IP Library Granted Patent US 11,254,731
Granted Patent B2
US 11,254,731 · App. 16/211,202 · Granted Feb 22, 2022

Viral vectors encoding recombinant FVIII variants with increased expression for gene therapy of hemophilia A

Inventors: Falko-Günter Falkner (Orth/Donau, AT); Franziska Horling (Gaenserndorf, AT); Johannes Lengler (Vienna, AT); Hanspeter Rottensteiner (Vienna, AT); Friedrich Scheiflinger (Vienna, AT)
Assignee: Takeda Pharmaceutical Company Limited
C07K14/755A61K48/0008A61K48/0058A61K48/0066C12N15/86C12N2750/14143C12N2800/22C12N2840/007
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Quick Facts
Patent No.
US 11,254,731
App. No.
16/211,202
Granted
Feb 22, 2022
Kind
B2
Abstract

The present disclosure provides, among other aspects, codon-altered polynucleotides encoding Factor VIII variants for expression in mammalian cells. In some embodiments, the disclosure also provides mammalian gene therapy vectors and methods for treating hemophilia A.

Claims (10)

1. A polynucleotide comprising the nucleotide sequence of SEQ ID NO: 13, wherein the polynucleotide encodes a Factor VIII polypeptide.

2. The polynucleotide of claim 1 , further comprising a promoter element operably linked to the polynucleotide encoding the Factor VIII polypeptide.

3. The polynucleotide of claim 2 , wherein the promoter element is a liver-specific promoter sequence upstream of the nucleotide sequence encoding the Factor VIII polypeptide.

4. The polynucleotide of claim 3 , further comprising an intron sequence positioned between the liver-specific promoter sequence and the nucleotide sequence encoding the Factor VIII polypeptide.

5. An adeno-associated virus (AAV) vector comprising a polynucleotide of claim 1 .

6. An adeno-associated virus (AAV) particle comprising a polynucleotide of claim 1 .

7. A host cell infected with an adeno-associated virus (AAV) particle comprising a polynucleotide of claim 1 .

8. A method for producing an adeno-associated virus (AAV) particle comprising introducing a polynucleotide of claim 1 into a mammalian host cell, wherein the polynucleotide is competent for replication in the mammalian host cell.

9. A method for treating hemophilia A comprising administering, to a patient in need thereof, an adeno-associated virus (AAV) particle according to claim 6 .

10. A method for transducing a host cell comprising contacting the host cell with an adeno-associated virus (AAV) particle according to claim 6 .

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 31, 2021
From: BAXALTA GMBH; BAXALTA INCORPORATED
To: TAKEDA PHARMACEUTICAL COMPANY LIMITED
Reel/Frame 055189/0177 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 5, 2018
From: FALKNER, FALKO-GUENTER; HORLING, FRANZISKA; LENGLER, JOHANNES; ROTTENSTEINER, HANSPETER; SCHEIFLINGER, FRIEDRICH
To: BAXALTA INCORPORATED; BAXALTA GMBH
Reel/Frame 047685/0691 →
Continuity (3)
Continuation 15349930 · Nov 11, 2016
Provisional Application 62255317 · Nov 13, 2015
Related Publication 20190194295A1 · Jun 27, 2019