# US 2016/0355604 A1 · Cancer therapy using cldn6 target-directed antibodies in vivo

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- Number: US 2016/0355604 A1
- Document ID: US20160355604A1
- Status: Published application
- Kind: A1
- Application number: 15/206,039
- Filed: 2016-07-08
- Published: 2016-12-08
- Earliest claimed: 2010-07-06
- Assignees: Ganymed Pharmaceuticals AG; Johannes Gutenberg-Universitat Mainz
- Applicants: Ganymed Pharmaceuticals AG; Johannes Gutenberg-Universitat Mainz
- Inventors: Ugur Sahin; Ozlem Tureci; Michael Koslowski; Korden Walter; Maria Kreuzberg; Sylvia Luxen
- Web page: https://patentgrep.com/patent/US20160355604A1

## CPC

- A61P 35/00: Antineoplastic agents
- C07K 16/30: from tumour cells
- C07K 16/28: against receptors, cell surface antigens or cell surface determinants
- C07K 16/3015: {Breast}
- C07K 16/3023: {Lung}
- C07K 16/3038: {Kidney, bladder}
- C07K 16/3046: {Stomach, Intestines}
- C07K 16/3053: {Skin, nerves, brain}
- C07K 16/3069: {Reproductive system, e.g. ovaria, uterus, testes, prostate}
- A61K 2039/505: {comprising antibodies}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/732: Antibody-dependent cellular cytotoxicity [ADCC]
- C07K 2317/734: Complement-dependent cytotoxicity [CDC]
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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 invention relates to the treatment and/or prevention of tumor diseases associated with cells expressing CLDN6, in particular cancer and cancer metastasis using antibodies which bind to CLDN6. The present application demonstrates that the binding of antibodies to CLDN6 on the surface of tumor cells is sufficient to inhibit growth of the tumor and to prolong survival and extend the lifespan of tumor patients. Furthermore, binding of antibodies to CLDN6 is efficient in inhibiting growth of CLDN6 positive germ cell tumors such as teratocarcinomas or embryonal carcinomas, in particular germ cell tumors of the testis.

## Claims

### Claim at position 1

1-20. (canceled)

### Claim 21

An anti-claudin 6 (CLDN6) antibody selected from the group consisting of
(i) an antibody produced by a hybridoma deposited under the accession no. DSM ACC3059 (GT512muMAB 36A), DSM ACC3058 (GT512muMAB 27A), or DSM ACC3057 (GT512muMAB 5F2D2),
(ii) a humanized or chimerized form of said antibody,
(iii) an antigen binding fragment of said antibody, and
(iv) a synthetic form of said antibody;
wherein the antibody or fragment of (i), (ii), (iii), and (iv) is capable of binding to CLDN6 having the amino acid sequence of SEQ ID NO: 2 or SEQ ID NO: 6, or having the amino acid sequence encoded by SEQ ID NO: 1; and
wherein the antibody or fragment of (i), (ii), (iii), and (iv), without an attached therapeutic effector moiety, when administered to a patient having a tumor characterized by tumor cells expressing CLDN6 inhibits growth of the tumor by binding to CLDN6.

### Claim 22 (depends on 21)

The antibody of claim 21, wherein the antibody is specific for CLDN6.

### Claim 23 (depends on 21)

A pharmaceutical composition comprising the antibody of claim 21 and a pharmaceutically acceptable carrier.

### Claim 24 (depends on 21)

The antibody of claim 21, wherein the tumor is selected from the group consisting of ovarian cancer, ovarian adenocarcinoma, ovarian teratocarcinoma, lung cancer, small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), squamous cell lung carcinoma, adenocarcinoma, gastric cancer, breast cancer, hepatic cancer, pancreatic cancer, skin cancer, basal cell carcinoma, squamous cell carcinoma, malignant melanoma, head and neck cancer, malignant pleomorphic adenoma, sarcoma, synovial sarcoma, carcinosarcoma, bile duct cancer, cancer of the urinary bladder, transitional cell carcinoma, papillary carcinoma, kidney cancer, renal cell carcinoma, clear cell renal cell carcinoma, papillary renal cell carcinoma, colon cancer, small bowel cancer, cancer of the ileum, small bowel adenocarcinoma, adenocarcinoma of the ileum, testicular embryonal carcinoma, placental choriocarcinoma, cervical cancer, testicular cancer, testicular seminoma, testicular teratoma, embryonic testicular cancer, uterine cancer, a germ cell tumor disease, a teratocarcinoma, an embryonal carcinoma, and the metastatic forms thereof.

