# US 2021/0275561 A1 · Compositions and methods to accelerate resolution of acute lung inflammation

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- Number: US 2021/0275561 A1
- Document ID: US20210275561A1
- Status: Published application
- Kind: A1
- Application number: 17/139,665
- Filed: 2020-12-31
- Published: 2021-09-09
- Earliest claimed: 2015-01-08
- Assignees: The Johns Hopkins University
- Applicants: The Johns Hopkins University
- Inventors: Franco D'Alessio; Benjamin David Singer; Landon King; Neil Raj Aggarwal
- Web page: https://patentgrep.com/patent/US20210275561A1

## CPC

- A61K 31/7068: having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
- A61K 31/166: having the carbon of a carboxamide group directly attached to the aromatic ring, e.g. procainamide, procarbazine, metoclopramide, labetalol
- A61K 31/245: Amino benzoic acid types, e.g. procaine, novocaine (salicylic acid esters A61K31/60)
- A61K 31/353: 3,4-Dihydrobenzopyrans, e.g. chroman, catechin
- A61K 31/502: ortho- or peri-condensed with carbocyclic ring systems, e.g. cinnoline, phthalazine
- A61K 31/706: containing six-membered rings with nitrogen as a ring hetero atom
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/16: for influenza or rhinoviruses
- 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

## Abstract

The present invention provides methods and compositions for treatment of acute inflammatory diseases or disorders and/or for treatment of lung injury. Certain exemplary methods involve administering an IL-4 polypeptide or fragment thereof possessing cytokine activity or an IL-4 agonist systemically to a subject having an inflammatory disease or disorder and/or a lung injury. Other exemplary methods involve administering an inhibitor of DNA methylation systemically to a subject and/or administering an inhibitor of DNA methylation to a cell population comprising T cells (e.g., Treg cells) for introduction/re-introduction to a subject having an inflammatory disease or disorder and/or a lung injury. Compositions and cells for use in such methods are also provided.

## Claims

### Claim 1

A method for treating an acute inflammatory disease or disorder in a subject, the method comprising:
identifying a subject having an acute inflammatory disease or disorder, and
administering a DNA methyltransferase inhibitor to the subject,
thereby treating the acute inflammatory disease or disorder in the subject; or
A method for treating a lung injury in a subject, the method comprising:
identifying a subject having a lung injury, and
administering a DNA methyltransferase inhibitor to the subject,
thereby treating the lung injury in the subject; or
A method for treating influenza in a subject, the method comprising:
identifying a subject having influenza, and
administering a DNA methyltransferase inhibitor to the subject,
thereby treating influenza in the subject.

### Claim at position 2

2-3. (canceled)

### Claim 4 (depends on 1)

The method of claim 1, wherein the DNA methyltransferase inhibitor is administered in an amount sufficient to increase Treg frequency in the subject.

### Claim 5

(canceled)

### Claim 6 (depends on 1)

The method of claim 1, wherein the DNA methyltransferase inhibitor is selected from the group consisting of 5-Azacytidine; 5-Aza-2′-deoxycytidine; zebularine; 5-Fluoro-2′-deoxycytidine; 5, 6-Dihydro-5-azacytidine; Hydralazine; Procainamide; Procaine; EGCG ((−)-epigallocatechin-3-gallate); Psammaplin A; MG98; RG108; a DNA methyltransferase-targeting antisense oligonucleotide; and a DNA methyltransferase-targeting RNAi agent.

### Claim 7 (depends on 1)

The method of claim 1, wherein the DNA methyltransferase inhibitor is 5-Aza-2′-deoxycytidine.

### Claim 8 (depends on 1)

The method of claim 1, wherein the acute inflammatory disease or disorder or lung injury is an acute lung injury.

### Claim 9 (depends on 1)

The method of claim 1, wherein the acute inflammatory disease or disorder or lung injury is acute respiratory distress syndrome (ARDS).

### Claim 10 (depends on 1)

The method of claim 1, wherein the subject is human.

### Claim at position 10

11-12. (canceled)

### Claim 13

A method for treating an acute inflammatory disease or disorder in a subject, the method comprising:
identifying a subject having an acute inflammatory disease or disorder;
obtaining a population of cells comprising T cells;
administering a DNA methyltransferase inhibitor to the population of cells in vitro, thereby generating a treated population of cells; and
administering the treated population of cells to the subject,
thereby treating the acute inflammatory disease or disorder in the subject.

### Claim 14

A method for treating influenza in a subject, the method comprising:
identifying a subject having influenza;
obtaining a population of cells comprising T cells;
administering a DNA methyltransferase inhibitor to the population of cells in vitro, thereby generating a treated population of cells; and
administering the treated population of cells to the subject,
thereby treating influenza in the subject.

### Claim at position 13

15-17. (canceled)

### Claim 18 (depends on 13)

The method of claim 13, wherein the DNA methyltransferase inhibitor is administered in an amount sufficient to increase Treg frequency in the treated population of cells.

### Claim 19

(canceled)

### Claim 20 (depends on 13)

The method of claim 13, wherein the DNA methyltransferase inhibitor is selected from the group consisting of 5-Azacytidine; 5-Aza-2′-deoxycytidine; zebularine; 5-Fluoro-2′-deoxycytidine; 5, 6-Dihydro-5-azacytidine; Hydralazine; Procainamide; Procaine; EGCG ((−)-epigallocatechin-3-gallate); Psammaplin A; MG98; RG108; a DNA methyltransferase-targeting antisense oligonucleotide; and a DNA methyltransferase-targeting RNAi agent.

### Claim 21 (depends on 13)

The method of claim 13, wherein the DNA methyltransferase inhibitor is 5-Aza-2′-deoxycytidine.

### Claim 22 (depends on 13)

The method of claim 13 wherein the acute inflammatory disease or disorder is an acute lung injury.

### Claim 23 (depends on 13)

The method of claim 13, wherein the acute inflammatory disease or disorder is acute respiratory distress syndrome (ARDS).

### Claim 24 (depends on 13)

The method of claim 13, wherein the subject is human.

### Claim 25 (depends on 13)

The method of claim 13, wherein the treated population of cells is administered to the subject at least 24 hours after a lung injury event in the subject.

### Claim 26 (depends on 13)

The method of claim 13, wherein the treated population of cells is administered to the subject within 24 hours after diagnosis of an acute inflammatory disease or disorder, a lung injury event or influenza in the subject.

### Claim at position 23

27-51. (canceled)