IL-7 binding proteins and their use in medical therapy

12122,828

18/460944

September 05, 2023

Provided herein are interleukin 7 (IL-7) binding proteins, pharmaceutical compositions and their use in the treatment or prevention of a disease or condition.

GlaxoSmithKline Intellectual Property Development Limited (Stevenage, GB)

GlaxoSmithKline Intellectual Property Development Limited (Stevenage, GB)

1. A method for the treatment of an autoimmune and/or inflammatory condition in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of an interleukin 7 (IL-7) binding protein or IL-7 binding fragment thereof comprising: (i) a heavy chain variable region CDR1 comprising the amino acid sequence of SEQ ID NO: 6; (ii) a heavy chain variable region CDR2 comprising the amino acid sequence of SEQ ID NO: 7; (iii) a heavy chain variable region CDR3 comprising the amino acid sequence of SEQ ID NO: 8; (iv) a light chain variable region CDR1 comprising the amino acid sequence of SEQ ID NO: 9; (v) a light chain variable region CDR2 comprising the amino acid sequence of SEQ ID NO: 10; and (vi) a light chain variable region CDR3 comprising the amino acid sequence of SEQ ID NO: 11.

2. The method of claim 1 , wherein the IL-7 binding protein or IL-7 binding fragment thereof comprises a heavy chain variable region having a sequence at least 90% identical to the amino acid sequence of SEQ ID NO: 4 and a light chain variable region having a sequence at least 90% identical to the amino acid sequence of SEQ ID NO: 5.

3. The method of claim 2 , wherein the IL-7 binding protein or IL-7 binding fragment thereof comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 4 and a light chain variable region comprising the amino acid sequence of SEQ ID NO: 5.

4. The method of claim 1 , wherein the IL-7 binding protein or IL-7 binding fragment thereof comprises a heavy chain having a sequence at least 80% identical to the amino acid sequence of SEQ ID NO: 2 and a light chain having a sequence at least 80% identical to the amino acid sequence of SEQ ID NO: 3.

5. The method of claim 4 , wherein the IL-7 binding protein or IL-7 binding fragment thereof comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 2 and a light chain comprising the amino acid sequence of SEQ ID NO: 3.

6. The method of claim 1 , wherein the IL-7 binding protein or IL-7 binding fragment thereof is an antibody.

7. The method of claim 6 , wherein the antibody comprises an IgG1 or IgG4 Fc region.

8. The method of claim 7 , wherein the antibody comprises a human IgG1 heavy chain constant region.

9. The method of claim 8 , wherein the antibody comprises a human IgG1 heavy chain constant region having an alanine residue at position 235 and position 237 according to EU numbering.

10. The method of claim 1 , wherein the autoimmune and/or inflammatory condition is multiple sclerosis, Sjögren's syndrome, rheumatoid arthritis, inflammatory bowel disease, Crohn's disease, ulcerative colitis, systemic lupus erythematosus, or type I diabetes.

11. The method of claim 10 , wherein the multiple sclerosis is clinically isolated syndrome, relapsed remitting, primary progressive or secondary progressive.

12. The method of claim 10 , wherein the autoimmune and/or inflammatory condition is systemic lupus erythematosus.

13. The method of claim 10 , wherein the autoimmune and/or inflammatory condition is inflammatory bowel disease.

14. The method of claim 10 , wherein the autoimmune and/or inflammatory condition is type 1 diabetes.

15. The method of claim 3 , wherein the autoimmune and/or inflammatory condition is multiple sclerosis, Sjögren's syndrome, rheumatoid arthritis, inflammatory bowel disease, Crohn's disease, ulcerative colitis, systemic lupus erythematosus, or type I diabetes.

16. The method of claim 15 , wherein the multiple sclerosis is clinically isolated syndrome, relapsed remitting, primary progressive or secondary progressive.

17. The method of claim 15 , wherein the autoimmune and/or inflammatory condition is systemic lupus erythematosus, inflammatory bowel disease, or type I diabetes.

18. The method of claim 5 , wherein the autoimmune and/or inflammatory condition is multiple sclerosis, Sjögren's syndrome, rheumatoid arthritis, inflammatory bowel disease, Crohn's disease, ulcerative colitis, systemic lupus erythematosus, or type I diabetes.

19. The method of claim 18 , wherein the multiple sclerosis is clinically isolated syndrome, relapsed remitting, primary progressive or secondary progressive.

20. The method of claim 18 , wherein the autoimmune and/or inflammatory condition is systemic lupus erythematosus, inflammatory bowel disease, or type I diabetes.

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