Anti-CGRP compositions and use thereof

Patent metadata

Field	Value
Publication number	US-10189895-B2
Application number	US-201815892956-A
Country	US
Kind code	B2
Filing date	Feb 9, 2018
Priority date	May 20, 2011
Publication date	Jan 29, 2019
Grant date	Jan 29, 2019

Abstract

The present invention is directed to antibodies and fragments thereof having binding specificity for CGRP. Another embodiment of this invention relates to the antibodies described herein, and binding fragments thereof, comprising the sequences of the VH, VL and CDR polypeptides described herein, and the polynucleotides encoding them. The invention also contemplates conjugates of anti-CGRP antibodies and binding fragments thereof conjugated to one or more functional or detectable moieties. The invention also contemplates methods of making said anti-CGRP antibodies and binding fragments thereof. Embodiments of the invention also pertain to the use of anti-CGRP antibodies, and binding fragments thereof, for the diagnosis, assessment and treatment of diseases and disorders associated with CGRP.

First claim

What is claimed is:

1. A pharmaceutical composition comprising a humanized anti-calcitonin gene related peptide (CGRP) antibody comprising a variable light (V L ) chain polypeptide comprising the complementarity-determining region (CDR) polypeptides CDR1, CDR2, and CDR3, respectively, of SEQ ID NO: 55, SEQ ID NO: 56 and SEQ ID NO: 57, and a variable heavy (V H ) chain polypeptide comprising the CDR polypeptides CDR1, CDR2, and CDR3, respectively, of SEQ ID NO: 58, SEQ ID NO: 59 and SEQ ID NO: 60, and a pharmaceutically acceptable excipient.

2. The pharmaceutical composition of claim 1 , wherein the humanized anti-CGRP antibody comprises a V L chain polypeptide possessing at least 90% sequence identity to SEQ ID NO: 51 and a V H chain polypeptide possessing at least 90% sequence identity to SEQ ID NO: 53.

3. The pharmaceutical composition of claim 1 , wherein the humanized anti-CGRP antibody comprises a V L chain polypeptide of SEQ ID NO: 51 and a V H chain polypeptide of SEQ ID NO: 53.

4. The pharmaceutical composition of claim 1 , wherein the humanized anti-CGRP antibody comprises a light chain polypeptide of SEQ ID NO:52 and heavy chain polypeptide of SEQ ID NO: 54.

5. The pharmaceutical composition of claim 1 , wherein the humanized anti-CGRP antibody comprises a human IgG1 constant domain.

6. The pharmaceutical composition of claim 1 , wherein the composition is suitable for intravenous administration.

7. The pharmaceutical composition of claim 2 , wherein the composition is suitable for intravenous administration.

8. The pharmaceutical composition of claim 3 , wherein the composition is suitable for intravenous administration.

9. The pharmaceutical composition of claim 4 , wherein the composition is suitable for intravenous administration.

10. The pharmaceutical composition of claim 5 , wherein the composition is suitable for intravenous administration.

11. The pharmaceutical composition of claim 1 , wherein the composition is suitable for subcutaneous administration.

12. The pharmaceutical composition of claim 2 , wherein the composition is suitable for subcutaneous administration.

13. The pharmaceutical composition of claim 3 , wherein the composition is suitable for subcutaneous administration.

14. The pharmaceutical composition of claim 4 , wherein the composition is suitable for subcutaneous administration.

15. The pharmaceutical composition of claim 5 , wherein the composition is suitable for subcutaneous administration.

16. The pharmaceutical composition of claim 1 , wherein the composition is an aqueous solution.

17. The pharmaceutical composition of claim 2 , wherein the composition is an aqueous solution.

18. The pharmaceutical composition of claim 3 , wherein the composition is an aqueous solution.

19. The pharmaceutical composition of claim 4 , wherein the composition is an aqueous solution.

20. The pharmaceutical composition of claim 5 , wherein the composition is an aqueous solution.

21. The pharmaceutical composition of claim 1 , wherein the composition is in lyophilized form.

22. The pharmaceutical composition of claim 2 , wherein the composition is in lyophilized form.

23. The pharmaceutical composition of claim 3 , wherein the composition is in lyophilized form.

24. The pharmaceutical composition of claim 4 , wherein the composition is in lyophilized form.

25. The pharmaceutical composition of claim 5 , wherein the composition is in lyophilized form.

26. The pharmaceutical composition of claim 1 , wherein the humanized anti-CGRP antibody is directly or indirectly attached to a detectable label or a therapeutic agent.

27. The pharmaceutical composition of claim 1 , wherein the humanized anti-CGRP antibody further comprises an effector moiety that is a detectable moiety or a functional moiety, wherein said detectable moiety is optionally a fluorescent dye, an enzyme, a substrate, a bioluminescent material, a radioactive material, or a chemiluminescent material and said functional moiety optionally is streptavidin, avidin, biotin, a cytotoxin, a cytotoxic agent, or a radioactive material.

28. The pharmaceutical composition of claim 1 , which further comprises another therapeutic agent selected from an analgesic, an anti-histamine, an anti-inflammatory agent, an antibiotic, a chemotherapeutic, an immunosuppressant, a cytokine, an anti-proliferative, an antiemetic or a cytotoxin.

29. The pharmaceutical composition of claim 1 , which further comprises a stabilizer.

Assignees

• Alderbio Holdings Llc

Inventors

• Kovacevich Brian Robert
• Garcia-Martinez Leon F
• Anderson Katie Olson
• Dutzar Benjamin H
• Billgren Jens J
• Latham John A
• Mitchell Danielle M
• Mcneill Patricia Dianne
• Janson Nicole M
• Loomis Maria-Cristina

Classifications

• A61P25/00

  Drugs for disorders of the nervous system · CPC title

• C07K2317/565

  Complementarity determining region [CDR] · CPC title

• C07K16/26 Primary

  against hormones {; against hormone releasing or inhibiting factors} · CPC title

• A61K2039/505

  comprising antibodies · CPC title

• C07K2317/56

  variable (Fv) region, i.e. VH and/or VL · CPC title