# US 12,180,276 B2 · Antibodies and antibody-drug conjugates targeting claudin 6

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- Number: US 12,180,276 B2
- Document ID: US12180276B2
- Status: Granted
- Kind: B2
- Application number: 18/656,234
- Filed: 2024-05-06
- Published: 2024-09-26
- Granted: 2024-12-31
- Earliest claimed: 2023-02-07
- Assignees: LaNova Medicines Limited Company
- Applicants: Lanova Medicines Limited
- Inventors: Runsheng Li; Wentao Huang; Ying Qin Zang; Zhifang Liu
- Web page: https://patentgrep.com/patent/US12180276B2

## CPC

- C07K 16/28: against receptors, cell surface antigens or cell surface determinants
- A61K 47/6803: {Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates}
- A61K 47/68031: {the drug being an auristatin}
- A61K 47/68037: {the drug being a camptothecin [CPT] or derivatives}
- A61K 47/6849: {the antibody targeting a receptor, a cell surface antigen or a cell surface determinant}
- A61K 47/6851: {the antibody targeting a determinant of a tumour cell}
- A61K 47/6877: {the antibody being an immunoglobulin containing regions, domains or residues from different species}
- A61K 47/6889: {Conjugates wherein the antibody being the modifying agent and wherein the linker, binder or spacer confers particular properties to the conjugates, e.g. peptidic enzyme-labile linkers or acid-labile linkers, providing for an acid-labile immuno conjugate wherein the drug may be released from its antibody conjugated part in an acidic, e.g. tumoural or environment}
- A61P 35/00: Antineoplastic agents
- A61K 2039/505: {comprising antibodies}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/52: Constant or Fc region; Isotype
- C07K 2317/56: variable (Fv) region, i.e. VH and/or VL
- C07K 2317/732: Antibody-dependent cellular cytotoxicity [ADCC]
- C07K 2317/77: Internalization into the cell
- 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

Provided are antibodies and fragments thereof having binding specificity to the claudin 6 (CLDN6) protein as well as their derivatives and uses.

## Claims

### Claim 1

An antibody or antigen-binding fragment thereof that has binding specificity to the human Claudin 6 (CLDN6) protein, wherein the antibody or the fragment thereof comprises a heavy chain variable region (VH) comprising heavy chain complementarity determining regions (CDR) VH CDR1, VH CDR2, and VH CDR3, and a light chain variable region (VL) comprising VL CDR1, VL CDR2, and VL CDR3, and wherein the VH CDR1, VH CDR2, VH CDR3, VL CDR1, VL CDR2, and VL CDR3, respectively, comprise:
(a) the amino acid sequences of SEQ ID NO:19, 73, 21, 22, 23 and 24;
(b) the amino acid sequences of SEQ ID NO:19-24;
(c) the amino acid sequences of SEQ ID NO:25-30;
(d) the amino acid sequences of SEQ ID NO:31-36;
(e) the amino acid sequences of SEQ ID NO:37-42;
(f) the amino acid sequences of SEQ ID NO:43-48;
(g) the amino acid sequences of SEQ ID NO:49-54;
(h) the amino acid sequences of SEQ ID NO:55-60;
(i) the amino acid sequences of SEQ ID NO:61-66; or
(j) the amino acid sequences of SEQ ID NO:67-72.

### Claim 2 (depends on 1)

The antibody or antigen-binding fragment thereof of claim 1, wherein:
the VH CDR1 comprises the amino acid sequence of SEQ ID NO:19,
the VH CDR2 comprises the amino acid sequence of SEQ ID NO:73,
the VH CDR3 comprises the amino acid sequence of SEQ ID NO:21,
the VL CDR1 comprises the amino acid sequence of SEQ ID NO:22,
the VL CDR2 comprises the amino acid sequence of SEQ ID NO:23, and
the VL CDR3 comprises the amino acid sequence of SEQ ID NO:24.

### Claim 3 (depends on 2)

The antibody or antigen-binding fragment thereof of claim 2, wherein the VH comprises the amino acid sequence of SEQ ID NO:74, 75 or 76, and the VL comprises the amino acid sequence of SEQ ID NO:77, 78, 79, 80 or 81.

### Claim 4 (depends on 2)

The antibody or antigen-binding fragment thereof of claim 2, wherein the VH comprises the amino acid sequence of SEQ ID NO:74, and the VL comprises the amino acid sequence of SEQ ID NO:81.

### Claim 5 (depends on 1)

The antibody or antigen-binding fragment thereof of claim 1, wherein the VH CDR1, VH CDR2, VH CDR3, VL CDR1, VL CDR2, and VL CDR3, respective, comprise the amino acid sequences of SEQ ID NO:19-24.

### Claim 6 (depends on 5)

The antibody or antigen-binding fragment thereof of claim 5, wherein the VH comprises the amino acid sequence of SEQ ID NO:1, and the VL comprises the amino acid sequence of SEQ ID NO:2.

