..Author: Ben Eversfield

Compelling new lung disease treatment pioneered in Victoria gains global attention alongside top researchers and drug developers

A novel drug treatment emerging from Victoria for the serious lung condition idiopathic pulmonary fibrosis will be spotlighted among world-leading researchers and scientists at the global IPF Summit in Boston (August 20-21).

Idiopathic pulmonary fibrosis (IPF) is a rare fibrotic lung condition that causes persistent and progressive scarring of the tiny air sacs (alveoli) in the lungs, with symptoms including shortness of breath and coughing[1]. Lung Foundation Australia estimate that there are around 2,300 new cases diagnosed in in Australia every year[2]. The prognosis of IPF is very poor, with a median survival of only three to five years after diagnosis.[3]

There are just treatments on the market and the disease continues to progress in the majority of patients despite treatment.[4]

The new drug, AD-114, is being developed by the Australian biotech AdAlta (ASX:1AD), using AdAlta’s proprietary ‘i-body’ technology. A phase 1 clinical trial will start next year.

AD-114 differs from existing treatment options and others currently in clinical development due to its unique mode of action that targets the GPCR chemokine receptor CXCR4. AD-114 has been demonstrated to have both anti-inflammatory and anti-fibrotic activity, hitting a sweet spot for a potential therapy for IPF.

The effects of AD-114 have been described by world-leading lung disease researcher Professor Cory Hogaboam (Cedars Sinai Medical Centre) as “impressive” and “providing a compelling case” for treating IPF.

AdAlta CEO, Sam Cobb, has been invited to speak at the inaugural summit to showcase the novel therapeutic approach to this largely under-treated area. Ms Cobb will represent the only Australian company in the line-up of academics, international biotech and pharma speakers that include Prof Hogaboam as well as speakers from Genentech, Bristol-Myers Squibb, Celgene and Medimmune.

“IPF is a disease with high unmet clinical need and we do believe AD-114 will provide the clinical community and patients with a much-needed new treatment option,” Ms Cobb said.

“Although our focus with AD-114 is IPF, AD-114 has the potential to treat a wide-range of fibrotic conditions including wet age-related macular degeneration, of which there are 21,000 new cases diagnosed in Australia each year[5] and non-alcoholic fatty liver disease, which affects around 5.5 million Australians and is a precursor to nonalcoholic steatohepatitis (NASH)[6].

“That we’ve been invited to speak alongside world experts at the inaugural IPF Summit is immensely validating of the critical nature of our work.”

AD-114 has received orphan drug status by the FDA, and if approved would be a first-in-class treatment. ‘Orphan’ drugs are those developed to treat a rare medical condition, and they are usually granted accelerated development and regulatory timelines.

More about the IPF Summit: http://ipf-summit.com/

More about AdAlta: http://adalta.com.au/

[1] Lung Foundation Australia [online] at http://lungfoundation.com.au/health-professionals/idiopathic-pulmonary-fibrosis-registry/ [accessed 3 August 2017]

[2] Lung Foundation Australia [online] at http://lungfoundation.com.au/patient-support/rarelung/idiopathic-pulmonary-fibrosis-ipf/ [accessed 3 August 2017]

[3] ATS, 2000; Raghu et al., 2011

[4] Tzouvelekis A, Bonella F, Spagnolo P, ‘Update on Therapeutic Management of Idiopathic Pulmonary Fibrosis’, Therapeutics and Clinical Risk Management, 2015 Mar 3;11:359-70. doi: 10.2147/TCRM.S69716. eCollection 2015

[5] Macular Degeneration Foundation [online] at https://www.mdfoundation.com.au/sites/default/files/MDBooklet_2017-04_WEB.pdf [accessed 7 August 2017]

[6] The Economic Cost and Health Burden of Liver Disease in Australia (Jan 2013), Gastroenterological Society of Australia)

Fellowship supports search for new disease treatments

La Trobe University and leading Australian biotech company AdAlta have received new funding to identify and develop potential treatments for a range of human diseases using the company’s novel class of drugs, known as i-bodies.

La Trobe University’s Dr Chris Hocking has been awarded a Science and Industry Endowment Fund (SIEF) Business Fellowship worth $427,000 ($210,000 from the CSIRO), further strengthening the collaboration between La Trobe University and AdAlta.

The SIEF Business Fellowship Program aims to build deeper connections and collaborations between researchers and industry, accelerate the adoption of new ideas and technology, while also helping to grow into larger and more profitable organisations. Furthermore, the program provides practical industry experience for early career researchers.

The SIEF Fellowship grant will support Dr Hosking’s work with AdAlta’s Chief Scientific Officer, Professor Mick Foley, at the La Trobe Institute for Molecular Science.

“Under the SIEF grant we will screen the i-body library to identify and develop new i-body candidates against difficult to access drug targets, such as complex signalling proteins called GPCRs,” Professor Foley said.

“Chris is an excellent candidate for the Fellowship because he has extensive experience working with phase displays and screening libraries. Chris brings significant expertise to the AdAlta team.”

