# US 11,078,265 B2 · Anti-IL-23 antibodies

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- Number: US 11,078,265 B2
- Document ID: US11078265B2
- Status: Granted
- Kind: B2
- Application number: 13/870,061
- Filed: 2013-04-25
- Published: 2014-06-26
- Granted: 2021-08-03
- Earliest claimed: 2012-05-03
- Assignees: Boehringer Ingelheim International GmbH
- Applicants: Boehringer Ingelheim International GmbH
- Inventors: Gerald Henry Nabozny; Annette Bettina Galler; Patrick Garidel; William Troy Loging; Steven John Padula; Torsten Schultz-Fademrecht; Elaine Ee-Ling Wang
- Web page: https://patentgrep.com/patent/US11078265B2

## CPC

- C07K 16/244: {Interleukins [IL]}
- A61K 39/39591: {Stabilisation, fragmentation}
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00)
- A61P 7/00: Drugs for disorders of the blood or the extracellular fluid
- A61P 7/06: Antianaemics
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 13/12: of the kidneys
- A61P 17/06: Antipsoriatics
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/14: for treating abnormal movements, e.g. chorea, dyskinesia
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/04: Antibacterial agents
- A61P 33/06: Antimalarials
- A61P 35/00: Antineoplastic agents
- A61P 35/02: specific for leukemia
- A61P 37/00: Drugs for immunological or allergic disorders
- A61P 37/02: Immunomodulators
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- A61K 2039/505: {comprising antibodies}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/34: Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
- C07K 2317/71: Decreased effector function due to an Fc-modification
- C07K 2317/90: characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present invention relates to anti-IL-23p19 binding compounds, in particular new humanized anti-IL-23p19 antibodies, pharmaceutical compositions and therapeutic and diagnostic methods and compositions for using the same.

## Claims

### Claim 1

A pharmaceutical composition comprising an antibody,
wherein said pharmaceutical composition is an aqueous formulation comprising 90 mg/ml of an anti-IL-23p19 antibody comprising a light chain that comprises the amino acid sequence of SEQ ID NO:174 and a heavy chain that comprises the amino acid sequence of SEQ ID NO:176, 225mM sorbitol, and 4.4mM succinate buffer;
wherein the pH of said pharmaceutical composition is in the range of pH 5.5 to 6.5 and the osmolarity of said pharmaceutical composition is 300 +/− 30 mOsmol/kg.

### Claim 2 (depends on 1)

The pharmaceutical composition according to claim 1, wherein said pharmaceutical composition further comprises 0.20 g/l of polysorbate 20.

### Claim 3 (depends on 1)

The pharmaceutical composition according to claim 1, wherein the osmolarity of said pharmaceutical composition is maintained within +/− 30 mOsmol/kg after 8 weeks of storage.

### Claim 4

A pharmaceutical composition comprising an antibody,
wherein said pharmaceutical composition is an aqueous formulation comprising 90 mg/ml of an anti-IL-23p19 antibody comprising a light chain that comprises the amino acid sequence of SEQ ID NO:174 and a heavy chain that comprises the amino acid sequence of SEQ ID NO:176 and 240mM sorbitol;
wherein the pH of said pharmaceutical composition is in the range of pH 5.5 to 6.5 and the osmolarity of said pharmaceutical composition is 300 +/− 30 mOsmol/kg.

### Claim 5 (depends on 4)

The pharmaceutical composition according to claim 4, wherein the osmolarity of said pharmaceutical composition is maintained within +/− 30 mOsmol/kg after 8 weeks of storage.

### Claim 6 (depends on 4)

The pharmaceutical composition according to claim 4, wherein said pharmaceutical composition further comprises 0.20 g/l of polysorbate 20.

### Claim 7

A liquid aqueous pharmaceutical formulation comprising (a) an anti-IL23p19 antibody in a concentration of 90 mg/ml, (b) a detergent, and (c) a tonicity agent, wherein the anti-IL23p19 antibody comprises a light chain amino acid sequence shown as SEQ ID NO:174 and a heavy chain amino acid sequence shown as SEQ ID NO:176, wherein the formulation is stable, isotonic, has a pH in the range of 5.5 to 6.5, and wherein the formulation optionally comprises a buffer.

### Claim 8 (depends on 7)

The liquid aqueous pharmaceutical formulation of claim 7, wherein the detergent is polysorbate 20 (PS20).

