Anti-IL-23 antibodies, compositions, methods and uses

• US 10,272,152 B2
• Filed: 06/19/2017
• Issued: 04/30/2019
• Est. Priority Date: 06/30/2005
• Status: Active Grant

• Current Assignee: Janssen Biotech, Inc. (Johnson & Johnson)
• Original Assignee: Janssen Biotech, Inc. (Johnson & Johnson)
• Inventors: Benson, Jacqueline, Cunningham, Mark, Duchala, Cynthia, Giles-Komar, Jill, Luo, Jinquan, Rycyzyn, Michael, Sweet, Raymond
• Primary Examiner(s): Mertz, Prema M
• Application Number:
  US15/626,697
• Publication Number:
  US 20170290912A1
• Time in Patent Office: 680 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;

29;

a CDRL2 amino acid sequence of SEQ ID NO;

30; and

a CDRL3 amino acid sequence of SEQ ID NO;

31,

and a heavy chain variable region comprising;

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

24;

a CDRH2 amino acid sequence of SEQ ID NO;

25; and

a CDRH3 amino acid sequence of SEQ ID NO;

26.

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

28.

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

23.

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 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.