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

June 4, 2019, Melbourne, Victoria – 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).

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Data show that PVX108 demonstrates exceptional safety in adults with peanut allergy

May 28, 2019, Melbourne, Victoria – Aravax, a clinical stage biotechnology company focused on developing the first safe and rapidly effective treatment for peanut allergy, will present 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.

Sara Prickett, BSc, PhD, Chief Scientific Officer at Aravax will present the data 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) at 15.30 on Tuesday 4 June 2019, in Hall 14.

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Melbourne biotech to take its revolutionary peanut allergy treatment to Phase II clinical trials

February 25, 2019, Melbourne, Australia – Aravax, a clinical stage biotechnology company focused on developing the next generation of peanut allergy immunotherapy with advantages in safety and practicality, has presented its clinical trial results at one of the world’s most prominent allergy conferences today.

Melbourne-based Aravax today announced positive results from the Phase I trial of its peanut allergy therapy, at the 2019 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting in San Francisco. The trial data showed that Aravax’s therapy has a highly favorable safety profile, even in patients with severe peanut allergies.

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February 13, 2019, MELBOURNE, Australia – Aravax, a clinical stage biotechnology company focused on developing the first safe and rapidly effective treatment for peanut allergy, will present 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 taking place February 22nd - 25th in San Francisco. 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.

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2 May 2018, Melbourne, Victoria – Aravax has received an additional investment of $1.9M from the Australian Medical Research Commercialisation Fund (MRCF) to complete the ongoing Phase 1 clinical trial, AVX001, and progress Phase 2 plans for its novel treatment of peanut allergy, PVX108.

These funds were released following Aravax’s achievement of research and development milestones to date, which related to progress in pharmaceutical and clinical development activities for PVX108.

We previously reported that in the single ascending dose stage of clinical trial AVX001, there were no adverse events of clinical concern, and no relationship between dose and frequency or severity of adverse events. The trial is now in its second stage which will evaluate the safety and tolerability of repeat administrations of PVX108.

Pascal Hickey, CEO of Aravax said “this additional investment recognises the tremendous progress made by our management and research teams on the development of PVX108 towards a very important cause.

We are now working hard on plans for Phase 2 clinical trials of PVX108 which will aim to identify an effective treatment regimen for sufferers of peanut allergy who currently have no therapeutic options available to them.” This $1.9 million investment tranche will be utilised for the completion of Aravax’s Phase 1 study (AVX001) and Phase 2 preparations

29th January 2018, Seattle, United States of America –The Benaroya Research Institute in Seattle announced receipt of National Institute of Health funding to support investigations into the immune mechanisms of PVX108. The research group led by Erik Wambre (PhD) from the Benaroya Research Institute, became a collaborator of the Australian Biotechnology company Aravax in January 2017. The goal of this funding is to accelerate discovery of treatments for peanut allergies through a collaborative, two-pronged project. The first part of the project aims to better understand and characterise the immune response to peanut in peanut allergic patients. The second part of the project will evaluate clinical samples obtained from clinical trials of novel treatment approaches for peanut allergy currently underway with Aravax in Australia and with Stanford University in the United States of America. The project collectively aims to determine how specific treatments can train the immune systems of peanut allergic subjects to tolerate peanut protein, paving the way for improved management and treatment in food allergy.

13th January 2018, California, United States of America – Australian biotechnology company Aravax presented preliminary data from the first Phase I clinical trial of its product known as PVX108 at the Gordon Research Conference on Food Allergy at Ventura Beach in California, held from the 7th-12th January 2018. The Gordon Research Conference brought together leading researchers, clinicians, regulatory and industry representatives from around the world who are working towards revolutionising the standard of clinical care for sufferers of food allergies.

