Intralytix

Last updated
Intralytix
Company type Private
Industry Biotechnology
Founded1998
Headquarters Columbia, Maryland, United States
Key people
Alexander Sulakvelidze (President and CEO)
Products Bacteriophage cocktails

Intralytix, Inc. is a privately owned biotech venture 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.

Contents

Company Background

Intralytix Headquarters Intralytix Exterior Spring.jpg
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.

Major Milestones

Fermentation Suite ITX Fermentor Room.jpg
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 in patients with inactive Crohn's disease (NCT03808103). [3]

As of 2022, Intralytix has the largest number of commercial FDA-approved phage food safety products with five FDA- and USDA-approved bacteriophage-based food safety products. [4] [5] [6] [7]

As of 2022, Intralytix is the largest commercial manufacturer of phage products for food safety applications in the US with a successful scale-up to a 1,500 L fermenter.

In 2024, Intralytix 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 [8]

Intralytix Facilities

Intralytix is located at 8681 Robert Fulton Drive, Columbia MD 21046, US. The 33,000-square-foot building has 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). [9] 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. [10] 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) acknowledgments. SalmoFresh, which is used to target Salmonella contamination, was declared GRAS in 2013 (GRN No. 435); ShigaShield, used to treat Shigella , received clearance by the FDA in 2017 (GRN No. 000672); and CampyShield, which is used to target Campylobacter contamination, was declared GRAS in October 2021 (GRN No. 000966). As of January 2023, Intralytix has five 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 worldwide.

Robotic platform allows long-term storage and testing of thousands of phages and bacteria. ITX Robotic Freezer.jpg
Robotic platform allows long-term storage and testing of thousands of phages and bacteria.

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 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. [11]

The company is currently 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 (NCT03808103). This trial is currently enrolling patients at the Icahn School of Medicine at the Mount Sinai Hospital in New York, NY and at the Johns Hopkins University in Baltimore, MD. The trial is expected to be completed in late 2024. [12]

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 began in February 2023 (NCT05182749). Phase 1 trial was completed in March 2023, and Phase 2a trial is expected to commence in November 2023. [13]

Also in Q3 2023, the company plans to begin clinical trials of another human therapeutic product, VRELysin, to treat Vancomycin Resistant Enterococci (NCT05715619). [14]

Intralytix scientist ITX Scientist.jpg
Intralytix scientist

Awards and recognition

Intellectual Property (IP) Portfolio

Intralytix is headed by Dr. Alexander Sulakvelidze, President and chief executive officer.

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.[ citation needed ] As of 2022, Intralytix has:

Intralytix Products

Phage production ITX Phage Production.jpg
Phage production

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.

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.

Therapeutic Products

Related Research Articles

<span class="mw-page-title-main">Bacteriophage</span> Virus that infects prokaryotes

A bacteriophage, also known informally as a phage, is a virus that infects and replicates within bacteria and archaea. The term is derived from Ancient Greek φαγεῖν (phagein) 'to devour' and bacteria. Bacteriophages are composed of proteins that encapsulate a DNA or RNA genome, and may have structures that are either simple or elaborate. Their genomes may encode as few as four genes and as many as hundreds of genes. Phages replicate within the bacterium following the injection of their genome into its cytoplasm.

<span class="mw-page-title-main">Infliximab</span> Biopharmaceutical drug for autoimmune disorders

Infliximab, a chimeric monoclonal antibody, sold under the brand name Remicade among others, is a medication used to treat a number of autoimmune diseases. This includes Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, and Behçet's disease. It is given by slow injection into a vein, typically at six- to eight-week intervals.

<span class="mw-page-title-main">Phage therapy</span> Therapeutic use of bacteriophages to treat bacterial infections

Phage therapy, viral phage therapy, or phagotherapy is the therapeutic use of bacteriophages for the treatment of pathogenic bacterial infections. This therapeutic approach emerged at the beginning of the 20th century but was progressively replaced by the use of antibiotics in most parts of the world after the Second World War. Bacteriophages, known as phages, are a form of virus that attach to bacterial cells and inject their genome into the cell. The bacteria's production of the viral genome interferes with its ability to function, halting the bacterial infection. The bacterial cell causing the infection is unable to reproduce and instead produces additional phages. Phages are very selective in the strains of bacteria they are effective against.

<span class="mw-page-title-main">ViroPharma</span> American pharmaceutical company

ViroPharma Incorporated was a pharmaceutical company that developed and sold drugs that addressed serious diseases treated by physician specialists and in hospital settings. The company focused on product development activities on viruses and human disease, including those caused by cytomegalovirus (CMV) and hepatitis C virus (HCV) infections. It was purchased by Shire in 2013, with Shire paying around $4.2 billion for the company in a deal that was finalized in January 2014. ViroPharma was a member of the NASDAQ Biotechnology Index and the S&P 600.

<span class="mw-page-title-main">Belimumab</span> Pharmaceutical drug

Belimumab, sold under the brand name Benlysta, is a human monoclonal antibody that inhibits B-cell activating factor (BAFF), also known as B-lymphocyte stimulator (BLyS). It is approved in the United States and Canada, and the European Union to treat systemic lupus erythematosus and lupus nephritis.

Ocrelizumab, sold under the brand name Ocrevus, is a medication used for the treatment of multiple sclerosis. It is a humanized anti-CD20 monoclonal antibody. It targets CD20 marker on B lymphocytes and is an immunosuppressive drug. Ocrelizumab binds to an epitope that overlaps with the epitope to which rituximab binds. It is administered by intravenous infusion. The fixed-dose combination ocrelizumab/hyaluronidase is administered by subcutaneous injection.

