Intralytix

Intralytix Headquarters

Intralytix was founded in 1998 in Baltimore, Maryland, by Drs. John Glenn Morris, Jr. and Alexander Sulakvelidze together with a group of other scientists and business professionals. The platform technology of Intralytix is based on using naturally occurring, non-genetically modified (non-GMO) lytic bacteriophages for developing “green” commercial products for a variety of applications. These products are all-natural, antibiotic-free ways to control disease causing bacterial pathogens.

Fermentation Suite

In 2006, Intralytix was the first company in the world to receive FDA/USDA approval for a bacteriophage-based food safety product, ListShield™.[1]

That same year, Intralytix was also the first company in the world to successfully assemble a Master Drug File (MDF) application with the FDA, and to manufacture and supply its phage product for the first-ever in the US human clinical trial when phages were used to treat infected venous ulcers.[2]

In 2018, Intralytix was granted the first FDA approved IND for a double-blind, randomized, placebo-controlled clinical trial in the US for an orally administered phage preparation.[3]

As of 2020, Intralytix has the largest number of commercial FDA-approved phage food safety products with four FDA- and USDA-approved bacteriophage-based food safety products, and the fifth food safety product approval expected in 2021.[4][5][6][7]

As of 2020, Intralytix is the largest commercial manufacturer of phage products for food safety applications in the US with successful scale up to a 1,500 L fermenter.

Intralytix is located at 8681 Robert Fulton Drive, Columbia MD 21046, US. The 33,000 square foot building has a dedicated C-suite and state-of-the-art R&D and GMP (21 CFR Part 111 and 117 compliant) production facilities with capabilities for:

• high-throughput robotic system for phage discovery and characterization;
• long-term cryogenic storage of hundreds of phages and thousands of bacteria strain stocks;
• manufacturing and production of phages in 1,500 L fermentation vessels with room to expand;
• customized large volume phage product mixing;
• and high-throughput automatic filling in facilities that meet industry standards (ISO 7 cleanroom/ISO 5 HEPA-filtered cabinet).

The first commercial bacteriophage food safety product developed was ListShield™, which targets Listeria monocytogenes contamination of foods. It received FDA/USDA approval in 2006. Two years later, ListShield™ was approved for use as an environmental decontaminant (e.g., for decontaminating inanimate surfaces in food processing facilities) by the Environmental Protection Agency (EPA) (EPA registration #74234-1).[8] In 2010, Intralytix began large scale commercial sales of ListShield™ to the food industry.

Other phage-based food safety phage products followed. In 2011, Intralytix received regulatory clearance from the FDA for its EcoShield™ food safety product effective against E. coli O157:H7 (FCN No. 1018) specific for the use of EcoShield™ on red meat parts and trim intended to be ground.[9] In the same year, EcoShield™ received regulatory clearance from the USDA’s Food Safety & Inspection Service (FSIS) for use on red meat to be ground and was determined to constitute an incidental aid that will not require labeling (i.e., “clean label”).

Subsequent phage preparations received regulatory clearance from the FDA through Generally Recognized As Safe (GRAS) acknowledgements. SalmoFresh™, which is used to target Salmonella contamination, was declared GRAS in 2013 and ShigaShield™, used to treat Shigella, received clearance by the FDA in 2017. As of May 2020, Intralytix has four FDA- and USDA-approved bacteriophage-based food safety products on the market. This is the largest number of FDA-approved phage food safety products for any company in the world.

Robotic platform allows long term storage and testing of thousands of phages and bacteria.

In addition to its line of food safety products, Intralytix is a world leader in human health applications for phage products. It has several all-natural, antibiotic-free phage-based products capable of treating human diseases of bacterial origin in various stages of development (preclinical through Phase 2a). In 2006, under Intralytix’s MDF and an investigator-initiated IND at the Southwest Regional Wound Care Center in Lubbock, Texas, Intralytix was the first company in the US to perform a first-in-human clinical trial where phages were used to treat infected venous ulcers.[10]

As of 2019, the company is sponsoring a Phase 1/2a clinical trial (under an IND approval from the FDA) of the EcoActive™ phage preparation for targeting adherent-invasive E. coli associated with Crohn’s disease. This trial is currently enrolling patients at the Icahn School of Medicine at the Mount Sinai Hospital in New York, NY, and is expected to be completed in 2022.[11] In May 2020, Intralytix received a multimillion-dollar grant (AI 148054) from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), for the clinical development of its bacteriophage therapy preparation, ShigActive™, for managing infections caused by the bacterial pathogen Shigella. These Phase 1/2a studies are anticipated to begin in 2021.

Also in 2021, the company plans to begin clinical trials of another human therapeutic product, VRELysin™, to treat Vancomycin Resistant Enterococci.

Intralytix scientist

• 2006 – Intralytix wins the Popular Science magazine’s “Best of What’s New” award for its food safety product ListShield™.[12]
• 2010 – The international research and consulting firm of Frost & Sullivan awards Intralytix its 2010 North American Technology Innovation of the Year Award for Intralytix’s bacteriophage technology.
• 2017 – Intralytix is rated as superior in 8 out of 10 categories used to rank the competitive companies by Lux Research. Lux Research is an independent research and advisory firm, providing strategic advice and ongoing intelligence on emerging technologies. Intralytix was given a positive #LuxTake by Lux Research in its report to its subscribing membership.[13]
• 2018 – Intralytix named among Top Biotechnology Companies of 2018 by Baltimore Business Journal (September 2018).

Intralytix is the world leader in bacteriophage technology, with experience in all technical, regulatory, and manufacturing aspects of the phage business. Intralytix is headed by Dr. Alexander Sulakvelidze, President and Chief Executive Officer, who is recognized as one of the world’s leading experts in bacteriophage technology.

Intralytix’s patent strategy is based on a multi-pronged approach, which provides broad and strong protection ranging from protecting specific bacteriophages that serve as the cornerstone of various company products to methods and applications of those bacteriophages in various settings. As of May 2020, Intralytix has:

• 15 issued / allowed patents;
• Several pending patent applications worldwide.

• Intralytix website.