Aravax’s Phase I clinical trial AVX-001 is a two stage, randomised, double blind, placebo-controlled study to evaluate the safety and tolerability of single and repeated administration of PVX108 in peanut allergic adults. Stage 1 is a single ascending dose study in 8 cohorts of 6 subjects randomised 2:1 active: placebo. Stage 2 is a multiple dose regimen with a total of 18 subjects randomised 2:1 active: placebo. Subjects will receive a total of 6 doses over 16 weeks. A safe starting dose for Stage 2 will be determined following review of safety and tolerability of single doses in Stage 1. AVX-001 commenced dosing in May 2017 and completed dosing in Stage 1 in December 2017. Stage 2 will commence dosing in January 2018. The trial is being conducted at the CMAX Clinical Research in Adelaide and at Nucleus Network in Melbourne. The preliminary blinded data from Stage 1 of AVX-001 presented at the Gordon Research Conference demonstrated that Aravax’s product has a highly favourable safety profile for the treatment of sufferers of peanut allergies, including those with severe peanut allergies. There were no serious adverse events or adverse events of clinical concern in any of the 48 subjects who received a single dose of PVX108 or placebo, with PVX108 doses ranging from 0.05 nmol to 150 nmol. These data suggest that Aravax has met its objective to develop a novel immunotherapy for peanut allergy with a greatly reduced potential to trigger acute allergic reactions. The Safety Review Committee confirmed the acceptable safety and tolerability of single doses of PVX108 in Stage 1 and approved commencement of the planned multidose regimen in Stage 2.

9th January 2018, California, United States of America – Aravax, an Australian biotechnology company revolutionising peanut allergy treatment, today held the first meeting of its newly appointed Scientific Advisory Board, at the Gordon’s Research Conference on Food Allergy at Ventura Beach in California. Aravax is delighted to welcome 5 members to the Scientific Advisory Board. Mark Larché, PhD, is Professor of Medicine at McMaster University, Canada. He is also Chair in Lung Immunology at St. Joseph’s Healthcare, and the Canada Research Chair in Allergy & Immune Tolerance. Professor Larché brings world leading expertise in translational medicine and the development of peptide-based vaccines for chronic immunological diseases including allergy. Wesley Burks, M.D, FAAAAI, is the Curnen Distinguished Professor of Pediatrics at the University of North Carolina (UNC) School of Medicine, United States of America. He is also Executive Dean for the School of Medicine at the UNC and Executive Director of the UNC Food Allergy Initiative. Professor Burks brings over 30 years of experience undertaking and leading clinical food allergy research, including clinical presentations of food allergy, immunotherapy for food allergy and the properties of food contributing to allergenicity. Katrina (Katie) Allen, MBBS, BMedSc., FRACP, PhD, FAAAAI, FAHMS, is Professor of Pediatric Food Allergy at the Murdoch Children’s Research Institute, Royal Children’s Hospital Melbourne, Australia. She is also Theme Director of Population Health and Director of the Australian Centre of Food and Allergy Research. Professor Allen brings extensive experience in translating research findings into clinical practice and public health policy to ensure the best outcomes for children with food allergy. Gideon Lack, MA, MBBCH, FRCP CH, MD, is Professor of Paediatric Allergy at King’s College London, U.K. He is also Head of the Clinical Academic Paediatric Allergy Service, Guy’s and St Thomas’ NHS Foundation Trust. Professor Lack brings over 20 years’ experience of research into severe childhood asthma, peanut allergy and new strategies to prevent and treat food allergies, eczema, asthma, and hay fever in children and adults. Kari C. Nadeau, MD, PhD, is Professor of Pediatric Food Allergy at the Stanford School of Medicine, United States of America. She is also Director of the Sean N. Parker Centre for Allergy and Asthma Research, a Section Chief of Allergy and Asthma at the Stanford School of Medicine, and an endowed Professor under the Naddisy Family Foundation. Professor Nadeau brings commercial, clinical and research expertise in understanding the factors responsible for the increased prevalence of allergies and asthma, improving diagnostics, developing new treatments and understanding the immunological mechanisms underlying these diseases. Pascal Hickey, CEO of Aravax, said “we are extremely pleased to have attracted such a distinguished panel of researchers to Aravax’s Scientific Advisory Board. We look forward to working closely with the Board members as we develop plans for phase 2 studies of PVX108 novel immunotherapy for the treatment of peanut allergy.”

