# US 10,370,423 B2 · Claudin-6-specific immunoreceptors and T cell epitopes

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 10,370,423 B2
- Document ID: US10370423B2
- Status: Granted
- Kind: B2
- Application number: 15/124,640
- Filed: 2015-03-30
- Published: 2017-01-19
- Granted: 2019-08-06
- Earliest claimed: 2014-04-01
- Assignees: Biotech Cell & Gene thrapies GMBH; Tron - Translationale Onkologie Ander Universitata tsmedizin Der Johannes Gutenberg-Universitat Main; Ganymed Pharmceuticals AG
- Applicants: BioNTech Cell & Gene Therapies GmbH; TRON-Translationale Onkologie an der Universitätsmedizin der Johannes Gutenberg-Universität Mainz gemeinnützige GmbH; Universitätsmedizin der Johannes Gutenberg-Universität Mainz; Ganymed Pharmaceuticals AG
- Inventors: Ugur Sahin; Özlem Türeci; Petra Simon; Tana Omokoko; Holger Hoff; Ralf-Holger Voss; Andrea Breitkreuz; Kathleen Hobohm; Karolina Anna Mroz
- Web page: https://patentgrep.com/patent/US10370423B2

## CPC

- C07K 14/4748: {Tumour specific antigens; Tumour rejection antigen precursors [TRAP], e.g. MAGE}
- A61K 40/11: T-cells, e.g. tumour infiltrating lymphocytes [TIL] or regulatory T [Treg] cells; Lymphokine-activated killer [LAK] cells
- A61K 40/31: Chimeric antigen receptors [CAR]
- A61K 40/32: T-cell receptors [TCR]
- A61K 40/4202: {Receptors, cell surface antigens or cell surface determinants}
- A61K 40/428: {Undefined tumor antigens, e.g. tumor lysate or antigens targeted by cells isolated from tumor}
- A61P 35/00: Antineoplastic agents
- A61P 37/04: Immunostimulants
- C07K 14/7051: {T-cell receptor (TcR)-CD3 complex}
- C07K 14/70521: {CD28, CD152}
- C07K 14/70539: {MHC-molecules, e.g. HLA-molecules}
- C07K 16/28: against receptors, cell surface antigens or cell surface determinants
- G01N 33/505: {involving T-cells}
- G01N 33/56972: {White blood cells}
- G01N 33/575: for cancer
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- A61K 2239/31: characterized by the route of administration
- A61K 2239/38: characterised by the dose, timing or administration schedule
- A61K 2239/59: Reproductive system, e.g. uterus, ovaries, cervix or testes
- C07K 2317/56: variable (Fv) region, i.e. VH and/or VL
- C07K 2317/622: Single chain antibody (scFv)
- C07K 2319/02: containing a signal sequence
- C07K 2319/03: containing a transmembrane segment
- C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
- 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
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

The present invention provides Claudin-6-specific immunoreceptors (T cell receptors and artificial T cell receptors (chimeric antigen receptors; CARs)) and T cell epitopes which are useful for immunotherapy.

## Claims

### Claim 1

A method of treating a cancer disease comprising administering a pharmaceutical composition to a patient having claudin-6 (CLDN6)-expressing cancer cells, the pharmaceutical composition comprising a nucleic acid having a nucleic acid sequence encoding an artificial T cell receptor which specifically binds CLDN6 and comprises an amino acid sequence at least 95% identical to SEQ ID NO: 46, wherein the binding domain for CLDN6 comprises the complementarity-determining regions CDR1, CDR2, and CDR3 of the heavy chain variable region according to SEQ ID NO: 32 and the complementarity-determining regions CDR1, CDR2, and CDR3 of the light chain variable region according to SEQ ID NO: 39.

### Claim 2

A method for inducing an immune response in a subject having claudin-6 (CLDN6)-expressing cancer cells, the method comprising administering to the subject a pharmaceutical composition comprising a nucleic acid having a nucleic acid sequence encoding an artificial T cell receptor which specifically binds CLDN6 and comprises an amino acid sequence at least 95% identical to SEQ ID NO: 46, wherein the binding domain for CLDN6 comprises the complementarity-determining regions CDR1, CDR2, and CDR3 of the heavy chain variable region according to SEQ ID NO: 32 and the complementarity-determining regions CDR1, CDR2, and CDR3 of the light chain variable region according to SEQ ID NO: 39.

### Claim 3

A method of killing cancer cells in a subject having CLDN6-expressing cancer cells, comprising the step of providing to the subject a therapeutically effective amount of a nucleic acid having a nucleic acid sequence encoding an artificial T cell receptor which specifically binds CLDN6 and comprises an amino acid sequence at least 95% identical to SEQ ID NO: 46, wherein the binding domain for CLDN6 comprises the complementarity-determining regions CDR1, CDR2, and CDR3 of the heavy chain variable region according to SEQ ID NO: 32 and the complementarity-determining regions CDR1, CDR2, and CDR3 of the light chain variable region according to SEQ ID NO: 39.

### Claim 4

A method of killing cancer cells in a subject having CLDN6-expressing cancer cells, comprising the step of providing to the subject a therapeutically effective amount of a cell comprising a nucleic acid having a nucleic acid sequence encoding an artificial T cell receptor which specifically binds CLDN6 and comprises an amino acid sequence at least 95% identical to SEQ ID NO: 46, wherein the binding domain for CLDN6 comprises the complementarity-determining regions CDR1, CDR2, and CDR3 of the heavy chain variable region according to SEQ ID NO: 32 and the complementarity-determining regions CDR1, CDR2, and CDR3 of the light chain variable region according to SEQ ID NO: 39.

### Claim 5

A method of killing cancer cells in a subject having CLDN6-expressing cancer cells, comprising the step of providing to the subject a therapeutically effective amount of an immunoreactive cell obtainable from a method comprising the step of transducing a T cell with a nucleic acid having a nucleic acid sequence encoding an artificial T cell receptor which specifically binds CLDN6 and comprises an amino acid sequence at least 95% identical to SEQ ID NO: 46, wherein the binding domain for CLDN6 comprises the complementarity-determining regions CDR1, CDR2, and CDR3 of the heavy chain variable region according to SEQ ID NO: 32 and the complementarity-determining regions CDR1, CDR2, and CDR3 of the light chain variable region according to SEQ ID NO: 39.

### Claim 6

A method of killing cancer cells in a subject having CLDN6-expressing cancer cells, comprising the step of providing to the subject a therapeutically effective amount of an artificial T cell receptor which specifically binds CLDN6 and comprises an amino acid sequence at least 95% identical to SEQ ID NO: 46, wherein the binding domain for CLDN6 comprises the complementarity-determining regions CDR1, CDR2, and CDR3 of the heavy chain variable region according to SEQ ID NO: 32 and the complementarity-determining regions CDR1, CDR2, and CDR3 of the light chain variable region according to SEQ ID NO: 39.

### Claim 7 (depends on 1, 2, 3, 4, 5, 6)

The method of claim 1, 2, 3, 4, 5 or 6, wherein the artificial T cell receptor comprises a binding domain, said binding domain comprises a heavy chain variable region (VH) and a light chain variable region (VL), and wherein the VH comprises an amino acid sequence of SEQ ID NO: 32 and the VL comprises an amino acid sequence of SEQ ID NO: 39.

### Claim 8 (depends on 1, 2, 3, 4, 5, 6)

The method of claim 1, 2, 3, 4, 5 or 6, wherein the artificial T cell receptor comprises an amino acid sequence of SEQ ID NO: 46.