Intralytix receives Phase II Fast Track NIH SBIR contract to continue development of a universal, scale-independent AI-based platform for manufacturing high titer bacteriophage preparations for clinical applications.

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Intralytix receives Phase II Fast Track NIH SBIR contract to continue development of a universal, scale-independent AI-based platform for manufacturing high titer bacteriophage preparations for clinical applications.
Columbia, Maryland, USA. – August 22, 2022 – Intralytix, Inc. announced today that it has received a Phase II contract in the amount of $1,498,045. This contract is made through the Small Business Innovation Research (SBIR)
Dr. Alexander “Sandro” Sulakvelidze, President & CEO of Intralytix.program from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). This project is the continuation of a successfully completed NIAID-funded Phase I contract (see Intralytix, Inc.) and will further leverage Intralytix’s existing proprietary PhageSelector™ program, big data, and manufacturing know-how along with machine learning to advance an artificial intelligence (AI)-based universal manufacturing platform, the PhageEngine™, to deliver methods for producing high titer, high quality bacteriophage preparations suitable for clinical applications. Dr. Alexander Sulakvelidze, President and CEO of Intralytix and the Principal Investigator of the SBIR contract, commented, “We are very pleased to further extend this work with support from NIH after successfully competing Phase I of the project. The resulting technology will significantly increase Intralytix’s capabilities as well as help…

Intralytix Granted Clearance by the FDA for an Investigational New Drug Application for Phase 1/2a Clinical Trials for Vancomycin Resistant Enterococci (VRE)-targeting Phage Preparation

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Intralytix, Inc. announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) application for its product VRELysin™, a bacteriophage preparation to manage colonization of vancomycin resistant Enterococcus (VRE) in the human gut. Under this IND, continuous, randomized, double-blind Phase 1/2a clinical trials will be performed to assess the safety and efficacy of VRELysin™ in decolonizing VRE in the gastrointestinal tract. Dr. Alexander Sulakvelidze, President and CEO of Intralytix, commented “This IND approved by the FDA is an exciting step in advancing phage therapy in the U.S. This study will address a significant public health issue and the resulting product is expected to help reduce serious bacterial infections caused by VRE.”

Intralytix Receives SBIR Grant to Develop Phage Preparation for Reducing Vibrio parahaemolyticus Contamination of Foods

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Intralytix, Inc. announced today that it has received a Phase I Small Business Innovation Research (SBIR) grant from the National Institute of Food and Agriculture (NIFA), an agency of the U.S. Department of Agriculture (USDA), for the development of a phage biocontrol solution for Vibrio parahaemolyticus
in various food products.

Is Maryland Becoming a Hub for Bacteriophage Technologies?

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The Bacteriophage (Phage) Therapy (PT) market is growing rapidly in the U.S. The rise of antibiotic resistant bacteria and multidrug-resistant bacteria (MDRs) across the globe has increased the value and industry acceptance of a phage approach, which can help combat bacteria that cannot be effectively treated by antibiotics. What’s more, the phage modality is a great fit for targeted personalized medicine approaches.

Intralytix Opens New HQ in Columbia, Maryland for Phage Research and Manufacturing Facility

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From left to right:

– Per Falk, President & CSO, Ferring Pharmaceuticals
– John Woloszyn, Founder, President & CEO, Intralytix, Inc.
– Calvin Ball, County Executive, Howard County, Maryland
– Alexander Sulakvelidze, Founder, EVP & CSO, Intralytix, Inc.
– Antoine Baule, CEO, Lesaffre Compagnie