# US 11,439,682 B2 · Treating IgE-mediated allergic diseases

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- Number: US 11,439,682 B2
- Document ID: US11439682B2
- Status: Granted
- Kind: B2
- Application number: 16/862,512
- Filed: 2020-04-29
- Published: 2020-09-24
- Granted: 2022-09-13
- Earliest claimed: 2017-10-31
- Assignees: Oneness Biotech Co., Ltd.
- Applicants: Oneness Biotech Co., Ltd.
- Inventors: Kung-Ming Lu; Nien-Yi Chen; Tien-Tien Cheng
- Web page: https://patentgrep.com/patent/US11439682B2

## CPC

- A61K 38/1774: {Immunoglobulin superfamily (e.g. CD2, CD4, CD8, ICAM molecules, B7 molecules, Fc-receptors, MHC-molecules)}
- A61P 37/00: Drugs for immunological or allergic disorders
- A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)}
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 31/56: Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61P 17/04: Antipruritics
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- C07K 16/4291: {against IgE}
- A61K 2039/505: {comprising antibodies}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- 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)

## Abstract

Methods for treating a disorder associated with immunoglobulin E (IgE) in a subject with antibodies capable of binding to the Cεmx domain of a membrane-bound IgE. The subject can be administered with at least two doses of the antibody, the two doses being at least three months apart.

## Claims

### Claim 1

A method for treating atopic dermatitis or pruritus, the method comprising:
(i) administering to a subject in need thereof a first dose of an antibody binding to a Cεmx domain of a membrane-bound IgE; and
(ii) administering to the subject a second dose of the antibody; wherein the second dose is administered at least 8 weeks and up to 6 months after the first dose;
wherein the antibody comprises a heavy chain variable region, which comprises (a) a heavy chain complementary determining region (CDR) 1, a heavy chain CDR2, and a heavy chain CDR3, and (b) a light chain variable region comprising a light chain CDR1, a light chain CDR2, and a light chain CDR3; and
wherein:
the heavy chain CDR1 comprises the amino acid sequence of residues 26-36 of SEQ ID NO:9;
the heavy chain CDR2 comprises the amino acid sequence of residues 51-66 of SEQ ID NO:9,
the heavy chain CDR3 comprises the amino acid sequence of residues 98-106 of SEQ ID NO:9,
the light chain CDR1 comprises the amino acid sequence of residues 24-39 of SEQ ID NO:10,
the light chain CDR2 comprises the amino acid sequence of residues 55-61 of SEQ ID NO:10; and
the light chain CDR3 comprises the amino acid sequence of residues 94-102 of SEQ ID NO:10.

### Claim 2 (depends on 1)

The method of claim 1, wherein the second dose is administered at least 3 months after the first dose.

### Claim 3 (depends on 2)

The method of claim 2, wherein the second dose is administered about 12 weeks to about 6 months after the first dose.

### Claim 4 (depends on 1)

The method of claim 1, wherein the first dose, the second dose, or both range from 0.5 mg/kg to 15 mg/kg.

### Claim 5 (depends on 4)

The method of claim 4, wherein the first dose, the second dose, or both range from 1 mg/kg to 8 mg/kg.

### Claim 6 (depends on 1)

The method of claim 1, wherein the first dose, the second dose, or both are administered by intravenous injection.

### Claim 7 (depends on 1)

The method of claim 1, wherein the antibody is a human antibody or a humanized antibody.

### Claim 8 (depends on 1)

The method of claim 1, wherein the antibody is a full length antibody or an antigen-binding fragment thereof.

### Claim 9 (depends on 1)

The method of claim 1, wherein the heavy chain variable region comprises the amino acid sequence of SEQ ID NO: 2, SEQ ID NO:8, or SEQ ID NO:9; and the light chain variable region comprises the amino acid sequence of SEQ ID NO: 3 or SEQ ID NO:10.

### Claim 10 (depends on 9)

The method of claim 9, wherein the heavy chain variable region comprises the amino acid sequence of SEQ ID NO:9 and the light chain variable region comprises the amino acid sequence of SEQ ID NO:10.

### Claim 11 (depends on 1)

The method of claim 1, wherein the antibody is an IgG1 molecule.

### Claim 12 (depends on 11)

The method of claim 11, wherein the antibody comprises a heavy chain comprising the amino acid sequence of SEQ ID NO:11 and a light chain comprising the amino acid sequence of SEQ ID NO:12.

### Claim 13 (depends on 1)

The method of claim 1, wherein the subject is a human patient having atopic dermatitis or pruritus.

### Claim 14 (depends on 1)

The method of claim 1, wherein the subject is a human patient having atopic dermatitis.

### Claim 15 (depends on 1)

The method of claim 1, wherein the antibody is formulated in a pharmaceutical composition comprising the antibody, a buffer, a salt, and a nonionic surfactant.

### Claim 16 (depends on 15)

The method of claim 15, wherein the pharmaceutical composition is an aqueous solution having a pH of 5 to 8.

### Claim 17 (depends on 15)

The method of claim 15, wherein the buffer is a histidine buffer, the salt is sodium chloride, and/or the nonionic surfactant is polysorbate 80.

### Claim 18 (depends on 17)

The method of claim 17, wherein the antibody in the pharmaceutical composition is about 10 mg/ml to 30 mg/ml, the histidine buffer is of a concentration of about 10 mM to 30 mM, the sodium chloride is of a concentration of about 120 mM to 160 mM, and the polysorbate 80 is of a concentration of about 0.01% to 0.03%.

### Claim 19 (depends on 1)

The method of claim 1, wherein the antibody comprises a heavy chain comprising the amino acid sequence of residues 20-466 of SEQ ID NO:11 and a light chain comprising the amino acid sequence of residues 21-239 of SEQ ID NO:12.