Intralytix receives Fast Track NIH SBIR contract to develop a universal, scale-independent AI-based platform for manufacturing high titer bacteriophage preparations for clinical applications

Columbia, Maryland, USA. – August 16, 2021 – Intralytix, Inc. announced today that it has received a Phase I award in the amount of $299,672 with an option for a Phase II award in the
Dr. Alexander "Sandro" Sulakvelidze, President & CEO of Intralytix.amount of $1,498,045. This award is made through the Small Business Innovation Research (SBIR) program under a Fast-Track Phase I / Phase II program providing for up to $1.8 million from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH). This NIAID-funded project will leverage Intralytix’s existing proprietary PhageSelector™ program, big data, and manufacturing know-how along with machine learning to create 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, “Interest in therapeutic phage applications is steadily growing worldwide. This is driven primarily by increasing antibiotic resistance (and the resulting need for alternative treatment strategies to manage drug-resistant infections) and by the exploding field of microbiome research (and the resulting need for approaches to help modulate the microbiome for various health benefits) – and the growing appreciation that phage technology can help address both of these needs. Having well characterized libraries of lytic bacteriophages and the technology to rapidly scale up their production to yield high titer, high quality phage preparations are some of the most critical factors for successful implementation of phage therapy in real life.” Dr. Sulakvelidze concluded, “We are very pleased to enter into this collaboration with the NIH. We believe that the resulting technology will
Bradley Anderson, Director of Production & Logistics of Intralytixsignificantly increase Intralytix’s capabilities as well as help advance the phage biocontrol / phage therapy field in general, and will ultimately have a very significant positive impact on public health.”

Bradley Anderson, Director of Production and Logistics at Intralytix and the main driving force behind the PhageSelector™ and PhageEngine™ platforms, also commented, “This NIH contract will help us accelerate our work on developing universal, scale-independent AI algorithms to define and deliver methods for large-scale, high quality, high titer phage production. This contract enables us to further optimize our existing proprietary software PhageSelector™ and to develop the PhageEngine™ that uses AI and machine learning along with high-throughput robotics to create a robust phage manufacturing platform.”

Dr. Jennifer Schwartz, Director of Clinical Development of IntralytixDr. Jennifer Schwartz, Director of Clinical Development at Intralytix, concluded, “Intralytix currently has an on-going phage therapy clinical trial at the Mount Sinai Hospital in New York, and three additional clinical trials in the pre-IND or IND-submission stages that will commence in the next 12-24 months; one of those clinical trials is funded under a grant by NIAID/NIH. The AI-supported PhageEngine™ platform to be developed under this NIAID-funded SBIR contract will play a significant role in accelerating our clinical programs by advancing Intralytix’s technology for rapidly generating high concentration, high purity phage preparations using methodologies fully compatible with the current Good Manufacturing Practices. We look forward to starting this important project in collaboration with the NIH.”

This project will be funded, in whole or in part, by NIAID/NIH under contract No. 75N93021C00034. The total NIH-funded dollar amount of this Fast-Track SBIR contract is $1,797,717. Funding for Phase II is contingent on successful completion of Phase I. The content of this press release is solely the responsibility of Intralytix and does not necessarily represent the official views of the NIH.

About Intralytix Inc.

Intralytix, Inc. is a privately held, revenue-generating company headquartered in Columbia, Maryland. The Company is focused on using its core bacteriophage technology platform to improve human health through the development and commercialization of innovative products for food safety, veterinary applications, human therapeutics, oral care, cosmetic, and dietary supplements/probiotic applications.

Intralytix was the first company in the world to receive FDA-approval for a bacteriophage-based product for food safety applications. The Company currently has the world’s largest portfolio of FDA-approved bacteriophage-based products on commercial markets and is the largest producer of FDA-approved bacteriophage preparations for food safety applications worldwide. Intralytix is currently sponsoring a clinical trial at the Mount Sinai Hospital in New York, for which it is IND-holder (https://clinicaltrials.gov/ct2/show/NCT03808103?term=Intralytix&rank=1), and the Company also has three additional human therapeutic bacteriophage products in the pre-IND or IND-submission stages. To learn more, please visit www.intralytix.com or contact Dr. Alexander Sulakvelidze (410-625-2533, asulakvelidze@intralytix.com).