7 March 2022 - - Australia-based biotechnology company Aravax has received a green light for its Investigational New Drug application from the US Food and Drug Administration, the company said.

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 US and expand its global operations.

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 profile for 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 US, EU and other jurisdictions. Additional patent families are also progressing well in these jurisdictions.

Aravax is a clinical stage biotechnology company focused on revolutionising the treatment of food allergies with next-generation specific immunotherapies.

Aravax applies proprietary technology and know-how to design highly targeted pharmacotherapies which reset the immune system to tolerate a specific allergen without evoking allergic reactions during treatment.

The lead product, PVX108, is being developed for the treatment of peanut allergy. Aravax is headquartered in Melbourne, Australia.