# US 11,306,138 B2 · Antibody molecules and uses thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,306,138 B2 - Document ID: US11306138B2 - Status: Granted - Kind: B2 - Application number: 15/556,145 - Filed: 2016-03-04 - Published: 2018-02-08 - Granted: 2022-04-19 - Earliest claimed: 2015-03-06 - Assignees: The University Court of the University of Aberdeen - Applicants: The University Court of the University of Aberdeen - Inventors: Neil Andrew Robert Gow; Fiona Marion Rudkin; Lars-Peter Erwig; Allan Jensen - Web page: https://patentgrep.com/patent/US11306138B2 ## CPC - C07K 16/14: against material from fungi, algea or lichens - A61K 39/39575: {against materials from other living beings excluding bacteria and viruses, e.g. protozoa, fungi, plants} - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - G01N 33/56961: {Plant cells or fungi} - A61K 2039/505: {comprising antibodies} - C07K 2317/21: from primates, e.g. man - C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity - C07K 2317/52: Constant or Fc region; Isotype - C07K 2317/56: variable (Fv) region, i.e. VH and/or VL - C07K 2317/565: Complementarity determining region [CDR] - C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value - G01N 2333/40: from Candida - G01N 2469/10: Detection of antigens from microorganism in sample from host - Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change - 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) - 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) - Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE ## Abstract This invention relates to recombinant human antibody molecules. The antibodies bind fungal antigens, for example from Candida spp. Human antibody encoding genes targeting clinically relevant Candida epitopes have been isolated from single B cells from carefully selected donors and screened with specified types of protein or cell wall extract. The panel of purified, fully human recombinant IgG1 mAbs generated displayed a diverse range of specific binding profiles and demonstrated efficacy in a disease model. The fully human mAbs and derivatives thereof have utility in the generation of diagnostics, therapeutics and vaccines. ## Claims ### Claim 1 A method comprising contacting a Candida cell with an anti-Candida antibody molecule, wherein the anti-Candida antibody molecule is a whole antibody comprising a VH domain comprising: (i) a HCDR1 having the amino acid sequence of SEQ ID NO: 39; (ii) a HCDR2 having the amino acid sequence of SEQ ID NO: 41; and (iii) a HCDR3 having the amino acid sequence of SEQ ID NO: 43; and a VL domain comprising: (i) a LCDR1 having the amino acid sequence of SEQ ID NO: 46; (ii) a LCDR2 having the amino acid sequence of SEQ ID NO: 48; and (iii) a LCDR3 having the amino acid sequence of SEQ ID NO: 50, wherein the binding of the anti-Candida antibody to the Candida cell (i) opsonises, or increases the rate of opsonisation of the Candida cell; or (ii) increases the rate of macrophage engulfment of the Candida cell; or (iii]) increases the rate of macrophage attraction to the Candida cell. ### Claim 2 A method of treatment of a Candida infection comprising administering an anti-Candida antibody molecule to an individual in need thereof, wherein the antibody molecule is a whole antibody comprising a VH domain comprising: (i) a HCDR1 having the amino acid sequence of SEQ ID NO: 39; (ii) a HCDR2 having the amino acid sequence of SEQ ID NO: 41; and (iii) a HCDR3 having the amino acid sequence of SEQ ID NO: 43; and a VL domain comprising: (i) a LCDR1 having the amino acid sequence of SEQ ID NO: 46; (ii) a LCDR2 having the amino acid sequence of SEQ ID NO: 48; and (iii) a LCDR3 having the amino acid sequence of SEQ ID NO: 50. ### Claim 3 (depends on 2) A method according to claim 2 wherein the fungal infection is caused by C. albicans and wherein the infection is in a hyphal or yeast phase. ### Claim 4 (depends on 2) A method according to claim 2, wherein the treatment further comprises administering an additional antifungal agent. ### Claim 5 A method for detecting the presence or absence of a fungus which is a Candida spp, the method comprising (i) contacting a sample suspected of containing the fungus with an anti-Candida antibody molecule, and (ii) determining whether the anti-Candida antibody molecule binds to the sample, binding of the antibody molecule to the sample indicates the presence