Imugene Ltd · ASX:IMU
Imugene — Investor Presentation (November 2019)
40 slides from Imugene's investor presentation, Nov 6, 2019
Slide 1: Imugene Investor Presentation November 2019
For personal use only November 2019 IMUGENE
Slide 2: For personal use only
For personal use only 2
Slide 3: Disclaimer
DISCLAIMER For personal use only 1. The information in this presentation does not constitute personal investment advice. The presentation is not intended to be comprehensive or provide all information required by investors to make an informed decision on any investment in Imugene Limited (Company).
Slide 4: Introduction to Imugene
INTRODUCTION TO IMUGENE For personal use only • Imugene is a biotech company headquartered in Australia and publicly traded on the Australian Securities Exchange (ASX:IMU) • Technology originated from the Medical University of Vienna, invented by Prof Christoph Zielinski and Prof Ursula Wiedermann •
Slide 5: Investment Highlights
INVESTMENT HIGHLIGHTS • Novel technology in one of the most sought-after areas of cancer immunotherapy For personal use only today: oncolytic viruses a.k.a. cancer killing viruses that stimulate immune recognition of cancer and our B-cell Immunotherapy pipeline • CF33 poised to enter into 2 x Phase
Slide 6: International leadership team with extensive commercialisation expertise
International leadership team with extensive commercialisation expertise in the sector Leslie Chong Paul Hopper Dr Axel Hoos Mr Charles Walker For personal use only SYDNEY, AU SYDNEY, AU PHILADELPHIA, USA BRISBANE, AU Managing Director & CEO Executive Chairman Non-Executive Director Non-Executive Di
Slide 7: Scientific Advisory Board
Imugene‘s Scientific Advisory Board consists of world leading oncologists, researchers and developers For personal use only Prof. Josep Tabernero Prof Pravin Kaumaya Dr. Michael Galigiuri VALL D’HEBRON, BARCELONA, Prof Tanios BekaiI Saab OHIO STATE UNIVERSITY, USA CITY OF HOPE, USA SPAIN MAYO CLINIC
Slide 8: Oncolytic Virus Scientific Advisors
ONCOLYTIC VIRUS SCIENTIFIC ADVISORS For personal use only Professor Yuman Fong, OV SAB Chair Prasad S. Adusumilli Dr Rebecca Auer Prof James Market Deputy Chief, Thoracic Service; Co-Director, Associate Scientist Cancer Therapeutics James Garber Galbraith Endowed Chair Mesothelioma Program; Head, So
Slide 9: Executive Summary
EXECUTIVE SUMMARY For personal use only Imugene is acquiring the worldwide exclusive The virus, known as CF33, is a chimeric poxvirus, license to a promising oncolytic virus and is poised to enter Phase 1 technology developed at the clinical trials in 2020. City of Hope Cancer Centre in Los Angeles.
Slide 10: Landscape: Recent Oncolytic Virus Transactions
LANDSCAPE: RECENT ONCOLYTIC VIRUS TRANSACTIONS For personal use only Oncolytic viruses are attracting the serious attention of big pharma companies such as $340m $200m $502m Merck, Boehringer and Janssen which have made three acquisitions in 2018 alone totalling over $1.0 billion, including Viralyti
Slide 11: Viralytics Case Study: Acquired by Merck for $502M
V I R A LY T I C S C A S E ST U DY ACQUIRED BY MERCK FOR $502M For personal use only $502M Acquired by MERCK @$1.75 Virus Picornovirus/coxsackie Stage of Development Phase 2 June 2018 Melanoma, bladder, colorectal, non Raised $28m Disease types @ 61.5 cents small cell lung Checkpoint combination tri
Slide 12: The Inventor & City of Hope
THE INVENTOR & CITY OF HOPE A pioneer, both in the operating room and in the laboratory, Prof Yuman Fong, M.D., The Sangiacomo Family For personal use only Chair in Surgical Oncology and chair of The City of Hope Dept of Surgery is an internationally recognized expert in liver and pancreatic cancer.
