# US 2021/0278418 A1 · Method for treating asthma or allergic disease

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- Number: US 2021/0278418 A1
- Document ID: US20210278418A1
- Status: Published application
- Kind: A1
- Application number: 16/979,382
- Filed: 2019-03-15
- Published: 2021-09-09
- Earliest claimed: 2018-03-15
- Assignees: Chidlren's Medical Center Corporation
- Applicants: The Chidlren's Medical Center Corporation
- Inventors: Talal Amine CHATILA; Hani HARB; Mingcan XIA; Amir MASSOUD
- Web page: https://patentgrep.com/patent/US20210278418A1

## CPC

- G01N 33/6893: {related to diseases not provided for elsewhere}
- A61K 31/7105: Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
- A61K 31/713: Double-stranded nucleic acids or oligonucleotides
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 11/06: Antiasthmatics
- C07K 16/28: against receptors, cell surface antigens or cell surface determinants
- A61K 2039/505: {comprising antibodies}
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C12Q 1/6883: for diseases caused by alterations of genetic material
- G01N 2800/122: Chronic or obstructive airway disorders, e.g. asthma COPD
- G01N 2800/24: Immunology or allergic disorders
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- 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)
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES

## Abstract

Described herein are methods and compositions for treating asthma or an allergic disease. Aspects of the invention relate to administering to a subject an agent that targets Notch4. In one embodiment, the agent is an anti-Notch4 antibody.

## Claims

### Claim 1

1) A method for treating or preventing asthma or an allergic disease, comprising administering to a subject having asthma or an allergic disease an effective amount of an agent that inhibits Notch4.

### Claim 2 (depends on 1)

2) The method of claim 1, further comprising, prior to administering,
identifying a subject as having asthma or an allergic disease.

### Claim 3 (depends on 1)

3) The method of claim 1, wherein the asthma is selected from the list consisting of allergic asthma, asthma without allergies, aspirin exacerbated respiratory disease, exercise induced asthma, cough variant, and occupational asthma.

### Claim 4 (depends on 1)

4) The method of claim 1, wherein the allergic disease is selected from the list consisting of allergic rhinitis, sinusitis, otitis media, atopic dermatitis, urticaria, angioedema, and anaphylaxis.

### Claim 5 (depends on 1)

5) The method of claim 1, wherein the agent that inhibits Notch4 is selected from the group consisting of a small molecule, an antibody, a peptide, a genome editing system, an antisense oligonucleotide, and an RNAi.

### Claim 6 (depends on 5)

6) The method of claim 5, wherein the antibody is a humanized antibody.

### Claim 7 (depends on 5)

7) The method of claim 5, wherein the RNAi is a microRNA, an siRNA, or a shRNA.

### Claim 8 (depends on 1)

8) The method of claim 1, wherein inhibiting Notch4 is inhibiting the expression level and/or activity of Notch4.

### Claim 9 (depends on 8)

9) The method of claim 8, wherein the expression level and/or activity of Notch4 is inhibited by at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, or more as compared to an appropriate control.

### Claim 10 (depends on 1)

10) The method of claim 1, wherein Notch4 is inhibited on T regulatory cells.

### Claim 11 (depends on 1)

11) The method of claim 1, further comprising administering at least one additional anti-asthma therapeutic.

### Claim 12 (depends on 1, 2)

12) The method of claim 1 and 2, further comprising administering at least one additional anti-allergic disease therapeutic.

### Claim 13

13) (canceled)

### Claim 14 (depends on 1)

14) The method of claim 1, further comprising, prior to administering, identifying a subject at risk of having asthma or an allergic disease.

### Claim 15

15) A composition for the treatment of asthma or an allergic disease, the composition comprising an agent that inhibits Notch4 and a pharmaceutically acceptable carrier.

### Claim at position 16

16)-18) (canceled)

### Claim 19 (depends on 15)

19) The composition of claim 15, wherein the composition is formulated for inhaled administration.

### Claim 20

20) A method for treating a subject at risk of having asthma or an allergic disease, the method comprising,
a. Obtaining a biological sample from the subject;
b. measuring the level of Notch4 in a population of candidate cells;
wherein the subject is at risk of having asthma or an allergic disease if the level of Notch is increased as compared to a reference level; and
c. administering an agent that inhibits Notch4 to a subject at risk.

### Claim 21 (depends on 20)

21) The method of claim 20, wherein the level of Notch4 is increased by at least 2-fold, at least 3-fold, at least 4-fold, at least 5-fold, at least 6-fold, at least 7-fold, at least 8-fold, at least 9-fold, at least 10-fold, or more as compared to a reference level.

### Claim 22

22) (canceled)

### Claim 23

23) (canceled)