Aravax doses first patient in Phase 2 peanut allergy clinical trials

MELBOURNE,Australia,June 1,2023 --The first patient has been dosed in a Phase 2 study (AVX-201) being run by biotechnology company Aravax,which is developing the novel therapy PVX108 for the safe and convenient treatment of peanut allergy. The study is being conducted under a U.S. FDA Investigational New Drug Application.

Allergy clinical trial centres across Victoria,South Australia,New South Wales,and Western Australia have invited children and adolescents aged four to 17 years with peanut allergy to take part in the Phase 2 study. Researchers aim to evaluate the efficacy of the novel therapy PVX108.

In Phase 1 trials,researchers observed that PVX108 produced relevant changes in the immune response to peanut protein,which continued to develop once dosing had completed.

"We're thrilled to have dosed our first patient in Phase 2. In this Phase 2 trial we will evaluate how the immunological changes observed in Phase 1 trials translate to clinical reductions in allergic reactivity and the development of tolerance to peanuts following 12 monthly doses of PVX108," says Dr Pascal Hickey,CEO,Aravax.

Unlike most treatments available or under development for peanut allergy,Aravax's PVX108 does not contain peanut proteins which put patients at risk of serious side effects. Aravax is applying its platform technology to develop specific immunotherapies for food allergies which are designed to precisely retrain the immune system to tolerate peanut allergens.

These therapies are anticipated to be highly differentiated based on greatly improved safety profile,and the potential for sustained clinical benefits possibly leading to reversal of allergic disease.

Clinical trial AVX-201 is led in Australia by regional principal investigator Associate Professor Kirsten Perrett,Population Allergy Group Leader at the Murdoch Children's Research Institute. Associate Professor Perrett is also a Paediatric Allergist and Vaccinologist and Director of the National Allergy Centre of Excellence (NACE).

Aravax will be attending BIO 2023 in Boston next week,and,Chief Scientific Officer Sara Prickett will be speaking at the European Academy of Allergy & Clinical Immunology Congress 2023 (Hamburg,9-11 June),in a presentation titled: 'A Peptide Immunotherapy for Peanut Allergy Safely Induces Durable Immune Changes in Peanut-Allergic Adults'.

"I'm excited to be speaking at EAACI to some of the world's top immunology experts about the great progress being made at Aravax to tackle peanut allergies,an issue that affects millions of people globally.I've seen the impact that peanut allergies not only have on patients,but also families," Prickett says.

Aravax's Phase 2 trials of PVX108 follow on from $20m investment as part of its series B funding round,led by Australian life science investors,Brandon Capital and Tenmile.

More information and details on how to apply to participate in the clinical trial can be found on the on the NACEand Aravaxwebsites.

CONTACT: Ciara Byrne,cb@manacommunications.com