La Trobe Pro Vice Chancellor Industry and Engagement, Dr Daniel Grant, congratulated Dr Hosking.

“La Trobe recognises the importance of engaging with, and building strong partnerships with, innovative companies,” Dr Grant said.

“We have had a longstanding and productive relationship with AdAlta and this Fellowship is a great outcome for both parties.”

I-bodies are a promising, novel class of drugs that offer a new and more effective approach to treatment of a wide range of human diseases.

AdAlta pioneered a technology that mimics the shape and stability of a crucial antigen-binding domain, which was discovered initially in sharks and then developed as a human protein.

Media Contact: Ilona Marchetta, Media and Digital Specialist @ IR Department +61 416 156 136

AdAlta releases Idiopathic Pulmonary Fibrosis Overview Document

MELBOURNE Australia, 1 May, 2017: AdAlta Limited (ASX:1AD), the biotechnology Company advancing its lead i-body candidate towards clinical development today announced the release of its Idiopathic Pulmonary Fibrosis (IPF) Overview Document. The document provides background into IPF pathology, current treatments, the market landscape as well as the progress of AdAlta’s lead i-body towards the clinic.

IPF is a lung disease the affects approximately 10,000 Australians and approximately 300,000 worldwide, with 50% of people dying within 2 to 3 years of diagnosis. Idiopathic pulmonary fibrosis causes scarring and stiffening of the lungs that restricts breathing and oxygen exchange. Currently approved therapies, Nintedanib and Pirfenidone, slow disease progression but do not act as a cure and are also associated with significant side effects.

AdAlta is developing its lead i-body candidate, AD-114, for the treatment of IPF and received Orphan Drug Designation from the United States Food and Drug Administration in January 2017. AD-114 has strong pre-clinical results for IPF, demonstrating both anti-fibrotic and anti-inflammatory activity in human lung tissue and greater efficacy than existing approved IPF drugs.

Chief Executive Officer Sam Cobb said “AdAlta is moving AD-114 towards the clinic to address the clear unmet medical need that exists for Idiopathic Pulmonary Fibrosis”

The IPF overview document is available on the AdAlta website along with a video presentation from AdAlta’s fibrosis briefing in February by Dr Glen Westall, IPF respiratory physician at The Alfred Hospital, Melbourne and AdAlta collaborator.

Notes to Editors
About AdAlta

AdAlta Limited is an Australian based drug development company headquartered in Melbourne. The Company is focused on using its proprietary technology platform to generate i-bodies, a new class of protein therapeutics, with applications as therapeutic drugs to treat disease.

I-bodies are a promising, novel class of drugs that offer a new and more effective approach to treating a wide range of human diseases. They are identified and developed using our proprietary technology platform.

We have pioneered a technology that mimics the shape and stability of a crucial antigen-binding domain, that was discovered initially in sharks and then developed as a human protein. The result is a range of unique compounds, now known as i-bodies, for use in treating serious diseases.

AdAlta is developing its lead i-body candidate, AD-114, for the treatment of idiopathic pulmonary fibrosis (IPF) and other human fibrotic diseases, for which current therapies are sub-optimal and there is a high-unmet medical need.

The Company also plans to continue further drug discovery and development directed towards other drug targets and diseases with its i-body technology platform.

Further information can be found at: www.adalta.com.au.

For more information, please contact:

AdAlta Limited
Sam Cobb, CEO
Tel: +61 (0)3 9479 5159
E: s.cobb@adalta.com.au

AdAlta CEO Sam Cobb to present at Stocks to Watch Roadshows

Sam Cobb, CEO AdAlta will be presenting at a Canary Networks event on Wednesday 3rd May in Melbourne and Thursday 4th May in Sydney.

Join other investors and industry leaders in hearing live presentations from some of Australia’s most exciting small-cap companies. You will also get the chance to network with your peers at our exclusive investor lunch and networking drinks.

If you cannot make the presentation a video will be made available on the AdAlta website after the event.

Registration is necessary to attend, as spaces are strictly limited.

Melbourne Event:

Date: Wednesday 3rd May 2017

Registration & Luncheon: 12.45 – 1.20pm

Presentations: 1.25pm – 3pm

AdAlta presentation: 2.15pm

Venue: Novotel, 270 Collins Street, VIC 3000

Sydney Event:

Date: Thursday 4th May, 2017

Registration & Luncheon: 12.45 – 1.20pm

Presentations: 1.25pm – 3pm

AdAlta presentation: 2.15pm

Venue: Royal Automobile Club – 89 Macquarie Street, NSW 2000

Cost: This is a free event for investors, stockbrokers and fund managers however registration is required. Please register ASAP to avoid disappointment.

AdAlta expands collaboration with The Alfred Hospital

MELBOURNE Australia, 21 March, 2017: AdAlta Limited (ASX: 1AD), the biotechnology company advancing its lead i-body candidate towards clinical development today announced the continuation of its collaboration with The Alfred hospital in Melbourne, Australia, and the clinical research team led by Dr Glen Westall, an expert in lung fibrosis and Idiopathic Pulmonary Fibrosis (IPF).