Slide 13: Oncolytic Virus (CF33) Mechanism of Action
ONCOLYTIC VIRUS (CF33) MECHANISM OF ACTION HOW A VIRUS KILLS A CELL For personal use only Step 1: Step 2: Step 3: Virus enters cell Virus duplicates itself Cell explodes, releasing thousands of brand new virus particles • Direct infection, replication within and cancer cell killing • Viral infection
Slide 14: Major Advantages of CF33
MAJOR ADVANTAGES OF CF33 K E Y D I F F E R E N T I AT I O N For personal use only 1. DNA virus - Much easier to manipulate and vectorize to carry foreign gene as therapeutic payloads 2. CF33 - more potent in terms of; a) Range of cancer cell types infectible, Preclinical data has Especially impressi
Slide 15: How Was CF33 Derived?
HOW WAS CF33 DERIVED? For personal use only Virus 1 Virus 2 Virus 3 1. 100 chimeric orthpoxviruses and 100 chimeric parapoxviruses were generated 2. Several orthopoxvirus and parapoxvirus chimeras showed superior cancer cell killing in the NCI-60 cell lines 3. CF33 is the chimeric orthopoxvirus chos
Slide 16: CF33 Shrinks Triple-Negative Breast Cancer
For personal use only CF33 SHRINKS TRIPLE- NEGATIVE BREAST CANCER 130 PBS #33, 10^3 pfu 110 Mice treated with both #33, 10^4 pfu % change in tumor volume 90 Intratumoral (IT) & IV virus 70 The viral dose used was 2-5 orders 50 of magnitude lower than doses used for oncolytic viruses under 30 clinica
Slide 17: Compelling Tumour Inhibition in Multiple Cancers
COMPELLING TUMOUR INHIBITION IN MULTIPLE CANCERS For personal use only 17
Slide 18: CF33 Outperforms Amgen & Genelux Viruses
CF33 OUTPERFORMS AMGEN & GENELUX VIRUSES For personal use only MICE BEARING THE A549 XENOGRAFTS WERE TREATED WITH INDICATED VIRUSES AT A DOSE OF 103 V0 V PFU/MOUSE PERCENT CELL SURVIVAL FOR INJECTED TUMORS NON-INJECTED TUMORS BXPC-3 PANCREATIC CANCER 2800 2400 PBS 100 2400 CF33 2000 PBS V0 V 80 Tumo
Slide 19: CF33 GMP Manufacturing at City of Hope
CF33 GMP MANUFACTURING AT CITY OF HOPE For personal use only Center for biomedicine and genetics (CBG) The Center for Biomedicine & Genetics (CBG) is a California-licensed, 20 000 square foot, multi- product biologics manufacturing facility within City of Hope. With twelve ISO7 production rooms in t
Slide 20: CHECKvacc: CF33 + hNIS + PD-L1
CHECKvacc: CF33 +hNIS+PD-L1 Proposed Phase 1 Triple Negative Breast Cancer Study For personal use only COHORT 6 | 3-6 PATIENTS COHORT 5 | 3-6 PATIENTS IDENTIFY Recommended Metastatic Triple Phase 2 Dose COHORT 4 | 3-6 PATIENTS Negative Breast (RP2D) RP2D EXPANSION Cancer Based on: 12 PATIENTS COHORT
Slide 21: Vaxinia: CF33 + hNIS
Vaxinia: CF33 +hNIS Proposed Phase 1 & Phase 2 MAST (MIXED ADVANCED SOLID TUMOURS) STUDY For personal use only MAST Study Phase 1 MAST Study Phase 2 Dose Seeking/Signal Finding Simon 2 Stage Design Lung, TNBC, Melanoma, Bladder, Indication Indication Select tumors from Phase 1 Gastric, Colorectal 1.
