# US 2015/0147342 A1 · Methods for Treating Cancer by Administering an Anti-Ang-2 Antibody

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- Number: US 2015/0147342 A1
- Document ID: US20150147342A1
- Status: Published application
- Kind: A1
- Application number: 14/616,534
- Filed: 2015-02-06
- Published: 2015-05-28
- Earliest claimed: 2009-07-29
- Assignees: Regeneron Pharmaceuticals, Inc.
- Applicants: Regeneron Pharmaceuticals, Inc.
- Inventors: Israel Lowy; Gavin Thurston; Christopher Daly
- Web page: https://patentgrep.com/patent/US20150147342A1

## CPC

- C07K 16/22: against growth factors {; against growth regulators}
- A61K 31/513: having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
- A61K 38/1866: {Vascular endothelial growth factor [VEGF]}
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61K 39/39558: {against tumor tissues, cells, antigens}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 2039/505: {comprising antibodies}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- C07K 2317/21: from primates, e.g. man
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/34: Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
- C07K 2317/565: Complementarity determining region [CDR]
- 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)

## Abstract

The present invention provides antibodies that bind to angiopoietin-2 (Ang-2) and methods of using same. According to certain embodiments of the invention, the antibodies are fully human antibodies that bind to human Ang-2. The antibodies of the invention are useful, inter alia, for the treatment of diseases and disorders associated with one or more Ang-2 biological activities including angiogenesis.

## Claims

### Claim at position 1

1-29. (canceled)

### Claim 30

A method for treating advanced hepatocellular cancer, the method comprising:
(a) selecting a patient with advanced hepatocellular carcinoma wherein the patient is resistant to conventional anti-tumor therapy; and
(b) sequentially administering to the patient in need thereof one or more doses of an antibody or antigen-binding fragment thereof which specifically binds human angiopoietin-2 (hAng-2) but does not substantially bind hAng-1, wherein the antibody or antigen-binding fragment thereof comprises a heavy chain variable region (HCVR) comprising three heavy chain CDRs (HCDR1, HCDR2 and HCDR3) from SEQ ID NO: 18, and a light chain variable region (LCVR) comprising three light chain CDRs (LCDR1, LCDR2 and LCDR3) from SEQ ID NO: 20.

### Claim 31 (depends on 30)

The method of claim 30, wherein:
(a) the HCDR1 comprises SEQ ID NO: 4;
(b) the HCDR2 comprises SEQ ID NO: 6;
(c) the HCDR3 comprises SEQ ID NO: 8;
(d) the LCDR1 comprises SEQ ID NO: 12;
(e) the LCDR2 comprises SEQ ID NO: 14; and
(f) the LCDR3 comprises SEQ ID NO: 16.

### Claim 32 (depends on 30)

The method of claim 30, wherein the HCVR comprises SEQ ID NO: 18.

### Claim 33 (depends on 30)

The method of claim 30, wherein the LCVR comprises SEQ ID NO: 20.

### Claim 34 (depends on 30)

The method of claim 30, wherein the HCVR comprises SEQ ID NO: 18 and the LCVR comprises SEQ ID NO: 20.

### Claim 35 (depends on 30)

The method of claim 30, wherein step (b) comprises administering an initial dose comprising the anti-Ang-2 antibody followed by one or more subsequent doses of the anti-Ang-2 antibody.

### Claim 36 (depends on 35)

The method of claim 35, wherein each subsequent dose is administered 2 weeks after the immediately preceding dose.

### Claim 37 (depends on 30)

The method of claim 30, wherein the one or more doses of the anti-Ang-2 antibody comprises 1-20 mg/kg of patient body weight.

### Claim 38 (depends on 30)

The method of claim 30, wherein the antibody or antigen-binding fragment thereof is administered in combination with a vascular endothelial growth factor (VEGF) antagonist.

### Claim 39 (depends on 38)

The method of claim 38, wherein the VEGF antagonist is selected from the group consisting of an anti-VEGF antibody, a small molecule kinase inhibitor of VEGF receptor and a VEGF-inhibiting fusion protein.