AVX-001

Aravax, a clinical stage biotechnology company focused on developing the first therapy for peanut allergy which is designed to be safe, effective and convenient, today announces that it has received a green light for its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA). 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). The IND will allow Aravax to progress the Phase 2 clinical trial program into the U.S. and expand its global operations. "We are excited to share that FDA has allowed Aravax to commence a Phase 2 efficacy study to identify the optimal dose of PVX108 in children with peanut allergy in the United States. This is a therapeutic area greatly underserved, and we believe our approach has significant advantages over available treatments with its precise mechanism of action and safety pro proven in Phase 1 clinical trials." said Aravax CEO, Dr Pascal Hickey. Previously, a randomized, double-blind, placebo-controlled Phase 1 trial in 66 peanut-allergic adults (AVX-001) showed no evidence of adverse events of clinical concern. Additionally, ex vivo studies providing a surrogate measure of safety (basophil activation) in 185 peanut-allergic blood donors confirmed a lack of basophil reactivity to PVX108 in contrast to peanut extract. These data demonstrate that PVX108 has a highly favourable safety pro treatment of peanut allergic patients, including those with severe allergy. Aravax's first patent covering the lead composition PVX108 has also been granted in the U.S., EU and other jurisdictions. Additional patent families are also progressing well in these jurisdictions. Internationally recognized expert in food allergy, Dr Robert A Wood, has joined Aravax's Scientific Advisory Board (SAB). Dr. Wood is a professor of pediatrics at the Johns Hopkins University School of Medicine and a professor of international health at the Johns Hopkins Bloomberg School of Public Health. An internationally recognized expert in food allergy and childhood asthma, Dr. Wood is chief of the Eudowood Division of Allergy and Immunology in the Johns Hopkins Children's Center. He has published more than 300 manuscripts in scientific journals, including The New England Journal of Medicine, JAMA, Pediatrics, and the Journal of Allergy and Clinical Immunology, as well as three books and numerous book chapters. "The exciting thing about PVX108 is that it has the potential to introduce a step-change in the treatment of peanut allergy by overcoming many of the problems with first-generation therapies which require long term treatment and carry significant risks," said Dr Wood. Dr Wood also serves as director and attending physician of the Pediatric Allergy Clinics at The Johns Hopkins Hospital and as director of the Pediatric Allergy Consultation Service. He has served as associate editor of the Journal of Allergy and Clinical Immunology, deputy editor of the journal Pediatric Allergy and Immunology, and associate editor of the Annals of Allergy, Asthma, and Immunology. He has served on the board of directors of the American Board of Allergy and Immunology and the American Academy of Allergy Asthma and Immunology and is a past president of the American Academy of Allergy, Asthma and Immunology.