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The data show that PVX108, a peptide-based immunotherapy, has a very favorable safety profile for the treatment of peanut allergy.
MELBOURNE, Australia, February 24, 2019 (GLOBE NEWSWIRE) – Aravax, a clinical-stage biotechnology company specializing in the development of a new generation of precision-targeted treatment for the treatment of allergy in humans. peanut, presented positive results in a Phase 1 clinical trial conducted recently at PVX108 immunotherapy at the annual meeting of the American Academy of Allergy, Asthma and Cancer. Immunology (YYYY) 2019. (click to tweet) The data shows that PVX108 has an extremely favorable safety profile, even in patients with severe peanut allergies. This is a significant advance over other immunotherapeutic approaches to peanut allergy, which are sometimes badociated with incidents of severe allergic reactions. The AAAAI Annual Conference will be held on February 22nd.North Dakota – 25th in San Francisco.
Unlike whole peanut protein immunotherapies, PVX108 uses carefully selected peptides from peanut proteins to induce immune tolerance to peanuts. The injection of these peptides in the absence of whole protein allergens, which can lead to potentially life-threatening anaphylactic reactions in patients, is designed to reprogram the immune cells causing the allergies to become tolerant. allergen. The peptides are designed to be unable to activate mast cells and basophils, cells that intervene in severe reactions (including anaphylaxis), thus significantly 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 treatments that address the underlying cause." of this potentially life-threatening disease, "said Pascal Hickey, CEO of Aravax. "The results of this phase 1 clinical trial demonstrate that our approach to peptide-based immunotherapy 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 on PVX108. We believe that this new peptide-based immunotherapy has great potential to improve the lives of millions of people allergic to peanuts. "
The poster entitled "Safety and Tolerability of a New Peptide Immunotherapy for the Treatment of Peanut Allergy" (Abstract L31) will be presented at 9:45 am PST on Monday, February 25th.th [Late Breaking Abstracts, Session 4216, Moscone Center South Hall B]. Dr. Robyn O. Hehir, Professor and Head of the Department of Respiratory Medicine, Allergy and Clinical Immunology, Central Clinical School of Monash University, and Chief Medical Advisor for the Phase 1 Trial, has Also discussed data at an AAAAI press conference on Sunday February. 24th.
The phase 1 study consisted of two phases. The first was to evaluate single ascending doses. [0.05 nmol – 150 nmol] PVX108 and eight cohorts of six subjects each. Subjects from each cohort were randomized to receive PVX108 or placebo. Cohorts were enrolled one at a time, starting with a single injection. The dose increased 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. The main conclusions of the study include:
- No serious adverse events were observed in patients treated with PVX108.
- Adverse events considered potentially or probably related to treatment were clbadified as mild or moderate, the majority being transient reactions at the injection site. No adverse events were deemed clinically of concern by the safety review committee.
- There was no relationship between the dose level and the frequency or severity of adverse events.
In another study using blood samples donated by people with peanut allergy, in vitro tests also confirmed the lack of reactivity of basophils with PVX108.
"Although they are at an early stage, these results suggest that a peptide-based approach for peanut allergy immunotherapy could offer significant safety benefits over other approaches at different stages of development. development, "said Dr. O'Hehir. "This is a significant advance in the search for a safe treatment for peanut allergy and builds on previous work showing that the PVX108 target the peanut-specific T cells, which are supposed to be the underlying cause of the disease. "
For more information on previous studies1.2 and PVX108, visit www.aravax.com.au.
About Aravax
Aravax is a clinical stage biotechnology company specializing in the development of the first safe and rapidly effective treatment for peanut allergy. The treatment uses a highly targeted technology that allows the immune system to restore peanut tolerance without causing allergic reactions during treatment.
Aravax's technology builds on more than a decade of research conducted by Professor Robyn O. Hehir and his team at Alfred Health and Monash University, supported by the Australian Food Allergy Foundation, the Alfred Hospital Trust and the National Health and Medical Research. Council of Australia.
The new technology uses carefully selected peanut protein fragments to turn off allergic reactions. The product does not contain whole protein allergens, known to cause life-threatening anaphylactic reactions. Aravax PVX108 could therefore break the paradigm of allergen immunotherapy by targeting the underlying cause of the disease without exposing patients to the risk of acute treatment reactions.
Aravax is headquartered in Melbourne, Australia.
For more information, visit: www.aravax.com.au
CONTACTS:
Media relations
Erich Sandoval, Lazar Partners
917-497-2867
[email protected]
References:
1 Prickett, S. R., Voskamp, L. L., Phan, T., Dacumos-Hill, A., Mannering, S.I., Rolland, J.M. and R.O. Hehir (2013). Peptides-based T-cell epitope Ara h 1 CD4 +: candidates for a therapeutic treatment of allergy to peanut. Clinical and Experimental Allergy: Review of the British Society of Allergy and Clinical Immunology, 43 (6), 684-97.
2 Prickett, S.R., Voskamp, A.L., Dacumos-Hill, A., K. Symons, K.M., Rolland, J.M., and O'Hehir, R.E. (2011). Ara h 2 peptides containing dominant epitopes of CD4 + T cells: candidates for treatment with peanut allergy. The Journal of Allergy and Clinical Immunology, 127 (3): 608-15.e1-5.
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