Human anti-IL-23 antibodies, compositions, methods and uses

• US 9,783,607 B2
• Filed: 04/29/2016
• Issued: 10/10/2017
• Est. Priority Date: 12/29/2005
• Status: Active Grant

• Current Assignee: Janssen Biotech, Inc. (Johnson & Johnson)
• Original Assignee: Janssen Biotech, Inc. (Johnson & Johnson)
• Inventors: Benson, Jacqueline, Carton, Jill, Cunningham, Mark, Orlovsky, Yevgeniya I., Rauchenberger, Robert, Sweet, Raymond
• Primary Examiner(s): SKELDING, ZACHARY S
• Application Number:
  US15/142,765
• Publication Number:
  US 20160237151A1
• Time in Patent Office: 529 Days
• Field of Search: None
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61K 39/3955 against proteinaceous materials, e.g. enzymes, hormones, lymphokines
• CPC Class Codes: 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
• CPC Class Codes: 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
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 17/06 Antipsoriatics
• CPC Class Codes: A61P 17/08 Antiseborrheics
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/02 for peripheral neuropathies
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 37/02 Immunomodulators
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: C07K 16/244 : Interleukins [IL]
• CPC Class Codes: C07K 2317/21 : from primates, e.g. man
• CPC Class Codes: C07K 2317/34 : Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
• CPC Class Codes: C07K 2317/52 : Constant or Fc region; Isotype
• CPC Class Codes: C07K 2317/55 : Fab or Fab'
• CPC Class Codes: C07K 2317/565 : Complementarity determining region [CDR]
• CPC Class Codes: C07K 2317/73 : Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
• CPC Class Codes: C07K 2317/76 : Antagonist effect on antigen, e.g. neutralization or inhibition of binding
• CPC Class Codes: C07K 2317/92 : Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
• CPC Class Codes: C07K 2319/00 : Fusion polypeptide
• CPC Class Codes: C07K 2319/30 : Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

Abstract

A human anti-IL-23p19 antibody, including isolated nucleic acids that encode at least one anti-IL-23p19 antibody, vectors, host cells, and methods of making and using thereof have applications in diagnostic and/or therapeutic compositions, methods and devices.

Claims

1. A prefilled syringe containing a liquid pharmaceutical formulation of an isolated IL-23p19 antibody, comprising a light chain variable region and a heavy chain variable region, said light chain variable region comprising:

a complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO;

50;

a CDRL2 amino acid sequence of SEQ ID NO;

56; and

a CDRL3 amino acid sequence of SEQ ID NO;

73,

said heavy chain variable region comprising;

a complementarity determining region heavy chain 1 (CDRH1) amino acid sequence of SEQ ID NO;

5;

a CDRH2 amino acid sequence of SEQ ID NO;

20; and

a CDRH3 amino acid sequence of SEQ ID NO;

44.

2. The prefilled syringe of claim 1, wherein the pH of the formulation is 5.8.

3. The prefilled syringe of claim 2, wherein the liquid pharmaceutical formulation comprises histidine.

11. The prefilled syringe of claim 2, wherein the liquid pharmaceutical formulation comprises sucrose.

12. The prefilled syringe of claim 2, wherein the liquid pharmaceutical formulation comprises poly sorbate 80.

13. The prefilled syringe of claim 2, wherein the liquid pharmaceutical formulation comprises water.

4. A prefilled syringe containing a liquid pharmaceutical formulation of an antibody comprising at least one member selected from the group consisting of a light chain variable region having the amino acid sequence of SEQ ID NO:

116, a heavy chain variable region having the amino acid sequence of SEQ ID NO;

106, and a heavy chain variable region having the amino acid sequence of SEQ ID NO;

106 with up to three substitutions from residues 50-66 of the amino acid sequence of SEQ ID NO;

106.

5. The prefilled syringe of claim 4, wherein the pH of the formulation is 5.8.

6. The prefilled syringe of claim 5, wherein the liquid pharmaceutical formulation comprises histidine.

14. The prefilled syringe of claim 5, wherein the liquid pharmaceutical formulation comprises sucrose.

15. The prefilled syringe of claim 5, wherein the liquid pharmaceutical formulation comprises poly sorbate 80.

16. The prefilled syringe of claim 5, wherein the liquid pharmaceutical formulation comprises water.

7. A prefilled syringe containing a liquid pharmaceutical formulation of an antibody comprising a light chain variable region having the amino acid sequence of SEQ ID NO:

116 and a heavy chain variable region having the amino acid sequence of SEQ ID NO;

106.

8. The prefilled syringe of claim 7, wherein the pH of the formulation is 5.8.

9. The prefilled syringe of claim 7, wherein the liquid pharmaceutical formulation comprises histidine.

17. The prefilled syringe of claim 7, wherein the liquid pharmaceutical formulation comprises sucrose.

18. The prefilled syringe of claim 7, wherein the liquid pharmaceutical formulation comprises poly sorbate 80.

19. The prefilled syringe of claim 7, wherein the liquid pharmaceutical formulation comprises water.

10. A prefilled syringe containing a liquid pharmaceutical formulation of an antibody comprising a light chain variable region having the amino acid sequence of SEQ ID NO:

116, a heavy chain variable region having the amino acid sequence of SEQ ID NO;

106, wherein the liquid pharmaceutical formulation comprises histidine and the pH of the formulation is 5.8.