Amplia Therapeutics Ltd. · ASX:ATX
Amplia Therapeutics — Investor Presentation (September 2021)
34 slides from Amplia Therapeutics's investor presentation, Sep 15, 2021
Slide 1: Amplia Provides Updated Investor Presentation
ABN 16 165 160 841 ASX RELEASE 15 September 2021 For personal use only Amplia Provides Updated Investor Presentation Amplia Therapeutics Limited (ASX: ATX) (“Amplia” or the “Company”) today released a new investor slide deck which provides further information on the Company’s technology and its plan
Slide 2: Amplia Therapeutics
For personal use only Amplia Therapeutics September 2021 Amplia Therapeutics Limited
Slide 3: Disclaimer
Disclaimer For personal use only 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 mad
Slide 4: Amplia Therapeutics is developing new drugs for the treatment of cancer and fibrosis
For personal use only Amplia Therapeutics is developing new drugs for the treatment of cancer and fibrosis 3
Slide 5: Investment highlights
Investment highlights For personal use only • Two Focal Adhesion Kinase (FAK) inhibitors with activity profiles supporting multiple therapeutic opportunities • Clear differentiation from other FAK inhibitors in development • AMP945 has completed a Phase 1 trial in 56 volunteers and was shown to have
Slide 6: Management Team
Management Team For personal use only John Lambert Mark Devlin Rhiannon Jones PhD, GAICD PhD, MBA PhD, BSc (Hons) MD & CEO CSO Director, Operations • Medicines Development • Cancer Therapeutics • Cancer Therapeutics for Global Health CRC CRC • Biota Pharmaceuticals • Director Translational • 10Y in
Slide 7: Amplia's pipeline
Amplia’s pipeline For personal use only DRUG INDICATION THERAPY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 & APPROVAL AMP945 Pancreatic cancer Combination therapy AMP945 Idiopathic pulmonary Monotherapy fibrosis (IPF) AMP945 Other cancers & Combo/Mono fibrotic diseases therapies AMP886 Cancers & Monotherap
Slide 8: Why is FAK a good target for drug development?
Why is FAK a good target for drug development? For personal use only Focal Adhesion Kinase (FAK) Indication FIBROTIC DISEASES SOLID CANCERS Opportunities Monotherapy Combination Therapy • Lung fibrosis • Pancreatic cancer • Liver fibrosis (NASH) • Ovarian cancer • Renal fibrosis • Breast cancer • Wo
Slide 9: Targeting cancer's defence mechanisms
Targeting cancer’s defence mechanisms For personal use only Fibrosis FAK helps establish and maintain the dense, fibrotic tissue around cancers FAK is involved in many cancer defence mechanisms that reduce the effectiveness of cancer drugs Immune activity Amplia is investigating the use of FAK FAK t
Slide 10: Amplia's target indications
Amplia’s target indications For personal use only Pancreatic Cancer Idiopathic Pulmonary Fibrosis (IPF) • 60,000 new diagnoses and 48,000 deaths from • Affects 130,000 in the US and ~3M people pancreatic cancer in the US each year worldwide • Difficult-to-treat cancer that is often surrounded • Deva
Slide 11: Why Target Pancreatic Cancer and Pulmonary Fibrosis?
Why Target Pancreatic Cancer and Pulmonary Fibrosis? For personal use only Pancreatic Cancer Pulmonary Fibrosis Preclinical data provides rationale for clinical study in this disease Data from Garvan collaboration shows AMP945 enhances Positive impact of AMP945 in the bleomycin mouse model the effic
Slide 12: Recent deals for anti-fibrotic and pancreatic cancer drugs
Recent deals for anti-fibrotic and pancreatic cancer drugs For personal use only US$1,300M Total disclosed upfront and milestones payments; excludes potential royalty payments US$870M US$785M US$20M + US$380M US$80M + milestones R&D US$235M Year 2021 2020 2020 2019 2019 2019 2019 Deal Licensing/R&D
Slide 13: Product differentiation
Product differentiation For personal use only Pancreatic Cancer Fibrosis FAK Company FAKi First Line Combo with Selectivity Amplia AMP945 Gem/nab-paclitaxel Verastem defactinib Pembrolizumab Pembrolizumab InxMed IN10018 KN046 Amplia’s AMP945 is differentiated from its competitor
Slide 14: Clinical Development of AMP945
For personal use only Clinical Development of AMP945 13
Slide 15: Phase 1 trial of AMP945 completed in May 2021
Phase 1 trial of AMP945 completed in May 2021 For personal use only • Trial execution: • Commenced in October 2020 - completed May 2021 • Recruited in 56 healthy volunteers aged 18 - 65 • Single site in Melbourne Australia, Nucleus Network • Phase 1 trial components: • Single Ascending Doses • Multi
Slide 16: Results
Results For personal use only • AMP945 was safe and well-tolerated at all doses tested • No Serious Adverse Events. AEs generally mild and considered not related to AMP945 • No evidence of food effect on oral absorption • Pharmacokinetics support once-a-day oral dosing • Supports advancing AMP945 in
Slide 17: Selectivity of AMP945 is underlined by a favourable clinical safety profile
Selectivity of AMP945 is underlined by a favourable clinical safety profile For personal use only Summary of Treatment Emergent Adverse Events from Amplia’s Phase 1 trial of AMP945 Single Dose Multiple Dose Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 1 Cohort 2 Cohort 3 Pooled Pooled AMP945 AMP945 AM
