IP Library Granted Patent US 10,336,995
Granted Patent B2
US 10,336,995 · App. 16/112,283 · Granted Jul 2, 2019

Beta-lactamases with improved properties for therapy

Inventors: Michael Kaleko (Rockville, MD); Sheila Connelly (Rockville, MD)
Assignee: SYNTHETIC BIOLOGICS, INC.
C12N9/86A61K9/0053A61K31/546A61K38/50A61K45/06C12Y305/02006A61K38/00
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Quick Facts
Patent No.
US 10,336,995
App. No.
16/112,283
Granted
Jul 2, 2019
Kind
B2
Abstract

This invention relates to, in part, compositions of beta-lactamases and methods of using these enzymes in, for example, gastrointestinal tract (GI tract) disorders such as C. difficile infection (CDI).

Claims (14)

1. A beta-lactamase comprising an amino acid sequence having at least 95% sequence identity with SEQ ID NO: 1 and the following mutations according to Ambler classification:

an aliphatic hydrophobic residue other than glutamine (Q) at position 135.

2. The beta-lactamase of claim 1 , wherein the aliphatic hydrophobic residue is selected from glycine (G), leucine (L), isoleucine (I), methionine (M), and valine (V).

3. The beta-lactamase of claim 2 , wherein the aliphatic hydrophobic residue is methionine (M).

4. A polynucleotide comprising a polynucleotide sequence encoding the beta-lactamase of claim 1 .

5. A host cell comprising the polynucleotide of claim 4 .

6. A pharmaceutical composition, comprising the beta-lactamase of claim 1 and a pharmaceutically acceptable carrier or excipient.

7. The pharmaceutical composition of claim 6 , wherein the pharmaceutical composition is formulated for oral administration, optionally selected from a tablet, multi-particulate sprinkle, and a multi-particulate capsule.

8. A method for preventing an antibiotic-induced adverse effect in the gastrointestinal (GI) tract, comprising administering an effective amount of a beta-lactamase to a patient in need thereof, wherein the beta-lactamase comprises an amino acid sequence having at least 95% sequence identity with SEQ ID NO: 1 and the following mutations according to Ambler classification:

an aliphatic hydrophobic residue other than glutamine (Q) at position 135.

9. The method of claim 8 , wherein the aliphatic hydrophobic residue is selected from glycine (G), leucine (L), isoleucine (I), methionine (M), and valine (V).

10. The method of claim 9 , wherein the aliphatic hydrophobic residue is methionine (M).

11. The method of claim 8 , wherein the subject is being administered or will be administered an antibiotic.

12. The method of claim 8 , wherein the antibiotic-induced adverse effect in the gastrointestinal (GI) tract is selected from C. difficile infection (CDI), C. difficile -associated disease, and antibiotic-associated diarrhea (AAD).

Assignments (2)
CHANGE OF NAME Recorded Feb 28, 2023
From: SYNTHETIC BIOLOGICS, INC.
To: THERIVA BIOLOGICS, INC.
Reel/Frame 062822/0493 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 18, 2018
From: KALEKO, MICHAEL; CONNELLY, SHEILA
To: SYNTHETIC BIOLOGICS, INC.
Reel/Frame 046901/0665 →
Continuity (11)
Continuation 15993159 · May 30, 2018
Continuation 15674177 · Aug 10, 2017
Continuation 15611881 · Jun 2, 2017
Continuation 15245517 · Aug 24, 2016
Continuation 15200508 · Jul 1, 2016
Continuation 15160669 · May 20, 2016
Continuation 15019474 · Feb 9, 2016
Continuation 14689877 · Apr 17, 2015
Provisional Application 62046627 · Sep 5, 2014
Provisional Application 61980844 · Apr 17, 2014
Related Publication 20180362954A1 · Dec 20, 2018