Data show that PVX108, a peptide-based immunotherapy, has a highly favorable safety profile for the treatment of peanut allergy
MELBOURNE, Australia, Feb. 24, 2019 (GLOBE NEWSWIRE) -- Aravax, a clinical stage biotechnology company focused on developing a precisely-targeted, next-generation treatment for peanut allergy, reported positive data from a recently completed Phase 1 clinical trial of PVX108 immunotherapy at the 2019 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting. (click to tweet) The data show that PVX108 has a highly favorable safety profile, even in patients with severe peanut allergies. This is a significant advance compared with other immunotherapeutic approaches to peanut allergy, which are sometimes associated with incidents of severe allergic reactions. The AAAAI Annual Meeting is taking place February 22nd - 25th in San Francisco.
Unlike whole peanut protein-based immunotherapies, PVX108 utilizes peptides that have been carefully selected from peanut proteins to induce immune tolerance to peanuts. Injection of these peptides in the absence of whole protein allergens, which can cause life-threatening anaphylactic reactions in patients, is designed to reprogram allergy-causing immune cells to become tolerant to the allergen. The peptides are designed to be incapable of activating mast cells and basophils, the cells that mediate severe reactions (including anaphylaxis), thus substantially reducing the risk of these reactions during treatment.
“Peanut allergy is the most common cause of food allergy-related deaths in children, and there is an urgent need for safe, effective and convenient therapies that address the underlying cause of this potentially fatal disease,” said Pascal Hickey, CEO of Aravax. “The results of this Phase 1 clinical trial demonstrate that our peptide-based immunotherapy approach has a very favorable safety profile, even in patients with severe peanut allergies. As a result, we are working with the clinical community to design a Phase 2 clinical study of PVX108. We believe that this novel peptide-based immunotherapy has important potential to improve the lives of millions of people with peanut allergies.”
The poster titled, “Safety and Tolerability of a Novel Peptide-Based Immunotherapy for Peanut Allergy” (Abstract L31), will be presented at 9:45 a.m. PST on Monday, February 25th [Late Breaking Abstracts, Session 4216, Moscone Center South Hall B]. Dr. Robyn O’Hehir, Professor and Head of Department of Respiratory Medicine, Allergy and Clinical Immunology, Central Clinical School, Monash University and Chief Medical Advisor on the Phase 1 trial, also discussed the data during an AAAAI press conference on Sunday, February 24th.
The Phase 1 study comprised two phases, the first of which assessed single, ascending doses [0.05 nmol – 150 nmol] of PVX108 and enrolled eight cohorts of six subjects each. Subjects of each cohort were randomized to receive PVX108 or the placebo. Cohorts were enrolled one at a time, starting with a single injection. The dose escalated for each successive cohort, with the eighth cohort receiving the highest dose. In the second phase, 18 additional subjects were randomized to receive six injections of 150 nmol over a 16-week period. Key findings from the study include:
- There were no serious adverse reactions in patients receiving PVX108.
- Adverse events considered possibly or probably related to treatment were graded mild or moderate, with the majority being transient injection site reactions. None of the adverse events was deemed of clinical concern by the study Safety Review Committee.
- There was no relationship between dose level and frequency or severity of adverse events.
In a separate study utilizing blood samples donated by peanut-allergy sufferers, in vitro assays also confirmed a lack of basophil reactivity to PVX108.
“Although early-stage, these results suggest that a peptide-based approach to peanut allergy immunotherapy could offer significant safety advantages over other approaches in later stages of development,” said Dr. O’Hehir. “This is a significant breakthrough in the search for a safe therapy for peanut allergy, and builds on prior work showing that PVX108 targets the peanut-specific T cells that are believed to be the underlying cause of disease.”
For more information on previous studies1,2 and PVX108, visit www.aravax.com.au.
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.
The novel technology uses carefully selected fragments of peanut proteins to switch off allergic reactions. The product does not contain whole protein allergens, which are known to cause life-threatening anaphylactic reactions. Aravax’s 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
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References:
1 Prickett, S. R., Voskamp, A. L., Phan, T., Dacumos-Hill, A., Mannering, S. I., Rolland, J. M., & O'Hehir, R. E. (2013). Ara h 1 CD4+ T cell epitope-based peptides: candidates for a peanut allergy therapeutic. Clinical and experimental allergy: journal of the British Society for Allergy and Clinical Immunology, 43(6), 684-97.
2 Prickett, S. R., Voskamp, A. L., Dacumos-Hill, A., Symons, K., Rolland, J. M., & O’Hehir, R. E. (2011). Ara h 2 peptides containing dominant CD4+ T-cell epitopes: candidates for a peanut allergy therapeutic. The Journal of Allergy and Clinical Immunology, 127(3):608-15.e1-5.