Adalta Ltd. · ASX:1AD
Adalta — Bioshares Biotech Summit 2017
28 slides from Adalta's conference presentation, Jul 21, 2017
Slide 1: AdAlta to present at 2017 Bioshares Biotech Summit
ASX / Media Release AdAlta to present at 2017 Bioshares Biotech Summit For personal use only MELBOURNE, Australia, 21 July 2017: AdAlta Limited (ASX: 1AD), the biotechnology company focused on advancing its lead i-body candidate towards clinical development today announced Chief Executive Officer Sa
Slide 2: Notes to Editors: About AdAlta
Notes to Editors About AdAlta AdAlta Limited is an Australian based drug development company headquartered in For personal use only Melbourne. The Company is focused on using its proprietary technology platform to generate i-bodies, a new class of protein therapeutics, with applications as therapeut
Slide 3: i-bodies – a new class of protein therapeutics to treat fibrosis
For personal use only i-bodies – a new class of protein therapeutics to treat fibrosis BIOSHARES JULY 2017 Sam Cobb, CEO and Managing Director AdAlta Limited (ASX:1AD) s.cobb@adalta.com.au
Slide 4: Disclaimer
Disclaimer For personal use only Investment in AdAlta is subject to investment risk, including possible loss of income and capital invested. AdAlta does not guarantee any particular rate of return or performance, nor do they guarantee the repayment of capital. This presentation is not an offer or in
Slide 5: About AdAlta
About AdAlta For personal use only AdAlta is a drug discovery and development company using its powerful technology platform to generate a promising new class of protein therapeutic, known as i-bodies, for treating a wide range of human diseases. 3
Slide 6: Corporate and investment summary
Corporate and investment summary Investment highlights For personal use only Capital structure ASX code 1AD Initial focus on treating fibrosis – high unmet Shares on issue* 101,110,890 medical need Share price (18 July 17) AU$0.235 Market capitalisation AU$23.5m Advanced lead fibrosis drug candidate
Slide 7: Fibrosis: A major problem
Fibrosis A major problem For personal use only Fibrosis can occur in many tissues of the body as a result of inflammation or damage As a result, collagen builds up and can result in scarring of vital organs such as the lung, liver, skin, eye, heart and kidney Leads to irreparable damage and eventual
Slide 8: AD-114 has broad application in treating fibrosis
AD-114 has broad application in treating fibrosis For personal use only AdAlta data shows that AD-114 can improve fibrosis across a range of fibrotic diseases LUNG: Idiopathic Pulmonary Fibrosis EYE: Wet Age Related Macular Degeneration LIVER: NASH SKIN: Hypertrophic scar KIDNEY: Chronic Kidney Dise
Slide 9: AD-114 targets inflammation and fibrosis in multiple ways
AD-114 targets inflammation and fibrosis in multiple ways For personal use only Here’s how it works… 7
Slide 10: Multiple cell types and complex process
Multiple cell types and complex process For personal use only Source: J. Exp. Med. 2011, Vol. 208 No. 7 1339-1350 8
Slide 11: Multiple cell types – an explanation
Multiple cell types – an explanation For personal use only In a number of animal models: ü AD-114 reduces inflammatory cell migration in vitro and in vivo ü AD-114 reduces anti- inflammatory effects in a number of animal models 9
Slide 12: Multiple cell types – an explanation
Multiple cell types – an explanation For personal use only In damaged mouse lungs of fibrosis: ü AD-114 blocks fibrocyte recruitment 10
Slide 13: Multiple cell types – an explanation
Multiple cell types – an explanation For personal use only In human lung and kidney tissue: ü AD-114 reduces epithelial– mesenchymal transition (EMT) in vitro 11
Slide 14: Multiple cell types – an explanation
Multiple cell types – an explanation For personal use only In human diseased lung tissue: ü AD-114 reduces fibroblast migration 12
Slide 15: Multiple cell types – an explanation
Multiple cell types – an explanation For personal use only In a number of fibrosis animal models and human tissues: ü AD-114 reduces collagen and extracellular matrix (ECM) deposition 13
Slide 16: Multiple cell types and complex process
