# US 11,999,785 B2 · Binding molecule specific for Lrig-1 protein 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 11,999,785 B2 - Document ID: US11999785B2 - Status: Granted - Kind: B2 - Application number: 17/672,208 - Filed: 2022-02-15 - Published: 2022-08-11 - Granted: 2024-06-04 - Earliest claimed: 2017-04-18 - Assignees: Good T Cells, Inc. - Applicants: Good T Cells, Inc. - Inventors: Jung Ho Kim; Beom Seok Kim - Web page: https://patentgrep.com/patent/US11999785B2 ## CPC - C07K 16/28: against receptors, cell surface antigens or cell surface determinants - A61P 35/00: Antineoplastic agents - A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection - C07K 16/18: against material from animals or humans - A61K 2039/505: {comprising antibodies} - C07K 2317/21: from primates, e.g. man - C07K 2317/52: Constant or Fc region; Isotype - 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: 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 - 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 The present invention relates to a binding molecule capable of specifically binding to Lrig-1 protein, which is located on the surface of a regulatory T cell. The binding molecule provided in the present invention can activate the function of regulatory T cells to effectively prevent, ameliorate, or treat diseases caused by excessive activation or expression of various immune cells and inflammatory cells, for example, immune-related diseases such as autoimmune disease, graft-versus-host disease, organ transplant rejection, asthma, atopy, acute or chronic inflammatory disease, etc. In addition, the binding molecule, preferably the antibody, specific for the Lrig-1 protein according to the present invention has advantages of more effectively targeting the Lrig-1 protein as compared with antibodies against Lrig-1 which are previously commercially available, and also possessing very good binding capacity thereto. ## Claims ### Claim 1 A binding molecule which specifically binds to leucine-rich and immunoglobulin-like domains 1(Lrig-1) protein, wherein the binding molecule is selected from the group consisting of the following (a) to (d): (a) a binding molecule comprising a heavy chain variable region that contains the heavy chain CDR1 represented by SEQ ID NO: 5, the heavy chain CDR2 represented by SEQ ID NO: 6, and the heavy chain CDR3 represented by SEQ ID NO: 7; and a light chain variable region that contains the light chain CDR1 represented by SEQ ID NO: 8, the light chain CDR2 represented by SEQ ID NO: 9, and the light chain CDR3 represented by SEQ ID NO: 10; (b) a binding molecule comprising a heavy chain variable region that contains the heavy chain CDR1 represented by SEQ ID NO: 13, the heavy chain CDR2 represented by SEQ ID NO: 14, and the heavy chain CDR3 represented by SEQ ID NO: 15; and a light chain variable region that contains the light chain CDR1 represented by SEQ ID NO: 16, the light chain CDR2 represented by SEQ ID NO: 17, and the light chain CDR3 represented by SEQ ID NO: 18; (c) a binding molecule comprising a heavy chain variable region that contains the heavy chain CDR1 represented by SEQ ID NO: 21, the heavy chain CDR2 represented by SEQ ID NO: 22, and the heavy chain CDR3 represented by SEQ ID NO: 23; and a light chain variable region that contains the light chain CDR1 represented by SEQ ID NO: 24, the light chain CDR2 represented by SEQ ID NO: 25, and the light chain CDR3 represented by SEQ ID NO: 26; and (d) a binding molecule comprising a heavy chain variable region that contains the heavy chain CDR1 represented by SEQ ID NO: 29, the heavy chain CDR2 represented by SEQ ID NO: 30, and the heavy chain CDR3 represented by SEQ ID NO: 31; and a light chain variable region that contains the light chain CDR1 represented by SEQ ID NO: 32, the light chain CDR2 represented by SEQ ID NO: 33, and the light chain CDR3 represented by SEQ ID NO: 34, wherein the binding molecule is antibody a bispecific antibody or fragment thereof. ### Claim 2 (depends on 1) The binding molecule according to claim 1, wherein the bispecific antibody specifically binds to leucine-rich and immunoglobulin-like domains 1 (Lrig-1) protein, and PD-1 or PD-L1. ### Claim 3 (depends on 1) The binding molecule according to claim 1, further comprising an Fc region or a constant region. ### Claim 4 (depends on 2) The binding molecule according to claim 2, wherein the Fc region is an Fc region of an IgG1, IgG2, IgG3, or IgG4 antibody, or a hybrid Fc region. ### Claim 5 (depends on 1) The binding molecule according to claim 1, further comprising a heavy chain constant region consisting of the amino acid sequence selected from the group consisting of SEQ ID NOs: 37, 39, 41, 42, 43, and 44. ### Claim 6 (depends on 1) The binding molecule according to claim 1, further comprising a light chain constant region consisting of the amino acid sequence represented by SEQ ID NO: 38 or 40. ### Claim 7 (depends on 1) The binding molecule according to claim 1, further comprising: a heavy chain constant region consisting of the amino acid sequence represented by SEQ ID NO: 37; and a light chain constant region consisting of the amino acid sequence represented by SEQ ID NO: 38. ### Claim 8 (depends on 1) The binding molecule according to claim 1, further comprising: a heavy chain constant region consisting of the amino acid sequence represented by SEQ ID NO: 39, 41, 42, or 43; and a light chain constant region consisting of the amino acid sequence represented by SEQ ID NO: 40. ### Claim 9 (depends on 1) The binding molecule according to claim 1, further comprising a heavy chain constant region consisting of the amino acid sequence represented by SEQ ID NO: 44. ### Claim 10 (depends on 1) A pharmaceutical composition comprising as an active ingredient the binding molecule according to claim 1. ### Claim 11 (depends on 1) A method for treating an immune-related disease, comprising: a step of administering the binding molecule according to claim 1 to a subject in need of treatment, so as to treat the immune-related disease, wherein the immune-related disease is an autoimmune disease, graft versus host disease, organ transplant rejection, asthma, atopy, or acute or chronic inflammatory disease. ### Claim 12 The method according to 11, wherein the binding molecule further comprises a heavy chain constant region consisting of the amino acid sequence selected from the group consisting of SEQ ID NOs: 37, 39, 41, 42, 43, and 44. ### Claim 13 (depends on 11) The method according to claim 11, wherein the binding molecule further comprises a light chain constant region consisting of the amino acid sequence represented by SEQ ID NO: 38 or 40. ### Claim 14 (depends on 11) The method according to claim 11, wherein the binding molecule further comprises: a heavy chain constant region consisting of the amino acid sequence represented by SEQ ID NO: 37; and a light chain constant region consisting of the amino acid sequence represented by SEQ ID NO: 38. ### Claim 15 (depends on 11) The method according to claim 11, wherein the binding molecule further comprises: a heavy chain constant region consisting of the amino acid sequence represented by SEQ ID NO: 39, 41, 42, or 43; and a light chain constant region consisting of the amino acid sequence represented by SEQ ID NO: 40. ### Claim 16 (depends on 11) The method according to claim 11, wherein the binding molecule further comprises a heavy chain constant region consisting of the amino acid sequence represented by SEQ ID NO: 44. ### Claim 17 (depends on 11) The method according to claim 11, wherein the bispecific antibody specifically binds to leucine-rich and immunoglobulin-like domains 1 (Lrig-1) protein, and PD-1 or PD-1.