Amplia Therapeutics Ltd. · ASX:ATX
Amplia Therapeutics — Investor Presentation (February 2021)
29 slides from Amplia Therapeutics's investor presentation, Feb 11, 2021
Slide 1: ASX Release: Investor Update
ABN 16 165 160 841 ASX RELEASE 11 February 2021 Investor Update Amplia Therapeutics Limited (ASX: ATX) (“Amplia” or the “Company”) is pleased to provide the attached Investor Update. This ASX announcement has been authorised for release by the Board. - End - For Further Information Dr. John Lambert
Slide 2: Amplia Therapeutics Investor Update February 2021
Amplia Therapeutics Investor Update February 2021 Amplia Therapeutics Limited
Slide 3: Disclaimer
Disclaimer The information contained in the presentation is not intended to be an offer for subscription, invitation or recommendation with respect to shares of Amplia Therapeutics Limited (“Amplia”) in any jurisdiction. No representation or warranty, express or implied, is made in relation to the a
Slide 4: Company highlights
Company highlights • Developing small molecule drugs against Focal Adhesion Kinase (FAK) for two, significant disease areas • cancer • fibrosis • Range of commercial opportunities for partnering, licensing and co-development • Capital raised in July 2020 to fund Phase 1 trial, preclinical studies an
Slide 5: Company snapshot
Company snapshot 1 Shares on issue 107.7M ATX Price and Volume – 12 months Market capitalization - $29.9M undiluted Options on issue 13.9M Cash 2 $2.8M Headquarters Melbourne Board Warwick Tong (Chair) John Lambert (MD) Robert Peach (NED) Chris Burns (NED) Substantial institutional Platinum – 16.2%
Slide 6: Focal Adhesion Kinase – dual purpose drug target
Focal Adhesion Kinase – dual purpose drug target Focal Adhesion Kinase (FAK) Cancer Fibrosis • Cell migration and metastasis • Collagen accumulation Biology • Collagen accumulation • Fibronectin production • Local regulation of immune response Combination Therapy Monotherapy Commercial Opportunity •
Slide 7: Amplia is developing two FAK inhibitors
Amplia is developing two FAK inhibitors Amplia has exclusive, worldwide licenses to two proprietary, FAK inhibitors: • AMP945 – highly potent, highly selective, orally bioavailable – only blocks the FAK protein • AMP886 – orally bioavailable, potent blocker of the FAK protein and other cancer drug t
Slide 8: AMP945 is highly selective for FAK
AMP945 is highly selective for FAK AMP945 Defactinib Non-specific kinase inhibition often leads to clinical side effects • 468 kinases screened at a concentration of 1µM • AMP945 shows improved selectivity compared to competitor agents – e.g. defactinib 7
Slide 9: Cancer treatments
Cancer treatments
Slide 10: Why cancer drugs often do not work
Why cancer drugs often do not work Pharmaceutical strategies to treat cancer: 1. cytotoxic drugs: target rapidly dividing cancer cells 2. targeted drugs: block specific proteins elevated in cancer cells 3. anti-angiogenic drugs: block new blood vessels which feed the cancer 4. immuno-oncology (I-O)
Slide 11: Targeting cancer's defence mechanisms
Targeting cancer’s defence mechanisms Fibrosis • FAK is involved in many cancer defence FAK helps establish and mechanisms that reduce the effectiveness of maintain the dense, scar cancer drugs tissue around cancers • Amplia is investigating the use of FAK inhibitors (FAKi’s) to disrupt cancer defen
Slide 12: AMP945 – potential to enhance cancer treatments
AMP945 – potential to enhance cancer treatments Reduced Reduced Improved immunosuppression angiogenesis efficacy tumour immune CD8 eff tumour response to chemotherapy macrophages suppressor cells T-cells endothelial cells drugs 4 0.8 0.4 0.20 800 * * ** * pancreatic tumour growth 3 0.6 0.3 0.15 600
Slide 13: AMP945 – treatment of solid tumours
AMP945 – treatment of solid tumours Pancreatic cancer • Devastating disease with very poor outcomes • 5-year survival rate is 10.7% • Limited treatment options • FDA Orphan Drug Designation for AMP945 in the treatment of pancreatic cancer received in March 2020 • Collaboration with Prof. Paul Timpso
Slide 14: Fibrosis treatments
Fibrosis treatments
Slide 15: FAK in lung fibrosis
FAK in lung fibrosis Idiopathic Pulmonary Fibrosis (IPF) is a devastating, progressive disease caused by the build-up of fibrotic tissue in the lung which affects 3M people worldwide, including 130,000 in the US Left untreated, the median survival time is 2-3 years, with lung transplantation the onl
