Bacteriophage preparations and method of use thereof
Inventors
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Assignees
Intralytix Inc • Zoetis Services LLC
MemberIntralytixIntralytixIntralytix is a biotechnology company specializing in bacteriophage-based solutions for controlling pathogenic bacteria in food safety, human and animal health, dietary supplements, environmental sanitation, and veterinary applications. The company utilizes lytic bacteriophages for targeted, non-chemical interventions and operates with in-house cGMP manufacturing, a broad patent portfolio, and ongoing clinical research, applying AI and machine learning in phage discovery and process optimization. Intralytix supports industry and academic progress through conference sponsorships and collaborative projects.
Intralytix is a biotechnology company specializing in bacteriophage-based solutions for controlling pathogenic bacteria in food safety, human and animal health, dietary supplements, environmental sanitation, and veterinary applications. The company utilizes lytic bacteriophages for targeted, non-chemical interventions and operates with in-house cGMP manufacturing, a broad patent portfolio, and ongoing clinical research, applying AI and machine learning in phage discovery and process optimization. Intralytix supports industry and academic progress through conference sponsorships and collaborative projects.
Publication Number
US-8956628-B2
Publication Date
2015-02-17
Expiration Date
Abstract
Disclosed herein are purified bacteriophage preparations that effectively lyse a plurality of C. perfringens strains. In one embodiment, a purified bacteriophage preparation includes four or more C. perfringens-specific bacteriophage, wherein each bacteriophage has lytic activity against at least five C. perfringens strains. In another embodiment, the purified bacteriophage preparation includes five or more C. perfringens-specific bacteriophage.
Core Innovation
The invention provides purified bacteriophage preparations comprising specific C. perfringens-specific bacteriophages, including CPAS-7, CPAS-15, CPAS-16, and CPLV-42, in which each bacteriophage has lytic activity against at least five C. perfringens strains which cause necrotic enteritis in poultry. The preparations are described as purified, characterized monophages and defined phage cocktail embodiments.
The cocktails are built from multiple phages such that the lytic activity covers a panel of C. perfringens strains, with performance limits including lysing at least 40/45 screened C. perfringens strains and at least 85% lysis of screened strains. Each individual C. perfringens-specific bacteriophage lyses 15% to 90% of the screened C. perfringens strains.
To support selective activity, the preparations include specificity and non-target incapacity limitations. The preparations are described as incapable of infecting at least ten non-target strains from E. coli, Listeria monocytogenes, Salmonella enterica, and Pseudomonas aeruginosa, while maintaining lytic activity against necrotic enteritis-causing C. perfringens strains.
The invention also describes purification and contaminant characterization, removal of undesirable genes based on sequencing and open reading frames, and a citrate-phosphate-thiosulfate water-conditioning buffer (CPT) to protect phage activity in chlorinated water systems, together with proof-of-principle poultry studies using INT-401/INT-402 regimens.
Claims Coverage
The independent claim is directed to a purified bacteriophage preparation comprising a defined set of C. perfringens-specific phages, with an inventive core centered on multi-strain lytic activity against necrotic enteritis-causing C. perfringens strains in poultry. The claim set further refines this with quantitative lysis performance, non-target infectivity limits, and formulation with a defined water-conditioning buffer.
Multi-phage purified preparation for necrotic enteritis-causing C. perfringens strains
A purified bacteriophage preparation comprising CPAS-7, CPAS-15, CPAS-16, and CPLV-42, wherein each bacteriophage has lytic activity against at least five C. perfringens strains which cause necrotic enteritis in poultry.
High-panel lysis and non-target incapacity
A purified bacteriophage preparation lyses at least 85% of at least 40 screened C. perfringens strains and is incapable of infecting at least ten strains of E. coli, L. monocytogenes, S. enterica, and P. aeruginosa.
Each individual phage lysis performance range
Each individual C. perfringens-specific bacteriophage lyses 15% to 90% of the screened C. perfringens strains.
Citrate-phosphate-thiosulfate water-conditioning buffer in defined composition
The water-conditioning agent is a 50 mM citrate-phosphate-thiosulfate buffer comprising about 40 mg sodium thiosulfate, 6.0 gm disodium phosphate (anhydrous), 1.1 gm citric acid (anhydrous) per liter of deionized water, pH 7.0, added at a 1:10 or greater ratio.
Overall, the claims coverage focuses on a purified, multi-phage preparation where each component phage has lytic activity against necrotic enteritis-causing C. perfringens strains in poultry, with additional inventive refinements specifying quantitative lysis coverage, incapacity to infect specified non-target strains, and a defined CPT water-conditioning buffer used within formulated embodiments.
Stated Advantages
Provides lytic activity against multiple C. perfringens strains which cause necrotic enteritis in poultry.
Is incapable of infecting specified non-target strains including E. coli, L. monocytogenes, S. enterica, and P. aeruginosa.
Demonstrates high killing/lysis performance across screened C. perfringens strain panels.
Is described as protecting phage activity in chlorinated watering systems using a citrate-phosphate-thiosulfate water-conditioning buffer.
Broiler proof-of-principle studies are described as reducing necrotic enteritis mortality relative to challenged controls for at least one described regimen.
Documented Applications
Poultry (broiler chickens) necrotic enteritis treatment/management using purified bacteriophage cocktail regimens, including oral gavage and described in-ovo/spray regimens in proof-of-principle challenge studies.
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