Trial results demonstrate excellent PVX108 safety profile in patients with prior anaphylaxis and current asthma

MELBOURNE, Australia, June 04, 2019 (GLOBE NEWSWIRE) — Aravax, a clinical stage biotechnology company focused on developing the first safe and rapidly effective treatment for peanut allergy, today reported additional data from a recently completed Phase 1 clinical trial of PVX108 immunotherapy at the 2019 European Academy of Allergy and Clinical Immunology (EAACI) Congress taking place June 1 – 5 in Lisbon, Portugal. PVX108 is a peptide-based immunotherapy designed to safely induce immune tolerance to peanut allergens without the safety limitations of other approaches that expose patients to intact, allergenic protein that may cause allergic reactions or anaphylaxis during treatment.

Preliminary results from the trial were previously presented at the 2019 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting in February 2019. The presentation at EAACI includes additional demographic data on the proportion of patients in the trial with prior anaphylactic responses to peanuts and/or current asthma, as well data demonstrating stable lung function following PVX108 administration. Sara Prickett, BSc, PhD, Chief Scientific Officer at Aravax presented the data today in an oral presentation titled: “PVX108 – A Peptide-Immunotherapy for Peanut Allergy Shows Exceptional Safety in Peanut-Allergic Adults (Abstract #2071) during Session LB OAS 03 (Advances in cellular immunology).

“The potential risk of severe allergic side effects has been an ongoing challenge in advancing immunotherapy-based approaches to treating peanut allergy,” said Dr. Prickett. “The additional data from the PVX108 Phase 1 Clinical Trial presented at EAACI demonstrate that a peptide-based approach to peanut allergy immunotherapy has a highly favorable safety profile, even in a population with a high percentage of patients with previous anaphylactic reactions to peanuts and who currently have asthma. The data demonstrating stable lung function following PVX108 administration provide additional evidence that this novel peptide therapy doesn’t induce allergic respiratory responses. Such responses are a particular risk in asthmatic patients with prior anaphylaxis. These data further validate the excellent safety profile of PVX108 and support its further evaluation in additional trials designed to demonstrate efficacy.”

New data from the PVX108 Phase 1 Clinical Trial presented at EAACI are:

• Of the 67 patients participating in the PVX108 Phase 1 trial, 63.3% of stage 1 patients and 61.1% of stage 2 patients had prior anaphylactic responses to peanuts and 32.7% of stage 1 subjects and 44.4% of stage 2 currently suffer from asthma.
• There was no change in lung function, as assessed by peak expiry flow every hour for 8 hours, following PVX108 administration.

“PVX108 is designed to specifically target the peanut-specific T-cells that are believed to be the underlying cause of peanut allergy,” said Pascal Hickey, CEO of Aravax. “Our peptide-based immunotherapy approach works to reprogram allergy-causing immune cells so that they become tolerant to peanut proteins. Unlike other immunotherapy strategies, our peptide-based approach doesn’t trigger the immune cells that cause anaphylaxis and other severe reactions. The data presented today further validate the safety of this approach. We are working with the clinical community to design a Phase 2 clinical program that will demonstrate the efficacy of PVX108 in addressing the significant unmet need in the treatment of peanut allergy.”

About Aravax
Aravax is a clinical stage biotechnology company focused on developing the first safe and rapidly effective treatment for peanut allergy. The treatment uses highly targeted technology that can reset the immune system to tolerate peanut without evoking allergic reactions during treatment.

Aravax’s technology is underpinned by over a decade of research led by Professor Robyn O’Hehir and her team at Alfred Health and Monash University, which has been supported by the Australian Food Allergy Foundation, the Alfred Hospital Trust, and the National Health and Medical Research Council of Australia.

Aravax developed PVX108 by carefully selecting fragments (peptides) of peanut proteins to switch off allergic reactions to peanuts. The product does not contain whole protein allergens, which are known to cause life-threatening anaphylactic reactions. PVX108 therefore has the potential to break the paradigm of allergen immunotherapy by targeting the underlying cause of disease without exposing patients to the risk of acute reactions to treatment.

Aravax is headquartered in Melbourne, Australia.

For more information visit: www.aravax.com.au

CONTACTS:

Media Relations
Erich Sandoval
Lazar Partners
917-497-2867
esandoval@lazarpartners.com