# US 11,999,795 B2 · Monoclonal 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 11,999,795 B2 - Document ID: US11999795B2 - Status: Granted - Kind: B2 - Application number: 16/763,386 - Filed: 2018-11-09 - Published: 2021-03-18 - Granted: 2024-06-04 - Earliest claimed: 2017-11-14 - Assignees: School Juridical Person Kitasato Institute - Applicants: School Juridical Person the Kitasato Institute - Inventors: Takashi Fukuyama; Hitoshi Yamazaki; Mariko Ogi; Noritada Kobayashi; Yoshinobu Ichiki; Masahiko Hatakeyama - Web page: https://patentgrep.com/patent/US11999795B2 ## CPC - C07K 16/30: from tumour cells - C07K 16/3069: {Reproductive system, e.g. ovaria, uterus, testes, prostate} - C07K 16/32: against translation products of oncogenes - C12N 5/12: Fused cells, e.g. hybridomas - G01N 33/575: for cancer - G01N 33/5753: of the stomach or small intestine - G01N 33/5759: {involving compounds localised on the membrane of tumour or cancer cells} - 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) - C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00) - 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 Provided is a monoclonal antibody or a fragment thereof in which heavy-chain complementarity-determining regions (CDRs) 1 to 3 respectively consist of amino acid sequences of SEQ ID NOs: 2 to 4 and light-chain CDRs 1 to 3 respectively consist of amino acid sequences of SEQ ID NOs: 5 to 7; a monoclonal antibody or a fragment thereof in which heavy-chain CDRs 1 to 3 respectively consist of amino acid sequences obtained by deleting, substituting, or adding one or several amino acids in the amino acid sequences of SEQ ID NOs: 2 to 4 and light-chain CDRs 1 to 3 respectively consist of amino acid sequences obtained by deleting, substituting, or adding one or several amino acids in the amino acid sequences of SEQ ID NOs: 5 to 7, and which has binding properties to a KK-LC-1 protein; or a monoclonal antibody or a fragment thereof which competes with the monoclonal antibody or a fragment thereof in which the heavy-chain CDRs 1 to 3 respectively consist of the amino acid sequences of SEQ ID NOs: 2 to 4 and the light-chain CDRs 1 to 3 respectively consist of the amino acid sequences of SEQ ID NOs: 5 to 7, and has binding properties to the KK-LC-1 protein. ## Claims ### Claim 1 A monoclonal antibody or an antigen binding fragment thereof that binds Kitakyushu lung cancer antigen-I (KK-LC-1), wherein the antibody or antigen binding fragment thereof comprises: heavy-chain complementarity-determining regions (CDRs) 1 to 3 that respectively consist of amino acid sequences of SEQ ID NOs: 2 to 4 and light-chain CDRs 1 to 3 that respectively consist of amino acid sequences of SEQ ID NOs: 5 to 7. ### Claim 2 (depends on 1) The monoclonal antibody or antigen binding fragment thereof according to claim 1, wherein the monoclonal antibody or the antigen binding fragment thereof is capable of histological staining the KK-LC-1 protein present in a fixed biological sample, wherein KK-LC-1 protein comprises the amino acid sequence of SEQ ID NO: 1. ### Claim 3 (depends on 2) The monoclonal antibody or the antigen binding fragment thereof according to claim 2, wherein the biological sample is fixed with a crosslinking fixative. ### Claim 4 (depends on 3) The monoclonal antibody or the antigen binding fragment thereof according to claim 3, wherein the crosslinking fixative is formaldehyde, paraformaldehyde, or glutaraldehyde. ### Claim 5 (depends on 1) The monoclonal antibody or the antigen binding fragment thereof according to claim 1, wherein the monoclonal antibody or the antigen binding fragment thereof has binding properties to the peptide consisting of the amino acid sequence set forth in SEQ ID NO: 1. ### Claim 6 (depends on 1) The monoclonal antibody or the antigen binding fragment thereof according to claim 1, wherein the monoclonal antibody or the antigen binding fragment thereof has binding properties to the peptide consisting of the amino acid sequence set forth in SEQ ID NO: 12. ### Claim 7 (depends on 1) The monoclonal antibody according claim 1, wherein the monoclonal antibody is produced by a hybridoma cell line having an accession number of NITE BP-02527. ### Claim 8 (depends on 1) A detection kit comprising the monoclonal antibody or the antigen binding fragment thereof according to claim 1. ### Claim 9 (depends on 1) A nucleic acid encoding the monoclonal antibody or the antigen binding fragment thereof as set forth in claim 1. ### Claim 10 A hybridoma cell line deposited at the National Institute of Technology and Evaluation under accession number NITE BP-02527. ### Claim 11 (depends on 1) An immunohistochemical method for detecting a KK-LC-1 protein comprising the amino acid sequence of SEQ ID NO: 1, in a biological sample, the method comprising a step of detecting the peptide consisting of an amino acid sequence set forth in SEQ ID NO: 1 or a partial peptide thereof, wherein the partial peptide is the peptide consisting of an amino acid sequence set forth in SEQ ID NO: 12, by contacting the sample with the monoclonal antibody or the antigen binding fragment thereof of claim 1.