Ramucirumab, sold under the brand name Cyramza, is a fully human monoclonal antibody (IgG1) used for the treatment of cancer. Ramucirumab is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist. Ramucirumab was developed by ImClone Systems. It was isolated from a native phage display library from Dyax.

<span class="mw-page-title-main">Pimavanserin</span> Atypical antipsychotic medication

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<span class="mw-page-title-main">Axona</span> Chemical compound

Axona was previously marketed as a medical food for the clinical dietary management of the impairment of metabolic processes associated with mild to moderate Alzheimer's disease. It is a proprietary formulation of fractionated palm kernel oil, a medium-chain triglyceride. Cericin, the company that makes Axona, states that during digestion, caprylic triglyceride is broken down into ketones, which provide an alternative energy source for the brain. Its use is based on the idea that the brain's ability to use its normal energy source, glucose, is impaired in Alzheimer's disease. Axona was first sold in March 2009.

<span class="mw-page-title-main">Levomilnacipran</span> SNRI antidepressant drug

Levomilnacipran is an antidepressant which was approved in the United States in 2013 for the treatment of major depressive disorder (MDD) in adults. It is the levorotatory enantiomer of milnacipran, and has similar effects and pharmacology, acting as a serotonin–norepinephrine reuptake inhibitor (SNRI).

<span class="mw-page-title-main">Nintedanib</span> Chemical compound

Nintedanib, sold under the brand names Ofev and Vargatef, is an oral medication used for the treatment of idiopathic pulmonary fibrosis and along with other medications for some types of non-small-cell lung cancer.

<span class="mw-page-title-main">Fostamatinib</span> Chemical compound

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<span class="mw-page-title-main">Upadacitinib</span> Biopharmaceutical drug

Upadacitinib, sold under the brand name Rinvoq, is a medication used for the treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, and axial spondyloarthritis. Upadacitinib is a Janus kinase (JAK) inhibitor that works by blocking the action of enzymes called Janus kinases. These enzymes are involved in setting up processes that lead to inflammation, and blocking their effect brings inflammation in the joints under control.

References

  1. "CFR - Code of Federal Regulations Title 21".
  2. Rhoads, D.D.; Wolcott, R.D.; Kuskowski, M.A.; Wolcott, B.M.; Ward, L.S.; Sulakvelidze, A. (2009). "Bacteriophage therapy of venous leg ulcers in humans: Results of a phase I safety trial". Journal of Wound Care. 18 (6): 237–243. doi:10.12968/jowc.2009.18.6.42801. PMID   19661847.
  3. "A Phase 1/2a Double-Blind, Randomized, Placebo-Controlled Trial to Assess the Safety and Efficacy of Oral Administration of EcoActive on Intestinal Adherent Invasive Escherichia Coli (AIEC) in Patients with Inactive Crohn's Disease (CD)". 23 August 2021.
  4. "GRAS Notices".
  5. "GRAS Notices".
  6. "GRAS Notices".
  7. "GRAS Notices".
  8. https://www.sqfi.com/
  9. https://www3.epa.gov/pesticides/chem_search/ppls/074234-00001-20080618.pdf [ bare URL PDF ]
  10. "Inventory of Effective Food Contact Substance (FCS) Notifications".
  11. Rhoads, D.D.; Wolcott, R.D.; Kuskowski, M.A.; Wolcott, B.M.; Ward, L.S.; Sulakvelidze, A. (2009). "Bacteriophage therapy of venous leg ulcers in humans: Results of a phase I safety trial". Journal of Wound Care. 18 (6): 237–243. doi:10.12968/jowc.2009.18.6.42801. PMID   19661847.
  12. "A Phase 1/2a Double-Blind, Randomized, Placebo-Controlled Trial to Assess the Safety and Efficacy of Oral Administration of EcoActive on Intestinal Adherent Invasive Escherichia Coli (AIEC) in Patients with Inactive Crohn's Disease (CD)". 23 August 2021.
  13. "A Phase 1/2a Double-Blind, Randomized, Placebo-Controlled Trial to Assess the Safety and Efficacy of Oral Administration of the Bacteriophage Preparation, ShigActive™, in a Human Experimental Model of Shigellosis with Shigella Flexneri 2a Strain". 24 March 2023.
  14. "A Phase 1/2a Double-Blind, Randomized, Placebo-Controlled Trial to Assess the Safety and Efficacy of Oral Administration of the Phage Cocktail, VRELysin™, in Healthy and VRE-Colonized Subjects". 27 January 2023.
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  19. "GRAS Notices".
  20. "GRAS Notices".
  21. "GRAS Notices".
  22. "GRAS Notices".
  23. Mai, Volker; Ukhanova, Maria; Reinhard, Mary K.; Li, Manrong; Sulakvelidze, Alexander (2015). "Bacteriophage administration significantly reduces Shigellacolonization and shedding by Shigella-challenged mice without deleterious side effects and distortions in the gut microbiota". Bacteriophage. 5 (4): e1088124. doi: 10.1080/21597081.2015.1088124 . PMC   4745833 . PMID   26909243. S2CID   14981205.
  24. "Intralytix Receives Multimillion-Dollar Clinical Trial Award from NIAID to Manage Shigella Infections in Humans" (Press release).
  25. "A Phase 1/2a Double-Blind, Randomized, Placebo-Controlled Trial to Assess the Safety and Efficacy of Oral Administration of EcoActive on Intestinal Adherent Invasive Escherichia Coli (AIEC) in Patients with Inactive Crohn's Disease (CD)". 23 August 2021.
  26. "A Phase 1/2a Double-Blind, Randomized, Placebo-Controlled Trial to Assess the Safety and Efficacy of Oral Administration of the Phage Cocktail, VRELysin™, in Healthy and VRE-Colonized Subjects". 27 January 2023.