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Intralytix, Inc.

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Intralytix, Inc.

Intralytix is a biotech company specializing in bacteriophage-based products to control bacterial pa Intralytix, Inc. They are the natural enemies of bacteria.

is a biotechnology company focused on the discovery, production and marketing of bacteriophage-based products to control bacterial pathogens in environmental, food processing, and medical settings. Bacteriophages (bacteria-eater: from the Greek phago meaning "to eat" or "to develop at the expense of") are the most abundant microorganisms on earth. Lytic bacteriophages can very effectively kill their targeted specific bacteria without affecting anything else, ensuring an unprecedented level of safety for an antimicrobial.

09/18/2024

𝐉𝐔𝐒𝐓 𝐏𝐔𝐁𝐋𝐈𝐒𝐇𝐄𝐃:
𝐏𝐇𝐀𝐆𝐄𝐒 𝐂𝐀𝐍 𝐏𝐑𝐎𝐓𝐄𝐂𝐓 𝐀𝐆𝐀𝐈𝐍𝐒𝐓 𝐏𝐋𝐀𝐆𝐔𝐄 𝐏𝐎𝐒𝐓-𝐄𝐗𝐏𝐎𝐒𝐔𝐑𝐄

In the 14th century the “Black Death” or plague, caused by the bacteria Yersinia pestis, killed more than 50 million people. In modern times, sporadic or seasonal outbreaks occur in endemic areas, including rural areas of the U.S. Plague can have a 30 to 100% mortality rate, and while certain antibiotics are effective against it, antibiotic-resistant strains can occur.

Here, in a NIAID-funded study, Intralytix (led by Dr. Alexander 'Sandro' Sulakvelidze) in collaboration with Dr. Ashok Chopra at the University of Texas Medical Branch (UTMB) in Galveston, TX demonstrate that phages targeting Y. pestis provide strong post-exposure protection against lethal infection in rats.

https://journals.asm.org/doi/10.1128/spectrum.00942-24

This is yet another example of how phage-based antimicrobials can have significant implications for managing bacterial infections of public health concern!

06/26/2024

Do you have inactive Crohn’s disease and Adherent Invasive E. coli (AIEC)? A study to evaluate the safety and efficacy of EcoActive, a bacteriophage preparation that targets AIEC, is enrolling now in the New York and Baltimore-DC metropolitan areas. See if you qualify: https://bit.ly/45vGWQH

06/11/2024

Intralytix, Inc. presented bacteriophage food safety solutions at the 2024 Harvesting Hope - USDA's Agrifood Innovation Symposium demonstrating innovative technologies at the forefront of tackling foodborne bacterial pathogens!

This symposium showcases "the agricultural science and innovation that’s nourishing and powering our growing world."

Hosted by the USDA in partnership with the Foundation for Food & Agriculture Research.

05/03/2024

𝗛𝗘𝗔𝗟𝗧𝗛𝗬 𝗩𝗢𝗟𝗨𝗡𝗧𝗘𝗘𝗥𝗦 𝗡𝗘𝗘𝗗𝗘𝗗 𝗙𝗢𝗥 𝗜𝗡𝗩𝗘𝗦𝗧𝗜𝗚𝗔𝗧𝗜𝗢𝗡𝗔𝗟 𝗦𝗛𝗜𝗚𝗘𝗟𝗟𝗔 𝗣𝗛𝗔𝗚𝗘 𝗦𝗧𝗨𝗗𝗬

Researchers at the Center for Vaccine Development and Global Health, University of Maryland, Baltimore, are conducting a challenge study to evaluate the efficacy of an investigational phage
product targeting Shigella. The study is open to adults aged 18 – 50 years and consists of a 9 to 11-day inpatient stay, and up to 5 outpatient visits, including a screening session over 6 months
(plus up to 60 days for screening). During the inpatient stay, participants will be given 6 days of study product and “challenged” with live Shigella. The Shigella challenge involves exposure to
the Shigella bacteria in order to evaluate whether or not the product is effective in preventing Shigella infection.

Compensation up to $4,100.

𝗧𝗼 𝗾𝘂𝗮𝗹𝗶𝗳𝘆, 𝗰𝗮𝗹𝗹 𝟰𝟭𝟬-𝟳𝟬𝟲-𝟴𝟴𝟬𝟬 𝗼𝗿 𝗲𝗺𝗮𝗶𝗹 𝗰𝗹𝗶𝗻𝘁𝗿𝗶𝗮𝗹𝘀@𝘀𝗼𝗺.𝘂𝗺𝗮𝗿𝘆𝗹𝗮𝗻𝗱.𝗲𝗱𝘂

Phages are viruses that infect only specific bacteria. This study investigates a phage product that specifically targets Shigella. Shigella is a bacteria that can be ingested from contaminated
food or water and causes a serious diarrheal infection, called dysentery. Shigella is one of the leading causes of diarrhea worldwide and is especially detrimental to children in developing
countries. Globally, there are approximately 190 million diarrhea cases and an estimated 65,000 deaths due to Shigella each year. Shigella can be treated with oral and/or intravenous fluids and
antibiotics; however, antibiotic resistance is increasing. There are currently no licensed vaccines against Shigella.

