Food allergy has become a significant health problem with increasing incidence and severity, particularly in children but continuing throughout adulthood. There is no cure for food allergy, and allergic reactions can be life threatening. According to the Centers for Disease Control, an estimated 8% of children in the U.S. are now affected by food allergies, or roughly 2 students per classroom.
About Peanut Allergies
Since 1990, the incidence of self-reported peanut allergy has risen significantly representing a mounting financial burden to the healthcare system. Every seven minutes, a child goes to the emergency room in the U.S. for an allergic reaction to food. ER visits and therapeutic interventions result in an estimated cost of $25B annually.
Oral and epicutaneous peanut immunotherapy have been evaluated, and oral immunotherapy was recently approved as a daily treatment to temporarily de-sensitize patients to peanut allergen. But these treatments do not facilitate long-term protection and can have severe adverse side effects. Thus, there is an urgent need to develop strategies to induce long-term suppression of the Th2-biased cellular immunity that causes peanut-induced allergic inflammation.
Currently, there is no FDA-approved vaccine or treatment available that provides long-term protection for peanut allergy. Management of the disease largely consists of avoidance of peanuts and carrying an epinephrine autoinjector for use in the event of an allergic reaction. Recent developments in the field of allergy have led to many allergen specific immunotherapies being explored to combat this rapidly growing epidemic.
Oral immunotherapy has been shown to temporarily de-sensitize patients to peanut allergen, but this benefit is rapidly lost upon cessation of therapy and the treatment itself can lead to severe allergic responses including a 5x increase in anaphylactic reactions. Epicutaneous immunotherapy has demonstrated a better safety profile, but at the cost of greatly reduced efficacy.
BlueWillow’s intranasal immunotherapy (INIT) for peanut allergy leverages the novel characteristics of our underlying NanoVax® platform. INIT modulates or “re-programs” the immune system to respond properly to common allergens when they enter the body. By eliciting immune memory that can be recalled across mucosal surfaces in the gastrointestinal tract, we are able to provide long-term prevention of allergic responses following a handful of INIT applications.
In animals, three doses of our intranasal peanut immunotherapy given once every four weeks has been shown to (i) induce mucosal immune responses in the gastrointestinal tract where the allergen enters the body, (ii) induce systemic Th1 immunity, (iii) suppress pre-existing Th2 allergic immunity and IgE antibody production, and (iv) provide long-term protection against inflammatory and anaphylactic responses upon subsequent exposure to peanut allergen1. These results are achieved with an expected INIT dose that will contain less than 0.1% of the peanut protein in approved oral immunotherapy treatments, which is expected to result in a markedly improved safety profile. With the incorporation of NanoVax®, BlueWillow’s intranasal immunotherapy serves as a potential cure for children and adults who suffer from severe peanut allergy, whereas oral and epicutaneous therapies only temporarily desensitize patients to the allergen.
Similar results to those described above have recently been demonstrated by researchers at the University of Michigan in animal models of milk allergy2. The findings demonstrate the potential utility of BlueWillow’s intranasal immunotherapy in the settings of peanut and milk allergy, as well as the potential broader utility for treating other food allergies.
1 O’Konek et. al, J Allergy Clin Imm. 2018
2 O’Konek et. al, Allergy. 2019