# US 12,492,235 B2 · Cytokines and use thereof

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- Number: US 12,492,235 B2
- Document ID: US12492235B2
- Status: Granted
- Kind: B2
- Application number: 17/416,829
- Filed: 2019-12-20
- Published: 2022-03-03
- Granted: 2025-12-09
- Earliest claimed: 2018-12-21
- Assignees: The Catholic University of Korea Foundation Industry-Academic Cooperation
- Applicants: The Catholic University of Korea Industry—Academic Cooperation Foundation
- Inventors: Mi-La Cho; Chul-Woo Yang; Sung-Hwan Park; Seon-Yeong Lee; Young-Mee Moon; Seung-Ki Kwok; Hyeon-Beom Seo; Jun-Geol Ryu; Eun-Kyung Kim
- Web page: https://patentgrep.com/patent/US12492235B2

## CPC

- C07K 14/5434: {IL-12}
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 37/00: Drugs for immunological or allergic disorders
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- C07K 14/54: Interleukins [IL]
- G01N 33/6869: {Interleukin}
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- C07K 2319/00: Fusion polypeptide
- C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
- G01N 2333/54: Interleukins [IL]
- G01N 2333/5434: IL-12
- G01N 2333/715: for cytokines; for lymphokines; for interferons
- 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
- 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)

## Abstract

The present invention relates to a novel complex that is formed by linking p40 subunit and EBI3 subunit via a linker and has excellent anti-inflammatory effects and immunomodulatory effects.

## Claims

### Claim 1

A complex formed by linking p40 subunit and EBI3 subunit by a linker, wherein the complex includes an amino acid sequence selected from the group consisting of amino acid sequences represented by SEQ ID NOs: 2, 4, 6 and 12.

### Claim 2

A complex formed by linking p40 subunit and EBI3 subunit by a linker, wherein the complex is encoded by a polynucleotide sequence selected from the group consisting of polynucleotide sequences represented by SEQ ID NOs: 1, 3, 5, 10 and 11.

### Claim 3 (depends on 1)

The complex of claim 1, wherein the complex further includes an immunoglobulin moiety.

### Claim 4 (depends on 3)

The complex of claim 3, wherein the immunoglobulin moiety is an Fc fragment.

### Claim 5 (depends on 3)

The complex of claim 3, wherein the immunoglobulin moiety is linked to the EBI3 subunit.

### Claim 6 (depends on 3)

The complex of claim 3, wherein the complex includes an amino acid sequence represented by SEQ ID NO: 9.

### Claim 7 (depends on 3)

The complex of claim 3, wherein the complex is encoded by a polynucleotide sequence represented by SEQ ID NO: 7 or 8.

### Claim 8

A polynucleotide comprising a gene sequence selected from the group consisting of SEQ ID NOs: 1, 3, 5, 7, 8, 10 and 11.

### Claim 9 (depends on 8)

A vector comprising the polynucleotide of claim 8.

### Claim 10 (depends on 9)

A host cell comprising the vector of claim 9.

### Claim 11 (depends on 1)

A pharmaceutical composition for prevention or treatment of an immune disease, the composition comprising the complex of claim 1.

### Claim 12 (depends on 11)

The composition of claim 11, wherein the immune disease is selected from the group consisting of rheumatoid arthritis, ankylosing spondylitis, experimental autoimmune encephalomyelitis, post transplantation late and chronic solid organ rejection, skin sclerosis, psoriasis, Sjogren's syndrome, inflammatory bowel disease and graft-versus-host disease.

### Claim 13 (depends on 9)

A pharmaceutical composition for prevention or treatment of an immune disease, the composition comprising the vector of claim 9.

### Claim 14 (depends on 13)

The composition of claim 13, wherein the immune disease is selected from the group consisting of rheumatoid arthritis, ankylosing spondylitis, experimental autoimmune encephalomyelitis, post transplantation late and chronic solid organ rejection, skin sclerosis, psoriasis, Sjogren's syndrome, inflammatory bowel disease and graft-versus-host disease.

### Claim 15 (depends on 1)

A standard protein complex for quantitative analysis of p40 subunit and EBI3 subunit complex comprising the complex of claim 1.

### Claim 16 (depends on 1)

A kit for detecting p40 subunit and EBI3 subunit complex, the kit comprising an agent for measuring the complex of claim 1 at a protein level.

### Claim 17 (depends on 16)

The kit of claim 16, wherein the agent measured at the protein level is selected from the group consisting of an antibody, antibody fragment, aptamer, avidity multimer, and peptidomimetics, that specifically recognizes full length or fragment of the protein of the p40-EBI3.

### Claim 18 (depends on 16)

The kit of claim 16, wherein the measurement is performed by a method selected from the group consisting of Western blot, enzyme linked immunosorbent assay (ELISA), sandwich enzyme linked immunosorbent assay (Sandwich ELISA), radioimmunoassay (RIA), radioimmunodiffusion, immunoelectrophoresis, tissue immunostaining, immunoprecipitation assay, complement fixation assay, FACS, mass spectrometry and protein microarray.

### Claim 19 (depends on 1)

A kit for quantifying p40 subunit and EBI3 subunit complex comprising the complex of claim 1 as a standard protein complex.

### Claim 20 (depends on 11)

A method for treating an immune disease, the method comprising administering the pharmaceutical composition of claim 11 to an individual in a pharmaceutically effective amount.

### Claim 21 (depends on 13)

A method for treating an immune disease, the method comprising administering the pharmaceutical composition of claim 13 to an individual in a pharmaceutically effective amount.
