IL-31 monoclonal antibody formulations

• US 9,738,715 B2
• Filed: 07/13/2016
• Issued: 08/22/2017
• Est. Priority Date: 12/07/2007
• Status: Active Grant

• Current Assignee: Zymogenetics Incorporated (Bristol-Myers Squibb Company), Merck Serono SA (Merck & Co., Inc.)
• Original Assignee: Zymogenetics Incorporated (Bristol-Myers Squibb Company), Merck Serono SA (Merck & Co., Inc.)
• Inventors: Bondensgaard, Kent, Beckmann, Roland
• Primary Examiner(s): KEMMERER, ELIZABETH
• Application Number:
  US15/208,990
• Publication Number:
  US 20160311898A1
• Time in Patent Office: 405 Days
• Field of Search: None
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61K 39/00114 Interleukins [IL]
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/04 Antipruritics
• CPC Class Codes: A61P 17/14 for baldness or alopecia
• 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 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C07K 16/244 Interleukins [IL]
• CPC Class Codes: C07K 2317/24 containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
• CPC Class Codes: C07K 2317/51 Complete heavy chain or Fd fragment, i.e. VH + CH1
• CPC Class Codes: C07K 2317/515 Complete light chain, i.e. VL + CL
• CPC Class Codes: C07K 2317/52 Constant or Fc region; Isotype
• CPC Class Codes: C07K 2317/56 variable (Fv) region, i.e. VH and/or VL
• 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: C12N 15/63 Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
• CPC Class Codes: C12N 5/10 Cells modified by introduction of foreign genetic material

Abstract

The invention provides humanized mouse anti-human IL-31 antibodies and antibody fragments that are capable of binding IL-31 and thereby neutralizing, inhibiting, limiting, or reducing the proinflammatory or pro-pruritic effects of IL-31.

Claims

1. A pharmaceutical composition comprising a monoclonal antibody that specifically binds to human IL-31 and a pharmaceutically acceptable carrier, wherein the monoclonal antibody comprises a heavy chain variable domain comprising the amino acid sequence of SEQ ID NO:

44, and a light chain variable domain comprising the amino acid sequence of SEQ ID NO;

26, and wherein the composition is suitable for intravenous, intraarterial, intraperitoneal, intramuscular or subcutaneous injection.

2. The pharmaceutical composition of claim 1, wherein the monoclonal antibody is in a lyophilized form and reconstituted in the pharmaceutically acceptable carrier prior to injection.

3. The pharmaceutical composition of claim 1, wherein the monoclonal antibody comprises a human Fc domain.

4. The pharmaceutical composition of claim 3, wherein the isotype of the human Fc domain is IgG1, IgG2, IgG3 or IgG4.

5. The pharmaceutical composition of claim 3, wherein the isotype of the human Fc domain is IgG4.

6. The pharmaceutical composition of claim 5, wherein the IgG4human Fc domain has a serine to proline mutation at position 241 as determined by Kabat.

7. The pharmaceutical composition of claim 1, wherein the heavy chain domain of the monoclonal antibody comprises the amino acid sequence of SEQ ID NO:

47.

8. The pharmaceutical composition of claim 1, wherein the light chain domain of the monoclonal antibody comprises the amino acid sequence of SEQ ID NO:

46.