# US 2014/0235532 A1 · Immunogenic escherichia coli heat stable enterotoxin

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- Number: US 2014/0235532 A1
- Document ID: US20140235532A1
- Status: Published application
- Kind: A1
- Application number: 14/186,497
- Filed: 2014-02-21
- Published: 2014-08-21
- Earliest claimed: 2008-09-03
- Assignees: Board of Trustees of Michigan State University
- Applicants: Board of Trustees of Michigan State University
- Inventors: A. Mahdi Saeed
- Web page: https://patentgrep.com/patent/US20140235532A1

## CPC

- A61K 38/164: {from bacteria}
- A61K 39/0258: {Escherichia}
- A61K 47/646: {the entire peptide or protein drug conjugate elicits an immune response, e.g. conjugate vaccines}
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/12: Antidiarrhoeals
- A61P 31/04: Antibacterial agents
- A61P 35/00: Antineoplastic agents
- A61P 37/04: Immunostimulants
- C07K 16/1232: Escherichia (G)
- A61K 2039/505: {comprising antibodies}
- A61K 2039/6081: {Albumin; Keyhole limpet haemocyanin [KLH]}
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present invention relates to methods and compositions for the treatment and prevention of diarrhea and diarrheal related diseases and disorders in both animals and humans. In some embodiments, the invention relates to the treatment of said diarrhea and diarrheal related diseases and disorders with a vaccine. In still further embodiments, the invention relates to the treatment of constipation using the disclosed methods and compositions.

## Claims

### Claim 1

(canceled)

### Claim 2

A conjugate that comprises a heat-stable enterotoxin (STa) protein from Escherichia coli having an amino terminus that is covalently attached to a carrier protein via a succinylated group selected from the group consisting of a succinylated carrier protein lysine group, and a succinylated carrier protein N-terminal amino group.

### Claim 3 (depends on 2)

The conjugate of claim 2, wherein the carrier protein is selected from the group consisting of keyhole limpet hemocyanin (KLH), bovine serum albumin (BSA), ovalbumin (OVA), beta-galactosidase (B-GAL), penicillinase, poly-DL-alanyl-poly-L-lysine, and poly-L-lysine.

### Claim 4 (depends on 2)

The conjugate of claim 2, wherein the carrier protein is tetanus toxoid.

### Claim 5 (depends on 2)

The conjugate of claim 2, wherein the carrier protein is bovine serum albumin.

### Claim 6 (depends on 5)

The conjugate of claim 5, wherein the ratio of enterotoxin molecules to one molecule of bovine serum albumin is between 1 and 10.

### Claim 7 (depends on 2)

The conjugate of claim 2, formulated for prophylactic, parenteral, intradermal, intramuscular, intraperitoneal, intravenous, subcutaneous, epidural, mucosal, intranasal, rectal, vaginal, sublingual, buccal, or oral administration.

### Claim 8 (depends on 2)

The conjugate of claim 2, formulated for parenteral, intradermal, intramuscular, or oral administration.

### Claim 9

A method comprising administering to a mammal a conjugate that comprises a heat-stable enterotoxin (STa) protein from Escherichia coli having an amino terminus that is covalently attached to a carrier protein via a succinylated group selected from the group consisting of succinylated carrier protein lysine group, and a succinylated carrier protein N-terminal amino group.

### Claim 10 (depends on 9)

The method of claim 9, wherein administration is prophylactic, parenteral, intradermal, intramuscular, intraperitoneal, intravenous, subcutaneous, epidural, mucosal, intranasal, rectal, vaginal, sublingual, buccal, or oral.

### Claim 11 (depends on 9)

The method of claim 9, wherein the mammal is pregnant with an unborn mammal, or is at risk for diarrhea or a diarrheal related disease.

### Claim 12 (depends on 11)

The method of claim 11, wherein the diarrhea or diarrheal related disease or disorder is selected from the group consisting of secretory diarrhea, osmotic diarrhea, motility-related diarrhea, inflammatory diarrhea, dysentery, infectious diarrhea, malabsorption disorders, inflammatory bowel syndrome, ischemic bowel disease, bowel cancer, hormone-secreting tumor related disorders, bile-salt diarrhea and chronic ethanol ingestion.

### Claim 13 (depends on 9)

The method of claim 9, wherein the conjugate is administered to treat chronic constipation, urinary retention, colon polyps, cancer, or high blood pressure.

### Claim 14 (depends on 9)

The method of claim 9, wherein the conjugate is administered as a laxative prior to colonoscopy or intestinal surgery.

### Claim 15 (depends on 9)

The method of claim 9, wherein the carrier protein is selected from the group consisting of keyhole limpet hemocyanin (KLH), bovine serum albumin (BSA), ovalbumin (OVA), beta-galactosidase (B-GAL), penicillinase, poly-DL-alanyl-poly-L-lysine, and poly-L-lysine.

### Claim 16 (depends on 9)

The method of claim 9, wherein the carrier protein is tetanus toxoid.

### Claim 17 (depends on 9)

The method of claim 9, wherein the carrier protein is bovine serum albumin.

### Claim 18 (depends on 9)

The method of claim 9, wherein the ratio of enterotoxin molecules to one molecule of bovine serum albumin is between 1 and 10.