US2023279428A1PendingUtilityA1

Adenovirus vectors and methods for using adenovirus vectors

72
Assignee: MAYO FOUND MEDICAL EDUCATION & RESPriority: Aug 17, 2020Filed: Aug 17, 2021Published: Sep 7, 2023
Est. expiryAug 17, 2040(~14 yrs left)· nominal 20-yr term from priority
Inventors:Michael A. Barry
Y02A50/30C12N 15/86C12N 7/00C07K 14/005A61P 31/04A61P 37/04A61P 31/14A61K 9/006A61K 39/12A61K 39/08C12N 2770/20022C12N 2750/14122A61K 2039/541A61K 2039/5256A61K 2039/575A61K 2039/545A61K 2039/543C12N 2710/10041C12N 2710/10343C12N 2770/20034C12N 2710/10322C12N 9/485C12Y 304/17023C12N 2750/14143C07K 2319/33
72
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Claims

Abstract

This document provides adenovirus vectors and methods and materials related to using adenovirus vectors. For example, adenoviruses for delivering nucleic acid encoding one or more immunogens (e.g., one or more immunogens associated with a pathogen causing an infection) to cells within a mammal such that the mammal produces an effective immune response against the immunogen(s) are provided.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A single-cycle adenovirus (SC-Ad), wherein said SC-Ad comprises a genome lacking at least a portion of a nucleic acid sequence that encodes an adenovirus polypeptide, wherein said SC-Ad comprises said adenovirus polypeptide, and wherein said SC-Ad comprises a nucleic acid sequence encoding a coronavirus immunogen. 
     
     
         2 . The SC-Ad of  claim 1 , wherein said adenovirus polypeptide is selected from the group consisting of a fiber polypeptide, a V polypeptide, a hexon polypeptide, a penton base polypeptide, and a pIIIa polypeptide. 
     
     
         3 . The SC-Ad of any one of  claims 1 - 2 , wherein said coronavirus immunogen comprises a coronavirus Spike polypeptide or an immunogenic fragment thereof. 
     
     
         4 . The SC-Ad of  claim 3 , wherein said coronavirus immunogen consists of or consists essentially of an amino acid sequence set forth in any one of SEQ ID NOs:1-4. 
     
     
         5 . The SC-Ad of any one of  claims 1 - 4 , wherein said SC-Ad further comprises a nucleic acid sequence encoding an adjuvant polypeptide. 
     
     
         6 . The SC-Ad of  claim 5 , wherein said adjuvant polypeptide is selected from the group consisting of a granulocyte-macrophage colony-stimulating factor (GM-CSF) polypeptide, an interleukin 4 (IL-4) polypeptide, an interleukin 21 (IL-21) polypeptide, a CD40 ligand (CD40L) polypeptide, a 4-1BB ligand (4-1BBL) polypeptide, a transforming growth factor beta (TGF-β) polypeptide, a  Clostridium difficile  TcdA polypeptide, a  C. difficile  TcdB polypeptide, and biologically active fragments thereof. 
     
     
         7 . The SC-Ad of  claim 5  or  claim 6 , wherein said coronavirus Spike polypeptide is fused to said adjuvant polypeptide. 
     
     
         8 . The SC-Ad of  claim 7 , wherein said coronavirus Spike polypeptide fused to said adjuvant polypeptide consists essentially of or consists of an amino acid sequence set forth in SEQ ID NO:5. 
     
     
         9 . The SC-Ad of any one of  claims 1 - 4 , wherein said SC-Ad further comprises a nucleic acid sequence encoding a chaff polypeptide. 
     
     
         10 . The SC-Ad of  claim 9 , wherein said chaff polypeptide is a fragment of an ACE2 polypeptide. 
     
     
         11 . The SC-Ad of  claim 10 , wherein said fragment of an ACE2 polypeptide comprises the extracellular region of an ACE2 polypeptide and lacks a transmembrane domain. 
     
     
         12 . The SC-Ad of  claim 11 , wherein said chaff polypeptide consists essentially of or consists of an amino acid sequence set forth in SEQ ID NO:8 or SEQ ID NO:9. 
     
