IP Library Granted Patent US 12,234,261
Granted Patent B2
US 12,234,261 · App. 18/074,302 · Granted Feb 25, 2025

Hepatitis B vaccines and uses of the same

Inventors: Douglas E. Brough (Germantown, MD); Cheryl G. Bolinger (Germantown, MD); Ramya Yarlagadda (Germantown, MD); Vinodhbabu Kurella (Germantown, MD); Prabakaran Ponraj (Germantown, MD); Simon Metenou (Germantown, MD); Kuan-Fu Ding (Germantown, MD)
Assignee: Precigen, Inc.
C07K14/005A61K39/12A61K39/292A61K48/0066C07K14/02C12N7/00C12N15/861C07K2319/33C12N2710/20022C12N2710/20034
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Quick Facts
Patent No.
US 12,234,261
App. No.
18/074,302
Granted
Feb 25, 2025
Kind
B2
Abstract

Provided herein are engineered hepatitis B virus (HBV) molecular vaccine constructs. Vaccine constructs can also include ligand-inducible engineered gene switch systems for modulating expression of heterologous genes, such as a cytokines, in host cells.

Claims (27)

1. A polypeptide construct comprising:

(a) (i) an HBV Pol domain consisting of SEQ ID NO: 99, and (ii) at least one additional domain selected from: an HBV Envelope domain consisting of SEQ ID NO: 100; an HBV Core domain consisting of SEQ ID NO: 101; and an HBx domain consisting of SEQ ID NO: 98; or

(b) (i) an ankyrin-like repeat domain, and (ii) an HBV polypeptide.

2. The polypeptide construct of claim 1 , wherein the polypeptide construct comprises: (a) an ankyrin-like repeat domain; and (b) an HBV polypeptide; wherein:

the ankyrin-like repeat domain is a human ankyrin-like repeat domain; and/or

the HBV polypeptide comprises a sequence of any one of SEQ ID NOs: 45-60 and 112-127.

3. The polypeptide construct of claim 1 , comprising the sequence of any one of SEQ ID NOs: 106, 108, and 109.

4. A polynucleotide encoding the polypeptide construct of claim 1 .

5. A polynucleotide construct comprising: (a) the polynucleotide of claim 4 ; and (b) one or more additional polynucleotides encoding components of a gene switch system, wherein the gene switch system is operably linked to regulate the expression of the polypeptide construct encoded by the polynucleotide of (a).

6. The polynucleotide construct of claim 5 , wherein the gene switch is an ecdysone receptor-based (EcR-based) gene switch system.

7. A method of regulating the expression of a polypeptide construct in a cell, the method comprising:

(a) introducing into the cell the polynucleotide construct of claim 4 that encodes the polypeptide construct, and

(b) exposing the cell to a compound in an amount sufficient to modulate expression of the polypeptide construct.

8. The method of claim 7 , wherein the gene switch system comprises a ligand binding domain derived from a receptor selected from: an ecdysone receptor (EcR), a ubiquitous receptor, an orphan receptor 1, an NER-1, a steroid hormone nuclear receptor 1, a retinoid X receptor interacting protein-15, a liver X receptor b, a steroid hormone receptor like protein, a liver X receptor, a liver X receptor a, a farnesoid X receptor, a receptor interacting protein 14, and a famesol receptor.

9. A vector comprising the polynucleotide of claim 4 .

10. The vector of claim 9 , wherein the vector is a gorilla adenoviral vector.

11. The vector of claim 10 , wherein the vector is a GC46 vector.

12. The polypeptide construct of claim 1 , comprising the following HBV polypeptides:

(a) an HBV Envelope domain consisting of SEQ ID NO: 100;

(b) an HBV Core domain consisting of SEQ ID NO: 101;

(c) an HBx domain consisting of SEQ ID NO: 98; and

(d) an HBV Pol domain consisting of SEQ ID NO: 99;

wherein at least two of the HBV polypeptides are connected by a linker.

13. The polypeptide construct of claim 1 , comprising, from N-terminus to C-terminus, the following domains: (a) the HBV Envelope domain; (b) the HBV Core domain; (c) the HBx domain; and (d) the HBV Pol domain.

14. The polypeptide construct of claim 13 , wherein: the HBV Envelope domain and the HBV Core domain are connected by a first linker; the HBV Core domain and the HBx domain are connected by a second linker; the HBx domain and the HBV domain are connected by a third linker; and each linker comprises the amino acid sequence SEQ ID NO: 129.

15. A polynucleotide encoding the polypeptide construct of claim 14 .

16. The polypeptide construct of claim 1 , comprising the sequence of SEQ ID NO: 106.

Assignments (1)
PATENT SECURITY AGREEMENT Recorded Sep 3, 2025
From: PRECIGEN, INC.; GENVEC LLC; PRECIGEN ACTOBIO, INC.; EXEMPLAR GENETICS, LLC
To: BIOPHARMA CREDIT PLC, AS COLLATERAL AGENT
Reel/Frame 072828/0564 →