Adalta Limited (ASX:1AD)
AdAlta Limited is a drug discovery and development company focused on using its powerful technology platform to generate a promising new class of protein therapeutics, known as i-bodies, for treating a wide range of human diseases.
i-bodies are a human analogue of the antigen binding domain of the shark antibody; they combine the high target specificity and affinity advantages of antibodies with the beneficial features of small molecule drugs.
The Company’s lead i-body candidate, AD-114, is being developed for the treatment of idiopathic pulmonary fibrosis (IPF) and other fibrotic diseases, for which current therapies are sub-optimal and there is a high-unmet medical need. AdAlta intends to continue further discovery and development activities directed towards other disease targets for in-house development or partnering.
The Company is led by an experienced management team and Board and is supported by a world class scientific advisory board.
Both AdAlta’s i-body technology platform and lead i-body drug candidate, AD-114, are protected by a strong portfolio of worldwide granted patents and pending applications.
AdAlta is headquartered in Melbourne, Australia.
There is a large unmet medical need for therapies to treat fibrosis.
Recent transactions confirm a number of major pharmaceutical companies are focused on acquiring fibrosis drug candidates at an early stage – typically based on Phase I clinical trial results.
The data available also suggests average value of deals done with fibrosis drugs in Phase I are around US$100 million with an average of US$400 to US$500 million in milestones plus royalties on sales.
AdAlta is focused on seeking a partner for the further development of AD-114 once it has completed Phase I studies.
AdAlta also has the potential to complete multiple research projects with other companies and to also develop a pipeline of i-body-based therapies using its novel drug discovery platform.
On the basis of strong pre-clinical data, AdAlta is committed to developing its lead drug candidate, AD-114, for the treatment of fibrosis. AdAlta’s strategy is to further develop and then license its lead candidate to a pharmaceutical or biotechnology company, potentially earning up-front, milestone payments and licensing revenues.
AdAlta is also committed to developing other therapeutic candidates from its i-body technology platform. The i-body provides drug developers with a new class of therapeutics that combines the advantages of small molecules and antibodies. The i-body platform provides an opportunity for the expansion of the pipeline of i-body drug candidates in multiple therapeutic areas.
AdAlta intends to implement this strategy through:
- completing the required pre-clinical, manufacturing and Phase 1 human clinical trial of its lead i-body candidate, AD-114;
- continuing research and development activities in other therapeutic areas with the i-body technology platform; and
- partnering and licensing of the lead drug candidate, AD-114, the i-body technology platform and future drug candidates through business development activities.
What is the market opportunity for the lead candidate?
AD-114 potentially provides a first in class treatment for IPF, a disease with a high unmet medical need.
There is currently no cure for IPF with most people living on average only three to five years after diagnosis of IPF. The two currently approved drugs for IPF have limited efficacy in individual patients, either having no effect or slowing down disease progression.
Evaluate Pharma estimates that the worldwide sales of drugs for the treatment of IPF will be approximately US$4.2 billion by 2020.
In the pharmaceutical sector there have been significant licensing and acquisition deals completed for anti-fibrotic drug candidates in Phase I clinical development. AdAlta’s strategy is to license its lead candidate to a biotechnology or pharmaceutical company.
What is the market opportunity for i-body therapeutics?
AdAlta believes its i-body technology platform can be used for the generation and identification of novel therapeutics to many different disease targets.
i-bodies offer a new and potentially more effective approach to the treatment of a wide range of human diseases.
The long binding loop of the i-body, which is lacking in traditional antibodies, enables i-bodies to bind to a range of therapeutically-relevant targets, including those that are difficult to target with current antibody therapies, such as G-protein coupled receptors (GPCRs) and ion channels.
While small molecules can have an increased risk of toxicity and off- target side effects due to their lack of specificity, the i-body with its high affinity and specificity and long binding loop can access GPCRs and ion channels without the off-target side effects.
AdAlta has demonstrated its lead drug candidate has significant anti-fibrotic and anti-inflammatory activity in human tissue and multiple animal models and that it is more effective than two current treatments for Idiopathic Pulmonary Fibrosis (IPF), a chronic and ultimately fatal disease characterised by a progressive decline in lung function. Both of the existing two marketed drugs have limited efficacy in individual patients and have no effect on slowing progression of the disease.
