Aravax appoints Principal Investigators for PVX108 Phase 2 trials in United States and Australia
27 August 2021, Melbourne, AUSTRALIA: Aravax, a clinical stage biotechnology company focused on developing the first therapy for peanut allergy which is designed to be safe, effective and convenient, has appointed Principal Investigators for Phase 2 clinical trials of PVX108 in the United States and Australia.
Aravax plans to submit its Investigational New Drug (IND) application to the U.S. Food & Drug Administration later this year and commence Phase 2 trials in 2022. The Phase 2 trials will identify the optimal dose of PVX108 in children with peanut allergy, using peanut food challenges prior to and following treatment.
“We are extremely pleased that Drs. Brian Vickery and Kirsten Perrett have agreed to lead the Phase 2 clinical trials of PVX108. They are well renowned in the field of food allergy treatment and highly experienced investigators, and bring significant expertise in the conduct of food challenges in peanut-allergic children, which can be challenging,” said Aravax CEO Pascal Hickey.
Dr. Brian Vickery is an Associate Professor of Pediatrics at Emory University and the founding Director of the Food Allergy Center at Children’s Healthcare of Atlanta. Over the last 11 years, he has led patient-oriented research teams focused on translational therapeutic development for IgE-mediated food allergies, work spanning preclinical murine models to Phase 3 trials. With the first new therapies poised for FDA approval and translation into clinical care, he is particularly interested in the intersection of translational and outcomes research in generating rational, evidence-driven treatment strategies that maximize benefit/risk and improve patient-centered outcomes. Dr Vickery will be the overall Principal Investigator and lead trial sites in the United States.
Dr Kirsten Perrett is Associate Professor of Paediatrics at the University of Melbourne, Group Leader of Population Allergy Research at the Murdoch Children’s Research Institute, Consultant Pediatrician at the Royal Children’s Hospital, Melbourne, and and has more than 16 years of experience in leading Investigator-led and Industry-sponsored clinical trials in vaccinology and allergy. She did her PhD with the Oxford Vaccine Group (University of Oxford, UK) and was a Visiting Scholar with the Stanford Lucille-Packard Children's Hospital Vaccine Program (Stanford University, US). Dr Perrett has developed and leads a large program of clinical trials for the prevention and early intervention/treatment of food allergy, and collaborates on research exploring vaccine allergy and the immunological mechanisms underlying allergic disease. Dr Perrett will lead trial sites in Australia.
PVX108 is a next-generation, allergen-specific immunotherapy using peptides that represent critical fragments of peanut proteins to precisely target the T cells driving peanut allergy. Administered once per month, therapy is designed to precisely induce tolerance to peanut protein without the safety concerns constraining the use of the only registered therapy which uses natural extracts from peanuts. The presence of whole peanut allergens in those extracts exposes patients to significant risks of anaphylaxis (Chu et al. The Lancet 2019).