# US 2016/0353718 A1 · Production of transgenic avians using improved retroviral vectors

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- Number: US 2016/0353718 A1
- Document ID: US20160353718A1
- Status: Published application
- Kind: A1
- Application number: 15/181,987
- Filed: 2016-06-14
- Published: 2016-12-08
- Earliest claimed: 2004-12-29
- Assignees: Alexion Pharmaceuticals, Inc.
- Applicants: Alexion Pharmaceuticals, Inc.
- Inventors: Alex J. Harvey; Jeffrey C. Rapp
- Web page: https://patentgrep.com/patent/US20160353718A1

## CPC

- A01K 67/0278: Knock-in vertebrates, e.g. humanised vertebrates
- A01K 67/0275: Genetically modified vertebrates, e.g. transgenic
- C07K 14/56: IFN-alpha
- C07K 14/70521: {CD28, CD152}
- C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00)
- C12N 15/8509: {for producing genetically modified animals, e.g. transgenic}
- C12N 15/86: Viral vectors
- A01K 2207/15: Humanized animals
- A01K 2217/052: inducing gain of function
- A01K 2227/30: Bird
- A01K 2267/01: Animal expressing industrially exogenous proteins
- C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
- C12N 2015/8518: {expressing industrially exogenous proteins, e.g. for pharmaceutical use, human insulin, blood factors, immunoglobulins, pseudoparticles}
- C12N 2740/11043: viral genome or elements thereof as genetic vector
- C12N 2800/24: Vectors characterised by the absence of particular element, e.g. selectable marker, viral origin of replication
- C12N 2830/008: cell type or tissue specific enhancer/promoter combination
- C12N 2830/15: chimeric enhancer/promoter combination
- C12N 2830/90: avian
- A01K: ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
- 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

A transgenic avian containing in its genome an exogenous nucleotide sequence which includes a promoter component and a vector with reduced promoter interference wherein the exogenous nucleotide sequence is integrated into the genome and the avian.

## Claims

### Claim 1

A transgenic avian containing in its genome an exogenous nucleotide sequence comprising a promoter component and a SIN vector wherein the exogenous nucleotide sequence is integrated into the genome and the avian produces an exogenous protein which is deposited in a hard shell egg laid by the avian.

### Claim 2 (depends on 1)

The transgenic avian of claim 1 wherein the promoter component is an oviduct specific promoter.

### Claim 3 (depends on 1)

The transgenic avian of claim 1 wherein the avian is selected from the group consisting of a chicken, a turkey and a quail.

### Claim 4 (depends on 1)

The transgenic avian of claim 1 wherein the promoter component is linked to a coding sequence exogenous to the avian.

### Claim 5 (depends on 1)

The transgenic avian of claim 1 wherein the promoter component is an avian ovomucoid promoter component.

### Claim 6 (depends on 1)

The transgenic avian of claim 1 wherein the promoter component is an avian ovalbumin promoter component.

### Claim 7 (depends on 1)

The transgenic avian of claim 1 wherein the promoter component is an avian lysozyme promoter component.

### Claim 8 (depends on 1)

The transgenic avian of claim 1 wherein the exogenous protein is a therapeutic protein.

### Claim 9 (depends on 1)

The transgenic avian of claim 1 wherein the exogenous protein is a cytokine.

### Claim 10

(canceled)

### Claim 11 (depends on 1)

The transgenic avian of claim 1 wherein the retrovirus is selected from the group consisting of avian leukosis virus vector (ALV), a murine leukemia virus (ML V) retroviral vector, maloney murine leukemia Virus (MMLV) and a lentiviral vector.

### Claim 12

A transgenic avian comprising an oviduct cell which contains an exogenous nucleotide sequence comprising a promoter component linked to an exogenous coding sequence contained in an integrated SIN vector wherein the exogenous coding sequence is expressed in the oviduct cell and is secreted from the oviduct cell.

### Claim 13 (depends on 12)

The transgenic avian of claim 12 wherein the avian is a chicken.

### Claim 14 (depends on 12)

The transgenic avian of claim 12 wherein the oviduct cell is a tubular gland cell.

### Claim 15 (depends on 12)

The transgenic avian of claim 12 wherein the promoter component is an avian ovomucoid promoter component.

### Claim 16 (depends on 12)

The transgenic avian of claim 12 wherein the promoter component is an avian ovalbumin promoter component.

### Claim 17 (depends on 12)

The transgenic avian of claim 12 wherein the promoter component is an avian lysozyme promoter component.

### Claim 18

A method of producing an exogenous protein comprising producing a transgenic avian having a nucleotide sequence in its genome comprising a vector which is at least one of a SIN vector and an SC negative vector wherein the nucleotide sequence comprises a promoter component linked to an exogenous coding sequence.

### Claim 19 (depends on 18)

The method of claim 18 wherein the exogenous coding sequence encodes a human protein.

### Claim 20 (depends on 18)

The method of claim 18 wherein the exogenous coding sequence encodes a therapeutic protein.

### Claim 21 (depends on 18)

The method of claim 18 wherein the promoter component comprises a functional promoter sequence of a promoter selected from the group consisting of avian ovalbumin promoter component, avian ovomucoid promoter component, avian lysozyme promoter component and avian conalbumin promoter component.

### Claim at position 22

22-25. canceled