17th November 2017 – Aravax today signed a collaborative agreement with Stanford University in California. The Stanford research group, led by Professor Kari Nadeau, will collaborate with Aravax to further explore immunological responses to Aravax's revolutionary peanut allergy therapy, PVX108. Professor Kari Nadeau is one of the foremost experts in adult and pediatric allergy and asthma and is the Director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford University. As part of the collaborative agreement, Professor Kari Nadeau's group will receive clinical samples from Aravax's ongoing clinical trial, AVX001.

PVX108 utilises peptides that represent carefully selected fragments of peanut proteins to switch off allergic reactions to peanuts. Unlike other peanut allergy immunotherapies under development, the peptides do not contain the parts of the peanut proteins that cause life-threatening anaphylactic reactions. This collaboration now involves Aravax, Stanford University, and the Benaroya Research Institute and will enable further testing of PVX108 used in our clinical trial, which is expected to be completed the second half of 2018.

Pascal Hickey, CEO of Aravax said "Aravax is proud to expand our collaborative efforts and announce the addition of Stanford University to the ongoing research we are conducting with the Benaroya Research Institute. We look forward to the completion of our phase 1 clinical trials."

16 May 2017, Melbourne, Victoria – Australian biotechnology company Aravax has commenced clinical trials of a potentially life-changing product developed to treat sufferers of peanut allergy. Aravax’s technology uses carefully selected fragments of peanut proteins to switch off allergic reactions. The product is designed to be safer, more rapid, and more convenient than other approaches currently under development. Aravax anticipates that simple, monthly injections will be sufficient to achieve clinical benefit. Pascal Hickey, CEO of Aravax, said, “We want to help people around the world who suffer from peanut allergy to live stress-free lives without constantly fearing a major health event from accidental consumption. Our technology aims to alleviate that stress by reprogramming the immune system to tolerate peanuts. By creating a safe, convenient and fast solution to a very serious problem we believe our product will have a global health impact by transforming the lives of patients and their carers.“ Almost two in every hundred Australians suffer from peanut allergy, and currently there is no therapy to reduce the severity of allergic reactions that can occur following accidental consumption. Despite patients attempting to follow a peanut-free diet, every year around 40% of peanut allergic individuals will suffer a serious adverse event from inadvertent exposure, including anaphylaxis which can lead to death. Traditionally, allergy specialists have treated patients using repeated doses of the allergy-causing substance. Similar approaches are being developed to treat peanut allergy, but the use of preparations containing whole peanut protein carries a high risk of severe reactions and requires daily dosing for lengthy periods. Aravax’s product is different because it does not contain the parts of peanut protein that cause severe allergic reactions, and its once-a-month dosing regimen is a far simpler solution than remembering to take medication every day. In the first ever trial of its product known as PVX108, Aravax will evaluate the safety and tolerability of single and repeated administration across a wide range of doses to determine an appropriate dosing regimen. This double-blinded and placebo controlled trial commenced dosing on 10th May 2017 with the first group of subjects safely receiving the lowest dose of PVX108. The trial is being conducted at CMAX Clinical Research in Adelaide, and at Nucleus Network in Melbourne. 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. In 2015, Aravax secured over $4.85 million in investment from the Medical Research Commercialisation Fund (MRCF) to develop the technology through to initial clinical trials, with Phase 1 clinical trials commencing last week.

Peanut allergy sufferers interested in participating in the trials are invited to refer to the Product Development page for further information.