Multiple cell types and complex process For personal use only Source: J. Exp. Med. 2011, Vol. 208 No. 7 1339-1350 14
Slide 17: In summary: one drug, broad anti-fibrotic action
In summary: one drug, broad anti-fibrotic action For personal use only Unlike other drugs In a disease that is poorly AdAlta’s AD-114 targets understood, this approach multiple processes and multiple gives us multiple shots on cell types target We have demonstrated anti-fibrotic effects and anti- in
Slide 18: AD-114 binds to CXCR4
AD-114 binds to CXCR4 For personal use only CXCR4 is a GPCR chemokine receptor present on bone marrow derived cells including T cells, B cells and leukocytes (monocytes) and blood cells CXCR4 is low or absent in healthy tissues but shown to be expressed in over twenty three types of cancer, includin
Slide 19: Evidence supporting CXCR4 as a fibrosis target
Evidence supporting CXCR4 as a fibrosis target For personal use only Receptors & Clinical Investigation 2015; 2: e791. doi: 10.14800/rci.791; © 2015 by Leah Campeau, et al. Significant literature to support hypothesis of the involvement of CXCR4 in fibrosis http://www.smartscitech.com/index.php/rci
Slide 20: CXCR4 increased in disease
CXCR4 increased in disease CXCR4 Normal human Diseased lung For personal use only lung tissue tissue Demonstrated CXCR4 expression increased in a number of human fibrotic diseased tissue (represented by brown staining) For example: IPF diseased lung tissue in upper right panel compared with normal l
Slide 21: CXCR4 as a biomarker in IPF
Thoracic Society and European Respiratory Society (3). Surgical lung were quantified as overall extent of interstitial changes, reticulation, biopsy had been done in 17 patients to establish a diagnosis of UIP. ground-glass opacity, coarseness, and emphysema. Defining criteria for exacerbations incl
Slide 22: CXCR4 as a biomarker in IPF
evaluated using quantitative positron emission tomography (PET), in order to test its role as a p=0 Figure 2: CXCR4 PET/CT scan of a patient with IPF/UIP. CT p=0 potential biomarker for IPF. scan shows the definite UIP pattern with basal and predominatly CXCR4 as a biomarker in IPF wit . subpleural
Slide 23: AD-114 safe in non-human primates
AD-114 safe in non-human primates For personal use only PK determined both subcutaneously and intravenously – T ½ ~24hrs either route of administration Ascending dose range finder study up to 30mg/kg – AD-114 was well tolerated and there were no adverse effects with increased doses demonstrated by h
Slide 24: Long loop of i-body: novel CXCR4 mechanism
Long loop of i-body: novel CXCR4 mechanism For personal use only High affinity and specificity like an antibody with lower toxicity expected (does not bind to any other GPCR) unlike CXCR4 small molecule AMD3100 Long loop binds deep in groove like a small molecule Combining advantages of antibodies a
Slide 25: AD-114 key advantages compared to existing IPF treatments
AD-114 key advantages compared to existing IPF treatments For personal use only AD-114 has greater in vitro efficacy compared to the No effect Effect on only approved therapies Nintedanib and Pirfenidone Human tissue on normal diseased / In vitro activity tissue IPF tissue for IPF treatment – Existi
Slide 26: AD-114 efficacy and safety
AD-114 efficacy and safety For personal use only Efficacy Safety – Lung: IPF – NHP studies: • Animal models • PK: IV and SC • Human IPF tissue • Dose range finder • Biomarker assessments • Multi dosing studies (Alfred Health & others) – PK-PD assays developed – Broad fibrotic application demonstrati
Slide 27: AD-114 development: key milestones
AD-114 development: key milestones For personal use only FY2018 FY2019 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Manufacturing Partnering of lead candidate Toxicology based on other studies benchmark deals Phase I Publication of data BD and partnerships 25
Slide 28: AdAlta / AD-114 summary
AdAlta / AD-114 summary For personal use only IPO August 2016 raised $10M to meet major milestones: phase I clinical trials of AD-114 in lung fibrosis and development of i-body pipeline Initial focus on treating Idiopathic Pulmonary Fibrosis (IPF) and other fibrotic diseases - high unmet clinical ne