Intralytix
Intralytix, Inc. () is a privately held “C” corporation that was incorporated in the State of Maryland on July 28, 1998. Intralytix specializes in bacteriophage-based products used to control bacterial pathogens in environmental, agricultural, food processing, and medical (including skin care and oral care) settings. Company Background. 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. Major Milestones. In 2006, Intralytix was the first company in the world to receive FDA/USDA approval for a bacteriophage-based food safety product, ListShield . 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. 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. As of 2021, Intralytix has the largest number of commercial FDA-approved phage food safety products with five FDA- and USDA-approved bacteriophage-based food safety products. As of 2021, 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 Facilities. 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: Pioneer in Food Safety. 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). 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" (FCN No. 1018) specific for the use of EcoShield on red meat parts and trim intended to be ground. 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. Expansion into Human Therapeutics. 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 Phase2a). 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. As of 2019, the company is sponsoring a Phase1/2a 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. 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 Phase1/2a 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". Intellectual Property (IP) Portfolio. 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: Intralytix Products. Food Safety Products. These phage-based  products are designed to be applied to food before, during, or after processing or packaging, as appropriate. They work by targeting and killing specific human (including animal) pathogenic bacteria that may be present in food. These products do not alter the color, taste, or smell of food in any way. All of these products are 100% natural and non-GMO. Most of them are also certified Kosher and Halal, and are OMRI-listed as suitable ingredients in the production of organic foods. Pre-Harvest Intervention Products. These food safety related products are designed to be applied to live animals prior  to entering the processing facility, through spray application to the animals’ hide, skin, or feathers. After application, the phages act to reduce the contamination of specific target bacteria, if present on the animal, and prevent it from entering the facility.