# US 2014/0155580 A1 · Transgenic aves producing human polyclonal antibodies

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- Number: US 2014/0155580 A1
- Document ID: US20140155580A1
- Status: Published application
- Kind: A1
- Application number: 13/930,973
- Filed: 2013-06-28
- Published: 2014-06-05
- Earliest claimed: 2004-09-22
- Assignees: Synageva BioPharma Corp.
- Applicants: Synageva BioPharma Corp.
- Inventors: Robert J. Etches; Robert M. Kay; Philip Leighton; Lei Zhu
- Web page: https://patentgrep.com/patent/US20140155580A1

## CPC

- C07K 16/461: {Igs containing Ig-regions, -domains or -residues form different species}
- A01K 67/0275: Genetically modified vertebrates, e.g. transgenic
- A01K 67/0278: Knock-in vertebrates, e.g. humanised vertebrates
- C07K 14/70503: {Immunoglobulin superfamily}
- C07K 16/02: from eggs
- C12N 15/8509: {for producing genetically modified animals, e.g. transgenic}
- A01K 2207/15: Humanized animals
- A01K 2217/00: Genetically modified animals
- A01K 2217/075: inducing loss of function, i.e. knock out
- A01K 2227/30: Bird
- A01K 2267/01: Animal expressing industrially exogenous proteins
- C07K 2317/21: from primates, e.g. man
- C12N 2800/204: of bacterial origin, e.g. BAC
- C12N 2800/30: Vector systems comprising sequences for excision in presence of a recombinase, e.g. loxP or FRT
- 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)
- A01K: ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

Human antibodies are produced in transgenic chickens having functional genetic components of the human immune system stably integrated in the genome. Techniques are described to integrate unrearranged human heavy and light chain immunoglobulin loci into the genome of the transgenic chicken. The functional description of the endogenous immunoglobulin loci yields an animal whose antibody repertoire in response to antigen is fully human. In the preferred embodiment, the human immunoglobulin locus is at least as large as the native human locus and exhibits functional class switching to yield IgG isotype antibodies. In addition to monoclonal antibodies secreted from immortalized B cell populations, polyclonal antibodies may be obtained from eggs laid by the transgenic chickens of the invention.

## Claims

### Claim at position 1

-20. (canceled)

### Claim 21

An isolated human polyclonal antibody obtained from a transgenic chicken in response to antigen stimulation, wherein the transgenic chicken has a functional disruption of an endogenous chicken immunoglobulin heavy chain and light chain gene and comprising a transgene comprising a nucleic acid molecule encoding a human immunoglobulin heavy chain and a human immunoglobulin light chain.

### Claim 22 (depends on 21)

The antibody of claim 21, wherein the human immunoglobulin heavy chain is comprised of at least one human V gene, at least one human heavy chain D gene, and at least one human heavy chain J gene.

### Claim 23 (depends on 21)

The antibody of claim 21, wherein the transgene comprises a plurality of human heavy chain V genes.

### Claim 24 (depends on 21)

The antibody of claim 21, wherein the transgene further comprises a chicken B lymphocyte specific regulatory region operably linked to the human immunoglobulin heavy chain and the human immunoglobulin light chain.