Intralytix: then and now

Issue 183 | July 8, 2022
9 min read
Capsid and Tail

This week Madhav Madurantakam Royam, a PhD student at the University of Warwick, talks to Dr. Alexander Sulakvelidze, founder and CEO of Intralytix, one of the first modern phage companies to have products on the market.

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PHAGE Journal is celebrating the 130th birthday of George Eliava with a focused issue of phage therapy then and now — just released!

Phage Therapy: Insights from the Past, the Great Need of the Present, and Glimpses into the Future

A sneak peak into the new issue:

Phage Therapy in Israel, Past, Present, and Future, by Amit Rimon, Daniel Gelman, Ortal Yerushalmy, Shunit Coppenhagen-Glazer, Eyal Katvan, Ran Nir-Paz, and Ronen Hazan

Pathways to Phage Therapy Enlightenment, or Why I Have Become a Scientific Curmudgeon, by Stephen T. Abedon

Data to Power Precision Phage Therapy: A Look at the Phage Directory–Phage Australia Partnership, by Jessica C. Sacher, Jan Zheng, and Ruby C.Y. Lin

What’s New

Paper: Gut virome profiling identifies a widespread bacteriophage family associated with metabolic syndrome.

Metabolic syndromeResearch paper

Paper: Effect of freeze drying, spray drying and electrospraying on the morphological, thermal, and structural properties of powders containing phage Felix O1 and activity of phage Felix O1 during storage.

FormulationResearch paper

Paper: Widespread phages of endosymbionts: Phage WO genomics and the proposed taxonomic classification of Symbioviridae.

Research paperSymbiosis

Paper: Bacteriophage-mediated perturbation of defined bacterial communities in an in vitro model of the human gut.

GutResearch paper

Review: Novel antimicrobial agents for combating antibiotic-resistant bacteria.

AMRResearch paper

Latest Jobs

Post Bac
Postbaccalaureate fellow: The Stibitz lab at the FDA (Silver Spring, MD) is recruiting a postbaccalaureate fellow to characterize and engineer the lytic activity of Lactic acid bacteria bacteriophage endolysins.
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Lecturer: University of Toronto is seeking a Sessional Microbiology Lecturer to teach in-depth discussion of bacterial structure and ultrastructure; physiology and nutrition; growth and cultivation; nature of viruses (bacteriophage and a limited survey of animal viruses and their properties), and more.

Community Board

Anyone can post a message to the phage community — and it could be anything from collaboration requests, post-doc searches, sequencing help — just ask!

INCATE, the Incubator for Antibacterial Therapies in Europe, INCATE brings together translational and basic research, industry, experienced entrepreneurs and investors to accelerate your innovation. We do this by providing advice, community and funding.

Phages are of particular interest and we already support several start-ups in the field.

Contact: [email protected]

EntrepreneurshipIncubatorPhage Therapy

I was wondering if anyone has a library (small or large) of Campylobacter phages and willing to share. If yes, please contact me at [email protected].

Seeking phages

Baylor College of Medicine is putting out a reverse phage alert. If you need phage for patients we have some purified, USP certified, sequenced and endotoxin quantified ready for use!

  • 2 phage cocktails for E. coli
  • 1 phage cocktail for S. maltophilia
  • 1 phage for P. aeruginosa.

Physicians that are interested please contact [email protected]

Phage TherapyPhages available

The Targeting Infectious Diseases Committee is hosting the 6th World Conference on Targeting Phage & Antibiotic Resistance November 24-25 2022 in Paris, France & online.

The 2-day meeting will gather leading experts from around the world to explore the most recent studies in phage therapy including its pros and cons. The major aim is to cover the aspects of phage therapy today, especially with the emergence of phage resistance. It will also shed light on the new bacteriophage-based innovations and discoveries.

Register by August 30 get the early bird offer.

ConferencePhage Therapy

Intralytix: then and now

Profile Image
Graduate Student
Puxty Lab,
University of Warwick, Coventry, UK
Skills

Biotechnology, Phage isolation, Phage Therapy, Phage-host interactions, Data Analytics, Molecular Biology

I am Madhav Madurantakam Royam, a first year Ph.D. student at Puxty’s Lab at the School of Life Sciences, University of Warwick, UK. My Ph.D. work focuses on elucidating the role of tRNA’s in mycobacteriophages with respect to its virulence and host range. My work involves evolution of mycobacteriophages against their hosts and generating tRNA mutants in them. I have finished my Master of Science (MSc) and Master of Technology [By Research] degrees from Vellore Institute of Technology, Vellore, India. I have had experiences on working with Gram-negative pathogens such as Citrobacter sp. Pseudomonas aeruginosa, Klebsiella sp, and Escherichiacoli. During my Master of Technology [By Research] degree, I have isolated lytic bacteriophages against Citrobacter sp. and characterized their in vitro & in vivo efficacy in a zebrafish model.

My research interests are to understand the evolution of phages against their hosts and characterise their defence mechanism them using various molecular biology and bioinformatic tools.

