# US 11,111,289 B2 · Anti-CGRP compositions and use thereof

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- Number: US 11,111,289 B2
- Document ID: US11111289B2
- Status: Granted
- Kind: B2
- Application number: 16/248,284
- Filed: 2019-01-15
- Published: 2019-07-11
- Granted: 2021-09-07
- Earliest claimed: 2011-05-20
- Assignees: H. Lundbeck A/S
- Applicants: H. Lundbeck A/S
- Inventors: Brian Robert Kovacevich; Leon F. Garcia-Martinez; Katie Olson Anderson; Benjamin H. Dutzar; Jens J. Billgren; John A. Latham; Danielle M. Mitchell; Patricia Dianne McNeill; Nicole M. Janson; Maria-Cristina Loomis
- Web page: https://patentgrep.com/patent/US11111289B2

## CPC

- C07K 16/18: against material from animals or humans
- A61K 31/485: Morphinan derivatives, e.g. morphine, codeine
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61K 49/00: Preparations for testing in vivo
- A61P 25/00: Drugs for disorders of the nervous system
- C07K 16/26: against hormones {; against hormone releasing or inhibiting factors}
- A61K 2039/505: {comprising antibodies}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/52: Constant or Fc region; Isotype
- C07K 2317/55: Fab or Fab'
- C07K 2317/56: variable (Fv) region, i.e. VH and/or VL
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/567: Framework region [FR]
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## 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.

## Claims

### Claim 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.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 1)

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.

### Claim 4 (depends on 1)

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.

### Claim 5 (depends on 1)

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.

### Claim 6 (depends on 1)

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.

### Claim 7 (depends on 6)

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

### Claim 8 (depends on 1)

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

### Claim 9 (depends on 8)

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

### Claim 10 (depends on 8)

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

### Claim 11 (depends on 1)

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

### Claim 12 (depends on 11)

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

### Claim 13 (depends on 1)

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

### Claim 14 (depends on 13)

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

### Claim 15 (depends on 1)

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.

### Claim 16 (depends on 15)

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.