### Claim 7 (depends on 1)

The antibody or antigen-binding fragment thereof of claim 1, wherein the VH CDR1, VH CDR2, VH CDR3, VL CDR1, VL CDR2, and VL CDR3, respective, comprise the amino acid sequences of SEQ ID NO:25-30.

### Claim 8 (depends on 7)

The antibody or antigen-binding fragment thereof of claim 7, wherein the VH comprises the amino acid sequence of SEQ ID NO:3, and the VL comprises the amino acid sequence of SEQ ID NO:4.

### Claim 9 (depends on 1)

The antibody or antigen-binding fragment thereof of claim 1, wherein the VH CDR1, VH CDR2, VH CDR3, VL CDR1, VL CDR2, and VL CDR3, respective, comprise the amino acid sequences of SEQ ID NO:31-36.

### Claim 10 (depends on 9)

The antibody or antigen-binding fragment thereof of claim 9, wherein the VH comprises the amino acid sequence of SEQ ID NO:5, and the VL comprises the amino acid sequence of SEQ ID NO:6.

### Claim 11 (depends on 1)

The antibody or antigen-binding fragment thereof of claim 1, wherein the VH CDR1, VH CDR2, VH CDR3, VL CDR1, VL CDR2, and VL CDR3, respective, comprise the amino acid sequences of SEQ ID NO:37-42.

### Claim 12 (depends on 11)

The antibody or antigen-binding fragment thereof of claim 11, wherein the VH comprises the amino acid sequence of SEQ ID NO:7, and the VL comprises the amino acid sequence of SEQ ID NO:8.

### Claim 13 (depends on 1)

The antibody or antigen-binding fragment thereof of claim 1, wherein the VH CDR1, VH CDR2, VH CDR3, VL CDR1, VL CDR2, and VL CDR3, respective, comprise the amino acid sequences of SEQ ID NO:43-48.

### Claim 14 (depends on 13)

The antibody or antigen-binding fragment thereof of claim 13, wherein the VH comprises the amino acid sequence of SEQ ID NO:9, and the VL comprises the amino acid sequence of SEQ ID NO:10.

### Claim 15 (depends on 1)

The antibody or antigen-binding fragment thereof of claim 1, wherein the VH CDR1, VH CDR2, VH CDR3, VL CDR1, VL CDR2, and VL CDR3, respective, comprise the amino acid sequences of SEQ ID NO:49-54.

### Claim 16 (depends on 15)

The antibody or antigen-binding fragment thereof of claim 15, wherein the VH comprises the amino acid sequence of SEQ ID NO:11, and the VL comprises the amino acid sequence of SEQ ID NO:12.

### Claim 17 (depends on 1)

The antibody or antigen-binding fragment thereof of claim 1, wherein the VH CDR1, VH CDR2, VH CDR3, VL CDR1, VL CDR2, and VL CDR3, respective, comprise the amino acid sequences of SEQ ID NO:55-60.

### Claim 18 (depends on 17)

The antibody or antigen-binding fragment thereof of claim 17, wherein the VH comprises the amino acid sequence of SEQ ID NO:13, and the VL comprises the amino acid sequence of SEQ ID NO:14.

### Claim 19 (depends on 1)

The antibody or antigen-binding fragment thereof of claim 1, wherein the VH CDR1, VH CDR2, VH CDR3, VL CDR1, VL CDR2, and VL CDR3, respective, comprise the amino acid sequences of SEQ ID NO:61-66.

### Claim 20 (depends on 19)

The antibody or antigen-binding fragment thereof of claim 19, wherein the VH comprises the amino acid sequence of SEQ ID NO:15, and the VL comprises the amino acid sequence of SEQ ID NO:16.

### Claim 21 (depends on 1)

The antibody or antigen-binding fragment thereof of claim 1, wherein the VH CDR1, VH CDR2, VH CDR3, VL CDR1, VL CDR2, and VL CDR3, respective, comprise the amino acid sequences of SEQ ID NO:67-72.

### Claim 22 (depends on 21)

The antibody or antigen-binding fragment thereof of claim 21, wherein the VH comprises the amino acid sequence of SEQ ID NO:17, and the VL comprises the amino acid sequence of SEQ ID NO:18.

### Claim 23 (depends on 1)

One or more polynucleotide(s) encoding the antibody or antigen-binding fragment thereof of claim 1.

### Claim 24 (depends on 1)

An antibody-drug conjugate comprising a drug moiety conjugated to the antibody or antigen-binding fragment thereof of claim 1.

### Claim 25 (depends on 24)

The antibody-drug conjugate of claim 24, wherein the drug moiety is selected from the group consisting of eribulin, monomethyl auristatin E (MMAE), monomethyl auristatin F (MMAF), exatecan,

### Claim 26 (depends on 1)

A method of treating cancer in a patient in need thereof, comprising administering to the patient the antibody or antigen-binding fragment thereof of claim 1.