Currently there are 15+ Million Americans affected by peanut allergies and all of all of them, we’d hope, brush their teeth. What does this have to do with anything? With Intrommune Therapeutics’ newest product OMIT, you can brush your teeth with allergy preventing toothpaste. Unlike other painful or overly expensive treatments OMIT is as simple as brushing your teeth and takes away the anxiety you may already feel towards peanuts.
We spoke with cofounder Danya Glabau about how exactly this magical toothpaste works as well as got the detailed story on how the company started.
Tell us about the product or service.
Intrommune Therapeutics is developing a novel therapeutic platform for food allergies that works while users brush their teeth. The proprietary platform is called oral mucosal immunotherapy (OMIT). The lead product candidate is INT-301 for treating peanut allergy, which addresses an unmet medical need for millions of people worldwide (including upwards of 3 million Americans) with a potentially deadly allergy to peanut. INT-301 will allow users to seamlessly integrate disease-modifying treatment for peanut allergy into their everyday routines. With long-term, consistent use of the product, it is expected that peanut allergic users will fundamentally decrease their sensitivity to peanuts and reducing the ever-present fear of accidental ingestion of even minute amounts of peanut.
Millions of people worldwide live with the constant anxiety caused by food allergies, including 15 million Americans. There is no FDA-approved, disease-modifying treatment or cure for food allergies. Strict avoidance of allergy-causing foods and emergency management of life-threatening anaphylactic reactions are the current standard of care. These measures come at a great cost: up to $25 billion per year in the US, social exclusion, and psychological stress for allergic individuals and parents of allergic children.
How is it different?
OMIT greatly improves upon other investigational techniques for allergy immunotherapy by integrating therapy into the daily routine and targeting the entire surface of the oral cavity, which is expected to optimize therapeutic effects. Allergy immunotherapy is the only approach that has been shown to treat the root cause of allergic diseases. The effectiveness of immunotherapy greatly relies on a user’s long-term, consistent use of the treatment.
Techniques like oral immunotherapy (OIT), where patients eat their allergen, and sublingual immunotherapy (SLIT), where patients hold liquid allergen extracts under the tongue, are difficult or unpleasant to administer, and challenging to fit into a daily routine. In addition, there is a potential for serious side effects, especially with OIT. Another immunotherapy option under investigation is an allergen-coated patch that delivers immunotherapy via the skin. However, immunological changes from these patches appear to take longer to develop for many users than with SLIT and OIT. OMIT is expected to optimize user-friendliness and efficacy compared to these other approaches. We will test these (and many more) aspects of the technology in upcoming clinical trials.
What market are you attacking and how big is it?
Intrommune’s lead product candidate is INT-301 for peanut allergy. Approximately 3 million people in the US alone have peanut allergy. 8 key foods – peanut, tree nut, wheat, milk, egg, soy, fish, and shellfish – account for 90% of food allergies experienced by the 15 million food allergic people in the US. After tackling peanut allergy, the future pipeline and new markets corresponding to additional indications are clearly laid out for us.
What is the business model?
Intrommune is pursuing FDA-approval for INT-301 for peanut allergy, with additional FDA-approved products to address other common food allergies on the horizon. We anticipate that Intrommune’s products will be priced and reimbursed by US insurance payers according to their demonstrated pharmaco-economic benefits. Intrommune’s products will also be developed for regulatory approval in other global regions, including the EU and Japan.
What inspired the business?
The idea for OMIT struck when Dr. William Reisacher, an Otolaryngologist and Associate Professor at Weill Cornell Medicine, was brushing his teeth while thinking about how to improve adherence to therapy among his respiratory allergy immunotherapy patients. He noticed the toothpaste welled up right in the areas of the mouth theorized to be most effective for driving allergy desensitization, such as in the vestibular area between the cheek and the teeth. Another company, Allovate Therapeutics, worked to secure existing IP and to generate new IP to protect the idea. Allovate also initiated development of prototype OMIT toothpaste formulations.
Intrommune was created late in 2015 to develop products using the OMIT technology that are tailored to the technical and safety challenges specific to food allergy, including seeking capital-efficient FDA approval of INT-301, a fixed-formulation product for peanut allergy.
Members of the team had worked together on two other allergy-related companies in NYC prior to launching Intrommune. They formed Allovate Therapeutics (which still owns the core OMIT IP and is licensing it to Intrommune Therapeutics for food allergy products) to begin developing the OMIT platform, and that company continues to develop it for respiratory allergies, like allergies to pollen and pets. They also worked on Immunovent, an allergy diagnostics company that resided at the Harlem Biospace for over a year. All three of the companies are based on ideas from Dr. Reisacher, who continues to act as a Senior Advisor to each company.
What is it like to build a biotech company in NYC?
The last decade has seen the biotech community of NYC increasingly thrive. The geographic concentration of business experts, financial resources, and scientific research forms a great substrate for meeting people, developing ideas, and accessing talent and capital. Two of Intrommune’s co-founders met at an informal, monthly biotech entrepreneur gathering and later connected with Dr. Reisacher through the Weill Cornell Medical College technology transfer office. I am the fourth co-founder, and I got involved in the company through my food allergy-focused dissertation research. The company’s story really attests to the growing vibrancy of the NYC biotech ecosystem.
Space is always an issue, but to date Intrommune has been run on a virtual model. The company’s home base is a converted floor-through apartment in Harlem that was taken over from a friend’s small design firm. The company works with many outside specialists, such as leading experts in food allergy research, manufacturing, and other functions, to help manage clinical and product development.
What are the milestones that you plan to achieve within six months?
Intrommune is currently securing a Series A round of financing. We are simultaneously tightening up plans for clinical studies and manufacturing in preparation for conversations with the FDA concerning the requirements for eventual approval of INT-301.
What is the one piece of startup advice that you never got?
It is incredibly helpful to have a well-connected investor relations professional to open doors during fundraising, no matter the founders’ connections or backgrounds. We work with the incredible Jennifer Zimmons, who is also based in NYC.
If you could be put in touch with anyone in the New York community who would it be and why?
You caught us on a day when the two music fans on the team are in the office together. It’s a toss up between Phillip Glass and Laurie Anderson. Staying engaged in arts and music helps to balance the demands of running a start up.
Why did you launch in New York?
The technology was created here, our people were based here and met here, and we all have roots here now – some lifelong, some intergenerational, some social. So far, we’ve seen no reason to leave.
What’s your favorite rooftop bar in NYC to unwind?
Since two of us live in Brooklyn, we tend to spend more time in parks and backyards than rooftops! The running loop in Prospect Park and the relocated Sunday Smorgasburg are two evening-and-weekend favorites.