Fibrosis accounts for 45 per cent of all diseases globally in the developed world and represents a large unmet medical need.

The expanded collaboration between AdAlta and The Alfred to further validate AD-114’s role in the treatment of IPF will run for an additional six months and will be funded by an Innovation Connection grant from the Australian Federal Government as well as AdAlta’s research and development, and clinical budget.

AdAlta Chief Executive Officer Sam Cobb said “Our multiple collaborations and strategic alliances across commercial, clinical and manufacturing areas with world-leading partners, such as the team at The Alfred, further enhance the potential for the success of our new treatments for fibrosis.”

Respiratory Physician at The Alfred hospital, Dr Glen Westall and his team are international leaders in the field of lung fibrosis with access to human IPF patient tissue for evaluation with AdAlta’s lead candidate AD-114.

Dr Westall, said, “We are excited to continue working with AdAlta to further understand this complex fibrotic disease and how the Company’s novel i-body may play a role in the treatment of IPF, for which there is currently no cure.”

Dr Westall recently spoke at AdAlta’s inaugural fibrosis investor briefing, where he provided an overview of IPF and currently available treatments. The full-length presentation is available on AdAlta’s website as well as a video highlight of the day.

Notes to Editors
About AdAlta

AdAlta Limited is an Australian based drug development company headquartered in Melbourne. The Company is focused on using its proprietary technology platform to generate i-bodies, a new class of protein therapeutics, with applications as therapeutic drugs to treat disease.

The i-body is a human analogue of the antigen binding domain of the shark antibody, which combines the advantages of monoclonal antibodies (high target specificity and affinity) with the beneficial stability features of small molecules. In addition to stability, the i-body has a long binding loop that is a feature of shark antibodies not present in either human or next generation antibodies. This feature enables the i-body to recognise and bind to a diverse range of different therapeutically-relevant drug targets, including those that are difficult/intractable to access by current antibody therapies. These include clinically important targets such as G-protein coupled receptors (GPCRs) and ion channels.

AdAlta is developing its lead i-body candidate, AD-114, for the treatment of idiopathic pulmonary fibrosis (IPF) and other human fibrotic diseases, for which current therapies are sub-optimal and there is a high-unmet medical need.

The Company also plans to continue further drug discovery and development directed towards other drug targets and diseases with its i-body technology platform.

Further information can be found at: www.adalta.com.au.

For more information, please contact:

AdAlta Limited
Sam Cobb, CEO
Tel: +61 (0)3 9479 5159
E: s.cobb@adalta.com.au

Media (Australia)
Andrew Geddes
Tel: +61 (0)408 677 734
E: adalta@instinctif.com

Media (International)
Sue Charles / Daniel Gooch
Tel: +44 (0)20 7866 7905
E: adalta@instinctif.com

Fibrosis symposium video material

MELBOURNE Australia 21 March 2017: AdAlta Limited (ASX: 1AD), the biotechnology company advancing AD-114, its lead i-body candidate for the treatment of idiopathic pulmonary fibrosis (IPF) and other human fibrotic diseases towards clinical development, is pleased to release the full length videos of each speaker from its R&D briefing meeting on fibrosis for analysts and investors.

Fibrosis accounts for 45% of all diseases globally in the developed world and represents a large unmet medical need.

These following presentations and videos from the symposium included:

The highlights from the symposium are available at the following link www.adalta.com.au.

To find out more about AdAlta, contact Sam Cobb, CEO, Tel: (03) 9479 5159 or email enquiries@adalta.com.au.

Notes to editors

AdAlta Limited (ASX:1AD) is an Australian based drug development company headquartered in Melbourne. The Company is focused on using its proprietary technology platform to generate i-bodies, a new class of protein therapeutics, with applications as therapeutic drugs to treat diseases. AdAlta is developing its lead i-body candidate, AD-114, for the treatment of idiopathic pulmonary fibrosis (IPF) and other human fibrotic diseases, for which current therapies are sub-optimal and there is a high-unmet medical need. AD-114 has strong pre-clinical results for IPF, demonstrating both anti-fibrotic and anti-inflammatory activity in human lung tissue and indicating greater efficacy than existing approved IPF drugs. The i-body is a human analogue of the antigen binding domain of the shark antibody, which combines the advantages of monoclonal antibodies (high target specificity and affinity) with the beneficial stability features of small molecules. In addition to stability, the i-body has a long binding loop that is a feature of shark antibodies not present in either human or next generation antibodies. This feature enables the i-body to recognise and bind to a diverse range of different therapeutically-relevant drug targets, including those that are difficult/intractable to access by current antibody therapies. These include clinically important targets such as G-protein coupled receptors (GPCRs) and ion channels.

Contact:

At AdAlta

Sam Cobb
Chief Executive Officer
AdAlta Limited
Tel: +61 (0) 3 9479 5159
E: s.cobb@adalta.com.au

Media (Australia)
Andrew Geddes
Tel: +61 (0) 408 677 734
E: adalta@instinctif.com

Media (International)
Sue Charles/Daniel Gooch
Tel: +44 (0) 20 7866 7905
E: adalta@instinctif.com