This week Madhav Madurantakam Royam, a PhD student at the University of Warwick, talks to Dr. Alexander Sulakvelidze, founder and CEO of Intralytix, one of the first modern phage companies to have products on the market.

sandro s

Alexander Sulakvelidze is founder and CEO of Intralytix, which produces phages for food and therapeutic applications.

Madhav: Can you give us a short intro about yourself and how you got into phage therapy?

Alexander Sulakvelidze: I am a PhD microbiologist born and raised in Georgia, the former Soviet Union, where the Eliava Institute is located. Phages have been commonly used as medication there for many years. In 1993, I received a fellowship from the National Academy of Sciences. I came to the USA to do postdoctoral training at the University of Maryland, Baltimore. While I was working at the medical school, by accident, I came to know that bacteriophages are not used therapeutically in this country, and this was a big shocker to me as I always assumed they were used everywhere, just like in my country. That made no sense, and this discovery triggered a series of conversations.

How was Intralytix started?

In 1998, with some of my colleagues, I formed a company called Intralytix, Inc.; the goal was to develop bacteriophages for therapeutic applications. Several phage companies were formed along with us, but most of them went out of business; some were acquired by others or are functioning under different names.

Human therapy was our original idea, but back in 1998, phages were not as famous as today, and quickly we realized that securing funding would be challenging to move forward with therapeutic development. So the company’s focus shifted to agricultural products and food safety applications.

Intralytix is now one of the oldest companies profiting from FDA approved phage product sales. We were the first company to receive FDA approval for food safety applications. The company has been growing fairly rapidly (about 34% annually) in the last four years. We have become the largest producer of bacteriophage products operating under Current Good Manufacturing Practices conditions.

What is Intralytix’s current focus?

Our company is increasingly becoming active in human therapy; we are working with various partners in other applications such as veterinary, nutraceutical, skincare, and other applications.

Our other curiosity lies in the microbiome field, which interests me even more, where phages can be used for fine tuning the microbiome and not just for drug-resistant pathogens. The rational examination of the gut composition might indicate that some diseases like cancer, Alzheimer’s and obesity are connected to the presence of certain microbes. I hypothesize that once you have that link, then phages can be used to fine tune the microbiome, not only gut but also skin, vaginal, oral, etc.

Can you tell us about some of Intralytix’s phage products and phage production capacity?

We currently have five approved products for food safety applications, which is the most extensive portfolio globally.

As our food safety business was growing, we started to explore other areas. In March 2022, we launched our first nutraceutical called “Digest select”, marketed by the French company Gnosis. It’s a dry powder formulation that includes phages for Listeria monocytogenes, Salmonella and Shiga toxin-producing E. coli (STEC). It is sold as a pill/capsule that people can swallow that enhances natural gut resilience. In the process, we became the only company that has a spray drying capability for FDA approved phage products in the USA and the ability to produce dry phages on a commercial scale and blend them for packaging.

We expect to introduce additional nutraceuticals and food grade products to the market by the end of 2023.

Our production is currently at a capacity of 1500 L, and we are looking to double it or more. Most of our sales are in the USA; some of our products are also approved in Canada and Israel.

Do you have clinical trials running at Intralytix?

We were the first company to successfully assemble a Master Drug File with the FDA for a human clinical trial in the USA; it was a physician-initiated Investigational New Drug, which was tested in a phase I safety trial for venous leg ulcers at the Wound Care Center in Lubbock, Texas. It was completed in 2008.

We are running a full blown IND (not compassionate use but a complete trial) in New York at Mount Sinai. It is a phase 1/2a trial testing E. coli phages to target adherent invasive E. coli, which is thought to be responsible for Crohn’s disease and inflammatory bowel disease. We also have two additional IND trials approved by the FDA: one is for Shigella, fully funded by NIAID, taking place at the University of Maryland medical school. It is a phase 1/2a trial, and it will look for both safety and efficacy. It will be starting in the next 30 to 60 days.

We had another IND approved earlier this month, which is a clinical trial for vancomycin-resistant Enterococcus (VRE). VRE is not very common but is pathogenic for immune-compromised people undergoing chemotherapy or transplantation. This bacteria can enter your bloodstream, causing potentially lethal sepsis. Interestingly enough, VRE was the bacterium that killed a patient of one of our founders back in 1998 and triggered us into this research. This trial will be carried out in Pittsburgh, USA, and we will be enrolling patients this fall.

A couple of other products are in the pipeline and will be starting to file for clinical trials with the FDA in the next 18-24 months.

What do you think about phage-related IP?

Patents are limited for phages, but are not impossible; we have managed to develop an IP portfolio, and have been issued 15 patents, with several more pending. Of them, two are directly dealing with the microbiome, where one is using phages to change the human microbiome, explicitly killing problem-causing pathogens and other animal-related applications. 13 of our patents are for specific bacteriophages dealing with particular applications and formulations.

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