# US 11,999,788 B2 · Treatment or prevention method of radiation damage by administration of IL-5 receptor alpha chain binding antibody

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- Number: US 11,999,788 B2
- Document ID: US11999788B2
- Status: Granted
- Kind: B2
- Application number: 17/530,150
- Filed: 2021-11-18
- Published: 2022-05-05
- Granted: 2024-06-04
- Earliest claimed: 2017-01-24
- Assignees: Kyowa Kirin Co., Ltd.; The University of Tokyo
- Applicants: Kyowa Kirin Co., Ltd.; The University of Tokyo
- Inventors: Kazuki Okada; Kiyotoshi Mori; Satoshi Uematsu; Naoki Takemura
- Web page: https://patentgrep.com/patent/US11999788B2

## CPC

- C07K 16/2866: {against receptors for cytokines, lymphokines, interferons}
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
- A61P 13/00: Drugs for disorders of the urinary system
- A61P 39/00: General protective or antinoxious agents
- C07K 14/7155: {for interleukins [IL]}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 2039/505: {comprising antibodies}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/73: Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
- C07K 2317/732: Antibody-dependent cellular cytotoxicity [ADCC]
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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)

## Abstract

A therapeutic or prophylactic agent for radiation damage associated with radiation exposure, comprising an eosinophil-removing agent as an active ingredient and the like are provided as a technique for efficiently treating or preventing radiation damage associated with radiation exposure. According to the therapeutic or prophylactic agent comprising an eosinophil-removing agent according to the present invention, by suppressing migration and/or infiltration into target tissue and/or proliferation in the tissue of eosinophils and/or inhibiting the activity or function of the eosinophils, pathological conditions such as inflammatory responses and fibrosis of tissue can be suppressed to effectively treat or prevent radiation damage. Moreover, effective radiation therapy can be performed by suppressing radiation damage.

## Claims

### Claim 1

A method for treating radiation damage associated with radiation exposure during radiation therapy of cancer in a patient, wherein the radiation therapy is radiation therapy for any cancer selected from the group consisting of small intestinal cancer, colorectal cancer, gastrointestinal stromal tumor (GIST), gastrointestinal carcinoid, gastric cancer, esophageal cancer, liver cancer, gallbladder/biliary cancer, pancreatic cancer, pancreatic/gastrointestinal neuroendocrine tumor, Langerhans cell histiocytosis, renal cell cancer, renal pelvic/ureteral cancer, adrenal tumor, osteosarcoma, soft tissue sarcoma, malignant lymphoma, bladder cancer, urethral cancer, prostate cancer, testicular tumor, penile cancer, endometrial cancer, cervical cancer, uterine tumor, ovarian tumor, female genital cancer, lung cancer, thymic tumor, mesothelioma, and breast cancer, wherein the method comprises administering an effective amount of an IL-5 receptor α chain binding antibody, wherein the IL-5 receptor α chain binding antibody or antibody-binding fragment thereof comprises:
a heavy chain variable region comprising a complementary determining region 1 (HCDR1), a complementary determining region 2 (HCDR2) and a complementary determining region 1 (HCDR3) comprising the amino acid sequences SEQ ID NO: 1, SEQ ID NO: 2, and SEQ ID NO: 3, respectively; and
a light chain variable region comprising a complementary determining region 1 (LCDR1), a complementary determining region 2 (LCDR2), and a complementary determining region 3 (LCDR3) comprising the amino acid sequences of SEQ ID NO: 4, SEQ ID NO: 5, and SEQ ID NO: 6, respectively.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the radiation is X-ray radiation or γ-ray radiation.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the radiation damage is early radiation damage or delayed radiation damage.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the radiation damage is damage to any one or more organs selected from the group consisting of the small intestine, the large intestine, the stomach, the bladder, the liver, and the kidney.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the antibody or the fragment thereof is an antibody or a fragment thereof having antibody-dependent cellular cytotoxicity activity.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the IL-5 receptor α chain binding antibody comprises a human Fc region or a human constant region.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the IL-5 receptor α chain binding antibody is any antibody selected from the group consisting of a chimeric antibody, a humanized antibody, and a human antibody.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the radiation damage associated with the radiation therapy is suppressed by at least 5% in a patient treated with the IL-5 receptor α chain binding antibody compared to a patient receiving radiation therapy without IL-5 receptor α chain binding antibody treatment.

### Claim 9 (depends on 1)

The method according to claim 1, wherein a tolerance radiation dose for the radiation therapy of the patient treated with the IL-5 receptor α chain binding antibody is increased by 5% or more compared to that for a patient receiving radiation therapy without IL-5 receptor α chain binding antibody treatment.

### Claim 10 (depends on 1)

The method according to claim 1, wherein the radiation damage is damage to the small intestine or the large intestine.