Anti-IL-23 antibody compositions

• US 9,714,287 B2
• Filed: 10/28/2016
• Issued: 07/25/2017
• Est. Priority Date: 06/30/2005
• Status: Active Grant

• Current Assignee: Janssen Biotech, Inc. (Johnson & Johnson)
• Original Assignee: Janssen Biotech, Inc. (Johnson & Johnson)
• Inventors: Giles-Komar, Jill, Duchala, Cynthia, Luo, Jinquan, Rycyzyn, Michael, Benson, Jacqueline, Cunningham, Mark, Sweet, Raymond
• Primary Examiner(s): MERTZ, PREMA MARIA
• Application Number:
  US15/337,512
• Publication Number:
  US 20170044252A1
• Time in Patent Office: 270 Days
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61K 2039/55527 Interleukins
• CPC Class Codes: A61K 2039/55544 Bacterial toxins
• CPC Class Codes: A61K 39/00 Medicinal preparations containing antigens or antibodies materials for immunoassay G01N33/53
• CPC Class Codes: A61K 39/3955 against proteinaceous materials, e.g. enzymes, hormones, lymphokines
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• 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 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 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders
• 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 2317/30 characterized by aspects of specificity or valency
• CPC Class Codes: C07K 2317/33 : Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
• 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 2317/56 : variable (Fv) region, i.e. VH and/or VL
• CPC Class Codes: C07K 2317/565 : Complementarity determining region [CDR]
• 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 2319/55 : containing a fusion with a toxin, e.g. diphteria toxin
• CPC Class Codes: G01N 2333/54 : Interleukins [IL]
• CPC Class Codes: G01N 33/6869 : Interleukin
• CPC Class Codes: 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

Abstract

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

Claims

1. An isolated IL-23p19 antibody fragment, comprising a light chain variable region comprising:

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

19;

a CDRL2 amino acid sequence of SEQ ID NO;

20; and

a CDRL3 amino acid sequence of SEQ ID NO;

21,

and/or a heavy chain variable region comprising;

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

14;

a CDRH2 amino acid sequence of SEQ ID NO;

15; and

a CDRH3 amino acid sequence of SEQ ID NO;

16.

2. The isolated IL-23p19 antibody fragment of claim 1, comprising a light chain variable region amino acid sequence of SEQ ID NO:

18.

3. The isolated IL-23p19 antibody fragment of claim 1, comprising a heavy chain variable region amino acid sequence of SEQ ID NO:

13.

4. The isolated IL-23p19 antibody fragment of claim 1, wherein said antibody light chain variable region is at least one of chimerized, humanized, and CDR-grafted.

5. A composition comprising the isolated IL-23p19 antibody fragment of claim 1, and at least one pharmaceutically acceptable carrier or diluent.

6. The composition of claim 5, further comprising at least one compound or polypeptide selected from a detectable label or reporter, a TNF antagonist, an anti-infective drug, a cardiovascular (CV) system drug, a central nervous system (CNS) drug, an autonomic nervous system (ANS) drug, a respiratory tract drug, a gastrointestinal (GI) tract drug, a hormonal drug, a drug for fluid or electrolyte balance, a hematologic drug, an antineoplastic, an immunomodulation drug, an opthalmic, otic or nasal drug, a topical drug, a nutritional drug, a cytokine, and a cytokine antagonist.

7. The isolated IL-23p19 antibody fragment of claim 1, wherein said fragment is selected from the group consisting of a Fab, Fab′

, F(ab′

)₂, pFc, Fd, Fv, scFv, and fragments thereof.

8. An antibody that competitively binds to IL-23p19 with the isolated IL-23p19 antibody fragment of claim 1.

9. The isolated IL-23p19 antibody fragment of claim 1, wherein said antibody fragment binds IL-23p19 with at least one affinity selected from at least 10⁻

9 M, at least 10<sup>−

10</sup> M, at least 10<sup>−

11</sup> M, and at least 10<sup>−

12</sup> M, at least 10<sup>−

13</sup> M, at least 10<sup>−

14</sup> M, and at least 10<sup>−

15</sup> M, as determined by surface plasmon resonance or the Kinexa method.

10. The isolated IL-23p19 antibody fragment of claim 1, wherein said antibody fragment binds IL-23p19 with an affinity between about 3.38×

10<sup>−

10</sup> M and about 4.3×

10<sup>−

11</sup> M, as determined by surface plasmon resonance.

11. The isolated IL-23-p19 antibody fragment of claim 1, wherein said antibody fragment downregulates an activity of the IL-23 polypeptide comprising SEQ ID NO:

1, the activity being selected from the group consisting of binding to the IL-23 receptor (IL-23R), induction of STAT3 phosphorylation, and IL-17 production.