US2022364115A1PendingUtilityA1

Enhanced promoter

Assignee: GLAXOSMITHKLINE BIOLOGICALS SAPriority: Oct 16, 2017Filed: Apr 27, 2022Published: Nov 17, 2022
Est. expiryOct 16, 2037(~11.2 yrs left)· nominal 20-yr term from priority
Inventors:Stefano Colloca
C12N 2830/00C12N 2830/001A61P 37/04C12N 15/86A61K 39/155C12N 2710/10334A61K 2039/5256C12N 2840/44C12N 2710/10343C12N 2710/10321
70
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Claims

Abstract

A new promoter comprising: (i) an hCMV enhancer sequence; (ii) an hCMV promoter sequence; (iii) a splice donor region; (iv) a cell-derived enhancer sequence; and (v) a splice acceptor region.

Claims

exact text as granted — not AI-modified
1 - 18 . (canceled) 
     
     
         19 . An adenoviral vector comprising an expression cassette, wherein the expression cassette comprises a transgene and a promoter, wherein the promoter comprises:
 (i) an hCMV enhancer sequence;   (ii) an hCMV promoter sequence;   (iii) a splice donor region;   (iv) a cell-derived enhancer sequence; and   (v) a splice acceptor region,   wherein the promotor comprises a nucleic acid sequence having at least 85% sequence identity to SEQ ID NO: 3.   
     
     
         20 . The adenoviral vector of  claim 19 , wherein the adenoviral vector comprises a first expression cassette and a second expression cassette, wherein both the first expression cassette and the second expression cassette comprise a transgene and a promoter, wherein the promoter comprises:
 (i) an hCMV enhancer sequence;   (ii) an hCMV promoter sequence;   (iii) a splice donor region;   (iv) a cell-derived enhancer sequence; and   (v) a splice acceptor region,   wherein the promotor comprises a nucleic acid sequence having at least 85% sequence identity to SEQ ID NO: 3.   
     
     
         21 . The adenoviral vector of  claim 19 , wherein the components (i) to (v) of the promoter are provided in the order listed. 
     
     
         22 . The adenoviral vector of  claim 19 , wherein the cell-derived enhancer sequence is an ubitquitin (UBC) enhancer sequence, and wherein the UBC enhancer sequence comprises the sequence of SEQ ID NO: 11. 
     
     
         23 . The adenoviral vector of  claim 19 , wherein the promotor comprises a sequence having at least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% sequence identity to one or more of SEQ ID NO: 8, SEQ ID NO:10, SEQ ID NO:11, and SEQ ID NO:12. 
     
     
         24 . The adenoviral vector of  claim 19 , wherein the promotor comprises:
 (i) the hCMV enhancer sequence;   (ii) the hCMV promoter sequence of SEQ ID NO: 8;   (iii) the splice donor region of SEQ ID NO:10;   (iv) the UBC enhancer sequence of SEQ ID NO:11; and   (v) the splice acceptor region of SEQ ID NO: 12.   
     
     
         25 . The adenoviral vector of  claim 19 , wherein the promotor further comprises a fragment of the beta-actin sequence, wherein the fragment of the beta-actin sequence comprises a 5′ untranslated region of the beta actin sequence and does not contain the promoter sequence. 
     
     
         26 . The adenoviral vector of  claim 25 , wherein the beta-actin sequence comprises a sequence having at least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% sequence identity to SEQ ID NO: 9. 
     
     
         27 . The adenoviral vector of  claim 25 , wherein the fragment of the beta-actin sequence is located between the hCMV promoter region and the splice donor region. 
     
     
         28 . The adenoviral vector of  claim 19 , wherein the adenoviral vector is derived from a simian adenovirus. 
     
     
         29 . A composition comprising the adenoviral vector of  claim 19  and a pharmaceutically acceptable excipient. 
     
     
         30 . A method of inducing an immune response against a disease caused by a pathogen in a subject in need thereof comprising administering an immunologically effective amount of the composition of  claim 29  to the subject. 
     
     
         31 . A method of inducing an immune response against a disease caused by a pathogen in a subject in need thereof comprising administering an immunologically effective amount of the adenoviral vector of  claim 19  to the subject. 
     
     
         32 . A method of treating a subject infected with a disease caused by a pathogen comprising administering an effective amount of the adenoviral vector of  claim 19  to the subject. 
     
     
         33 . A method of treating a subject infected with a disease caused by a pathogen comprising administering an effective amount of the composition of  claim 29  to the subject.

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