Granted Patent
B2
US 12,448,438 · App. 18/311,777 · Granted Oct 21, 2025
Anti-IL31 antibodies for veterinary use
Inventors:
Shyr Jiann Li (Burlingame, CA); Lam Nguyen (Burlingame, CA); Hangjun Zhan (Burlingame, CA)
Assignee:
Elanco US Inc.
C07K16/244A61K2039/552C07K2317/24C07K2317/33C07K2317/34C07K2317/52C07K2317/56C07K2317/565C07K2317/76C07K2317/92C07K2317/94
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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.
Claims (39)
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.
Assignments (2)
MERGER AND CHANGE OF NAME
Recorded Oct 2, 2023
From: KINDRED BIOSCIENCES, INC.; ELANCO US INC.
To: ELANCO US INC.
Reel/Frame 065091/0055 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded May 4, 2023
From: LI, SHYR JIANN; NGUYEN, LAM; ZHAN, HANGJUN
To: KINDRED BIOSCIENCES, INC.
Reel/Frame 063528/0936 →
Continuity (3)
Continuation
16488045
Provisional Application
62463543
· Feb 24, 2017
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