# US 2023/0054956 A1 · Human monoclonal antibodies that neutralize pandemic gii.4 noroviruses > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2023/0054956 A1 - Document ID: US20230054956A1 - Status: Published application - Kind: A1 - Application number: 17/807,773 - Filed: 2022-06-20 - Published: 2023-02-23 - Earliest claimed: 2021-06-21 - Assignees: Vanderbilt University - Applicants: Vanderbilt University - Inventors: James E. CROWE, Jr. - Web page: https://patentgrep.com/patent/US20230054956A1 ## CPC - C07K 16/10: RNA viruses - C07K 16/106: Picornaviridae (F), e.g. hepatitis A virus - G01N 33/56983: {Viruses} - C07K 2317/21: from primates, e.g. man - C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity - C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding - C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value - G01N 2333/08: RNA viruses - G01N 2333/085: Picornaviridae, e.g. coxsackie virus, echovirus, enterovirus - G01N 2469/10: Detection of antigens from microorganism in sample from host - 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) - 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 The present disclosure is directed to antibodies binding to and neutralizing norovirus and methods for use thereof. ## Claims ### Claim 1 A method of detecting a norovirus infection in a subject comprising: (a) contacting a sample from said subject with an antibody or antibody fragment having clone-paired heavy and light chain CDR sequences from Tables 3 and 4, respectively; and (b) detecting norovirus in said sample by binding of said antibody or antibody fragment to a norovirus antigen in said sample. ### Claim at position 2 2-12. (canceled) ### Claim 13 A method of treating a subject infected with norovirus, or reducing the likelihood of infection of a subject at risk of contracting norovirus, comprising delivering to said subject an antibody or antibody fragment having clone-paired heavy and light chain CDR sequences from Tables 3 and 4, respectively. ### Claim 14 (depends on 13) The method of claim 13, the antibody or antibody fragment is encoded by clone-paired light and heavy chain variable sequences as set forth in Table 1. ### Claim 15 (depends on 13) The method of claim 13, the antibody or antibody fragment is encoded by clone-paired light and heavy chain variable sequences having 95% identity to as set forth in Table 1. ### Claim 16 (depends on 13) The method of claim 13, wherein said antibody or antibody fragment is encoded by light and heavy chain variable sequences having 70%, 80%, or 90% identity to clone-paired sequences from Table 1. ### Claim 17 (depends on 13) The method of claim 13, wherein said antibody or antibody fragment comprises light and heavy chain variable sequences according to clone-paired sequences from Table 2. ### Claim 18 (depends on 13) The method of claim 13, wherein said antibody or antibody fragment comprises light and heavy chain variable sequences having 70%, 80% or 90% identity to clone-paired sequences from Table 2. ### Claim 19 (depends on 13) The method of claim 13, wherein said antibody or antibody fragment comprises light and heavy chain variable sequences having 95% identity to clone-paired sequences from Table 2. ### Claim 20 (depends on 13) The method of claim 13, wherein the antibody fragment is a recombinant scFv (single chain fragment variable) antibody, Fab fragment, F(ab′)2 fragment, or Fv fragment. ### Claim 21 (depends on 13) The method of claim 13, wherein said antibody is an IgG, or a recombinant IgG antibody or antibody fragment comprising an Fc portion mutated to alter (eliminate or enhance) FcR interactions, to increase half-life and/or increase therapeutic efficacy, such as a LALA, LALA-PG, N297, GASD/ALIE, DHS, YTE or LS mutation or glycan modified to alter (eliminate or enhance) FcR interactions such as enzymatic or chemical addition or removal of glycans or expression in a cell line engineered with a defined glycosylating pattern. ### Claim 22 (depends on 13) The method of claim 13, wherein said antibody is a chimeric antibody or a bispecific antibody. ### Claim 23 (depends on 13) The method of claim 13, wherein said antibody or antibody fragment is administered prior to infection or after infection. ### Claim 24 (depends on 13) The method of claim 13, wherein said subject is a pregnant female, a sexually active female, or a female undergoing fertility treatments. ### Claim 25 (depends on 13) The method of claim 13, wherein delivering comprises antibody or antibody fragment administration, or genetic delivery with an RNA or DNA sequence or vector encoding the antibody or antibody fragment. ### Claim 26 A monoclonal antibody, wherein the antibody or antibody fragment is characterized by clone-paired heavy and light chain CDR sequences from Tables 3 and 4, respectively. ### Claim at position 17 27-35. (canceled) ### Claim 36 A hybridoma or engineered cell encoding an antibody or antibody fragment wherein the antibody or antibody fragment is characterized by clone-paired heavy and light chain CDR sequences from Tables 3 and 4, respectively. ### Claim at position 19 37-46. (canceled) ### Claim 47 A vaccine formulation comprising one or more antibodies or antibody fragments characterized by clone-paired heavy and light chain CDR sequences from Tables 3 and 4, respectively. ### Claim at position 21 48-56. (canceled) ### Claim 57 (depends on 26) A vaccine formulation comprising one or more expression vectors encoding a first antibody or antibody fragment according to claim 26. ### Claim at position 23 58-60. (canceled) ### Claim 61 A method of protecting the health of a placenta and/or fetus of a pregnant a subject infected with or at risk of infection with norovirus comprising delivering to said subject an antibody or antibody fragment having clone-paired heavy and light chain CDR sequences from Tables 3 and 4, respectively. ### Claim at position 25 62-75. (canceled) ### Claim 76 A method of determining the antigenic integrity, correct conformation and/or correct sequence of a norovirus antigen comprising: (a) contacting a sample comprising said antigen with a first antibody or antibody fragment having clone-paired heavy and light chain CDR sequences from Tables 3 and 4, respectively; and (b) determining antigenic integrity, correct conformation and/or correct sequence of said antigen by detectable binding of said first antibody or antibody fragment to said antigen. ### Claim at position 27 77-96. (canceled) ### Claim 97 A human monoclonal antibody or antibody fragment, or hybridoma or engineered cell producing the same, wherein said antibody or antibody fragment binds to norovirus capsid protein P domain and/or S domain. ### Claim at position 29 98-101. (canceled)