# US 12,448,419 B2 · Methods and compositions for treating inflammation

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- Number: US 12,448,419 B2
- Document ID: US12448419B2
- Status: Granted
- Kind: B2
- Application number: 17/153,212
- Filed: 2021-01-20
- Published: 2021-07-29
- Granted: 2025-10-21
- Earliest claimed: 2012-03-26
- Assignees: UTI Limited Partnership
- Applicants: UTI Limited Partnership
- Inventors: Pedro Santamaria
- Web page: https://patentgrep.com/patent/US12448419B2

## CPC

- C07K 14/47: from mammals
- A61K 39/0008: {Antigens related to auto-immune diseases; Preparations to induce self-tolerance}
- A61K 39/0216: {Bacteriodetes, e.g. Bacteroides, Ornithobacter, Porphyromonas}
- A61K 47/6923: {the form being an inorganic particle, e.g. ceramic particles, silica particles, ferrite or synsorb}
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 1/12: Antidiarrhoeals
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/04: Antibacterial agents
- A61P 37/02: Immunomodulators
- A61P 37/04: Immunostimulants
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 14/195: from bacteria
- A61K 2039/55555: {Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers}
- Y10T 428/2982: Particulate matter [e.g., sphere, flake, etc.]
- 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)
- 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
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

This disclosure provides therapeutic compositions and methods for inducing an anti-inflammatory response and/or treating inflammation in the gastrointestinal tract and/or accumulating gut microbial antigen-specific anti-inflammatory T cells in a patient in need thereof.

## Claims

### Claim 1

A method for treating inflammation in the gastrointestinal (GI) tract of a patient in need thereof comprising parenterally administering to the patient an effective amount of a nanoparticle composition, wherein the composition does not comprise an adjuvant, wherein the composition comprises a plurality of nanoparticle cores, each nanoparticle core coupled to a plurality of peptide antigen-MHC complexes, wherein:
the peptide antigen comprises a peptide having at least 80% identity to a peptide sequence chosen from SEQ ID NO:4 to SEQ ID NO:8 across the entire length;
the nanoparticle core has a diameter from about 1 nm to about 100 nm; and
the ratio of peptide antigen-MHC complexes per nanoparticle core is from about 10:1 to about 1000:1; and
the peptide antigen is a T cell epitope.

### Claim 2 (depends on 1)

The method of claim 1, wherein the nanoparticle core has a diameter of from about 5 nm to about 50 nm and wherein the ratio of peptide antigen-MHC complexes per nanoparticle core is from about 50:1 to about 500:1.

### Claim 3 (depends on 1, 2)

The method of claim 1 or 2, wherein the patient suffers from a gastrointestinal disease of the group: inflammatory bowel disease, colitis, Crohn's disease, allergic inflammation of the gastrointestinal tract, and celiac disease.

### Claim 4 (depends on 1, 2)

The method of claim 1 or 2, wherein inflammation of the gastrointestinal tract is treated.

### Claim 5 (depends on 1, 2)

The method of any one of claims 1 or 2, wherein the nanoparticle core further comprises a biodegradable layer on the outer surface of the nanoparticle core and the antigen MHC complexes are coupled to the nanoparticle core or the biodegradable layer on the nanoparticle core.

### Claim 6 (depends on 5)

The method of claim 5, wherein the biodegradable layer comprises one or more of dextran, mannitol, or poly(ethylene glycol).

### Claim 7 (depends on 5)

The method of claim 5, wherein the antigen-MHC complexes are covalently linked or non-covalently linked to the nanoparticle core or the biodegradable layer.

### Claim 8 (depends on 5)

The method of claim 5, wherein the antigen-MHC complexes are covalently linked to the nanoparticle core or the biodegradable layer through a linker less than 5 kD in size.

### Claim 9 (depends on 8)

The method of claim 8, wherein the linker comprises poly(ethylene) glycol.

### Claim 10 (depends on 5)

The method of claim 5, wherein the nanoparticle core comprises a metal, a metal oxide, a metal sulfide, a metal selenide, a magnetic material, or a polymer.

### Claim 11 (depends on 10)

The method of claim 10, wherein the metal is gold or iron, and the metal oxide is iron oxide.

### Claim 12 (depends on 1)

The method of claim 1, wherein the nanoparticle composition is administered intravenously.

### Claim 13 (depends on 1)

The method of claim 1, wherein the nanoparticle composition is administered subcutaneously.

### Claim 14 (depends on 1)

The method of claim 1, wherein the peptide comprises an amino acid sequence having at least 80% identity to SEQ ID NO:4 across the entire length.

### Claim 15 (depends on 1)

The method of claim 1, wherein the peptide comprises an amino acid sequence having at least 80% identity to SEQ ID NO:5 across the entire length.

### Claim 16 (depends on 1)

The method of claim 1, wherein the peptide comprises an amino acid sequence having at least 80% identity to SEQ ID NO:6 across the entire length.

### Claim 17 (depends on 1)

The method of claim 1, wherein the peptide comprises an amino acid sequence having at least 80% identity to SEQ ID NO:7 across the entire length.

### Claim 18 (depends on 1)

The method of claim 1, wherein the peptide comprises an amino acid sequence having at least 80% identity to SEQ ID NO:8 across the entire length.