Christian Hansen : New partnership to develop treatment for peanut allergies

Prota Therapeutics, the developer of oral immunotherapies to treat food allergies, has partnered with Chr. Hansen. The partnership will assess the world's best documented probiotic strain, LGG®, in a Phase III clinical trial to develop a treatment for peanut allergy.

Approximately 220-250 million people globally suffer from food allergies, an increase of 350 per cent over the past 20 years. The economic impact for treatment of food allergies in the US has been estimated at US$24.8 billion per year¹.

Peanut allergy is the most common cause of anaphylaxis, a life-threatening allergic reaction, and one of the most common causes of death from food allergy². More than 3 million Americans suffer from peanut allergy³ resulting in a global peanut allergy therapeutics market estimated to reach more than US$10 billion by 2025².

Prota Therapeutics is pioneering a new form of oral immunotherapy treatment. It combines Chr. Hansen's specifically formulated LGG®⁴ probiotic strain, Lactobacillus rhamnosus, with targeted doses of proprietary formulations of peanut protein. The treatment is designed to reprogram the immune system's response to peanuts and eventually develop tolerance.

One of the first Phase III clinical trials with a live microorganism
Building upon earlier trials conducted at the Murdoch Children's Research Institute, Prota Therapeutics is progressing towards a large-scale Phase III clinical trial, under a US Investigational New Drug Application (IND). The aim is to commercialize a medicinal product using a new pharmaceutical grade therapeutic dosage form for treating peanut allergy, and to explore indications for treating other food allergies.

'An effective therapy to treat peanut allergies is now a realistic target. Chr. Hansen is the ideal partner for us in this next step, both as the owner of one of the key components in the therapeutic product - LGG® - and as a leading expert in microbial solutions. Chr. Hansen has demonstrated the capability to deliver a pharmaceutical quality product that can be regulated as a biological therapeutic product. Together with our proprietary peanut protein formulation, we aim to progress this through to commercialization of a treatment for peanut allergies,' says Dr. Suzanne Lipe, CEO at Prota Therapeutics.

Unlocking the potential of good bacteria
Numerous studies have highlighted the therapeutic potential of specific bacteria in preventing and treating metabolic, gastrointestinal and other diseases. Investigating specific bacteria for the treatment of food allergies is an area that has recently gained momentum.

Having produced LGG® for more than 10 years before fully acquiring LGG® from Valio in 2016, this new partnership is an example of how Chr. Hansen's focus on industry leading product quality and clinical documentation can expand the potential of the LGG® probiotic strain into a new breakthrough area.

Christian Barker, Executive Vice President, Health & Nutrition at Chr. Hansen says:

'Chr. Hansen has the ability to maximize the value of a probiotic strain through our deep experience in microbial process development and formulation, our focus on quality, and our global reach. The partnership with Prota Therapeutics is part of our strategy to become the partner of choice for companies wanting to develop new generations of therapeutic microbes.'

World's best documented probiotic strain
Lactobacillus rhamnosus is the best documented probiotic strain in the world. It has been used in food, dietary supplements and infant nutrition since 1990 and has shown beneficial effects on the gastrointestinal and immune system. It is supported by more than 300 clinical studies and 1,200 scientific publications.

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Notes:
(1) Gupta R et. al., JAMA Pediatrics 2013; 167(11):1026-103
(2) DelveInsight, 'Peanut Allergy - Competitive Landscape, Market Insights, Epidemiology and Market Forecast-2025'
(3) Sicherer et. al., J Allergy Clin Immunol 2010;125:1322-6
(4) LGG® is a trademark of Chr. Hansen

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About Prota Therapeutics
Prota Therapeutics is a private Australian company developing oral immunotherapy based treatments for food allergy. The company's lead product builds on innovative probiotic based research lead by Prof Mimi Tang and licensed from the Murdoch Children's Research Institute and is under development as a treatment for the most common cause of life-threatening anaphylaxis, peanut allergy. The new treatment for peanut allergy is rapidly progressing through clinical development and commercialization through its partnership with Chr. Hansen and support of investors, led by Sydney based venture capital firm OneVentures. In addition to leading the initial Series A financing for Prota in 2016, OneVentures has led further funding for Prota, through its fund that is supported by the Australian Government's Biomedical Translation Fund initiative.

About MCRI
The Murdoch Children's Research Institute (MCRI) is the largest child health research institute in Australia and is one of the top five worldwide. MCRI is renowned as a world leader in paediatric research including allergy, infectious diseases, immune disorders, genetics, cancer, stem cell technology and population health. The Institute is co-located with campus partners The Royal Children's Hospital and the University of Melbourne. This unique position allows MCRI to translate discoveries in laboratory, clinical and public health research into real benefits to help children around Australia and the world live healthier, happier lives. Read more about MCRI athttps://www.mcri.edu.au

About OneVentures
OneVentures is an Australian venture capital firm with $320M under management launching its first fund in 2010. OneVentures utilises its strengths in business building to accelerate portfolio company performance. OneVentures has three main funds, two of which are actively investing. The OneVentures Innovation and Growth Fund II and OneVentures Healthcare Fund III, have approximately $200M in available capital for technology and healthcare businesses. The OneVentures Healthcare Fund III launched in December 2016. The $170M fund is licenced under the Australian Government's Biomedical translation Fund (BTF) program and is actively seeking investments in Australian domiciled companies commercialising medical devices and drugs in clinical development and diagnostics. Read more about OneVentures atwww.one-ventures.com

Chr. Hansen is a leading, global bioscience company that develops natural ingredient solutions for the food, nutritional, pharmaceutical and agricultural industries. We develop and produce cultures, enzymes, probiotics and natural colors for a rich variety of foods, confectionery, beverages, dietary supplements and even animal feed and plant protection. Our product innovation is based on more than 30,000 microbial strains - we like to refer to them as 'good bacteria'. Our solutions enable food manufacturers to produce more with less - while also reducing the use of chemicals and other synthetic additives - which make our products highly relevant in today's world. We have been delivering value to our partners - and, ultimately, end consumers worldwide - for over 140 years. We are proud that more than one billion people consume products containing our natural ingredients every day. Revenue in the 2016/17 financial year was EUR 1,063 million. Chr. Hansen was founded in 1874 and is listed on Nasdaq Copenhagen.