# US 12,760,093 B2 · CLDN18.2 antibody and use thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,760,093 B2 - Document ID: US12760093B2 - Status: Granted - Kind: B2 - Application number: 17/798,863 - Filed: 2021-02-10 - Published: 2023-10-05 - Granted: 2026-10-13 - Earliest claimed: 2020-02-10 - Assignees: Shanghai Escugen Biotechnology Co., Ltd. - Applicants: Shanghai Escugen Biotechnology Co., Ltd. - Inventors: Qing Zhou; Chuanying Xu; Weihong Nian; Xiangyu He; Xinmin Zhang; Xintong Zheng; Feng He; Jing Xiao - Web page: https://patentgrep.com/patent/US12760093B2 ## CPC - C07K 16/28: against receptors, cell surface antigens or cell surface determinants - A61P 35/00: Antineoplastic agents - C12N 15/63: Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression - C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered - C07K 2317/31: multispecific - C07K 2317/565: Complementarity determining region [CDR] - 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) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00) ## Abstract Provided are an antibody against claudin 18.2 (CLDN18.2) and a use thereof in diagnosing and treating cancer of the stomach, pancreas and esophagus. ## Claims ### Claim 1 A CLDN18.2 monoclonal antibody comprising heavy chain CDRs and light chain CDRs, wherein the heavy chain CDRs comprise: CDR1 having the sequence of SEQ ID NO:18, CDR2 having the sequence of SEQ ID NO:19, and CDR3 having the sequence of SEQ ID NO:20, and wherein the light chain CDRs comprise: CDR1 having the sequence of SEQ ID NO:24, CDR2 having the sequence of SEQ ID NO:25, and CDR3 having the sequence of SEQ ID NO:26; or wherein the heavy chain CDRs comprise: CDR1 having the sequence of SEQ ID NO:21, CDR2 having the sequence of SEQ ID NO:22, and CDR3 having the sequence of SEQ ID NO:23, and wherein the light chain CDRs comprise: CDR1 having the sequence of SEQ ID NO:27, CDR2 having the sequence of SEQ ID NO:28, and CDR3 having the sequence of SEQ ID NO:29; wherein the CDRs are numbered according to Chothia system. ### Claim 2 (depends on 1) The CLDN18.2 monoclonal antibody of claim 1, comprising the heavy chain variable region having the sequence of SEQ ID NO:36 and the light chain variable region having the sequence of SEQ ID NO:38. ### Claim 3 (depends on 1) The CLDN18.2 monoclonal antibody of claim 1, comprising a heavy chain variable region as shown in SEQ ID NO:37 and a light chain variable region as shown in SEQ ID NO: 39. ### Claim 4 (depends on 1) The CLDN18.2 monoclonal antibody of claim 1, which is a chimeric antibody or a humanized antibody. ### Claim 5 (depends on 1) The CLDN18.2 monoclonal antibody of claim 1, which is an IgG antibody. ### Claim 6 (depends on 5) The CLDN18.2 monoclonal antibody of claim 5, which is Fab, Fab′-SH, Fv, scFv or (Fab′)2. ### Claim 7 (depends on 1) The CLDN18.2 monoclonal antibody of claim 1, which is a multispecific antibody or a bispecific antibody. ### Claim 8 (depends on 7) The CLDN18.2 monoclonal antibody of claim 7, wherein the multispecific or bispecific antibody comprises a binding domain that binds to a second biomolecule, wherein the second biomolecule is a cell surface antigen. ### Claim 9 (depends on 8) The CLDN18.2 monoclonal antibody of claim 8, wherein the cell surface antigen is a tumor antigen. ### Claim 10 (depends on 9) The CLDN18.2 monoclonal antibody of claim 9, wherein the tumor antigen is selected from the group consisting of: CD3, CD20, FcRH5, HER2, LYPD1, LY6G6D, PMEL17, LY6E, CD19, CD33, CD22, CD79A, CD79B, EDAR, GFRA1, MRP4, RET, Steap1 and TenB2. ### Claim 11 (depends on 1) An immunoconjugate, comprising a therapeutic agent, an agonist of stimulator of interferon genes (STING) receptor, a cytokine, a radionuclide or an enzyme linked to the CLDN18.2 monoclonal antibody of claim 1. ### Claim 12 (depends on 11) The immunoconjugate of claim 11, wherein the therapeutic agent is a chemotherapeutic drug or a cytotoxic agent. ### Claim 13 (depends on 1) A fusion protein or polypeptide comprising the CLDN18.2 monoclonal antibody of claim 1 or an antigen-binding fragment thereof. ### Claim 14 (depends on 1) A pharmaceutical composition comprising the CLDN18.2 monoclonal antibody of claim 1. ### Claim 15 (depends on 1) A cancer detection reagent comprising the CLDN18.2 monoclonal antibody of claim 1 or an antigen-binding fragment thereof. ### Claim 16 (depends on 15) The cancer detection reagent of claim 15, wherein the CLDN18.2 monoclonal antibody or antigen-binding fragment thereof is chemically labeled. ### Claim 17 (depends on 16) The cancer detection reagent of claim 16, wherein the label is an enzymatic label, a fluorescent label, an isotopic label or a chemiluminescent label. ### Claim 18 (depends on 15) A cancer diagnosis kit comprising the cancer detection reagent of claim 15, wherein the cancer is a CLDN18.2-related cancer. ### Claim 19 (depends on 18) The kit of claim 18, wherein the cancer is a gastric cancer, a pancreatic cancer or an esophageal cancer.