# US 2023/0406902 A1 · Peptide mimotopes of claudin 18.2 and uses thereof

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

- Number: US 2023/0406902 A1
- Document ID: US20230406902A1
- Status: Published application
- Kind: A1
- Application number: 18/316,893
- Filed: 2023-05-12
- Published: 2023-12-21
- Earliest claimed: 2016-07-25
- Assignees: BioNTech SE; TRON—Translationale Onkologie an der Universitätsmedizin der Johannes Gutenberg-Universität Mainz; JPT Peptide Technologies GmbH
- Applicants: BioNTech SE; Tron-Translationale Onkologie an der Universitätsmedizin der Johannes Gutenberg-Universität Mainz; JPT Peptide Technologies GmbH
- Inventors: Ugur Sahin; Matin Daneschdar; Hans-Ulrich Schmoldt; Laura-Marie Kring (née Plum); Markus Fiedler; Ulf Reimer; Karsten Schnatbaum
- Web page: https://patentgrep.com/patent/US20230406902A1

## CPC

- C07K 14/705: Receptors; Cell surface antigens; Cell surface determinants {(tumour specific antigens C07K14/4748)}
- A61K 38/08: Peptides having 5 to 11 amino acids {(A61K38/043 - A61K38/046 take precedence)}
- A61K 38/12: Cyclic peptides {, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C (A61K38/043 - A61K38/046 take precedence)}
- A61K 39/0005: {Vertebrate antigens (from snakes A61K39/38)}
- C07K 7/64: Cyclic peptides containing only normal peptide links
- G01N 33/5308: {for analytes not provided for elsewhere, e.g. nucleic acids, uric acid, worms, mites}
- G01N 33/5759: {involving compounds localised on the membrane of tumour or cancer cells}
- G01N 2333/705: Assays involving receptors, cell surface antigens or cell surface determinants
- G01N 2500/02: Screening involving studying the effect of compounds C on the interaction between interacting molecules A and B (e.g. A = enzyme and B = substrate for A, or A = receptor and B = ligand for the receptor)
- G01N 2500/04: Screening involving studying the effect of compounds C directly on molecule A (e.g. C are potential ligands for a receptor A, or potential substrates for an enzyme A)
- 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)
- 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 molecules that mimic antigenic determinants of the integral transmembrane protein claudin 18.2 (CLDN18.2). These molecules compete with CLDN18.2 for binding to a CLDN18.2 binding domain, e.g. a CLDN18.2 binding domain of an antibody, and are capable of detecting antibodies against CLDN18.2. The mimotopes of the invention may be used to generate or inhibit immune responses in animals and preferably humans. Furthermore, they can be used for purposes of detecting agents comprising a CLDN18.2 binding domain in biological samples as well as for purifying agents comprising a CLDN18.2 binding domain.

## Claims

### Claim at position 1

1-63. (canceled)

### Claim 64

A method for treating a patient affected from a cancer characterized by cancer cells expressing CLDN18.2 comprising a step of administering to the patient a cell comprising a chimeric antigen receptor (CAR), the CAR comprising a single-chain variable fragment (scFV) fused to a CD3-zeta transmembrane and endodomain,
wherein said scFV comprises a heavy chain variable region (VH) and a light chain variable region (VL), each comprising a set of three complementarity-determining regions (CDR1, CDR2, and CDR3),
wherein the VH CDR1, CDR2, and CDR3 have the amino acid sequences of positions 45-52, positions 70-77, and positions 116-126 of SEQ ID NO: 12, respectively, and
wherein the VL CDR1, CDR2, and CDR3 have the amino acid sequences of positions 47-58, positions 76-78, and positions 115-123 of SEQ ID NO: 13, respectively.

### Claim 65

(canceled)

### Claim 66

(canceled)

### Claim 67

(canceled)

### Claim 68 (depends on 64)

The method of claim 64, wherein the cell is an immune effector cell.

### Claim 69 (depends on 64)

The method of claim 64, wherein the cell is a T cell.

### Claim 70 (depends on 64)

The method of claim 64, wherein the VH comprises an amino acid sequence represented by SEQ ID NO: 2 and the VL comprises an amino acid sequence represented by SEQ ID NO: 3.

### Claim 71 (depends on 70)

The method of claim 70, wherein the scFV further comprises a peptide linker connecting the VH and VL, wherein the peptide linker comprises the amino acid sequence (GGGGS)3, VE(GGSGGS)2GGVD, (GGGGS)4, (GGGGS)5, or GGGGS(GGS)3GGGS.

### Claim 72 (depends on 71)

The method of claim 71, wherein the cell is an immune effector cell.

### Claim 73 (depends on 71)

The method of claim 71, wherein the cell is a T cell.

### Claim 74 (depends on 64)

The method of claim 64, wherein the cancer comprises a primary tumor.

### Claim 75 (depends on 64)

The method of claim 64, wherein the cancer is gastric cancer, esophageal cancer, pancreatic cancer, lung cancer, ovarian cancer, colon cancer, hepatic cancer, head-neck cancer, or cancers of the gallbladder

### Claim 76 (depends on 64)

The method of claim 64, wherein the chimeric antigen receptor is expressed on the surface of the cell.

### Claim 77 (depends on 64)

The method of claim 64, wherein the CD3-zeta endodomain transmits an activation signal in response to recognition by the scFv of claudin 18.2 (CLDN18.2) on a target cell and the T cell mediates killing of the target cell that expresses CLDN18.2.

### Claim 78

A method for treating a patient affected from a cancer characterized by cancer cells expressing CLDN18.2 comprising a step of administering to the patient an immune effector cell comprising a chimeric antigen receptor (CAR), the CAR comprising a single-chain variable fragment (scFV) fused to a CD3-zeta transmembrane and endodomain,
wherein said scFV comprises a heavy chain variable region (VH) and a light chain variable region (VL), each comprising a set of three complementarity-determining regions (CDR1, CDR2, and CDR3),
wherein the VH CDR1, CDR2, and CDR3 have the amino acid sequences of positions 45-52, positions 70-77, and positions 116-126 of SEQ ID NO: 12, respectively, and
wherein the VL CDR1, CDR2, and CDR3 have the amino acid sequences of positions 47-58, positions 76-78, and positions 115-123 of SEQ ID NO: 13, respectively; and
wherein the CAR is expressed on the cell surface of said immune effector cell.

### Claim 79 (depends on 78)

The method of claim 78, wherein the VH comprises an amino acid sequence represented by SEQ ID NO: 2 and the VL comprises an amino acid sequence represented by SEQ ID NO: 3.

### Claim 80 (depends on 79)

The method of claim 79, wherein the scFV further comprises a peptide linker connecting the VH and VL, wherein the peptide linker comprises the amino acid sequence (GGGGS)3, VE(GGSGGS)2GGVD, (GGGGS)4, (GGGGS)5, or GGGGS(GGS)3GGGS.

### Claim 81 (depends on 78)

The method of claim 78, wherein the immune effector cell is a T cell.

### Claim 82 (depends on 78)

The method of claim 78, wherein the cancer comprises a primary tumor.

### Claim 83 (depends on 78)

The method of claim 78, wherein the cancer is gastric cancer, esophageal cancer, pancreatic cancer, lung cancer, ovarian cancer, colon cancer, hepatic cancer, head-neck cancer, or cancers of the gallbladder.

### Claim 84 (depends on 78)

The method of claim 78, wherein the CD3-zeta endodomain transmits an activation signal in response to recognition by the scFv of claudin 18.2 (CLDN18.2) on a target cell and the T cell mediates killing of the target cell that expresses CLDN18.2.