IP Library Granted Patent US 12,116,402
Granted Patent B2
US 12,116,402 · App. 17/538,731 · Granted Oct 15, 2024

Antibodies against clostridium difficile toxins and methods of using the same

Inventors: Stephen F. Anderson (Arlington, MA); Natalie Anosova (Lexington, MA); Nicola Beltraminelli (Lyons, FR); Pierre Garrone (Lyons, FR); Harold Kleanthous (Chelmsford, MA); Majid Mehtali (Paris, FR); Jianxin Zhang (Acton, MA)
Assignee: SANOFI PASTEUR INC.
C07K16/1282A61K39/40A61K2039/505A61K2039/507C07K2317/21C07K2317/30C07K2317/31C07K2317/34C07K2317/76C07K2317/92
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Quick Facts
Patent No.
US 12,116,402
App. No.
17/538,731
Granted
Oct 15, 2024
Kind
B2
Abstract

Monoclonal antibodies, or antigen-binding fragments thereof, that bind to Clostridium difficile ( C. difficile ) toxin A or toxin B and methods of using the same to detect or treat C. difficile infections and/or C. difficile -associated disease.

Claims (28)

1. An isolated nucleic acid that encodes the amino acid sequence of one or more of the complementarity determining regions (CDRs) of a heavy chain variable domain and/or light chain variable domain of an isolated monoclonal antibody that binds to Clostridium difficile toxin A,

(a) wherein the heavy chain variable domain comprises the amino acid sequence of SEQ ID NO:2 and the light chain variable domain comprises the amino acid sequence of SEQ ID NO:4;

(b) wherein the heavy chain variable domain comprises the amino acid sequence of SEQ ID NO:20 and the light chain variable domain comprises the amino acid sequence of SEQ ID NO:22;

(c) wherein the heavy chain variable domain comprises the amino acid sequence of SEQ ID NO:38 and the light chain variable domain comprises the amino acid sequence of SEQ ID NO:40;

(d) wherein the heavy chain variable domain comprises the amino acid sequence of SEQ ID NO:56 and the light chain variable domain comprises the amino acid sequence of SEQ ID NO:58; or

(e) wherein the heavy chain variable domain comprises the amino acid sequence of SEQ ID NO:74 and the light chain variable domain comprises the amino acid sequence of SEQ ID NO:76; or

an isolated monoclonal antibody that binds to Clostridium difficile toxin B,

(a) wherein the heavy chain variable domain comprises the amino acid sequence of SEQ ID NO:92 and the light chain variable domain comprises the amino acid sequence of SEQ ID NO:94;

(b) wherein the heavy chain variable domain comprises the amino acid sequence of SEQ ID NO:110 and the light chain variable domain comprises the amino acid sequence of SEQ ID NO:112;

(c) wherein the heavy chain variable domain comprises the amino acid sequence of SEQ ID NO:128 and the light chain variable domain comprises the amino acid sequence of SEQ ID NO:130;

(d) wherein the heavy chain variable domain comprises the amino acid sequence of SEQ ID NO:146 and the light chain variable domain comprises the amino acid sequence of SEQ ID NO: 148;

(e) wherein the heavy chain variable domain comprises the amino acid sequence of SEQ ID NO: 164 and the light chain variable domain comprises the amino acid sequence of SEQ ID NO:166; or

(f) wherein the heavy chain variable domain comprises the amino acid sequence of SEQ ID NO:182 and the light chain variable domain comprises the amino acid sequence of SEQ ID NO:184.

2. An isolated nucleic acid that encodes the amino acid sequence of the heavy and/or light chain variable regions of an isolated monoclonal antibody that binds to Clostridium difficile toxin A,

(a) wherein the heavy chain variable domain comprises a complementarity determining region 1 (CDR1) comprising the amino acid sequence of SEQ ID NO:6; a CDR2 comprising the amino acid sequence of SEQ ID NO:8; and a CDR3 comprising the amino acid sequence of SEQ ID NO:10; and wherein the light chain variable domain comprises: a CDR1 comprising the amino acid sequence of SEQ ID NO: 13; a CDR2 comprising the amino acid sequence of SEQ ID NO:15; and a CDR3 comprising the amino acid sequence of SEQ ID NO:17;

(b) wherein the heavy chain variable domain comprises a CDR1 comprising the amino acid sequence of SEQ ID NO:24; a CDR2 comprising the amino acid sequence of SEQ ID NO:26; and a CDR3 comprising the amino acid sequence of SEQ ID NO:28; and wherein the light chain variable domain comprises: a CDR1 comprising the amino acid sequence of SEQ ID NO:31; a CDR2 comprising the amino acid sequence of SEQ ID NO:33; and a CDR3 comprising the amino acid sequence of SEQ ID NO:35;

(c) wherein the heavy chain variable domain comprises a CDR1 comprising the amino acid sequence of SEQ ID NO:42; a CDR2 comprising the amino acid sequence of SEQ ID NO:44; and a CDR3 comprising the amino acid sequence of SEQ ID NO:46; and wherein the light chain variable domain comprises: a CDR1 comprising the amino acid sequence of SEQ ID NO:49; a CDR2 comprising the amino acid sequence of SEQ ID NO:51; and a CDR3 comprising the amino acid sequence of SEQ ID NO:53;

(d) wherein the heavy chain variable domain comprises a CDR1 comprising the amino acid sequence of SEQ ID NO:60; a CDR2 comprising the amino acid sequence of SEQ ID NO:62; and a CDR3 comprising the amino acid sequence of SEQ ID NO:64; and wherein the light chain variable domain comprises: a CDR1 comprising the amino acid sequence of SEQ ID NO:67; a CDR2 comprising the amino acid sequence of SEQ ID NO:69; and a CDR3 comprising the amino acid sequence of SEQ ID NO:71; or

