IP Library Granted Patent US 9,650,639
Granted Patent B2
US 9,650,639 · App. 14/341,215 · Granted May 16, 2017

Dual delivery system for heterologous antigens

Inventors: Paulo Maciag (Long Grove, IL); Anu Wallecha (Yardley, PA); Vafa Shahabi (Valley Forge, PA)
Assignee: ADVAXIS, INC.
C12N15/74A61K38/19A61K39/0011A61K39/39C07K14/4748C07K14/515A61K2039/523A61K2039/6006
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Quick Facts
Patent No.
US 9,650,639
App. No.
14/341,215
Granted
May 16, 2017
Kind
B2
Abstract

Provided herein are recombinant Listeria strains expressing a tumor-specific antigenic polypeptide and, optionally, an angiogenic polypeptide wherein a nucleic acid molecule encoding at least one of the polypeptides is operably integrated into the Listeria genome in an open reading frame with a nucleic acid sequence encoding a PEST-containing polypeptide, methods of preparing same, and methods of inducing an immune response, and treating, inhibiting, or suppressing cancer or tumors comprising administering same.

Claims (18)

1. A recombinant Listeria strain comprising a first and second nucleic acid molecule, each said nucleic acid molecule encoding a heterologous antigenic polypeptide or immunogenic fragment thereof, wherein said first nucleic acid molecule is operably integrated into the Listeria genome in an open reading frame with a first endogenous PEST-containing gene, and wherein said recombinant Listeria strain comprises an episomal expression vector comprising said second nucleic acid molecule encoding a heterologous antigen operably fused to a second PEST-containing gene, wherein said Listeria strain is a recombinant dal/dat mutant strain, wherein said Listeria strain comprises a mutation or deletion of said Listeria endogenous actA gene.

2. The recombinant Listeria of claim 1 , wherein said episomal expression vector comprises an open reading frame encoding a metabolic enzyme for complementing said dal/dat mutant.

3. The recombinant Listeria strain of claim 1 , wherein said first PEST-containing gene is LLO.

4. The recombinant Listeria strain of claim 1 , wherein said first PEST-containing gene is ActA.

5. The recombinant Listeria strain of claim 1 , wherein said first or second nucleic acid molecule encodes a polypeptide expressed by a tumor cell.

6. The recombinant Listeria strain of claim 1 , wherein said first or second nucleic acid molecule encodes an angiogenic polypeptide.

7. The recombinant Listeria strain of claim 1 , wherein said first or second nucleic acid molecule encodes a prostate specific antigen (PSA).

8. The recombinant Listeria strain of claim 1 , wherein said first or second nucleic acid molecule encodes a High Molecular Weight-Melanoma Associated Antigen (HMW-MAA).

9. The recombinant Listeria strain of claim 1 , wherein said first or second nucleic acid molecule encodes a chimeric Her2 antigen (cHer2).

10. The recombinant Listeria strain of claim 1 , wherein said first nucleic acid molecule is a vector designed for site-specific homologous recombination into the Listeria genome.

11. The recombinant Listeria strain of claim 1 , wherein said recombinant Listeria strain is an auxotrophic Listeria strain.

12. The recombinant Listeria strain of claim 2 , wherein said metabolic enzyme is an alanine racemase enzyme.

13. The recombinant Listeria strain of claim 2 , wherein said metabolic enzyme is a D-amino acid transferase enzyme.

14. The recombinant Listeria strain of claim 1 , wherein said recombinant Listeria strain has been passaged through an animal host.

15. The recombinant Listeria strain of claim 1 , wherein said recombinant Listeria strain is a recombinant Listeria monocytogenes strain.

16. An immunogenic composition comprising the recombinant Listeria strain of claim 1 and an adjuvant, cytokine, chemokine, or combination thereof.

17. The recombinant Listeria strain of claim 1 , wherein said first or second nucleic acid molecule encodes a carbonic anhydrase 9 (CA9) antigen or fragment thereof.

18. The recombinant Listeria strain of claim 1 , wherein said second PEST-containing gene comprises a truncated LLO (tLLO), a truncated ActA, or a PEST sequence peptide.

Assignments (2)
CHANGE OF NAME Recorded Nov 20, 2025
From: ADVAXIS, INC.
To: AYALA PHARMACEUTICALS, INC.
Reel/Frame 073682/0045 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 29, 2014
From: MACIAG, PAULO; WALLECHA, ANU; SHAHABI, VAFA
To: ADVAXIS, INC
Reel/Frame 034058/0706 →
Continuity (10)
Continuation In Part 14204806 · Mar 11, 2014
Division 12993380
Division 14341215 · Jul 25, 2014
Continuation In Part 14268436 · May 2, 2014
Continuation In Part 14189008 · Feb 25, 2014
Continuation In Part 13210696 · Aug 16, 2011
Continuation In Part 12945386 · Nov 12, 2010
Provisional Application 61071792 · May 19, 2008
Provisional Application 61260277 · Nov 11, 2009
Related Publication 20140335120A1 · Nov 13, 2014