# US 2020/0399357 A1 · Anti-NGF Antibodies for Treatment of Various Disorders

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- Number: US 2020/0399357 A1
- Document ID: US20200399357A1
- Status: Published application
- Kind: A1
- Application number: 16/871,525
- Filed: 2020-05-11
- Published: 2020-12-24
- Earliest claimed: 2001-05-30
- Assignees: Genentech, Inc.
- Applicants: Genentech, Inc.
- Inventors: David L. Shelton
- Web page: https://patentgrep.com/patent/US20200399357A1

## CPC

- C07K 16/22: against growth factors {; against growth regulators}
- A61K 31/573: substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61K 39/39566: {against immunoglobulins, e.g. anti-idiotypic antibodies}
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 11/04: for throat disorders
- A61P 11/06: Antiasthmatics
- A61P 13/10: of the bladder
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 17/06: Antipsoriatics
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/22: for herpes viruses
- A61P 35/02: specific for leukemia
- A61P 37/02: Immunomodulators
- A61P 39/02: Antidotes
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 16/241: {Tumor Necrosis Factors}
- C07K 16/4291: {against IgE}
- C07K 16/468: {Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies}
- A61K 2039/505: {comprising antibodies}
- A61K 2039/507: {Comprising a combination of two or more separate antibodies}
- C07K 2317/21: from primates, e.g. man
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/31: multispecific
- C07K 2317/54: F(ab')2
- C07K 2317/55: Fab or Fab'
- C07K 2317/622: Single chain antibody (scFv)
- C07K 2317/626: Diabody or triabody
- C07K 2317/73: Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- 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 relates generally to methods of using anti-NGF antibodies in the treatment of various NGF-related disorders, including pain, asthma, arthritis and psoriasis. The methods are effective in treating these disorders in a patient without having a significant adverse effect on the immune system of the patient.

## Claims

### Claim 1

A method of controlling an NGF-related disorder in a human patient, comprising administering to said patient an effective amount of an anti-human NGF (anti-hNGF) monoclonal antibody capable of binding hNGF with an affinity in the nanomolar range, and inhibiting the binding of hNGF to human TrkA (hTrkA) in vivo, wherein said antibody has no significant adverse effect on the immune system of said patient.

### Claim 2 (depends on 1)

The method of claim 1 wherein the binding affinity of said antibody to hNGF is about 0.10 to about 0.80 nM.

### Claim 3 (depends on 2)

The method of claim 2 wherein the binding affinity of said antibody to hNGF is about 0.15 to about 0.75 nM.

### Claim 4 (depends on 2)

The method of claim 2 wherein the binding affinity of said antibody to hNGF is about 0.18 to about 0.72 nM.

### Claim 5 (depends on 1)

The method of claim 1 wherein said antibody binds essentially the same hNGF epitope as an antibody selected from the group consisting of MAb 911, MAb 912, and MAb 938.

### Claim 6 (depends on 5)

The method of claim 5 wherein said antibody binds essentially the same hNGF epitope as the antibody MAb 911.

### Claim 7 (depends on 1)

The method of claim 1 wherein said antibody is also able to bind murine NGF (muNGF).

### Claim 8 (depends on 1)

The method of claim 1 wherein said antibody is an antibody fragment.

### Claim 9 (depends on 8)

The method of claim 8 wherein said antibody fragment is selected from the group consisting of Fab, Fab′, F(ab′)2, Fv fragments, diabodies, single-chain antibody molecules, and multispecific antibodies formed from antibody fragments.

### Claim 10 (depends on 9)

The method of claim 9 wherein said single-chain antibody molecule is a single-chain Fv (scFv) molecule.

### Claim 11 (depends on 1)

The method of claim 1 wherein said antibody is a chimeric.

### Claim 12 (depends on 1)

The method of claim 1 wherein said antibody is humanized.

### Claim 13 (depends on 1)

The method of claim 1 wherein said antibody is human.

### Claim 14 (depends on 1)

The method of claim 1 wherein said antibody is a bispecific antibody.

### Claim 15 (depends on 14)

The method of claim 14 wherein said bispecific antibody has an anti-IgE specificity.

### Claim 16 (depends on 1)

The method of claim 1 wherein said NGF-related disorder is other than a disorder associated with the effect of NGF on the neuronal system.

### Claim 17 (depends on 16)

The method of claim 16 wherein said NGF-related disorder is an inflammatory condition.

### Claim 18 (depends on 17)

The method of claim 17 wherein said inflammatory condition is selected from the group consisting of asthma, multiple sclerosis, arthritis, lupus erythematosus, and psoriasis.

### Claim at position 19

-29. (canceled)

### Claim 30

A pharmaceutical composition comprising a chimeric, humanized or human anti-human NGF (anti-hNGF) monoclonal antibody capable of binding hNGF with an affinity in the nanomolar range, and inhibiting the binding of hNGF to human TrkA (hTrkA) in vivo, wherein said antibody has no significant adverse effect on the immune system of a patient, in combination with a pharmaceutically acceptable carrier.

### Claim at position 21

-42. (canceled)

### Claim 43 (depends on 30)

An article of manufacture comprising:
a container;
a pharmaceutical composition of claim 30; and
instructions for using the composition of matter to control an NGF-related disorder in a human patient.

### Claim at position 23

-47. (canceled)