     
         13 . The SC-Ad of any one of  claims 9 - 12 , wherein said coronavirus Spike polypeptide is fused to said chaff polypeptide. 
     
     
         14 . A composition comprising the SC-Ad of any one of  claims 1 - 13 . 
     
     
         15 . A method for inducing an immune response against a coronavirus in a mammal, wherein said method comprises administering the SC-Ad of any one of  claims 1 - 13  or the composition of  claim 14  to said mammal under conditions wherein said SC-Ad infects a cell of said mammal, and wherein expression of said immunogen in said cell leads to induction of said immune response. 
     
     
         16 . The method of  claim 15 , wherein said mammal is a human. 
     
     
         17 . The method of any one of  claims 15 - 16 , wherein said coronavirus is a betacoronavirus. 
     
     
         18 . The method of  claim 17 , wherein said betacoronavirus is SARS-CoV-2. 
     
     
         19 . The method of any one of  claims 15 - 18 , wherein said administering comprising mucosal delivery of said SC-Ad. 
     
     
         20 . A SC-Ad, wherein said SC-Ad comprises a genome lacking at least a portion of a nucleic acid sequence that encodes an adenovirus polypeptide, wherein said SC-Ad comprises said adenovirus polypeptide, and wherein said SC-Ad comprises (a) a nucleic acid sequence encoding an immunogen and (b) a nucleic acid sequence encoding an adjuvant polypeptide. 
     
     
         21 . The SC-Ad of  claim 20 , wherein said adenovirus polypeptide is selected from the group consisting of a fiber polypeptide, a V polypeptide, a hexon polypeptide, a penton base polypeptide, and a pIIIa polypeptide. 
     
     
         22 . The SC-Ad of any one of  claims 20 - 21 , wherein said immunogen is a coronavirus immunogen. 
     
     
         23 . The SC-Ad of  claim 22 , wherein said coronavirus immunogen comprises a coronavirus Spike polypeptide or an immunogenic fragment thereof. 
     
     
         24 . The SC-Ad of  claim 23 , wherein said coronavirus immunogen consists of or consists essentially of an amino acid sequence set forth in any one of SEQ ID NOs:1-4. 
     
     
         25 . The SC-Ad of any one of  claims 20 - 24 , wherein said adjuvant polypeptide is selected from the group consisting of a GM-CSF polypeptide, an IL-4 polypeptide, an IL-21 polypeptide, a CD40L polypeptide, a 4-1BBL polypeptide, a TGF-β polypeptide, a  Clostridium difficile  TcdA polypeptide, a  C. difficile  TcdB polypeptide, and biologically active fragments thereof. 
     
     
         26 . The SC-Ad of  claim 25 , wherein said coronavirus Spike polypeptide is fused to said adjuvant polypeptide. 
     
     
         27 . The SC-Ad of  claim 26 , wherein said coronavirus Spike polypeptide fused to said adjuvant polypeptide consists essentially of or consists of an amino acid sequence set forth in SEQ ID NO:5. 
     
     
         28 . The SC-Ad of any one of  claims 20 - 27 , wherein said SC-Ad further comprises a nucleic acid sequence encoding a chaff polypeptide. 
     
     
         29 . The SC-Ad of  claim 28 , wherein said chaff polypeptide is a fragment of an ACE2 polypeptide. 
     
     
         30 . The SC-Ad of  claim 29 , wherein said fragment of an ACE2 polypeptide comprises the extracellular region of an ACE2 polypeptide and lacks a transmembrane domain. 
     
     
         31 . The SD-Ac of  claim 30 , wherein said chaff polypeptide consists essentially of or consists of an amino acid sequence set forth in SEQ ID NO:8 or SEQ ID NO:9. 
     
     
         32 . A composition comprising the SC-Ad of any one of  claims 20 - 31 . 
     
     
         33 . A method for inducing an immune response against a virus in a mammal, wherein said method comprises administering the SC-Ad of any one of  claims 20 - 31  or the composition of  claim 32  to said mammal under conditions wherein said SC-Ad infects a cell of said mammal, and wherein expression of said immunogen in said cell leads to induction of said immune response. 
     
