IP Library › Granted Patent US 10,744,168
Granted Patent B2
US 10,744,168 · App. 15/800,529 · Granted Aug 18, 2020

Genetically modified probiotic for the treatment of phenylketonuria (PKU) disease

Inventors: Katherine Durrer (Irving, TX); Michael Allen (Denton, TX); Ione Hunt von Herbing (Denton, TX)
Assignee: UNIVERSITY OF NORTH TEXAS
A61K35/747A61K9/0053A61K38/51A61P3/00C12Y403/01024
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Quick Facts
Patent No.
US 10,744,168
App. No.
15/800,529
Granted
Aug 18, 2020
Kind
B2
Abstract

A GMP adapted to provide the PAL gene for the treatment of PKU when administered orally. The GMP of the present invention may include a probiotic, a PAL gene to be expressed using the probiotic, wherein the PAL gene is functionally attached to a promoter and a ribosome binding site, and may be codon-optimized for expression in a certain host organism. A method of treating the metabolic disease of PKU by oral administration and ingestion of a GMP is also provided.

Claims (10)

1. A composition for treating phenylketonuria, comprising:

a probiotic bacterium from the Lactobacillus genera selected from the group consisting of Lactobacillus acidophilus, Lactobacillus brevis, Lactobacillus casei, Lactobacillus plantarum , and Lactobacillus reuteri , wherein the probiotic bacterium is genetically modified to express an exogenous nucleotide sequence encoding a functional phenylalanine ammonia-lyase (PAL) enzyme protein, and wherein the nucleotide sequence encoding the phenylalanine ammonia-lyase (PAL) comprises SEQ ID NO:15.

2. The composition of claim 1 , wherein the nucleotide sequence encoding the phenylalanine ammonia-lyase (PAL) is integrated into the chromosome of the probiotic bacterium.

3. The composition of claim 1 , wherein the probiotic bacterium carries a recombinant plasmid vector comprising the nucleotide sequence encoding the phenylalanine ammonia-lyase (PAL), and wherein the recombinant plasmid vector comprises a nucleotide sequence comprising SEQ ID NO: 13 or SEQ ID NO:14.

4. The composition of claim 1 , wherein the probiotic bacterium is Lactobacillus reuteri.

5. The composition of claim 1 , wherein the probiotic bacterium is Lactobacillus acidophilus.

6. A method for administering a composition for treating phenylketonuria, comprising the step of:

administering a therapeutically effective amount of the composition of claim 1 to a patient in need thereof, wherein said administration is oral.

7. A composition for treating phenylketonuria, comprising:

a probiotic bacterium, wherein the probiotic bacterium is Lactobacillus acidophilus , wherein the probiotic bacterium is genetically modified to integrate an exogenous nucleotide sequence encoding a functional phenylalanine ammonia-lyase (PAL) enzyme protein into the chromosome of the probiotic bacterium, wherein the probiotic bacterium expresses the nucleotide sequence encoding the phenylalanine ammonia-lyase (PAL), and wherein the nucleotide sequence encoding the phenylalanine ammonia-lyase (PAL) comprises SEQ ID NO: 15.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 9, 2018
From: DEMING, KATHERINE; ALLEN, MICHAEL; VON HERBING, IONE HUNT
To: UNIVERSITY OF NORTH TEXAS
Reel/Frame 044573/0115 →
Continuity (3)
Continuation In Part 14417176
Provisional Application 61676461 · Jul 27, 2012
Related Publication 20180117101A1 · May 3, 2018