### Claim 25 (depends on 21)

The antibody of claim 21, wherein the tumor is a germ cell tumor of the testis.

### Claim 26

An anti-claudin 6 (CLDN6) antibody selected from the group consisting of
(i) an antibody produced by a hybridoma deposited under the accession no. DSM ACC3059 (GT512muMAB 36A), DSM ACC3058 (GT512muMAB 27A), or DSM ACC3057 (GT512muMAB 5F2D2),
(ii) a humanized or chimerized form of said antibody,
(iii) an antigen binding fragment of said antibody, and
(iv) a synthetic form of said antibody;
wherein the antibody or fragment of (i), (ii), (iii), and (iv) is capable of binding to CLDN6 and binds to an epitope within SEQ ID NO: 2 or SEQ ID NO: 6, or to an epitope within SEQ ID NO: 3 and/or SEQ ID NO: 5, or to an epitope within an amino acid sequence encoded by SEQ ID NO: 1; and wherein the antibody or fragment of (i), (ii), (iii), and (iv), without an attached therapeutic effector moiety, when administered to a patient having a tumor characterized by tumor cells expressing CLDN6 inhibits growth of the tumor by binding to CLDN6.

### Claim 27 (depends on 21)

An antibody which binds to the same epitope as the antibody of claim 21.

### Claim 28 (depends on 26)

A pharmaceutical composition comprising the antibody of claim 26 and a pharmaceutically acceptable carrier.

### Claim 29

An anti-claudin 6 antibody selected from the group consisting of:
(i) an antibody produced by a hybridoma deposited under the accession no. DSM ACC3059 (GT512muMAB 36A), DSM ACC3058 (GT512muMAB 27A), or DSM ACC3057 (GT512muMAB 5F2D2);
(ii) a humanized or chimerized form of the antibody under (i); and
(iii) an antigen binding fragment of the antibody under (i) or (ii).

### Claim 30 (depends on 29)

The antibody of claim 29, wherein the antibody is a monoclonal antibody.

### Claim 31 (depends on 29)

The antibody of claim 29, wherein the antibody is a chimerized form of the antibody produced by a hybridoma deposited under the accession no. DSM ACC3059 (GT512muMAB 36A).

### Claim 32 (depends on 29)

The antibody of claim 29, wherein the antibody is a chimerized form of the antibody produced by a hybridoma deposited under the accession no. DSM ACC3058 (GT512muMAB 27A).

### Claim 33 (depends on 29)

The antibody of claim 29, wherein the antibody is a chimerized form of the antibody produced by a hybridoma deposited under the accession no. DSM ACC3057 (GT512muMAB 5F2D2).

### Claim 34 (depends on 29)

The antibody of claim 29, wherein the antibody is a humanized form of the antibody produced by a hybridoma deposited under the accession no. DSM ACC3059 (GT512muMAB 36A).

### Claim 35 (depends on 29)

The antibody of claim 29, wherein the antibody is a humanized form of the antibody produced by a hybridoma deposited under the accession no. DSM ACC3058 (GT512muMAB 27A).

### Claim 36 (depends on 29)

The antibody of claim 29, wherein the antibody is a humanized form of the antibody produced by a hybridoma deposited under the accession no. DSM ACC3057 (GT512muMAB 5F2D2).

### Claim 37 (depends on 29)

The antibody of claim 29, wherein the antibody is attached to at least one therapeutic effector moiety.

### Claim 38 (depends on 37)

The antibody of claim 37, wherein the therapeutic effector moiety is a radiolabel, cytotoxin or cytotoxic enzyme.

### Claim 39 (depends on 29)

A pharmaceutical composition comprising the anti-claudin 6 antibody of claim 29 and a pharmaceutically acceptable carrier.