# US 11,306,136 B2 · Selective IL-6-trans-signalling inhibitor compositions

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- Number: US 11,306,136 B2
- Document ID: US11306136B2
- Status: Granted
- Kind: B2
- Application number: 16/675,621
- Filed: 2019-11-06
- Published: 2020-04-23
- Granted: 2022-04-19
- Earliest claimed: 2014-12-01
- Assignees: Ferring B.V.
- Applicants: Ferring B.V.
- Inventors: Ian Cottingham; Daniel Plaksin; Jérémy Duboeuf
- Web page: https://patentgrep.com/patent/US11306136B2

## CPC

- C07K 14/7155: {for interleukins [IL]}
- 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 38/177: {Receptors; Cell surface antigens; Cell surface determinants}
- A61K 38/1793: {for cytokines; for lymphokines; for interferons}
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 17/06: Antipsoriatics
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 27/02: Ophthalmic agents
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- C07K 14/5412: {IL-6}
- C12N 15/63: Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
- 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 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
- 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)
- 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
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

A selective IL-6-trans-signalling inhibitor can be used to treat a variety of IL-6-mediated conditions, including inflammatory diseases and cancer. The inhibitor can safely be administered to humans at a variety of doses.

## Claims

### Claim 1

A method of treating a subject suffering from or susceptible to a chronic inflammatory disease or a chronic IL-6-mediated condition, the method comprising:
administering to a subject a composition comprising a polypeptide dimer comprising two gp130-Fc monomers comprising an amino acid sequence at least 95% identical to SEQ ID NO: 1,
wherein the composition comprises no greater than 6 mol % of galactose-alpha-1,3-galactose per mole polypeptide; and
wherein the chronic inflammatory disease or chronic IL-6-mediated condition is inflammatory bowel disease.

### Claim 2 (depends on 1)

The method of claim 1, wherein the administration induces remission of the inflammatory bowel disease.

### Claim 3 (depends on 1)

The method of claim 1, wherein the inflammatory bowel disease is Crohn's disease or ulcerative colitis.

### Claim 4 (depends on 1)

The method of claim 1, wherein prior to administration of the composition the subject is in remission of inflammatory bowel disease, and administration of the composition maintains the remission of inflammatory bowel disease.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the composition is administered parenterally.

### Claim 6 (depends on 5)

The method according to claim 5, wherein the composition is administered intravenously or subcutaneously.

### Claim 7

A method of treating a chronic inflammatory disease or a chronic IL-6-mediated condition in a subject comprising:
administering to a subject in need thereof a composition comprising a polypeptide dimer comprising two gp130-Fc monomers comprising the amino acid sequence at least 95% identical to SEQ ID NO: 1, wherein the monomers comprise the gp130 D6 domain corresponding to the amino acids at positions 585-595 of the amino acid sequence of SEQ ID NO:1, an Fc domain hinge region comprising the amino acids at positions 609-612 of the amino acid sequence of SEQ ID NO:1, and the monomers do not comprise a linker between the gp130 D6 domain and the Fc domain hinge region, wherein:
the composition comprises no greater than 6 mol % of galactose-alpha-1,3-galactose per mole polypeptide.

### Claim 8 (depends on 7)

The method of claim 7, wherein the chronic inflammatory disease or chronic IL-6-mediated condition is inflammatory bowel disease.

### Claim 9 (depends on 8)

The method of claim 8, wherein the administration of the composition induces remission of the inflammatory bowel disease.

### Claim 10 (depends on 8)

The method of claim 8, wherein the inflammatory bowel disease is Crohn's disease or ulcerative colitis.

### Claim 11 (depends on 8)

The method of claim 8, wherein prior to the administration of the composition the subject is in remission of inflammatory bowel disease and administration of the composition maintains the remission of inflammatory bowel disease.

### Claim 12 (depends on 7)

The method of claim 7, wherein the composition is administered parenterally.

### Claim 13 (depends on 12)

The method of claim 12, wherein the composition is administered intravenously or subcutaneously.