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Leading Bacteriophage Company Expands Clinical Pipeline, Poised for Growth in Maryland

06/16/20204 years ago

Intralytix, the largest food safety phage company in the world, sits on the precipice of substantial growth and success. 23 years of building unrivaled bacteriophage expertise, developing and securing 15 issued patents, and being one of two phage companies in the world with sales revenue have put his Columbia, Maryland-based company in a position to harness several positive macro-market forces to fuel its expansion.

Increased food safety regulatory pressure, the growing market for organic, non-chemically treated foods, and the continued rise of drug resistant bacteria have intersected with a rapidly emerging microbiome field and personalized medicine to create advantageous market conditions for Intralytix.

Founded in 1998 by Dr. John Glenn Morris, Jr., Dr. Alexander “Sandro” Sulakvelidze, and other business partners, Intralytix 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.

A bacteriophage, or phage, is a type of virus that can infect and then replicate within bacteria, attacking only the bacteria itself and not human cells. Loosely translated bacteriophage means “bacteria devourer.”

Dr. Alexander Sulakvelidze “I was born and grew up in Georgia where phages are commonly used and they are still used. I never thought twice about bacteriophages just like people in the U.S. don't think much about using antibiotics,” stated Sandro, Intralytix's Chief Scientific Officer.

Sandro came to the United States in 1993 and was brought over by Glenn Morris who was a practicing physician at the time. They became friends and one day Glenn was walking around in a sad mood and told Sandro a patient of his recently underwent a very complex surgery that went well, but he eventually died of a vancomycin-resistant enterococcus (VRE) bacterial infection.

“I asked him why didn't the bacteriophage take care of it? I asked him because I knew bacteriophages could kill bacteria that could not be killed by antibiotics. And Glenn looked at me and said 'What are you talking about?' Then it hit me: someone's father, brother or friend had just died in the most developed country in the world from a simple bacterial infection that could have been treated in Georgia, a developing country. This made no sense and we started Intralytix to fix this problem,” he added.

“When we formed the company in 1998 we were way ahead of the curve and people thought we were crazy,” continued Sandro.

Early in its history, the founders realized they couldn't do a clinical trial so they turned to food safety, which paved the way for the company to stay afloat and start to grow.

The company's platform leverages bacteriophages, the most prevalent microorganisms on the globe, to kill off harmful bacteria in a highly targeted manner that is both safe and effective. Intralytix has the potential to deploy its phage platform across a wide array of areas, including food safety, environmental sanitation, veterinary applications, human therapeutics, probiotics and cosmetics.

Most recently, the company was awarded a multi-million dollar grant from the National Institute of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID) for the clinical development of its bacteriophage therapy preparation for managing infections caused by the bacterial pathogen Shigella. Shigellosis, according to the Center for Disease Control (CDC), is caused by the Shigella bacteria and impacts approximately 125M people globally each year with the “...majority of the associated 14,000 deaths occurring in young children,” according to Dr. Jennifer Schwartz, Director of Clinical Development at Intralytix.

Intralytix's Shigella phage therapy Phase 1/2a clinical trial is on the horizon. Phage therapy for Shigella is currently approved for use in Asia and Eastern Europe but is not yet approved in the U.S. If approved, the company's phage therapy for Shigella could yield significant public health benefits and pave the way for use in other indications like Cholera, for example.

The NIAID grant is just the latest milestone achievement in Intralytix's storied history.

In 2006, Intralytix received U.S. Food & Drug Administration (FDA)/U.S. Department of Agriculture (USDA) approval for a bacteriophage-based food safety product, ListShield™, making it the first company in the world to receive approval for a product of this kind. In the same year Intralytix, according to Wikipedia, “...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 Investigational New Drug (IND) for a “...double-blind, randomized, placebo-controlled clinical trial in the U.S. for an orally administered phage preparation.” (Source: Wikipedia.) Around this same time, the company expanded into a GMP facility in Columbia with state-of-the-art robotics and other instrumentation to support its future growth plans. The facility can scale up to a 1,500-liter fermenter, which is very large for phage manufacturing.

As of last year, Intralytix has the most FDA-approved phage food safety products with four; a fifth approval is expected in 2021. Over the last five years, Intralytix has seen a 1,600% increase in sales, as the phage approach is becoming more widely accepted by companies.

Despite the pandemic, the company hasn't laid off any staff and has continued to progress its pipeline. Intralytix currently has one clinical trial that is ongoing and expects to start two additional clinical trials and launch a dietary/probiotic product in 2021/2022. They are also developing several cosmetic products.

The breadth and diversity of their portfolio showcases the clear advantage of their platform technology which can be used in various fields as long as the problem is caused by a single or small group of bacteria.

“It is our hope that our phage approach continues to gain acceptance so that we can increase our revenue while also doing a lot of public good,” stated Sandro.

The phage approach is an excellent complementary modality to antibiotics; the rise of antibiotic resistant bacteria across the globe has increased the value and industry acceptance of a phage approach, which can help combat bacteria that cannot be effectively treated by antibiotics. What's more, the phage modality is a great fit for targeted personalized medicine approaches.

“Our phage technology platform can be used in various fields and applications as long as the problem is caused by a single or small number of bacteria pathogens. The platform can be used to remove foodborne bacteria from foods and we are already impacting public health in that regard; it can be used to treat animals; and it also can be used in human therapies, microbiome change, oral applications and cosmetics. It is a really broad spectrum platform,” stated Sandro.

food safety paved the road for us and now we are expanding. Many years for our company have just been about survival; it's such a different technology and it's been a challenge to get the message across. When we started we were way ahead of our time. There were only four or five companies in the phage space and they all went out of business. We survived. And now things have started to align for us,” he added.

Sandro continued, “We've been very lucky at Intralytix that we've had people willing to sacrifice for the company - some even put in their own money to keep us going. There were some very hard times in the past. We just persisted and kept pushing.”

“We now have a beautiful facility with some very smart people and a lot of intriguing ideas and opportunities to grow,” Sandro stated.

23 years of sacrifice, innovation and perseverance are starting to pay off for Intralytix. The future looks very bright for its phage platform with many exciting milestones on the horizon.
By Steven Surdez, Principal at StoryCore