of the fungus, and wherein the anti-Candida antibody molecule comprises a VH domain comprising: (i) a HCDR1 having the amino acid sequence of SEQ ID NO: 39; (ii) a HCDR2 having the amino acid sequence of SEQ ID NO: 41; and (iii) a HCDR3 having the amino acid sequence of SEQ ID NO: 43; and a VL domain comprising (i) a LCDR1 having the amino acid sequence of SEQ ID NO: 46; (ii) a LCDR2 having the amino acid sequence of SEQ ID NO: 48; and (iii) a LCDR3 having the amino acid sequence of SEQ ID NO: 50. ### Claim 6 A lateral flow device (LFD) for detecting the presence of an analyte which is a fungal pathogen in a sample fluid, wherein said LFD comprises: (i) a housing, and ii) at least one flow path leading from a sample well to a viewing window, wherein said flow path comprises one or more carriers along which the sample fluid is capable of flowing by capillary action, and wherein the one or more carriers comprise an analyte-detecting means; wherein the presence of analyte produces a line in the viewing window which indicates the presence of the fungal pathogen, wherein the fungal pathogen is a Candida spp. and the at least one analyte-detecting means is an anti-Candida antibody molecule comprising a VH domain comprising: (i) a HCDR1 having the amino acid sequence of SEQ ID NO: 39; (ii) a HCDR2 having the amino acid sequence of SEQ ID NO: 41; and (iii) a HCDR3 having the amino acid sequence of SEQ ID NO: 43; and a VL domain comprising: (i) a LCDR1 having the amino acid sequence of SEQ ID NO: 46; (ii) a LCDR2 having the amino acid sequence of SEQ ID NO: 48; and (iii) a LCDR3 having the amino acid sequence of SEQ ID NO: 50. ### Claim 7 (depends on 6) The device as claimed in claim 6, wherein the one or more carriers comprises a plurality of analyte-detecting means, each analyte-detecting means is specific for a different fungal pathogen, and wherein the plurality of analyte-detecting means are capable of distinguishing between multiple fungal pathogens. ### Claim 8 (depends on 7) The device as claimed in claim 7 wherein the multiple fungal pathogens comprise C. albicans, and at least one fungus selected from the group consisting of Aspergillus fumigatus, Cryptococcus neoformans, Pneumocystis jirovecii, a zygomycete fungus, and a skin dermatophytic fungus. ### Claim 9 (depends on 2) The method according to claim 2, wherein the VH domain comprises at least one sequence selected from the following: (i) a FW1 having the amino acid sequence of SEQ ID NO: 38; (ii) a FW2 having the amino acid sequence of SEQ ID NO: 40; (iii) a FW3 having the amino acid sequence of SEQ ID NO: 42; and (iv) a FW4 having the amino acid sequence of SEQ ID NO: 44. ### Claim 10 (depends on 2) The method according to claim 2, wherein the VL domain comprises at least one sequence selected from the following: (i) a FW1 having the amino acid sequence of SEQ ID NO: 45; (ii) a FW2 having the amino acid sequence of SEQ ID NO: 47; (iii) a FW3 having the amino acid sequence of SEQ ID NO: 49; and (iv) a FW4 having the amino acid sequence of SEQ ID NO: 51. ### Claim 11 (depends on 2) The method according to claim 2, wherein the VH domain and the VL domain have amino acid sequences of SEQ ID NO: 2 and SEQ ID NO: 20, respectively. ### Claim 12 (depends on 2) The method of claim 2, wherein the fungal infection is caused by a species selected from the group consisting of C. albicans, C. dubliniensis, C. tropicalis, C. parapsilosis and C. lusitaniae. ### Claim 13 (depends on 4) The method of claim 4, wherein the additional antifungal agent is an azole, a polyene or an echinocandin. ### Claim 14 A method comprising contacting a Candida cell with an anti-Candida antibody molecule, wherein the anti-Candida antibody molecule comprises a VH domain comprising: (i) a HCDR1 having the amino acid sequence of SEQ ID NO: 39; (ii) a HCDR2 having the amino acid sequence of SEQ ID NO: 41; and (iii) a HCDR3 having the amino acid sequence of SEQ ID NO: 43; and a VL domain comprising: (i) a LCDR1 having the amino acid sequence of SEQ ID NO: 46; (ii) a LCDR2 having the amino acid sequence of SEQ ID NO: 48; and (iii) a LCDR3 having the amino acid sequence of SEQ ID NO: 50, wherein the anti-Candida antibody molecule binds to the Candida cell or a hyphae of the cell, and wherein the method further comprises detecting the bound anti-Candida antibody to identify or detect the Candida cell or a hyphae of the Candida cell.