Anti-CGRP compositions and use thereof

Patent metadata

Field	Value
Publication number	US-11111289-B2
Application number	US-201916248284-A
Country	US
Kind code	B2
Filing date	Jan 15, 2019
Priority date	May 20, 2011
Publication date	Sep 7, 2021
Grant date	Sep 7, 2021

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 V H , V L 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 method of making Pichia pastoris or a CHO cell cultures which express an anti-CGRP antibody or antibody fragment, wherein said anti-CGRP antibody or antibody fragment comprises a variable light chain comprising CDRs comprising the amino acid sequences of SEQ ID NO: 55, 56 and 57 and a variable heavy chain comprising CDRs comprising the amino acid sequences of SEQ ID NO: 58, 59 and 60; comprising:
(i) introducing at least one expression vector containing one or more heterologous polynucleotides encoding said antibody or antibody fragment operably linked to a promoter and a signal sequence into one or more Pichia pastoris or CHO cells;
(ii) culturing said Pichia pastoris or a CHO cells; and
(iii) selecting Pichia pastoris or CHO cell cultures that express said antibody.

2. The method of claim 1 , wherein the antibody or antibody fragment is humanized.

3. The method of claim 1 , wherein the antibody or antibody fragment is in a form selected from the group consisting of (i) is aglycosylated, (ii) is glycosylated, wherein the glycosylation consists of only contains only mannose residues and (iii) is not N-glycosylated.

4. The method of claim 1 , wherein the antibody or antibody fragment contains an Fc region that has been modified to alter effector function, half-life, proteolysis, and/or glycosylation.

5. The method of claim 1 , wherein the antibody or antibody fragment contains a human IgG1, IgG2, IgG3 or IgG4 Fc region that has been modified to alter effector function, half-life, proteolysis, and/or glycosylation.

6. The method of claim 1 , wherein said heterologous polynucleotide comprises a sequence encoding the polypeptides contained in SEQ ID NO:51 and SEQ ID NO:53.

7. The method of claim 6 , wherein said anti-CGRP antibody or antibody fragment is secreted into the culture medium.

8. The method of claim 1 which comprises making Pichia pastoris cell cultures which produce said anti-CGRP antibody or antibody fragment.

9. The method of claim 8 , wherein the Pichia pastoris cell cultures are polyploid.

10. The method of claim 8 , wherein the Pichia pastoris cell cultures are diploid.

11. The method of claim 1 which comprises making CHO cell cultures which produce said anti-CGRP antibody or antibody fragment.

12. The method of claim 11 , wherein said anti-CGRP antibody or antibody fragment is secreted into the culture medium.

13. The method of claim 1 , wherein said anti-CGRP antibody or antibody fragment is secreted into the culture medium.

14. The method of claim 13 , wherein said anti-CGRP antibody or antibody fragment is secreted into the culture medium.

15. The method of claim 1 , wherein the antibody or antibody fragment contains a human IgG1 Fc region that has been modified to alter effector function, half-life, proteolysis, and/or glycosylation.

16. The method of claim 15 , wherein the antibody comprises the IgG2 light and heavy chain constant regions respectively comprised in the light chain of SEQ ID NO: 52 and the heavy chain of SEQ ID NO: 54.

Assignees

• H Lundbeck As

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

• C07K16/28 Primary

  against receptors, cell surface antigens or cell surface determinants · CPC title

• A61K39/395

  Antibodies (agglutinins A61K38/36 {; as drug carriers A61K47/50}); Immunoglobulins; Immune serum, e.g. antilymphocytic serum · CPC title

• A61P35/00

  Antineoplastic agents · CPC title

• C07K16/26 Primary

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

• C12N15/11

  DNA or RNA fragments; Modified forms thereof (DNA or RNA not used in recombinant technology, C07H21/00); {Non-coding nucleic acids having a biological activity} · CPC title