Paul has wide ranging, hands on experience across the biotechnology sector, encompassing technical, commercial and financial areas. With a career spanning veterinary practice, the pharmaceutical/biotechnology and investment banking sectors, Paul has experience in capital raising, business development, research management, technology commercialisation, staff development, and sales and marketing. He has also founded life sciences startups in the biologics area and worked in investment banking focusing on the analysis and financing of technology companies. Paul is currently CEO of ASX-listed pharmaceutical manufacturing company IDT Australia Ltd (ASX:IDT).
MANAGING DIRECTOR & CEO
Sam is the founding CEO of AdAlta and has over fifteen years’ experience in business development and commercialisation of early stage scientific technologies. Prior to AdAlta, Sam was the Business Development Director at the Co-operative Research Centre for Diagnostics. Sam has also worked for the biotech start up companies Sensologix Inc and Nephrogenix Pty Ltd and at the University of Queensland’s technology commercialisation companies, Uniquest Pty Ltd and IMBcom Pty Ltd. Sam has a Bachelor of Science, a Masters of Intellectual Property Law and has completed the Australian Institute of Company Directors course.
James Williams PhD
James is a co-founder and Investment Director of Yuuwa Capital LP, a venture capital firm based in Western Australia. Prior to Yuuwa Capital, he was Managing Director of two medical device companies, ASX-listed Resonance Health Ltd and Argus Biomedical Pty Ltd, both of which secured regulatory approvals under his leadership. He conceived, co-founded and is a former CTO and Director of iCeutica, Inc., a clinical stage nano drug reformulation company. iCeutica was acquired by Philadelphia-based Iroko Pharmaceuticals in 2011, achieving a ten-fold uplift on the valuation of the company from its original capital raising value. Iroko received FDA approval for the first three iCeutica formulations between 2013 and 2015. James is the Executive Chariman of ASX-listed clinical stage drug discovery and development company Dimerix Ltd (ASX:DXB) and Director of Yuuwa investee companies PolyActiva Pty Ltd and Nexgen Plants Pty Ltd. He is also a Director of Linear Clinical Research Ltd, a specialist early phase clinical trial unit and a member of the “Panel of Experts” for the University of Western Australia’s Pathfinder Fund.
Liddy is a co-founder and Investment Director of Yuuwa Capital LP. Liddy is also a Director of Yuuwa investee companies Gordiantec Pty Ltd and iCetana Pty Ltd. Her experience includes drug development and medical device projects. She was a co-founder and director of iCeutica Inc. iCeutica was acquired by Philadelphia-based Iroko Pharmaceuticals in 2011. Iroko received FDA approval for the first three iCeutica formulations between 2013 and 2015. Liddy was co-founder and Director of Tessitura Pty Ltd, a consulting company providing services to the biotechnology industry. Previously, Liddy was an Associate Director in the Corporate Advisory Group of Macquarie Bank and prior to that worked as a lawyer with a leading Australian law firm.
John Chiplin PhD
John has significant international experience in the life science and technology industries, from both an operational and investment perspective. Recent transactions in which John has been instrumental include Benitec BioPharma (US IPO), Medistem (acquired by Intrexon Corporation for US$26 million), former CEO of ASX-listed Arana Therapeutics (acquired by Cephalon Inc. for US$200 million), and Domantis (acquired by GSK for £230 million). Immediately prior to running Arana, John was head of the ITI Life Sciences investment fund in the UK, negotiating significant funding with Government Ministers. His own investment company, Newstar Ventures Ltd., has funded more than a dozen early stage companies in the past ten years. John’s Pharmacy and Doctoral degrees are from the University of Nottingham, UK. He currently serves on the boards of Batu Biologics, Benitec BioPharma (NASDAQ:BNTC), The Coma Research Institute, Cynata Therapeutics (ASX:CYN), Prophecy Inc, Scancell Holdings plc (LSE:SCLP), and ScienceMedia Inc
Ian is an experienced chartered accountant and chartered secretary who acts as non-executive director and company secretary to ASX-listed companies, trustee corporations, charitable trusts and private organisations. Ian has had 30 years professional accounting, financial management, corporate governance, capital raising and transaction and due diligence experience drawn from exposure to a variety of industries. Ian has previously worked for large chartered accounting firms together with commercial experience in Australia, UK and Canada. Ian is a facilitator with the Australian Institute of Company Directors and presents the finance units for its Company Director Course.
AdAlta finalised its oversubscribed IPO mid-August 2016 raising AU$10 million to advance its first therapy towards clinical development and early partnering. Over 60 per cent of the offer was taken up by Institutional support.
The funds from the IPO will allow AdAlta to expedite the first phase of a clinical study aimed at validating its lead i-body candidate drug called AD-114. The compound shows promise in treating a range of fibrotic diseases.