Slide 16: Other opportunities in anti-fibrotic therapy
Other opportunities in anti-fibrotic therapy Amplia is investigating a number of other fibrotic diseases could benefit from a FAK inhibitor Silicosis – non-clinical study commencing in Q1 Silicosis is an industrial lung disease in which dust particles from sand, rock and minerals containing silica a
Slide 17: AMP945 inhibits new collagen deposition in vitro
AMP945 inhibits new collagen deposition in vitro Picosirius red staining for total collagen Vehicle 5 nM 10 nM Decreased collagen 20 nM 50 nM 100 nM Take home messages: • Collagen is one of the key building blocks of fibrotic tissue • Fibroblasts remodel collagen and also lay down new collagen • AMP
Slide 18: AMP945 inhibits collagen cross-linking in vitro
AMP945 inhibits collagen cross-linking in vitro Decreased crosslinking Take home messages: • Crosslinked collagen is a key building block of fibrotic tissues • AMP945 inhibits collagen cross-linking Vehicle 5 nM 10 nM 20 nM 50 nM 100 nM 17 Data produced in the laboratory of Professor Paul Timpson (G
Slide 19: AMP945 – prevention and treatment of lung fibrosis in vivo
AMP945 – prevention and treatment of lung fibrosis in vivo control – healthy lung • Amplia holds FDA Orphan Drug Designation for AMP945 in the treatment of idiopathic pulmonary fibrosis (IPF) • Preclinical studies of AMP945 using the industry-standard bleomycin model of bleomycin – fibrotic lung lun
Slide 20: Program Status and Plans
Program Status and Plans
Slide 21: Amplia's Lead Drug Candidate – AMP945
Amplia’s Lead Drug Candidate – AMP945 • Parallel development underway in both pancreatic cancer and fibrosis • Orphan Drug Designations received from FDA for AMP945 in both pancreatic cancer and idiopathic pulmonary fibrosis • Kilo-scale manufacture undertaken • Phase 1-enabling toxicology studies c
Slide 22: First human trial of AMP945 is underway
First human trial of AMP945 is underway • In October 2020, Amplia commenced dosing subjects in the first clinical trial of AMP945 • Phase 1 clinical trial in healthy volunteers: • Approximately 64 healthy volunteers • Single ascending dose, multiple ascending dose • Safety, pharmacokinetic and explo
Slide 23: Phase 1 Trial Update
Phase 1 Trial Update • Single ascending doses tested so-far • Well tolerated • No safety concerns so-far • Showing excellent pharmaceutic properties • Multiple ascending dose expected to start soon • On track to complete dosing in Q2 2021 22
Slide 24: Phase 2 Planning - Pulmonary Fibrosis
Phase 2 Planning - Pulmonary Fibrosis • Amplia proposes to accelerate its clinical development plans in pulmonary fibrosis • Phase 1 trial on track • Recent discussions with pulmonary clinicians indicate significant interest in running a Phase 2 trial in pulmonary fibrosis patients • New preclinical
Slide 25: Provisional Pulmonary Fibrosis Trial Design
Provisional Pulmonary Fibrosis Trial Design • Key design elements • Patients with known progressive interstitial lung disease • Up to 3 months’ dosing with AMP945 • Compare safety and efficacy of AMP945 to placebo • 2-3 dose levels expected, ~10 patients per group • 4x Australian sites • Potential t
Slide 26: Projected Timeline
Projected Timeline 2021 2022 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr Drug Substance Capsules Toxicology (3mo) Protocol preparation Site selection HREC Recruit 25
Slide 27: Phase 2 Planning – Pancreatic Cancer
Phase 2 Planning – Pancreatic Cancer • Trial design expected to be combination study of AMP945 with a standard of care • Final design is subject to preclinical data currently being generated • Subject to results, pancreatic cancer trial may start earlier than pulmonary fibrosis trial • Status • Clin
Slide 28: Provisional Pancreatic Cancer Trial Design
Provisional Pancreatic Cancer Trial Design • Selected design elements • Patients with unresectable pancreatic cancer • Combination therapy of AMP945 and gemcitabine/abraxane in novel dosing regimen • Compare safety and efficacy of combination therapy to standard of care alone • 60-80 patients • Aust
Slide 29: ampliatx.com
lasmoplia Exposing cancer. Enhancing treatment. ampliatx.com
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