Anti-IL31 antibodies for veterinary use

Patent metadata

Field	Value
Publication number	US-12448438-B2
Application number	US-202318311777-A
Country	US
Kind code	B2
Filing date	May 3, 2023
Priority date	Feb 24, 2017
Publication date	Oct 21, 2025
Grant date	Oct 21, 2025

Abstract

Provided are various embodiments relating to anti-IL31 antibodies binding to canine IL31. Such antibodies can be used in methods to treat IL31-induced conditions in companion animals, such as canines, felines, and equines.

First claim

What is claimed is:

1. A pharmaceutical composition comprising an anti-IL31 antibody and a pharmaceutically acceptable carrier, wherein the antibody comprises:
a) (i) a CDR-H1 comprising the amino acid sequence of SEQ ID NO: 1,
(ii) a CDR-H2 comprising the amino acid sequence of SEQ ID NO: 2,
(iii) a CDR-H3 comprising the amino acid sequence of SEQ ID NO: 3, and

b) (i) a CDR-L1 comprising the amino acid sequence of SEQ ID NO: 8,
(ii) a CDR-L2 comprising the amino acid sequence of SEQ ID NO: 9,
(iii) a CDR-L3 comprising the amino acid sequence of SEQ ID NO: 10.

2. The composition of claim 1 , wherein the antibody comprises:
a) (i) a variable light chain sequence having at least 95% sequence identity to the amino acid sequence of SEQ ID NO: 24; (ii) a variable heavy chain sequence having at least 95% sequence identity to the amino acid sequence of SEQ ID NO: 25; or (iii) a variable light chain sequence as in (i) and a variable heavy chain sequence as in (ii); or
b) (i) a variable light chain sequence having at least 95% sequence identity to the amino acid sequence of SEQ ID NO: 16; (ii) a variable heavy chain sequence having at least 95% sequence identity to the amino acid sequence of SEQ ID NO: 15; or (iii) a variable light chain sequence as in (i) and a variable heavy chain sequence as in (ii).

3. The composition of claim 1 , wherein the antibody comprises (a) a canine heavy chain constant region selected from an IgG-A, IgG-B, IgG-C, and IgG-D constant region; or (b) a feline heavy chain constant region selected from an IgG1, IgG2a, and IgG2b constant region.

4. The composition of claim 1 , wherein the antibody comprises: a) (i) a light chain amino acid sequence of SEQ ID NO: 26; (ii) a heavy chain amino acid sequence of SEQ ID NO: 27; or (iii) a light chain amino acid sequence as in (i) and a heavy chain amino acid sequence as in (ii); or b) (i) a light chain amino acid sequence of SEQ ID NO: 30; (ii) a heavy chain amino acid sequence of SEQ ID NO: 31; or (iii) a light chain amino acid sequence as in (i) and a heavy chain amino acid sequence as in (ii).

5. The composition of claim 1 , wherein the antibody binds to canine IL31 with a dissociation constant (Kd) of between 5×10 −11 M and 1×10 −12 M, as measured by biolayer interferometry.

6. The composition of claim 1 , wherein the antibody is a monoclonal antibody.

7. The composition of claim 1 , wherein the antibody is a canonized or a felinized antibody.

8. The composition of claim 1 , wherein the antibody is an antibody fragment selected from Fv, scFv, Fab, Fab′, F(ab′) 2 , and Fab′-SH.

9. The composition of claim 1 , wherein the composition further comprises:
a) a Jak inhibitor, a PI3K inhibitor, an AKT inhibitor, or a MAPK inhibitor; or
b) one or more antibodies selected from an anti-IL17 antibody, an anti-TNFα antibody, an anti-CD20 antibody, an anti-CD19 antibody, an anti-CD25 antibody, an anti-IL4 antibody, an anti-IL13 antibody, an anti-IL23 antibody, an anti-IgE antibody, an anti-CD11 antibody, anti-IL6R antibody, anti-α4-Intergrin antibody, an anti-IL12 antibody, an anti-IL1β antibody, and an anti-BlyS antibody.