04/26/2024

𝐈𝐧𝐭𝐫𝐚𝐥𝐲𝐭𝐢𝐱 𝐨𝐧𝐜𝐞 𝐚𝐠𝐚𝐢𝐧 𝐬𝐞𝐥𝐞𝐜𝐭𝐞𝐝 𝐚𝐬 𝟐𝟎𝟐𝟒 “𝐓𝐨𝐩 𝐅𝐨𝐨𝐝 𝐒𝐚𝐟𝐞𝐭𝐲 𝐒𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬 𝐏𝐫𝐨𝐯𝐢𝐝𝐞𝐫” 𝐛𝐲 𝐭𝐡𝐞 𝐅𝐨𝐨𝐝 𝐚𝐧𝐝 𝐁𝐞𝐯𝐞𝐫𝐚𝐠𝐞 𝐓𝐞𝐜𝐡𝐧𝐨𝐥𝐨𝐠𝐲 𝐑𝐞𝐯𝐢𝐞𝐰 𝐦𝐚𝐠𝐚𝐳𝐢𝐧𝐞!

Click for the full article:
https://www.fbtechreview.com/intralytix

02/14/2024

𝙄𝙣𝙩𝙧𝙖𝙡𝙮𝙩𝙞𝙭 𝙧𝙚𝙘𝙚𝙞𝙫𝙚𝙨 𝙎𝙖𝙛𝙚 𝙌𝙪𝙖𝙡𝙞𝙩𝙮 𝙁𝙤𝙤𝙙 (𝙎𝙌𝙁) 𝙘𝙚𝙧𝙩𝙞𝙛𝙞𝙘𝙖𝙩𝙞𝙤𝙣.

Columbia, Maryland, USA. – February 14, 2024 – Intralytix announced today that it has received the highly coveted Safe Quality Food (SQF) certification for food manufacturing. This comprehensive Hazard Analysis and Critical Control Points (HACCP)-based food safety and quality management certification sets Intralytix apart as the first and so far, the only bacteriophage company in history to attain such certification.

Hal Warso, Director of Quality Assurance at Intralytix, commented: “SQF is an international food safety standard recognized by the Global Food Safety Initiative, which is approved as one of the benchmarked schemes for meeting very stringent requirements for food safety management systems worldwide. Intralytix receiving SQF certification is a testament to our dedication to producing safe and high-quality phage products for all our customers, and it further underscores the revolutionary impact that bacteriophage-based antimicrobials can have on ensuring a safer food supply chain.” Alexander Sulakvelidze, President and CEO of Intralytix, echoed the significance of this milestone, stating, "Our Company always has been on the forefront of everything bacteriophage technology-related, including acquiring and maintaining Kosher, Halal, and OMRI (organic) certifications for our phage products for food safety applications. We were the first phage company in the World to manufacture phage products in compliance with 21 CFR 117 cGMP standards. We have now added SQF certification to the list.” Dr. Sulakvelidze concluded: “This SQF certification is yet another milestone in Intralytix's commitment to ensuring the highest standards of our phage products and food safety and quality. It further solidifies the Company's position as a leader in the development and production of bacteriophage-based antimicrobials, providing innovative solutions to combat the growing global concerns of antibiotic resistance and foodborne illnesses."

Intralytix's bacteriophage-based antimicrobials offer a sustainable, environmentally friendly, and targeted approach for controlling harmful bacteria in food products, ensuring the safety and well-being of consumers in the United States. With SQF certification in hand, the company is poised to set new industry standards and continue its mission to provide innovative solutions to the global challenges of antibiotic resistance and foodborne illnesses.

𝘼𝙗𝙤𝙪𝙩 𝙄𝙣𝙩𝙧𝙖𝙡𝙮𝙩𝙞𝙭, 𝙄𝙣𝙘.:

