# US 11,078,271 B2 · Anti-claudin-2 monoclonal antibody > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,078,271 B2 - Document ID: US11078271B2 - Status: Granted - Kind: B2 - Application number: 16/473,413 - Filed: 2017-12-25 - Published: 2020-05-07 - Granted: 2021-08-03 - Earliest claimed: 2016-12-28 - Assignees: Osaka University - Applicants: Osaka University; Japan AS Represented By Director General of National Institute of Health Sciences - Inventors: Masuo Kondoh; Kiyohito Yagi; Akihiro Watari; Masayoshi Fukasawa; Minoru Tada; Jun Kunisawa - Web page: https://patentgrep.com/patent/US11078271B2 ## CPC - A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants - C07K 16/28: against receptors, cell surface antigens or cell surface determinants - C07K 16/30: from tumour cells - A61K 2039/505: {comprising antibodies} - C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered - C07K 2317/30: characterized by aspects of specificity or valency - C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity - C07K 2317/732: Antibody-dependent cellular cytotoxicity [ADCC] - C07K 2317/734: Complement-dependent cytotoxicity [CDC] - C07K 2317/75: Agonist effect on antigen - C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding - C07K 2317/77: Internalization into the cell - 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 An object of the present invention is to provide a monoclonal antibody that recognizes an extracellular region of Claudin-2. A monoclonal antibody that specifically binds to an extracellular region of Claudin-2. ## Claims ### Claim 1 A monoclonal antibody that specifically binds to an extracellular region of Claudin-2, the monoclonal antibody comprising: the heavy-chain variable region comprising the amino acid sequence having at least 90% identity with the amino acid sequence of SEQ ID NO: 13 and the light-chain variable region comprising the amino acid sequence having at least 90% identity with the amino acid sequence of SEQ ID NO: 15; and wherein the heavy-chain variable region comprising: heavy-chain CDR1 comprising the amino acid sequence of SEQ ID NO: 1, heavy-chain CDR2 comprising the amino acid sequence of SEQ ID NO: 3, and heavy-chain CDR3 comprising the amino acid sequence of SEQ ID NO: 5; and wherein the light-chain variable region comprising: light-chain CDR1 comprising the amino acid sequence of SEQ ID NO: 7, light-chain CDR2 comprising the amino acid sequence of SEQ ID NO: 9, and light-chain CDR3 comprising the amino acid sequence of SEQ ID NO: 11. ### Claim 2 (depends on 1) The monoclonal antibody according to claim 1, wherein the monoclonal antibody recognizes a three-dimensional structure of the extracellular region of Claudin-2. ### Claim 3 (depends on 1) The monoclonal antibody according to claim 1, wherein the extracellular region is an extracellular region first loop of Claudin-2. ### Claim 4 (depends on 1) The monoclonal antibody according to claim 1, wherein the monoclonal antibody has a structure of Fab, Fab′, (Fab′)2, Fv, scFv, or a combination thereof. ### Claim 5 (depends on 1) The monoclonal antibody according to claim 1, wherein the monoclonal antibody is a chimeric antibody or a humanized antibody. ### Claim 6 (depends on 1) A pharmaceutical composition comprising the monoclonal antibody according to claim 1. ### Claim 7 (depends on 6) The pharmaceutical composition according to claim 6, wherein the pharmaceutical composition is used for the treatment of inflammatory bowel disease. ### Claim 8 (depends on 6) The pharmaceutical composition according to claim 6, wherein the pharmaceutical composition is used for the treatment of cancer. ### Claim 9 A monoclonal antibody that specifically binds to an extracellular region of Claudin-2, the monoclonal antibody comprising: the heavy-chain variable region comprising the amino acid sequence having at least 90% identity with the amino acid sequence of SEQ ID NO: 14 and the light-chain variable region comprising the amino acid sequence having at least 90% identity with the amino acid sequence of SEQ ID NO: 16; and wherein the heavy-chain variable region comprising: heavy-chain CDR1 comprising the amino acid sequence of SEQ ID NO: 2, heavy-chain CDR2 comprising the amino acid sequence of SEQ ID NO: 4, and heavy-chain CDR3 comprising the amino acid sequence of SEQ ID NO: 6; and wherein the light-chain variable region comprising: light-chain CDR1 comprising the amino acid sequence of SEQ ID NO: 8, light-chain CDR2 comprising the amino acid sequence of SEQ ID NO: 10, and light-chain CDR3 comprising the amino acid of SEQ ID NO: 12. ### Claim 10 (depends on 9) The monoclonal antibody according to claim 9, wherein the monoclonal antibody recognizes a three-dimensional structure of the extracellular region of Claudin-2. ### Claim 11 (depends on 9) The monoclonal antibody according to claim 9, wherein the extracellular region is an extracellular region first loop of Claudin-2. ### Claim 12 (depends on 9) The monoclonal antibody according to claim 9, wherein the monoclonal antibody has a structure of Fab, Fab′, (Fab′)2, Fv, scFv, or a combination thereof. ### Claim 13 (depends on 9) The monoclonal antibody according to claim 9, wherein the monoclonal antibody is a chimeric antibody or a humanized antibody. ### Claim 14 (depends on 9) A pharmaceutical composition comprising the monoclonal antibody according to claim 9. ### Claim 15 (depends on 14) The pharmaceutical composition according to claim 14, wherein the pharmaceutical composition is used for the treatment of inflammatory bowel disease. ### Claim 16 (depends on 14) The pharmaceutical composition according to claim 14, wherein the pharmaceutical composition is used for the treatment of cancer.