10. The composition of claim 1 , wherein the pharmaceutically acceptable carrier comprises L-histidine.

11. The composition of claim 1 , wherein the pharmaceutically acceptable carrier comprises sodium chloride.

12. The composition of claim 1 , wherein the pharmaceutically acceptable carrier comprises L-polysorbate 80.

13. The composition of claim 1 , wherein the composition has a pH of from 5.0 to 6.2.

14. The composition of claim 10 , wherein the composition has an L-histidine concentration of from 5 mM to 100 mM.

15. The composition of claim 11 , wherein the composition has a sodium chloride concentration of from 80 to 200 mM.

16. The composition of claim 12 , wherein the composition has a L-polysorbate 80 concentration of from 0.005 mg/mL to 0.5 mg/mL.

17. The composition of claim 1 , wherein the pharmaceutically acceptable carrier comprises at least one sugar.

18. The composition of claim 17 , wherein the at least one sugar is present in the pharmaceutically acceptable carrier at a concentration of from 0.5% to 20%.

19. The composition of claim 1 , wherein the pharmaceutically acceptable carrier comprises an ingredient selected from the group consisting of sucrose, trehalose, D-mannitol, maltose, sorbitol, and combinations thereof.

20. The composition of claim 1 , wherein the pharmaceutically acceptable carrier comprises an anti-bacterial agent.

21. The composition of claim 20 , wherein the anti-bacterial agent is selected from the group consisting of m-cresol, methylparaben, and combinations thereof.

22. The composition of claim 1 , wherein the antibody further comprises one or more of (a) a variable region heavy chain framework 1 (HC-FR1) sequence of SEQ ID NO: 4; (b) a HC-FR2 sequence of SEQ ID NO: 5; (c) a HC-FR3 sequence of SEQ ID NO: 6; (d) a HC-FR4 sequence of SEQ ID NO: 7; (e) a variable region light chain framework 1 (LC-FR1) sequence of SEQ ID NO: 11; (f) an LC-FR2 sequence of SEQ ID NO: 12; (g) an LC-FR3 sequence of SEQ ID NO: 13; or (h) an LC-FR4 sequence of SEQ ID NO: 14.

23. The composition of claim 1 , wherein the antibody comprises a variable light chain sequence having at least 95% sequence identity to the amino acid sequence of SEQ ID NO: 16 and a variable heavy chain sequence having at least 95% sequence identity to the amino acid sequence of SEQ ID NO: 15.

24. The composition of claim 23 , wherein the antibody comprises a variable light chain sequence comprising SEQ ID NO: 16 and a variable heavy chain sequence comprising SEQ ID NO: 15.

25. The composition of claim 23 , wherein the antibody comprises a canine heavy chain constant region from an IgG-B constant region.

26. The composition of claim 24 , wherein the antibody comprises a canine heavy chain constant region from an IgG-B constant region.

27. The composition of claim 1 , wherein the antibody comprises a heavy chain amino acid sequence at least 98% identical to SEQ NO: 18 and a light chain amino acid sequence at least 98% identical to SEQ ID NO: 21.

28. The composition of claim 1 , wherein the antibody comprises a heavy chain amino acid sequence at least 99% identical to SEQ NO: 18 and a light chain amino acid sequence at least 99% identical to SEQ ID NO: 21.

29. The composition of claim 1 , wherein the antibody comprises a heavy chain amino acid sequence 100% identical to SEQ NO: 18 and a light chain amino acid sequence 100% identical to SEQ ID NO: 21.

Assignees

• Elanco Us Inc

Inventors

• Li Shyr Jiann
• Nguyen Lam
• Zhan Hangjun

Classifications

• C07K2317/94

  Stability, e.g. half-life, pH, temperature or enzyme-resistance · CPC title

• A61K2039/552

  Veterinary vaccine · CPC title

• C07K2317/33

  Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity · CPC title

• C07K2317/565

  Complementarity determining region [CDR] · CPC title

• C07K2317/52

  Constant or Fc region; Isotype · CPC title