Aravax Completes Phase 2 Recruitment for PVX108 Peanut Allergy Immunotherapy

Aravax, a biotechnology company based in Melbourne, Australia, has recently announced the successful recruitment of patients for its Phase 2 clinical trial of PVX108, a groundbreaking immunotherapy aimed at treating peanut allergy. The trial, labeled AVX-201, has enrolled 95 participants at multiple sites in the United States and Australia. This study focuses on children and adolescents aged four to seventeen who suffer from peanut allergy.

PVX108 is an advanced treatment designed to retrain the immune system by targeting specific T cells with engineered peptides. This approach aims to mitigate the allergic response without using peanut proteins, which can cause severe side effects and require complex dosing schedules. Unlike most existing or developmental treatments for peanut allergy, PVX108's method significantly reduces the risk of adverse reactions, making it a safer and more convenient option.

The clinical trial under the U.S. FDA Investigational New Drug Application is double-blind and placebo-controlled. It aims to assess the safety and effectiveness of two different doses of PVX108 compared to a placebo, administered monthly over a year. In previous Phase 1 trials, PVX108 demonstrated meaningful changes in the immune system's reaction to peanut protein, with these changes continuing even after the dosing period had ended. The primary goal of the Phase 2 study is to determine the maximum tolerated dose of peanut protein during a controlled food challenge at the study's conclusion compared to the baseline. The initial results of this study are anticipated in the first half of 2026.

Dr. Pascal Hickey, the CEO of Aravax, highlighted the importance of completing patient recruitment across multiple sites in both the U.S. and Australia. He emphasized the urgent need for improved treatments for severe food allergies, noting that PVX108 is designed to offer a safe and convenient option with the potential to alter the course of allergic diseases. Dr. Hickey expressed optimism about the ongoing evaluation of PVX108's effectiveness in this trial, which could pave the way for Phase 3 studies.

Aravax, founded in 2015 with technology from Alfred Health and Monash University, aims to revolutionize food allergy treatments. The company focuses on developing next-generation immunotherapies that are safe, efficient, and convenient. Their proprietary technology allows for the creation of highly targeted treatments that reset the immune system to tolerate specific allergens without triggering allergic reactions. PVX108, their leading product, is under development specifically for peanut allergy treatment.

Aravax operates as a private entity headquartered in Melbourne, supported by investors such as Brandon Capital, Tenmile, Novartis Venture Fund, Breakthrough Victoria, Uniseed, UniSuper, and Agati Capital. The company utilizes a mixture of synthetic peptides in PVX108 to target T cells responsible for peanut allergies. Each peptide is designed to represent a dominant T cell epitope from key peanut allergens. PVX108, free from natural extracts or whole allergens, is engineered to avoid acute allergic reactions, offering a safe and long-lasting treatment option with monthly doses administered through a nearly needle-free intradermal method.

In summary, Aravax's completion of patient recruitment for the Phase 2 study of PVX108 marks a significant milestone in the development of a novel treatment for peanut allergy. With the potential to provide a safe, convenient, and effective therapy, PVX108 is a promising candidate for future clinical studies and eventual widespread use. The anticipated results in 2026 will be crucial in determining the next steps for this innovative treatment.