# US 12,110,325 B2 · TM4SF5-targeting humanized 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 12,110,325 B2 - Document ID: US12110325B2 - Status: Granted - Kind: B2 - Application number: 18/154,597 - Filed: 2023-01-13 - Published: 2023-09-07 - Granted: 2024-10-08 - Earliest claimed: 2022-01-14 - Assignees: Korea Research Institute of Bioscience and Biotechnology; Seoul National University R&Db Foundation - Applicants: Korea Research Institute of Bioscience and Biotechnology; Seoul National University R&Db Foundation - Inventors: Se Mi Kim; Jung Weon Lee; Dongjoon Ko; Junghwa Yoon; Eunmi Kim; Seo Hee Nam; Eun Ae Shin - Web page: https://patentgrep.com/patent/US12110325B2 ## CPC - C07K 16/28: against receptors, cell surface antigens or cell surface determinants - A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines} - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - C12N 15/63: Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression - A61K 2039/505: {comprising antibodies} - A61K 2039/545: {characterised by the dose, timing or administration schedule} - C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered - C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity - C07K 2317/565: Complementarity determining region [CDR] - C07K 2317/622: Single chain antibody (scFv) - C07K 2317/73: Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation - C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding - C07K 2317/77: Internalization into the cell - 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 - C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00) ## Abstract The present disclosure relates to TM4SF5-specific humanized antibodies and uses thereof. ## Claims ### Claim 1 An antibody or antigen-binding fragment thereof, that binds to transmembrane 4 L6 family member 5 (TM4SF5), comprising: a heavy chain variable domain comprising the sequence of SEQ ID NO: 7, which comprises HCDR1 comprising the sequence of SEQ ID NO: 9; HCDR2 comprising the sequence of SEQ ID NO: 10; and HCDR3 comprising the sequence of SEQ ID NO: 3; and a light chain variable domain comprising the sequence of SEQ ID NO: 8, which comprises LCDR1 comprising the sequence of SEQ ID NO: 4; LCDR2 comprising the sequence of SEQ ID NO: 5; and LCDR3 comprising the sequence of SEQ ID NO: 6, wherein the CDR sequences of SEQ ID NOS: 9 and 10 are assigned according to the numbering system of Chothia. ### Claim 2 (depends on 1) The antibody or antigen-binding fragment thereof according to claim 1, wherein the antibody is an IgG antibody. ### Claim 3 (depends on 1) A pharmaceutical composition for preventing or treating TM4SF5-related diseases comprising the antibody or antigen-binding fragment thereof of claim 1. ### Claim 4 (depends on 3) The pharmaceutical composition according to claim 3, wherein the TM4SF5-related diseases are selected from the group consisting of fatty liver, steatohepatitis, liver fibrosis, liver cirrhosis, portal hypertension, liver cancer, stomach cancer, colorectal cancer, rectal cancer, oral cancer, pharynx cancer, larynx cancer, lung cancer, colon cancer, breast cancer, cervical cancer, endometrial cancer, ovarian cancer, prostate cancer, testicular cancer, bladder cancer, kidney cancer, pancreatic cancer, bone cancer, connective tissue cancer, skin cancer, brain cancer, thyroid cancer, leukemia, Hodgkin's disease, soft tissue sarcoma, lymphoma, multiple myeloma, and blood cancer. ### Claim 5 (depends on 4) The pharmaceutical composition according to claim 4, wherein the TM4SF5-related diseases are selected from the group consisting of fatty liver, steatohepatitis, liver fibrosis, liver cirrhosis, portal hypertension, liver cancer, stomach cancer, colorectal cancer, colon cancer, prostate cancer, pancreatic cancer, and soft tissue sarcoma. ### Claim 6 (depends on 3) The pharmaceutical composition according to claim 3, wherein the pharmaceutical composition is administered alone or in combination with any one material selected from the group consisting of 5-fluorouracil (5-FU), oxaliplatin, doxorubicin, sorafenib, and cetuximab. ### Claim 7 (depends on 1) A polynucleotide encoding the antibody or antigen-binding fragment thereof according to claim 1. ### Claim 8 (depends on 7) An expression vector comprising the polynucleotide according to claim 7. ### Claim 9 (depends on 5) A transformant comprising the polynucleotide according to claim 5 or an expression vector comprising the same. ### Claim 10 (depends on 1) A composition for diagnosing TM4SF5-related diseases comprising the antibody or antigen-binding fragment thereof according to claim 1. ### Claim 11 (depends on 1) A method for detecting transmembrane 4 L6 family member 5(TM4SF5)-related diseases comprising detecting TM4SF5 protein in a biological sample through an antigen-antibody reaction using the antibody or antigen-binding fragment thereof according to claim 1. ### Claim 12 (depends on 1) A method for preventing or treating diagnosing transmembrane 4 L6 family member 5(TM4SF5)-related diseases, which includes administering an antibody or antigen-binding fragment thereof according to claim 1 to a subject.