(e) wherein the heavy chain variable domain comprises a CDR1 comprising the amino acid sequence of SEQ ID NO: 78; a CDR2 comprising the amino acid sequence of SEQ ID NO:80; and a CDR3 comprising the amino acid sequence of SEQ ID NO:82; and wherein the light chain variable domain comprises: a CDR1 comprising the amino acid sequence of SEQ ID NO:85; a CDR2 comprising the amino acid sequence of SEQ ID NO:87; and a CDR3 comprising the amino acid sequence of SEQ ID NO:89 or

an isolated monoclonal antibody that binds to Clostridium difficile toxin B,

(a) wherein the heavy chain variable domain comprises a complementarity determining region 1 (CDR1) comprising the amino acid sequence of SEQ ID NO:96; a CDR2 comprising the amino acid sequence of SEQ ID NO:98; and a CDR3 comprising the amino acid sequence of SEQ ID NO:100; and wherein the light chain variable domain comprises: a CDR1 comprising the amino acid sequence of SEQ ID NO: 103; a CDR2 comprising the amino acid sequence of SEQ ID NO:105; and a CDR3 comprising the amino acid sequence of SEQ ID NO:107;

(b) wherein the heavy chain variable domain comprises a CDR1 comprising the amino acid sequence of SEQ ID NO: 114; a CDR2 comprising the amino acid sequence of SEQ ID NO:116; and a CDR3 comprising the amino acid sequence of SEQ ID NO:118; and wherein the light chain variable domain comprises: a CDR1 comprising the amino acid sequence of SEQ ID NO:121; a CDR2 comprising the amino acid sequence of SEQ ID NO:123; and a CDR3 comprising the amino acid sequence of SEQ ID NO:125;

(c) wherein the heavy chain variable domain comprises a CDR1 comprising the amino acid sequence of SEQ ID NO: 132; a CDR2 comprising the amino acid sequence of SEQ ID NO: 134; and a CDR3 comprising the amino acid sequence of SEQ ID NO: 136; and wherein the light chain variable domain comprises: a CDR1 comprising the amino acid sequence of SEQ ID NO: 139; a CDR2 comprising the amino acid sequence of SEQ ID NO: 141; and a CDR3 comprising the amino acid sequence of SEQ ID NO:143;

(d) wherein the heavy chain variable domain comprises a CDR1 comprising the amino acid sequence of SEQ ID NO:150; a CDR2 comprising the amino acid sequence of SEQ ID NO:152; and a CDR3 comprising the amino acid sequence of SEQ ID NO: 154; and wherein the light chain variable domain comprises: a CDR1 comprising the amino acid sequence of SEQ ID NO:157; a CDR2 comprising the amino acid sequence of SEQ ID NO:159; and a CDR3 comprising the amino acid sequence of SEQ ID NO:161;

(e) wherein the heavy chain variable domain comprises a CDR1 comprising the amino acid sequence of SEQ ID NO:168; a CDR2 comprising the amino acid sequence of SEQ ID NO:170; and a CDR3 comprising the amino acid sequence of SEQ ID NO: 172; and wherein the light chain variable domain comprises: a CDR1 comprising the amino acid sequence of SEQ ID NO:175; a CDR2 comprising the amino acid sequence of SEQ ID NO: 177; and a CDR3 comprising the amino acid sequence of SEQ ID NO:179; or

(f) wherein the heavy chain variable domain comprises a CDR1 comprising the amino acid sequence of SEQ ID NO: 186; a CDR2 comprising the amino acid sequence of SEQ ID NO:188; and a CDR3 comprising the amino acid sequence of SEQ ID NO: 190; and wherein the light chain variable domain comprises: a CDR1 comprising the amino acid sequence of SEQ ID NO: 193; a CDR2 comprising the amino acid sequence of SEQ ID NO: 195; and a CDR3 comprising the amino acid sequence of SEQ ID NO:197.

3. A recombinant expression vector comprising the nucleic acid of claim 2 .

4. An isolated host cell comprising the recombinant expression vector of claim 3 .

Assignments (6)
MERGER Recorded Jul 13, 2022
From: SANOFI PASTEUR BIOLOGICS, LLC
To: SANOFI PASTEUR INC.
Reel/Frame 060498/0841 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 30, 2021
From: BELTRAMINELLI, NICOLA; GARRONE, PIERRE; MEHTALI, MAJID
To: VALNEVA
Reel/Frame 058247/0683 →
CHANGE OF NAME Recorded Nov 30, 2021
From: BLINK THERAPEUTICS SAS
To: BLINK BIOMEDICAL SAS
Reel/Frame 058247/0882 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 30, 2021
From: BLINK BIOMEDICAL SAS
To: SANOFI PASTEUR BIOLOGICS, LLC.
Reel/Frame 058247/0914 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 30, 2021
From: VALNEVA
To: BLINK THERAPEUTICS SAS
Reel/Frame 058291/0845 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 30, 2021
From: ANDERSON, STEPHEN F.; ANOSOVA, NATALIE; KLEANTHOUS, HAROLD; ZHANG, JIANXIN
To: SANOFI PASTEUR BIOLOGICS, LLC.
Reel/Frame 058952/0072 →
Continuity (4)
Division 16204624 · Nov 29, 2018
Continuation 14776146
Provisional Application 61794071 · Mar 15, 2013
Related Publication 20220089700A1 · Mar 24, 2022