US2021355193A1PendingUtilityA1

Monoclonal anitbody for spike protein of middle east respiratory syndrome coronavirus and use thereof

Assignee: KOREA CENTER DISEASE CONTROL & PREVENTIONPriority: Aug 23, 2017Filed: Aug 23, 2018Published: Nov 18, 2021
Est. expiryAug 23, 2037(~11.1 yrs left)· nominal 20-yr term from priority
C07K 16/102C07K 16/10G01N 33/56983C07K 2317/94G01N 2469/10C07K 2317/21G01N 2333/165C07K 2317/76C07K 2317/565A61K 47/68A61K 2039/505C07K 2317/92C07K 2317/24
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Claims

Abstract

The present invention relates to monoclonal antibodies for a spike protein of the Middle East respiratory syndrome coronavirus (MERS-CoV), and a use thereof. Particularly, monoclonal antibodies 77-A5, 77-A6, 90-A3, 90-A9, 90-B2, 90-B7, 90-C4, 90-E5, 90-E6, 90-F1 and 90-F2 according to the present invention have excellent attachment force with respect to a full-length spike protein of MERS-CoV and the Si domain of the protein, and, of the monoclonal antibodies, the monoclonal antibodies 90-F1, 90-E5, 90-E6, 90-F2, 77-A5 and 77-A6 have excellent attachment force with respect to an RBD antigen of MERS-CoV. Also, the antibodies 77-A5, 77-A6, 90-E5, 90-E6, 90-F1 and 90-F2 exhibit neutralizing capacity with respect to a MERS pseudovirus and MERS-CoV, and the antibodies 90-B2 and 90-B7 exhibit neutralizing capacity only with respect to MERS-CoV. Further, the monoclonal antibodies have a particular monomeric form, and have excellent stability and thus may be useful for treating or diagnosing MERS.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A heavy chain variable region of a monoclonal antibody having binding specificity to Middle East Respiratory Syndrome coronavirus (MERS-CoV) spike protein, wherein the complementarity determining region (CDR) of said heavy chain variable region comprises an amino acid sequence represented by SEQ. ID. NO: 1, SEQ. ID. NO: 3, SEQ. ID. NO: 5, SEQ. ID. NO: 7, SEQ. ID. NO: 9, SEQ. ID. NO: 11, SEQ. ID. NO: 13, SEQ. ID. NO: 15, SEQ. ID. NO: 17, SEQ. ID. NO: 19, or SEQ. ID. NO: 21. 
     
     
         2 . The heavy chain variable region according to  claim 1 , wherein the MERS-CoV spike protein comprises an amino acid sequence represented by SEQ. ID. NO: 23. 
     
     
         3 . The heavy chain variable region according to  claim 1 , wherein the heavy chain variable region has binding specificity to a region of the MERS-CoV spike protein comprising the 1 st  to 757 th  amino acids from the N-terminus of the MERS-CoV spike protein. 
     
     
         4 . A nucleic acid encoding the heavy chain variable region of  claim 1 . 
     
     
         5 . A recombinant vector comprising the nucleic acid of  claim 4 . 
     
     
         6 . A host cell having the nucleic acid of  claim 4  introduced therein. 
     
     
         7 . A host cell having the recombinant vector of  claim 5  introduced therein. 
     
     
         8 . A kit for the detection or quantification of an antigen of Middle East respiratory syndrome (MERS), the kit comprising the heavy chain variable region of  claim 1 . 
     
     
         9 . A light chain variable region of a monoclonal antibody having binding specificity to Middle East Respiratory Syndrome coronavirus (MERS-CoV) spike protein, wherein the complementarity determining region (CDR) of said light chain variable region comprises an amino acid sequence represented by SEQ. ID. NO: 2, SEQ. ID. NO: 4, SEQ. ID. NO: 6, SEQ. ID. NO: 8, SEQ. ID. NO: 10, SEQ. ID. NO: 12, SEQ. ID. NO: 14, SEQ. ID. NO: 16, SEQ. ID. NO: 18, SEQ. ID. NO: 20, or SEQ. ID. NO: 22. 
     
     
         10 . The light chain variable region according to  claim 9 , wherein the MERS-CoV spike protein comprises an amino acid sequence represented by SEQ. ID. NO: 23. 
     
     
         11 . The light chain variable region according to  claim 9 , wherein the light chain variable region has binding specificity to a region of the MERS-CoV spike protein comprising the 1 st  to 757 th  amino acids from the N-terminus of the MERS-CoV spike protein. 
     
     
         12 . A nucleic acid encoding the light chain variable region of  claim 9 . 
     
     
         13 . A recombinant vector comprising the nucleic acid of  claim 12 . 
     
     
         14 . A host cell having the nucleic acid of  claim 12  introduced therein. 
     
     
         15 . A host cell having the recombinant vector of  claim 13  introduced therein. 
     
     
         16 . A kit for the detection or quantification of an antigen of Middle East respiratory syndrome (MERS), the kit comprising the light chain variable region of  claim 9 . 
     
     
         17 . A monoclonal antibody having binding specificity to Middle East Respiratory Syndrome coronavirus (MERS-CoV) spike protein, the monoclonal antibody comprising a heavy chain variable region comprising a first complementarity determining region comprising an amino acid sequence represented by SEQ. ID. NO: 1, SEQ. ID. NO: 3, SEQ. ID. NO: 5, SEQ. ID. NO: 7, SEQ. ID. NO: 9, SEQ. ID. NO: 11, SEQ. ID. NO: 13, SEQ. ID. NO: 15, SEQ. ID. NO: 17, SEQ. ID. NO: 19, or SEQ. ID. NO: 21, and a light chain variable region comprising a second complementarity determining region comprising an amino acid sequence represented by SEQ. ID. NO: 2, SEQ. ID. NO: 4, SEQ. ID. NO: 6, SEQ. ID. NO: 8, SEQ. ID. NO: 10, SEQ. ID. NO: 12, SEQ. ID. NO: 14, SEQ. ID. NO: 16, SEQ. ID. NO: 18, SEQ. ID. NO: 20, or SEQ. ID. NO: 22. 
     
     
         18 . A nucleic acid encoding the monoclonal antibody of  claim 17 . 
     
     
         19 . A recombinant vector comprising the nucleic acid of  claim 18 . 
     
     
         20 . A host cell having the nucleic acid of  claim 18  introduced therein. 
     
     
         21 . A host cell having the recombinant vector of  claim 19  introduced therein. 
     
     
         22 . A kit for the detection or quantification of an antigen of Middle East respiratory syndrome (MERS), the kit comprising the monoclonal antibody of  claim 17 . 
     
     
         23 . A method for preventing, treating or diagnosing Middle East respiratory syndrome (MERS), the method comprising a step of administering the heavy chain variable region of  claim 1  to a subject. 
     
     
         24 . (canceled) 
     
     
         25 . A method for preventing, treating or diagnosing Middle East respiratory syndrome comprising a step of administering the light chain variable region of  claim 9  to a subject. 
     
     
         26 . (canceled) 
     
     
         27 . A method for preventing, treating or diagnosing Middle East respiratory syndrome comprising a step of administering the monoclonal antibody of  claim 17  to a subject. 
     
     
         28 . (canceled)

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