Amplia Therapeutics Ltd. · ASX:ATX
Amplia Therapeutics — BioShares Presentation (July 2024)
29 slides from Amplia Therapeutics's conference presentation, Jul 12, 2024
Slide 1: BioShares Presentation
BioShares Presentation 12 July 2024 ampliatx.com | @ampliatx
Slide 2: Disclaimer
DISCLAIMER This presentation (Presentation) contains summary information about Amplia Therapeutics market, regulatory and other relevant environments that will exist and affect Amplia’s business and Limited ACN 165 160 841 and its subsidiaries (the Company or Amplia) which is current as at 31 operat
Slide 3: Snapshot
SNAPSHOT Amplia is developing a pipeline of small molecule inhibitors of Focal Adhesion Kinase (FAK) - a validated target in cancer Amplia’s drugs were discovered at the Cancer Therapeutics CRC, in collaboration with Australia’s premier Medical Research Institutes (WEHI, Peter MacCallum Cancer Centr
Slide 4: Development Highlights
DEVELOPMENT HIGHLIGHTS Phase 2a clinical trial in advanced Orphan Drug Designation from pancreatic cancer underway US FDA for pancreatic cancer Well tolerated and IPF Preliminary signs of efficacy Interim readout planned for Q3 2024 Compelling preclinical data in disease models: Open IND* for narmaf
Slide 5: Corporate Summary
CORPORATE SUMMARY ASX:ATX 12 month share price chart Share price A$0.063 (9-Jul-24) Shares on 271.9m issue Market cap A$16.8m (9-Jul-24) Platinum Investment Management Ltd Substantial Blueflag Holdings Pty Ltd Shareholders Acorn Capital Ltd Pengana 5
Slide 6: Experienced Board and Management
EXPERIENCED BOARD AND MANAGEMENT BOARD Warwick Tong Robert Peach Jane Bell Chris Burns MB ChB MPP GAICD PhD LLB, LLM (Lond), FAICD PhD GAICD Chair Director Director CEO and MD 6
Slide 7: Experienced Board and Management
EXPERIENCED BOARD AND MANAGEMENT SENIOR TEAM Rhiannon Jones Terrie-Anne Cock Charlotte Mulder Adrian Sulistio PhD GAICD PhD BVSc (Hons) MBA B Eng (Hons), B Com, PhD COO Director Translational Science Director Early Clinical Development Manager Product Development 7
Slide 8: Amplia's drugs inhibit the enzyme Focal Adhesion Kinase (FAK)
Amplia’s drugs inhibit the enzyme Focal Adhesion Kinase (FAK)
Slide 9: Focal Adhesion Kinase (FAK)
FOCAL ADHESION KINASE (FAK) FAK is a critical protein in cancer growth and spread, and in formation of fibrotic (scar) tissue Broad clinical potential Amplia’s drugs potently and selectively block Cancer Fibrosis Scarring the activity of the FAK protein 9
Slide 10: FAK Inhibitors in Development
FAK INHIBITORS IN DEVELOPMENT Only 3 companies with bona fide FAK inhibitors in development Verastem Inxmed Good Good PK Selectivity DDI Clinical Notes Stage profile profile Amplia Narmafotinib Safe and well Ph 2a (Amplia) tolerated Defactinib Promising data in Narmafotinib has a superior (Verastem)
Slide 11: Narmafotinib
NARMAFOTINIB Drug-like small molecule Highly potent and selective Excellent PK; once-a-day dosing FAK Activity Highly potent FAK inhibitor Minimal DDI* risk when combining with other drugs Biochemical assays Selectivity IC 50 2.2 nM Highly selective for FAK K 29 pM Narmafotinib D Drug-like small mol
Slide 12: Narmafotinib in Cancer
NARMAFOTINIB IN CANCER Multi-action of narmafotinib Extensive preclinical data showing narmafotinib activity in cancer models Anti-proliferative Synergy with Reduces cell’s ability chemotherapies to proliferate Enhances activity of and migrate drugs and other Early signals of efficacy from ACCENT th
Slide 13: Broad Potential for FAK Inhibitors in Cancer
BROAD POTENTIAL FOR FAK INHIBITORS IN CANCER FAK inhibitors can enhance effects of existing therapeutic approaches in solid tumours Chemotherapy Radiotherapy ... but also newer targeted treatments Kinase Inhibitors Immune Checkpoint Inhibitors Antibodies and ADCs kRas Inhibitors Cell Therapies 13
Slide 14: Clinical studies of narmafotinib in pancreatic cancer
Clinical studies of narmafotinib in pancreatic cancer
Slide 15: Pancreatic Cancer
PANCREATIC CANCER An unmet need 13% Increasing Prevalence 5 year Market size survival Estimated 66,000 diagnoses Global treatment market and 50,000 deaths in Difficult-to-treat: estimated over US$6 billon US this year* typically detected late in in 2023 disease progression** 4,500 diagnoses in AU Pr
