We spoke to Michael Nelson, CEO, Intrommune Therapeutics.
How would you describe your company in a single tweet?
Intrommune Therapeutics is dedicated to simplifying treatment for food allergies by providing safe, effective, and convenient new options for food allergy sufferers.
How did it all start and why?
Intrommune was founded to support the millions of people suffering from food allergies worldwide. Intrommune’s core technology enables the delivery of immunotherapy with a commercial-grade toothpaste specifically designed to incorporate and stabilize allergenic proteins, representing a new approach for the treatment of peanut and other food allergies.
Delivering allergy immunotherapy by daily tooth brushing is referred to as oral mucosal immunotherapy (OMIT). OMIT delivers allergenic proteins to the areas of the oral cavity which drive the immune system towards tolerance, decreasing risks by avoiding ingestion of the allergen. OMIT addresses a significant health care need in the industrialized world, where the rise in prevalence of food allergies has been characterized as an “epidemic.”
The current approach to the management of peanut allergy is primarily focused on promoting a protective environment (“peanut free” eating areas in schools, enforcement of food labelling requirements) and making a rescue agent such as the epinephrine self-injector widely available.
Intrommune Therapeutics believes that oral mucosal delivery of peanut allergen via a toothpaste offers a significant competitive advantage due to greater adherence and potentially lower rates of discontinuation and side effects. The current dearth of FDA-approved therapies for food allergy provides a vast market for a company which can successfully bring a tolerable, effective therapy to market.
Our goal in developing the oral mucosal immunotherapy (OMIT) platform for food allergies is to find a long-term solution for the 220 million, including 9 million U.S. adults and 6 million U.S. children, who suffer from this life-altering condition.
What have you achieved so far?
The Intrommune team has made great strides in the development of its oral mucosal immunotherapy product INT301. INT301’s unique formulation is designed to desensitize an individual with peanut allergy using a toothpaste delivery system, protecting them in the event of accidental peanut exposure.
So far Intrommune has optimized its formulation of peanut OMIT per FDA standards. Intrommune has also completed its pre-IND meeting with the FDA. The company is completing its IND application. Intrommune has designed its phase 1 study and plans to launch this trial this year.
Intrommune has also secured its intellectual property for INT301 and its OMIT products. Intrommune has licensed the global, exclusive rights for food allergy OMIT, including 33 OMIT patents issued globally. Additional patents are pending, with global protection expected through 2034 and beyond.
What do you plan to achieve in the next 3-4 years?
Intrommune plans to bring its toothpaste to market as an FDA-approved and insurance-reimbursed product. In the near term, Intrommune will conduct the necessary clinical research required to demonstrate the safety and efficacy of INT301. Fortunately, the company is not introducing a new molecule: the active ingredient is peanut protein. Therefore, toxicology studies will not be required. Also, the effectiveness of the oral mucosal delivery of peanut allergen has been previously demonstrated.
How will you use your recent funding round?
Intrommune is completing a Series A round of fundraising. With proceeds from its most recent raise, Intrommune will support the launch and implementation of its phase 1 trial. The company will also invest in chemistry and manufacturing controls (CMC) to ensure scalability for future mass production of the product.
About Michael Nelson, JD, Chief Executive Officer
Mr. Nelson graduated from Cornell University and received his J.D. from New York University School of Law. He has a background in law, finance, and management. Previously, he was an analyst at Barclays Capital and ING, was an investment banker at Westwood Capital and CIBC World Markets and practiced law at Willkie Farr & Gallagher and Dewey Ballantine.
