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 4–6% of children in the U.S. are now affected by food allergies.
About Peanut Allergies
Since 1990, the incidence of self-reported peanut allergy has risen significantly, representing a mounting financial burden to the healthcare system. With no approved therapeutics available, various forms of peanut immunotherapy have been evaluated but generally do not facilitate long-term protection and can have 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 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. All of these approaches focus on altering immunologic responses to induce desensitization to the allergen. Various routes for immunotherapy are being tested, including subcutaneous, oral, sublingual and epicutaneous.
Subcutaneous immunotherapy has demonstrated promise for protection, however adverse reactions to this route are common and thus the therapy has not been proven to be safe. Oral, sublingual and epicutaneous immunotherapy elicit some efficacy, however protection is rapidly lost after therapy is ceased and severe adverse reactions have been reported in some patients.
BlueWillow’s intranasal Peanut vaccine candidate leverages the novel characteristics of our underlying NanoVaxTM technology. Intranasal NanoVax vaccines are unique to other technologies in that they have consistently been shown to facilitate mucosal and systemic immunity with a Th1/Th17 bias. In patients susceptible to peanut allergy, their immune response is characterized by an acutely sensitive, preexisting Th2-biased immunity that leads to severe inflammatory allergic reactions, including anaphylaxis and potentially death. Current strategies, including allergen-specific immunotherapy, are designed to suppress Th2-dependent immunity directly. However, efficacy is generally observed in a small proportion of the patient population. In cases where immunotherapy is effective, treatment must be applied indefinitely for long-term protection.
Our approach of employing the NanoVax platform redirects the host immune response to a protective Th1/Th17-biased immunity, which together suppress the Th2-mediated allergic response. Multiple preclinical studies conducted in animal models at the University of Michigan1 have demonstrated the effectiveness of our intranasal Peanut-NE01 vaccine. In rodents, intranasal immunization with a NanoVax-Peanut vaccine induces robust mucosal Th17-polarized immunity and systemic Th1-biased cellular immunity with suppression of pre-existing Th2. Immunizations resulted in marked decreases in TH2 cytokine, IgG1, and IgE levels. Following allergen challenge, NanoVax-vaccinated animals had significant reductions in allergic hypersensitivity. Animals that were vaccinated with intranasal peanut in saline as a control had no modulation of their allergic response.
The results observed to date demonstrate the potential therapeutic utility of an intranasal NanoVax-Peanut vaccine in the setting of peanut allergy, as well as the potential larger utility of NanoVax vaccines for treating other food allergies.
1 O’Konek et. al, J Allergy Clin Imm. 2018