Slide 16: Pancreatic Cancer
PANCREATIC CANCER Undisputed role of FAK in disease progression Over-expression FAK activity correlates Beneficial preclinical efficacy and increased FAK activity with worse outcome with FAK inhibition Narmafotinib decreases tumour Low levels active FAK = better survival fibrosis (collagen) High lev
Slide 17: Clinical data indicates narmafotinib safe and well tolerated with preliminary signs of efficacy
Clinical data indicates narmafotinib safe and well tolerated with preliminary signs of efficacy
Slide 18: ACCENT Trial Design
ACCENT TRIAL DESIGN Narmafotinib in combination with standard-of-care gemcitabine and Abraxane Orally-dosed narmafotinib in the days preceding weekly chemotherapy Dose Interim Phase 1b Selected Phase 2a Analysis Phase 2a (cont) 14 patients (400 mg) 26 patients >6 PR’s 24 patients COMPLETED RECRUITED
Slide 19: ACCENT Phase 1b
ACCENT PHASE 1b 3 Cohorts (100 mg, 200 mg, 400 mg) Orally dosed (capsules) Once-a-day Safe and well tolerated All patients elected to stay on drug post cycle 1 One DLT*: uncontrolled nausea Fatigue (Grade 3 or below) in more than 1 patient likely drug related *DLT = Dose Limiting Toxicity 19
Slide 20: ACCENT Phase 1b
ACCENT PHASE 1b Preliminary signs of efficacy observed Best Response (all patients) Improved response rate (PR and SD) compared to ACCENT Historical Best Overall Best Overall historical gemcitabine/Abraxane alone Classification Response* Response** n=14 (n=431) Comparison to pivotal trial (2013)** C
Slide 21: ACCENT Phase 1b
ACCENT PHASE 1b Tumour Reduction Preliminary signs of efficacy observed (% change from baseline) Improved response rate (PR and SD) compared to historical gemcitabine/Abraxane alone (individual patients) Comparison to pivotal trial (2013)** Better objective response (tumour reduction) at higher dose
Slide 22: ACCENT Phase 1b
ACCENT PHASE 1b Preliminary signs of efficacy observed Duration on trial Improved response rate (PR and SD) compared to historical gemcitabine/Abraxane alone Comparison to pivotal trial (2013)** Better objective response (tumour reduction) at higher doses 4 of 6 PRs with top dose narmafotinib Durati
Slide 23: Positioning narmafotinib as the preferred agent to enhance activity of drugs for solid tumours
Positioning narmafotinib as the preferred agent to enhance activity of drugs for solid tumours
Slide 24: Clinical Focus and Opportunity
CLINICAL FOCUS AND OPPORTUNITY Combinations in Combinations in Preclinical evidence - pancreatic cancer ovarian cancer other solid cancers Gemcitabine and Abraxane Platinum resistant disease Bile duct, oesophageal, head (ACCENT trial) - and neck cancer - Maintenance therapy post - FOLFIRINOX (US tri
Slide 25: Recent and Planned Milestones
RECENT AND PLANNED MILESTONES 2H 2023 / 1H 2024 2H 2024 1H 2025 Completion enrolment 50 pts ACCENT trial - Complete Phase 1b ACCENT trial - October 26 Patients recruited ACCENT trial - July March Korean regulatory approval - November Interim ACCENT trial data - October Initiation ovarian cancer tria
Slide 26: Valuations of Similar Small Molecule Oncology Companies
VALUATIONS OF SIMILAR SMALL MOLECULE ONCOLOGY COMPANIES Company Lead Asset Lead Indication Current Status Market Cap (US$) Positive Phase 2 results in Verastem Defactinib / Avutometinib LGSOC 74.5M KRAS mutant cancers Ikena Oncology IK-595 RAS & RAF mutant cancers Ongoing Phase 1 trial 78.6M Success
Slide 27: Oncology Licensing Deals
ONCOLOGY LICENSING DEALS Company Buyer Nature of Deal Year Indication Asset Stage Value (USD) Joyo Exclusive license (excl RAS and KRAS small 12.5M upfront; Erasca May 2024 Preclin Pharmatech mainland China) mutant tumours molecule 176M in milestones Medshine RAS and KRAS small 10M upfront; Erasca E
Slide 28: Phase 2 Oncology M&A
PHASE 2 ONCOLOGY M&A Company Buyer Nature of Deal Year Indication Lead Asset Value (USD) Profound Bio Genmab Acquisition May 2024 Ovarian Cancer ADC 1.8B AnHeart Nuvation Bio Acquisition Mar 2024 NSCLC small molecule undisclosed Therapeutics radio- Fusion Pharma AstraZeneca Acquisition Mar 2024 Pros
Slide 29: Chris Burns PhD GAICD, CEO and MD
Chris Burns PhD GAICD CEO and MD chris@ampliatx.com ampliatx.com | @ampliatx
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