Slide 18: Significance of data from Phase 1 clinical trial
Significance of data from Phase 1 clinical trial For personal use only • AMP945’s safety profile is significant because it supports: • Clinical trials in combination with chemotherapy in first-line pancreatic cancer patients • Clinical trials as a single-agent in idiopathic pulmonary fibrosis (IPF)
Slide 19: Phase 2 Clinical Trial in Pancreatic Cancer Patients
For personal use only Phase 2 Clinical Trial in Pancreatic Cancer Patients 18
Slide 20: Amplia's collaboration with the Garvan Institute
Amplia’s collaboration with the Garvan Institute For personal use only • Collaboration is focussed on enhancing efficacy of current standards of care • Differentiated from competitors who are seeking to install activity into drugs with no known efficacy in this disease • Garvan Provides • Exclusive
Slide 21: Key questions
Key questions For personal use only Does AMP945 enhance the efficacy of gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer? If AMP945 does enhance the efficacy of gemcitabine and nab-paclitaxel, how does this manifest clinically? Which patients respond best to AMP945 combined
Slide 22: AMP945 will be integrated into first-line therapy
AMP945 will be integrated into first-line therapy For personal use only US: 60,000 patients per year Pancreatic Cancer WW: 450,000 patients per year AMP945 + gemcitabine/ nab-paclitaxel ≥ 70% 5%-10% 10%-20% Non-resectable/ 1st line metastatic Borderline Resectable surgery chemotherapy 2nd line thera
Slide 23: Benefits of developing AMP945 as 1st line therapy
Benefits of developing AMP945 as 1st line therapy For personal use only Largest patient population: >70% newly diagnosed patients “With the exception of two targeted • Largest addressable market opportunity agents, which exhibited minimal or no overall survival benefit (erlotinib and • Large patient
Slide 24: Efficacy Endpoints for Phase 2 Trial
Efficacy Endpoints for Phase 2 Trial For personal use only • Primary Efficacy Endpoint – ORR • Widely used • Able to support accelerated approvals* • Sensitive endpoint – mitigates risk of false positive result • Secondary Endpoints – DoR, PFS, OS, CR, Symptoms, Pharmacokinetics • Alternate measures
Slide 25: Schedule
Schedule For personal use only CY2021 CY2022 CY2023 CY2024 Activity Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Pancreatic Cancer Drug Product Development Drug Interaction Studies HREC Filing IND filing Patient Recruitment Interim Analysis Pulmonary Fibrosis Extended Toxicology Patient Recruitment HRE
Slide 26: Preclinical Data
For personal use only Preclinical Data
Slide 27: AMP945 is the most selective FAK inhibitor currently in clinical development
AMP945 is the most selective FAK inhibitor currently in clinical development For personal use only Non-specific kinase inhibition often leads to clinical side effects AMP945 is currently the most selective FAK inhibitor in clinical development AMP945 Defactinib Number of kinases targeted in addition
Slide 28: AMP945 inhibits deposition of collagen
AMP945 inhibits deposition of collagen For personal use only Picosirius red staining for total collagen Decreasing collagen Vehicle 5 nM 10 nM 20 nM 50 nM 100 nM *** P ≤ 0.001 • Fibroblasts lay down new collagen • Collagen is a key component of fibrotic tissue Increasing AMP945 • AMP945 inhibits fib
Slide 29: AMP945 blocks collagen cross-linking
AMP945 blocks collagen cross-linking For personal use only Decreasing crosslinking • Crosslinking of collagen is required for the formation fibrotic tissues ** P ≤ 0.01 *** P ≤ 0.001 • AMP945 inhibits collagen cross-linking in a dose-dependent manner Increasing AMP945 Vehicle 5 nM 10 nM 20 nM 50 nM
Slide 30: AMP945 improves survival in pancreatic cancer model
AMP945 improves survival in pancreatic cancer model For personal use only • 25% improvement in survival when added to standard of care (p ≤ 0.001) • KPC is a highly aggressive animal model of human pancreatic cancer • Demonstrates pharmaceutical activity of AMP945 translates into survival benefit “A
Slide 31: AMP945 treats and prevents lung fibrosis
AMP945 treats and prevents lung fibrosis For personal use only Bleomycin animal model of lung fibrosis control – healthy lung PREVENTION TREATMENT • AMP945 administered before • AMP945 administered after onset of fibrosis onset of fibrosis • Evaluating ability of AMP945 to • Evaluating ability of AM
Slide 32: AMP945 and AMP886 are effective in an animal model of NASH
AMP945 and AMP886 are effective in an animal model of NASH* For personal use only Fibroblast marker Fibroblast activation NASH symptoms Fibrosis * P ≤ 0.05 ** P ≤ 0.01 *** P ≤ 0.001 ****P ≤ 0.0001 * Non-alcoholic steatohepatitis 31
Slide 33: Summary
Summary For personal use only • Successful Phase 1 trial completed • AMP945 now poised for development in 2 therapeutic areas • Phase 2 trial in pancreatic cancer expected to commence recruitment in Q1 2022 • Phase 2 trial in pulmonary fibrosis expected to commence recruitment in Q3 2022 • Preclinic
Slide 34: ampliatx.com
For personal use only ampliatx.com
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