### Claim 9 (depends on 8)

The liquid aqueous pharmaceutical formulation of claim 8, wherein the PS20 is present at a concentration of 0.2 mg/ml.

### Claim 10 (depends on 7)

The liquid aqueous pharmaceutical formulation of claim 7, wherein the formulation further comprises a buffer.

### Claim 11 (depends on 10)

The liquid aqueous pharmaceutical formulation of claim 10, wherein the buffer is succinate buffer.

### Claim 12 (depends on 11)

The liquid aqueous pharmaceutical formulation of claim 11, wherein the formulation comprises 4.4 mM succinate buffer.

### Claim 13 (depends on 7)

The liquid aqueous pharmaceutical formulation of claim 7, wherein the tonicity agent is sorbitol.

### Claim 14 (depends on 7)

The liquid aqueous pharmaceutical formulation of claim 7, wherein the formulation is stable following storage in a syringe for 8 weeks at 40° C.

### Claim 15 (depends on 7)

The liquid aqueous pharmaceutical formulation of claim 7, wherein the osmolarity of the formulation is 300 +/− 30 mOsmol/kg.

### Claim 16 (depends on 7)

The liquid aqueous pharmaceutical formulation of claim 7, wherein the formulation has a pH in the range of 5.5 to 6.1.

### Claim 17 (depends on 8)

The liquid aqueous pharmaceutical formulation of claim 8, wherein the formulation further comprises succinate buffer and wherein the tonicity agent is sorbitol.

### Claim 18 (depends on 17)

The liquid aqueous pharmaceutical formulation of claim 17, wherein the formulation comprises 4.4 mM succinate buffer and 225 mM sorbitol, and has an osmolarity of 300 +/− 30 mOsmol/kg.

### Claim 19

A liquid aqueous pharmaceutical formulation comprising (a) an anti-IL23p19 antibody, (b) a detergent, and (c) a tonicity agent, wherein the anti-IL23p19 antibody comprises a light chain amino acid sequence shown as SEQ ID NO:174 and a heavy chain amino acid sequence shown as SEQ ID NO:176, wherein the formulation is stable, isotonic, has a pH in the range of 5.5 to 6.5, and wherein the formulation optionally comprises a buffer.

### Claim 20 (depends on 19)

The liquid aqueous pharmaceutical formulation of claim 19, wherein the detergent is polysorbate 20 (PS20).

### Claim 21 (depends on 20)

The liquid aqueous pharmaceutical formulation of claim 20, wherein the PS20 is present at a concentration of 0.2 mg/ml.

### Claim 22 (depends on 19)

The liquid aqueous pharmaceutical formulation of claim 19, wherein the formulation further comprises a buffer.

### Claim 23 (depends on 22)

The liquid aqueous pharmaceutical formulation of claim 22, wherein the buffer is succinate buffer.

### Claim 24 (depends on 23)

The liquid aqueous pharmaceutical formulation of claim 23, wherein the formulation comprises 4.4 mM succinate buffer.

### Claim 25 (depends on 9)

The liquid aqueous pharmaceutical formulation of claim 9, wherein the tonicity agent is sorbitol.

### Claim 26 (depends on 25)

The liquid aqueous pharmaceutical formulation of claim 25, wherein the tonicity agent is sodium chloride.

### Claim 27 (depends on 19)

The liquid aqueous pharmaceutical formulation of claim 19, wherein the osmolarity of the formulation is 300 +/− 30 mOsmol/kg.

### Claim 28 (depends on 19)

The liquid aqueous pharmaceutical formulation of claim 19, wherein the formulation has a pH in the range of 5.5 to 6.1.

### Claim 29 (depends on 20)

The liquid aqueous pharmaceutical formulation of claim 20, wherein the formulation further comprises succinate buffer and wherein the tonicity agent is sorbitol.

### Claim 30 (depends on 20)

The liquid aqueous pharmaceutical formulation of claim 20, wherein the formulation comprises 4.4 mM succinate buffer and 225 mM sorbitol, and has an osmolarity of 300 +/− 30 mOsmol/kg.

### Claim 31 (depends on 7)

The liquid aqueous pharmaceutical formulation of claim 7, wherein the formulation does not comprise a buffer.

### Claim 32 (depends on 19)

The liquid aqueous pharmaceutical formulation of claim 19, wherein the formulation does not comprise a buffer.