IP Library Granted Patent US 10,357,557
Granted Patent B2
US 10,357,557 · App. 15/421,808 · Granted Jul 23, 2019

Isolated polypeptide of the toxin A and toxin B proteins of

Inventors: Larry R. Ellingsworth (Rockville, MD); David Flyer (Olney, MD); Jing-Hui Tian (Germantown, MD); Steven R. Fuhrmann (Germantown, MD); Stefanie Kluepfel-Stahl (Bethesda, MD); Gregory M. Glenn (Gaithersburg, MD); Kerstin Westritschnig (Vienna, AT)
Assignees: Valneva Austria GmbH; Valneva USA, Inc.
A61K39/08C07K14/33C07K16/1282A61K2039/53A61K2039/55505A61K2039/55544A61K2039/575C07K2317/76C07K2319/00C07K2319/40C07K2319/55
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Quick Facts
Patent No.
US 10,357,557
App. No.
15/421,808
Granted
Jul 23, 2019
Kind
B2
Abstract

This present invention provides C-TAB.G5 and C-TAB.G5.1 isolated polypeptides comprising the receptor binding domains of C. difficile toxin A and toxin B as set forth in the amino acid sequences of SEQ ID NO: 2 and SEQ ID NO: 4. The C-TAB.G5 and C-TAB.G5.1 isolated polypeptides may be used to neutralize toxic effects of C. difficile toxin A and/or toxin B.

Claims (15)

1. An isolated polypeptide comprising an amino acid sequence having at least 85% sequence identity to the amino acid sequence as set forth in SEQ ID NO: 4, wherein the sequence identity is determined by Needleman-Wunsch global alignment.

2. The polypeptide of claim 1 , wherein the polypeptide comprises 19 repeating units derived from the C-terminal domain of toxin A of Clostridium difficile.

3. The polypeptide of claim 1 , wherein the polypeptide comprises 23 repeating units derived from the C-terminal domain of toxin B of Clostridium difficile.

4. The polypeptide of claim 1 , wherein the polypeptide consists of the amino acid sequence as set forth in SEQ ID NO: 2 or SEQ ID NO: 4.

5. A pharmaceutical composition comprising the polypeptide of claim 1 and a pharmaceutically acceptable carrier or excipient.

6. An immunogenic or vaccine composition comprising an isolated polypeptide having at least 85% sequence identity to the amino acid sequence set forth in SEQ ID NO: 4 and a pharmaceutically acceptable carrier or excipient, wherein the sequence identity is determined by Needleman-Wunsch global alignment.

7. The composition of claim 6 , wherein the polypeptide comprises 19 repeating units derived from the C-terminal domain of toxin A of Clostridium difficile.

8. The composition of claim 6 , wherein the polypeptide comprises 23 repeating units derived from the C-terminal domain of toxin B of Clostridium difficile.

9. The composition of claim 6 , wherein the polypeptide consists of the amino acid sequence as set forth in SEQ ID NO: 2 or SEQ ID NO: 4.

10. The composition of claim 6 , wherein the composition further comprises a therapeutic agent and is for the prevention and treatment of a C. difficile associated disease (CDAD).

11. The composition of claim 6 , wherein the polypeptide has at least 99% sequence identity to the amino acid sequence as set forth in SEQ ID NO: 4.

12. The composition of claim 6 , further comprising an adjuvant.

13. The composition of claim 12 , wherein the adjuvant comprises alum.

14. An isolated polypeptide having at least 99% sequence identity to the amino acid sequence as set forth in SEQ ID NO: 4.

15. A pharmaceutical composition comprising the polypeptide of claim 14 and a pharmaceutically acceptable carrier or excipient.

Assignments (7)
AMENDED AND RESTATED PATENT SECURITY AGREEMENT Recorded Mar 31, 2026
From: VALNEVA AUSTRIA GMBH; VALNEVA SE; VALNEVA SWEDEN AB
To: BIOPHARMA CREDIT PLC, AS COLLATERAL AGENT
Reel/Frame 075335/0609 →
RELEASE OF SECURITY INTEREST Recorded Nov 10, 2025
From: WILMINGTON TRUST, NATIONAL ASSOCIATION, AS ADMINISTRATIVE AGENT
To: VALNEVA AUSTRIA GMBH; VALNEVA SE; VALNEVA USA, INC.
Reel/Frame 073516/0522 →
PATENT SECURITY AGREEMENT Recorded Oct 20, 2025
From: VALNEVA AUSTRIA GMBH; VALNEVA SE; VALNEVA SWEDEN AB
To: BIOPHARMA CREDIT PLC, AS COLLATERAL AGENT
Reel/Frame 073164/0032 →
CHANGE OF NAME Recorded Mar 13, 2020
From: INTERCELL USA, INC.
To: VALNEVA USA, INC.
Reel/Frame 052164/0750 →
SECURITY INTEREST Recorded Mar 4, 2020
From: VALNEVA SE; VALNEVA USA, INC.; VALNEVA AUSTRIA GMBH
To: WILMINGTON TRUST, NATIONAL ASSOCIATION
Reel/Frame 052016/0745 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 9, 2017
From: WESTRITSCHNIG, KERSTIN
To: VALNEVA AUSTRIA GMBH
Reel/Frame 043244/0283 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 9, 2017
From: ELLINGSWORTH, LARRY R.; FLYER, DAVID; TIAN, JING-HUI; FUHRMANN, STEVEN R.; KLUEPFEL-STAHL, STEFANIE; GLENN, GREGORY M.
To: INTERCELL USA, INC.
Reel/Frame 043244/0297 →
Continuity (2)
Division 14342565
Related Publication 20170239340A1 · Aug 24, 2017
Cited By (2)
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