Intralytix is a cutting-edge United States biotechnology company dedicated to developing and producing bacteriophage-based antimicrobials. With a commitment to innovation and excellence, Intralytix is using its core bacteriophage technology platform to improve human health through the development and commercialization of innovative bacteriophage-based products for food safety, animal health, human therapeutics, oral care, cosmetic, and dietary supplements/probiotic applications. The Company currently has the largest in the World portfolio of FDA- and USDA-approved phage products on the market for food safety applications. These products ensure the safety of foods against major foodborne bacterial pathogens such as Listeria monocytogenes, Salmonella spp., Shigella spp., Campylobacter spp., and Shiga toxin producing Escherichia coli or STEC (including E. coli O157:H7 and all “big six” STEC). Intralytix is actively expanding its nutraceutical product portfolio and is also working on developing phage therapeutics to combat various drug-resistant bacterial pathogens. To that end, Intralytix is currently the sponsor of three Investigational New Drugs (INDs) for randomized, controlled clinical trials designed to assess the safety and efficacy of oral administration of (1) EcoActive™ targeting adherent invasive E. coli (AIEC) in patients with inactive Crohn's disease (NCT03808103); (2) ShigActive™ targeting Shigella in a human model of shigellosis (NCT05182749); and (3) VRELysin™ targeting vancomycin-resistant Enterococci (VRE) in healthy and VRE colonized subjects (NCT05715619).

For more information, please visit www.intralytix.com or contact Dr. Alexander “Sandro” Sulakvelidze (410-625-2533, asulakvelidze@intralytix.com).

01/30/2024

Come meet the Intralytix, Inc. team showcasing our innovative antimicrobial bacteriophage solutions for food safety at !

Visit us at our 𝗕𝗼𝗼𝘁𝗵 # 𝗕𝟯𝟲𝟬𝟱𝟭 at the International Production & Processing Expo to learn more about our FDA- and USDA-approved phage food safety products targeting five major foodborne bacterial pathogens: Salmonella, E. coli, Listeria, Campylobacter and Shigella.

From left to right:
Greg Strang (Sales), Dr. Amit Vikram (Sales/R&D), Mary Theresa Callahan (R&D), Sam MacKenzie (R&D) & Dr. Sandro Sulakvelidze (President & CEO)

01/25/2024

Intralytix, Inc. will be at the International Production & Processing Expo in Atlanta next week (January 30 – February 1, 2024)!!!

Visit our 𝗕𝗼𝗼𝘁𝗵 # 𝗕𝟯𝟲𝟬𝟱𝟭 at .

Our sales and R&D teams will be showcasing the latest advancements in our FDA- and USDA-approved phage food safety products targeting five major foodborne bacterial pathogens:

• 𝙎𝙖𝙡𝙢𝙤𝙁𝙧𝙚𝙨𝙝™ - targets Salmonella spp. (including strains belonging to pathogenic serotypes Typhimurium, Enteritidis, Heidelberg, Newport, Hadar, Kentucky, and Infantis, among many others).
• 𝙀𝙘𝙤𝙎𝙝𝙞𝙚𝙡𝙙™ 𝙋𝙓 - targets Shiga-toxin producing E. coli (including strains belonging to the pathogenic serogroup O157:H7 as well as all “big six” STEC serogroups O26, O45, O103, O111, O121, and O145).
• 𝙎𝙝𝙞𝙜𝙖𝙎𝙝𝙞𝙚𝙡𝙙™ - targets Shigella spp.
• 𝘾𝙖𝙢𝙥𝙮𝙎𝙝𝙞𝙚𝙡𝙙™ - targets Campylobacter spp.
• 𝙇𝙞𝙨𝙩𝙎𝙝𝙞𝙚𝙡𝙙™ - targets Listeria monocytogenes.

Globally, we offer the broadest portfolio of FDA- and USDA- approved phage products for food safety applications, and the most innovative and environmentally friendly phage biocontrol technology designed to seamlessly integrate into your HACCP plans.

We look forward to connecting with you at !

01/18/2024

Intralytix Receives FDA Regulatory Clearance for Expanded Use in Grain and Grain Products for Phage-Based Salmonella Technology

Columbia, Maryland, USA – January 18, 2024. Intralytix, Inc. announced today that its food safety product, SalmoFresh™, has been granted a supplement to its GRAS (Generally Recognized As Safe) GRN 000435 status from the Food and Drug Administration (FDA), which expands the use of SalmoFresh™ to grain and grain products.

This GRAS Supplement broadens the existing antimicrobial use of SalmoFresh™, which was previously granted GRAS status for treating poultry products, fish, shellfish and fresh and processed fruits and vegetables. SalmoFresh™ can now also be used for treating grain and grain products, such as wheat, rye, rice, oats, corn, barley, flour, and products made from those grains, e.g., crackers, tortillas, grits, and breakfast cereals.

SalmoFresh™ is a non-chemical antimicrobial preparation for controlling the foodborne bacterial pathogen Salmonella. The active ingredients of SalmoFresh™ are naturally occurring lytic bacteriophages that selectively and specifically kill Salmonella enterica strains, including (but not limited to) strains belonging to the most common and highly pathogenic serotypes Typhimurium, Enteritidis, Heidelberg, Newport, Hadar, Kentucky, Thompson, Georgia, Agona, Grampian, Senftenberg, Alachua, Infantis, Reading, and Schwarzengrund. SalmoFresh™ is Kosher and Halal certified and is also OMRI listed (suitable for organic food production).