     
         34 . The method of  claim 33 , wherein said mammal is a human. 
     
     
         35 . The method of any one of  claims 33 - 34 , wherein said virus is a coronavirus, and wherein said immunogen is associated with said coronavirus. 
     
     
         36 . The method of any one of  claims 33 - 35 , wherein said coronavirus is a betacoronavirus. 
     
     
         37 . The method of  claim 36 , wherein said betacoronavirus is SARS-CoV-2. 
     
     
         38 . The method of any one of  claims 33 - 37 , wherein said administering comprising mucosal delivery of said SC-Ad. 
     
     
         39 . A SC-Ad, wherein said SC-Ad comprises a genome which lacks at least a portion of a nucleic acid sequence that encodes an adenovirus polypeptide, wherein said SC-Ad comprises said adenovirus polypeptide, and wherein said SC-Ad comprises (a) a nucleic acid sequence encoding an immunogen and (b) a nucleic acid sequence encoding a chaff polypeptide. 
     
     
         40 . The SC-Ad of  claim 39 , wherein said adenovirus polypeptide is selected from the group consisting of a fiber polypeptide, a V polypeptide, a hexon polypeptide, a penton base polypeptide, and a pIIIa polypeptide. 
     
     
         41 . The SC-Ad of any one of  claims 39 - 40 , wherein said immunogen is a coronavirus immunogen. 
     
     
         42 . The SC-Ad of  claim 41 , wherein said coronavirus immunogen comprises a coronavirus Spike polypeptide or an immunogenic fragment thereof. 
     
     
         43 . The SC-Ad of  claim 42 , wherein said coronavirus immunogen consists of or consists essentially of an amino acid sequence set forth in any one of SEQ ID NOs:1-4. 
     
     
         44 . The SC-Ad of  claim 43 , wherein said chaff polypeptide is a fragment of an ACE2 polypeptide. 
     
     
         45 . The SC-Ad of  claim 44 , wherein said fragment of an ACE2 polypeptide comprises the extracellular region of an ACE2 polypeptide and lacks a transmembrane domain. 
     
     
         46 . The SD-Ac of  claim 45 , wherein said chaff polypeptide consists essentially of or consists of an amino acid sequence set forth in SEQ ID NO:8 or SEQ ID NO:9. 
     
     
         47 . The SC-Ad of any one of  claims 39 - 46 , wherein said coronavirus Spike polypeptide is fused to said chaff polypeptide. 
     
     
         48 . The SC-Ad of any one of  claims 39 - 47 , wherein said SC-Ad further comprises a nucleic acid sequence encoding an adjuvant polypeptide. 
     
     
         49 . The SC-Ad of  claim 48 , wherein said adjuvant polypeptide is selected from the group consisting of a GM-CSF polypeptide, an IL-4 polypeptide, an IL-21 polypeptide, a CD40L polypeptide, a 4-1BBL polypeptide, a TGF-β polypeptide, a  Clostridium difficile  TcdA polypeptide, a  C. difficile  TcdB polypeptide, and biologically active fragments thereof. 
     
     
         50 . A composition comprising the SC-Ad of any one of  claims 39 - 49 . 
     
     
         51 . A method for inducing an immune response against a virus in a mammal, wherein said method comprises administering the SC-Ad of any one of  claims 39 - 49  or the composition of  claim 50  to said mammal under conditions wherein said SC-Ad infects a cell of said mammal, and wherein expression of said immunogen in said cell leads to induction of said immune response. 
     
     
         52 . The method of  claim 51 , wherein said mammal is a human. 
     
     
         53 . The method of any one of  claims 51 - 52 , wherein said virus is a coronavirus, and wherein said immunogen is associated with said coronavirus. 
     
     
         54 . The method of  claim 53 , wherein said coronavirus is a betacoronavirus. 
     
     
         55 . The method of  claim 54 , wherein said betacoronavirus is SARS-CoV-2. 
     
     
         56 . The method of any one of  claims 51 - 55 , wherein said administering comprising mucosal delivery of said SC-Ad.

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