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.
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.