Whilst various forms of peanut immunotherapy are being developed, they are generally forms of traditional specific immunotherapy which use crude natural extracts of allergens that do not meet the modern requirements for regulated medicines. Furthermore, they put patients at risk of suffering the very adverse reactions we are trying to treat, so careful, complex dose regimens are required. The unmet need for a safe, convenient and effective therapeutic is obvious.
PVX108 represents a significant leap forward over the traditional approach to specific immunotherapy. Novel research by Monash University and Alfred Health led to the identification of the product, which contains a mixture of peptides that represent the immunodominant human T cell epitopes identified from the major allergenic proteins in peanuts. The peptides stimulate peanut-specific T cells in an immunologically quiescent context to induce tolerance. Importantly, the product is designed to be devoid of the capability to cause acute allergic reactions and is manufactured to current pharmaceutical quality standards. It can be administered as a monthly injection, thus avoiding the need to comply with daily treatment regimens.
Aravax has shown that PVX108 is safe in nonclinical studies, and has a vastly reduced potential to induce acute allergic reactions when compared to peanut protein using blood samples obtained from peanut-allergic volunteers. A Phase 1 study of PVX108 in adults with peanut allergy is ongoing. The study includes an assessment of repeat dosing studies which will not only provide safety information relevant to the anticipated clinical dose regimen, but also biological samples for studies of immunological function in collaboration with leading international research teams. Aravax anticipates that PVX108 will progress to Phase 2 trials in 2019.