- 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
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The invention includes biologically active polypeptides comprising a therapeutically active polypeptide fused to human serum albumin or a variant of human serum albumin, methods for the preparation of such fusion polypeptides, nucleotide sequences encoding such fusion polypeptides, expression cassettes comprising such nucleotide sequences, self-replicating plasmids containing such expression cassettes, and pharmaceutical compositions containing such fusion polypeptides.

## Claims

### Claim 1

A nucleic acid molecule comprising a polynucleotide encoding a fusion protein wherein said fusion protein comprises a hormone and a mature form of albumin, wherein (i) said fusion protein has a higher plasma stability than the unfused hormone, (ii) said fusion protein retains the therapeutic activity of the unfused hormone, (iii) and said mature form of albumin is located either at the N-terminus or C-terminus of said fusion protein.

### Claim 2 (depends on 1)

The nucleic acid molecule of claim 1, wherein said fusion protein comprises an N-terminal methionine.

### Claim 3 (depends on 1)

The nucleic acid molecule of claim 1, wherein said fusion protein comprises a peptide linker.

### Claim 4 (depends on 1)

The nucleic acid molecule of claim 1, wherein said fusion protein comprises a secretion signal sequence.

### Claim 5 (depends on 1)

The nucleic acid molecule of claim 1, wherein said hormone is fused to the N-terminal end of said mature form of albumin.

### Claim 6 (depends on 1)

The nucleic acid molecule of claim 1, wherein said hormone is fused to the C-terminal end of said mature form of albumin.

### Claim 7 (depends on 1)

The nucleic acid molecule of claim 1, which further comprises a heterologous polynucleotide.

### Claim 8 (depends on 7)

The nucleic acid molecule of claim 7, wherein said heterologous polynucleotide is a vector sequence.

### Claim 9 (depends on 7)

The nucleic acid molecule of claim 7, wherein said heterologous polynucleotide is a promoter sequence.

### Claim 10 (depends on 9)

The nucleic acid molecule of claim 9, wherein said promoter sequence is a promoter selected from:
(a) a hybrid promoter;
(b) a constitutive promoter;
(c) a regulatable promoter;
(d) a yeast phosphoglycerate kinase (PGK) promoter;
(e) a yeast glyceraldehyde-3-phosphate dehydrogenase (GDP) promoter;
(f) a yeast lactase (LAC4) promoter;
(g) a yeast enolase (ENO) promoter;
(h) a yeast alcohol dehydrogenase (ADH) promoter;
(i) a yeast phosphatase (PHO5) promoter;
(j) a lambda bacteriophage PL promoter;
(k) a lambda bacteriophage PR promoter;
(l) a tryptophan Ptrp promoter; and
(m) a lactose Plac promoter.

### Claim 11 (depends on 7)

The nucleic acid molecule of claim 7, wherein said heterologous polynucleotide is a selectable marker.

### Claim 12 (depends on 11)

The nucleic acid molecule of claim 11, wherein said selectable marker is a selectable marker selected from:
(a) the URA3 gene;
(b) geneticin resistance;
(c) metal iron resistance; and
(d) ampicillin resistance.

### Claim 13 (depends on 7)

The nucleic acid molecule of claim 7, wherein said heterologous polynucleotide is a region for termination of transcription.

### Claim 14 (depends on 1)

The nucleic acid molecule of claim 1, wherein said nucleic acid molecule is part of an expression cassette.

### Claim 15 (depends on 1)

A vector comprising the nucleic acid molecule of claim 1.

### Claim 16 (depends on 1)

An isolated host cell comprising the nucleic acid molecule of claim 1.

### Claim 17 (depends on 15)

An isolated host cell comprising the vector of claim 15.

### Claim 18 (depends on 16, 17)

The isolated host cell of claim 16 or 17, wherein said isolated host cell is prokaryotic or eukaryotic.

### Claim 19 (depends on 18)

The isolated host cell of claim 18, wherein said isolated host cell is a yeast cell.

### Claim 20 (depends on 19)

The isolated host cell of claim 19, wherein said yeast cell is S. cerevisiae.

### Claim 21 (depends on 18)

The isolated host cell of claim 18, wherein said isolated host cell is an animal cell.

### Claim 22 (depends on 21)

The isolated host cell of claim 21, wherein said animal cell is a CHO cell or a COS cell.

### Claim 23 (depends on 18)

The isolated host cell of claim 18, wherein said isolated host cell is a fungi cell.

### Claim 24 (depends on 16)

A method for producing a fusion protein comprising:
(a) culturing the isolated host cell of claim 16 under conditions suitable to produce the fusion protein encoded by said polynucleotide; and
(b) recovering said fusion protein.

### Claim 25 (depends on 24)

A fusion protein produced by the method of claim 24.