Responding to food allergy leaders’ request to address a growing unmet medical need
Aimmune Therapeutics was created in response to a united call to action from an assembly of the leading minds and key stakeholders in food allergy.
At this landmark event, prominent academic researchers, senior government officials, and industry and advocacy leaders agreed that safe, effective, FDA-approved treatments to address the growing problem of food allergies were within reach. Among the outcomes of the meeting, the group concluded that there needed to be a large, Phase 3 registration trial of oral immunotherapy (OIT) — which had been explored since the beginning of the 20th century — to establish a validated, optimized OIT product and protocol.
But such an effort was beyond the scope and resources of academic researchers or nonprofits — it needed to happen in the professional realm of the biotechnology or pharmaceutical industry. Dr. Bryan Walser, who had facilitated the retreat as a consultant for FAI, sought a corporate partner for the development work to support a trial, but none emerged.
Ultimately, Dr. Walser drew from his biotech experience to put together Allergen Research Corporation (or ARC, now Aimmune) in 2011, dedicated to OIT drug development. Researchers from Duke University, the University of Arkansas, and Stanford University also played key roles in getting the company started by licensing their data from important OIT studies.
In 2012, FAI merged with the Food Allergy & Anaphylaxis Network (FAAN), the most trusted source of food allergy information, programs and resources, to form Food Allergy Research and Education (FARE), the nation’s leading nonprofit focused on food allergies.
With a mission of ensuring the safety and inclusion of individuals with food allergies while relentlessly seeking a cure, FARE invested the seed money to found ARC and used its extensive network to generate a total investment of $12M from FARE and several high net-worth individuals connected to food allergies. This funding allowed ARC to advance studies of OIT sufficiently to attract our first institutional investor, Longitude Capital, to complete a $17M Series A financing and execute on a Phase 2 clinical trial of OIT for peanut allergy. In 2015, along with the successful completion of our Phase 2 study, we closed an $80 million Series B financing.
Now, as Aimmune, we are conducting Phase 3 studies of our lead product candidate, AR101, a biologic oral immunotherapy for the treatment of peanut allergy, using characterized oral desensitization immunotherapy (CODIT™), our approach to OIT. We are also planning upcoming clinical trials with our CODIT approach for other common food allergies.
We aim to fulfill the 2011 shared vision of establishing a characterized OIT product and validated approach, to be made available in allergists’ offices nationwide and beyond, so that people with food allergies can live with less fear and more safety.