For product inquires or to place an order, email Intralytix at sales@intralytix.com or call 1 877 ITXPHAGE (1-877-489 7424) and select option 1.

01/18/2024

Intralytix Receives FDA Regulatory Clearance for Expanded Use in Grain and Grain Products for Phage-Based E. coli Technology.

Columbia, Maryland, USA – January 18, 2024. Intralytix, Inc. announced today that its food safety product, EcoShield™, has been granted a supplement to its GRAS (Generally Recognized As Safe) GRN 000834 status from the Food and Drug Administration (FDA), which expands the use of EcoShield™ PX to grain and grain products.

This GRAS Supplement broadens the existing antimicrobial use of EcoShield™ PX, which was previously granted GRAS status for treating meat, poultry, fruits, vegetables, dairy products (including cheese), fish, and other seafood with Shiga toxin producing E. coli or STEC. EcoShield™ PX can now also be used for treating grain and grain products, such as wheat, rye, rice, oats, corn, barley, flour, and products made from those grains, e.g., crackers, tortillas, grits, and breakfast cereals.

EcoShield™ PX is a non-chemical antimicrobial preparation for controlling Shiga-toxin producing E. coli. The active ingredients of EcoShield™ PX are naturally occurring lytic bacteriophages that selectively and specifically kill STEC strains, including strains belonging to the most common and highly pathogenic serogroup O157:H7 as well as all “big six” STEC serogroups O26, O45, O103, O111, O121, and O145. EcoShield™ PX is Kosher and Halal certified and is also OMRI listed (suitable for organic food production).

For product inquires or to place an order, email Intralytix at sales@intralytix.com or call 1 877 ITXPHAGE (1-877-489 7424) and select option 1.

10/16/2023

Join this new research study in Baltimore seeking healthy adults aged 18‐50 for an investigational oral phage product against shigella.

Study duration will be approximately 8 months. Volunteers will complete 5 outpatient visits and have a 9 to 11‐day inpatient stay. During the inpatient stay, participants will drink placebo or study product 3 times per day for 6 days and will be “challenged” with live Shigella.

Compensation up to $4,100 for qualified volunteers.

LEARN MORE:
https://www.medschool.umaryland.edu/CVD/trials/Shigella-32000-Phage-Study/

10/09/2023

Intralytix awarded patent by the European Patent Office for novel Shigella bacteriophages and their uses.

Patent # EP3253215 - Novel Shigella bacteriophage and uses thereof.

Columbia, Maryland, USA. – October 9, 2023 – Intralytix, Inc. announced today that it has been issued a patent by the European Patent Office covering its Shigella bacteriophages and their various applications. The patent broadly relates to several bacteriophages with strong lytic potency against Shigella spp., and their various formulations. The patent also covers specific uses of these formulations, such as improving food safety and human health, including maintaining healthy gut microflora by modulating a mammal’s microbiome and by reducing colonization by Shigella or levels of Shigella in the gut.

Dr. Alexander Sulakvelidze, President and CEO of Intralytix and one of the inventors listed on the patent, commented “This patent dramatically expands protection previously granted by the USA patent # US-10711252-B2 with the same title, by now also covering 17 countries in Europe: Austria, Bulgaria, Denmark, Germany, France, Belgium, Estonia, Finland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Portugal, Slovenia and Sweden, with issuance in 2 additional countries (Liechtenstein and Switzerland) expected momentarily.” Dr. Sulakvelidze added, “We are currently running Phase 1/2a clinical trials using our Shigella phage preparation at the University of Maryland School of Medicine in Baltimore (NCT05182749). The trial is conducted under the auspices of the clinical trial grant from the NIAID, NIH (Project # 5U01AI148054-03). This patent extends our intellectual protection for that product and approach beyond the United States to include several European countries. We look forward to continuing our ongoing clinical trials using this patented technology, and to bringing our Shigella-targeting phage preparation to markets worldwide in the not-too-distant future."

About Intralytix Inc.

Intralytix, Inc. is a privately held 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, animal health, human therapeutics, oral care, cosmetic, and dietary supplements/probiotic applications. Intralytix is currently the sponsor of (and holder of) three Investigational New Drugs (INDs) for randomized, controlled clinical trials: (1) at the Mount Sinai Hospital in New York and at the Johns Hopkins University in Baltimore (NCT03808103); (2) at the Center for Vaccine Development at the University of Maryland School of Medicine in Baltimore (NCT05182749); and (3) to target vancomycin-resistant Enterococci (VRE) in the gastrointestinal tract (NCT05715619). To learn more, please visit www.intralytix.com or contact Dr. Alexander “Sandro” Sulakvelidze (410-625-2533, asulakvelidze@intralytix.com).

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http://www.intralytix.com/

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