20th January 2017 – Today Aravax established a collaboration with the prestigious Benaroya Research Institute in Seattle. The research group led by Erik Wambre (PhD) will work with Aravax on research into immunological responses to Aravax’s therapy, PVX108. PVX108 utilises peptides that represent carefully selected fragments of peanut proteins to switch off allergic reactions to peanuts. Unlike other peanut allergy immunotherapies under development, the peptides do not contain the parts of the peanut proteins that cause life-threatening anaphylactic reactions. Understanding the mechanisms by which the immune system induces and controls allergic inflammation is critical to monitor and understand changes induced from therapeutics, such as PVX108. The collaboration with the Benaroya Research Institute will enable further validation and a better understanding of the immunological actions and effects of PVX108 and will help inform future clinical development. Aravax plans to commence clinical trials for this therapeutic later this year.

Melbourne, Australia, 23 November 2015: Two new Victorian medical technology companies have been awarded $9 million in venture capital funding to develop novel treatments for heart failure and peanut allergies.

The companies, Cardiora Pty Ltd and Aravax Pty Ltd -- spun out of the Baker IDI Heart and Diabetes Institute and Alfred Health and Monash University respectively – have secured vital venture capital support from the Brandon Capital managed Medical Research Commercialisation Fund (MRCF), which has State Government backing and was established in 2007 to promote the creation of early stage medical technology companies.

Under the latest funding program Cardiora will today officially receive up to $4.15 million to immediately pursue development of CRD-102, a new oral medicine for the treatment of end stage heart failure. Early studies indicate the drug is a potential new therapy to ease debilitating symptoms including shortness of breath, fluid build up and exercise intolerance.

The drug has been entirely developed in Australia but will now be the focus of international clinical trials.

In addition, Aravax has secured a $4.85 million investment to fast track clinical development of a safe and effective vaccine for peanut allergies. Spearheading this program will be globally regarded allergy researcher Professor Robyn O’Hehir whose novel allergen immunotherapy approach has been used to create an international company now worth around $1.6 billion.

MRCF Investment Manager and now Aravax Director, Dr Chris Smith, said peanut allergies could be life threatening, particularly in children.

“Establishing Aravax means that we are able to harness Professor O’Hehir’s research output with Australian investment funds and keep Aravax in Australia,” he said. “These funds allow us to capitalise on this country’s excellent expertise and infrastructure for conducting early stage clinical trials.”

MCRF Investment Manager and new Cardiora Director Dr Ingmar Wahlqvist said there was a clear unmet medical need for new therapies to help patients suffering heart failure.

“Early trials of Cardiora’s CRD-102 have produced highly encouraging results with the drug showing great potential as a new agent to improve the quality of life for millions of heart failure patients around the world,” he said.

“A new treatment for heart failure will potentially lower the economic burden of hospital admissions associated with this group of patients. It will be a win for patients, a win for the healthcare system and a win for government funders.”

MRCF Principal Executive Dr Chris Nave said Australia is ranked in the top four countries globally for biotechnology infrastructure and capability, citing Cardiora and Aravax as “excellent examples” of home grown medical research.

”This investment is a terrific example of how partnering great technologies with capital and the right expertise can facilitate the translation of Australian medical research,” he said.

“At a time when we are seeking to create sustainable jobs and income for the future, I believe the biotech sector warrants considered attention from government.

“Successful biotechnology ultimately requires smart manufacturing to make the new drug, vaccine or medical device. But it is manufacturing protected by patents and strict international regulations which protect it from lower cost economies duplicating products and undercutting on price. It is therefore, a manufacturing industry that can remain competitive for the long term. We need to look at ways to stop our home grown medical innovations from leaving our shores and this is where government can play a vital role.”

To date, the MRCF has invested in 25 start-up companies that are developing and commercialising Australian medical innovations. Notable investments include Spinifex Pharmaceuticals, which was recently sold to Novartis for over US$700 million; and Fibrotech, which was recently sold to Shire for US$557 million.