# US 12,214,028 B2 · Immunogenic formulation that induces protection against shiga toxin-producing Escherichia coli (STEC)

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- Number: US 12,214,028 B2
- Document ID: US12214028B2
- Status: Granted
- Kind: B2
- Application number: 17/615,554
- Filed: 2019-05-31
- Published: 2022-07-28
- Granted: 2025-02-04
- Earliest claimed: 2019-05-31
- Assignees: Universidad De Chile
- Applicants: Universidad De Chile
- Inventors: Roberto Mauricio Vidal Alvarez; Felipe Antonio Del Canto Fuentes; David Arturo Montero Forero; Juan Carlos Salazar Garrido
- Web page: https://patentgrep.com/patent/US12214028B2

## CPC

- A61K 39/0258: {Escherichia}
- A61K 47/6415: {Toxins or lectins, e.g. clostridial toxins or Pseudomonas exotoxins}
- A61K 47/6917: {the form being a lipoprotein vesicle, e.g. HDL or LDL proteins}
- A61P 31/04: Antibacterial agents
- C07K 14/245: Escherichia (G)
- A61K 2039/543: {intranasal}
- A61K 2039/55505: {Inorganic adjuvants}
- A61K 2039/55566: {Emulsions, e.g. Freund's adjuvant, MF59}
- A61K 2039/55572: {Lipopolysaccharides; Lipid A; Monophosphoryl lipid A}
- A61K 2039/575: {humoral response}
- A61K 2039/70: {Multivalent vaccine}
- 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

Disclosed is an immunogenic formulation that induces protection against Shiga Toxin-Producing Escherichia coli (STEC), the formulation comprising: one or more chimeric proteins derived wholly or in part from OmpT and Hes proteins of STEC; and at least one physiologically or pharmaceutically acceptable excipient, carrier and/or diluent.

## Claims

### Claim 1

An immunogenic formulation that induces protection against shiga Toxin-Producing Escherichia coli (STEC), the formulation comprising:
(i) a chimeric protein derived from OmpT and Hes proteins of STEC, having the amino acid sequence as set forth in SEQ ID NO: 1;
(ii) a second chimeric protein derived from α-Cah protein of STEC, having the amino acid sequence as set forth in SEQ ID NO: 2; and
(iii) at least one physiologically or pharmaceutically acceptable excipient, carrier and/or diluent.

### Claim 2 (depends on 1)

The immunogenic formulation according to claim 1, wherein both chimeric proteins are present in the formulation at a ratio of between 1:2 to 2:1.

### Claim 3 (depends on 2)

The immunogenic formulation according to claim 2, wherein both chimeric proteins are present in the formulation at a ratio of 1:1.

### Claim 4 (depends on 1)

The immunogenic formulation according to claim 1 for use in treatment or prophylactic treatment of STEC infection or a disorder associated with STEC infection, or inducing an immune response to STEC.

### Claim 5 (depends on 1)

A method of treatment or prophylactic treatment of STEC infection or a disorder associated with STEC infection, the method comprising administering to a subject a therapeutically effective amount of an immunogenic formulation as claimed in claim 1.

### Claim 6 (depends on 1)

A method for inducing immunity in an animal, such as a mammal, against shiga toxin-producing E. coli (STEC) or pathology caused by STEC comprising administering an immunogenic formulation as claimed in claim 1 to the animal.

### Claim 7 (depends on 1)

A method for protecting an animal, such as a mammal against infection with Shiga toxin-producing E. coli (STEC) or pathology caused by STEC comprising administration of an immunogenic composition as in claim 1 to the animal.

### Claim 8

A chimeric protein derived from OmpT and Hes proteins of shiga toxin-producing E. coli (STEC) comprising immunogenic epitopes having the amino acid sequence as set forth in SEQ ID NO: 1.

### Claim 9

A chimeric protein derived from α-Cah protein of shiga toxin-producing E. coli (STEC) comprising the amino acid sequence as set forth in SEQ ID NO: 2.