Slide 22: Intellectual Property
INTELLECTUAL PROPERTY F O U N D AT I O N PAT E N T ( 2 0 37 ) For personal use only PCT US2017/046163 Chimeric poxvirus compositions Title & use thereof Inventor Yuman Fong Assignee City of Hope Primary Date 9 August 2016 International 18 February 2018 Publication PCT application filing date was 8/9
Slide 23: Core Science Published in Leading Peer Publications
CORE SCIENCE PUBLISHED IN LEADING PEER PUBLICATIONS For personal use only 2018 2018 2018 2019 Mol Ther Oncolytics. 2018 Jun 29;9 Mol Ther Oncolytics. 2018 Jun 29;9 J Transl Med. 2018 Apr 26;16:110 Cancer Gene Ther. 2019 17 June A Novel Oncolytic Chimeric Endogenous AKT Activity Promotes Novel Oncoly
Slide 24: Selected Oncolytic Virus Deals
SELECTED ONCOLYTIC VIRUS DEALS Date Source Buyer Deal type Up-front ($m) Note For personal use only May 2019 Transgene Astrazeneca Licensing 10 Five research candidates Sep 2018 Viratherapeutics Boehringer Ingelheim Acquisition 245 VSV-GP project, preclinical Feb 2018 Viralytics Merck & Co Acquisiti
Slide 25: Key Current & Emerging Competition
KEY CURRENT & EMERGING COMPETITION For personal use only Company/Instituti Development Phase Product Target/Virus on & Key Results Squamous cell carcinoma of the head and Oncorine Sunway Approved in China neck/Ad Talimogene Melanoma/HSV-1 Amgen Approved in USA laherparepvec Pexa-Vec (JX-594) Hepatoc
Slide 26: CF33 Management Team
CF33 MANAGEMENT TEAM Paul Hopper For personal use only Executive Chairman Leslie Chong MD & CEO Dr Len Post Mark Grose Dr Seymour Fein Dr Evan Siegal Dr Mike White Dr Nick Ede Senior Scientific Clinical Trials Medical Monitor IND Lead on Vaxinia Biostatistician Advisor Manager IND Submission Former
Slide 27: HER-Vaxx Phase 1b/2 Study Design
HER-Vaxx PHASE 1B/2 STUDY DESIGN For personal use only PHASE 1B PHASE 2 R Cohort 3 3-6 IMU-131 + SOC chemo A Advanced N Adenocarcinoma D Interim PFS analysis for futility/superiority TREAT FOLLOW Cohort 2 3-6 RP2D 1:1 Primary endpoint – OS of the Stomach O UNTIL FOR OS Secondary endpoint PFS n=68 M
Slide 28: HER-Vaxx Phase 1b: Design & Results
HER-Vaxx PHASE 1B: DESIGN & RESULTS For personal use only Trial Patients Study Endpoints Study Results • HER2 Gastric • Advanced stage IIIb • 14 patients • Recommended • No safety or toxicity issues or GEJ cancer or IV in 3 cohorts (10µg (3), Phase 2 Dose of • All patients had increased • Phase 1b •
Slide 29: Going Forward: HER-Vaxx Phase 2 Commenced
GOING FORWARD: HER-Vaxx PHASE 2 COMMENCED For personal use only Trial Patients Study Primary Endpoints • Phase 2 • HER-2+++ Randomized • Overall survival • Open label • HER-2++ FISH/CISH +ve HER-Vaxx in combination • Asia • Advance or metastatic with standard of care Secondary Endpoints • Eastern Eu
Slide 30: HER-Vaxx Publications
HER-Vaxx PUBLICATIONS AACR ESMO-GI ASCO ESMO For personal use only AACR 2019 ESMO-GI 2019 ASCO 2019 ESMO-2019 A Phase Ib open label multicenter study A Phase 1B study of IMU-131 HER2/NEU A Phase 1b study of IMU-131 HER2/NEU Comprehensive results of a Phase Ib study with a HER2/neu peptide vaccine pe
Slide 31: How Does PD1-Vaxx Work?
HOW DOES PD1-Vaxx WORK? HOW CANCER STAYS UNDETECTED PD1-VAXX STOPS THE CANCER CELL FROM For personal use only BY THE IMMUNE SYSTEM AVOIDING T-CELL RECOGNITION AND KILLING PD-L1 PROTEIN L C EL T- Gives T-cells the ability to RE PD- recognise the cancer cell and ANTI PD-1 CANCER CE 1 PT O mount an imm
Slide 32: PD1-Vaxx Publications
PD1-Vaxx PUBLICATIONS AACR ESMO For personal use only AACR 2019 ESMO-2019 Development of a novel PD-1 vaccine and in Antitumor activity and safety of a combination with two Chimeric HER-2 novel PD-1 vaccine (PD1-Vaxx) alone peptide vaccine provides synergistic and in combination with two inhibition
Slide 33: Imugene Has a Developing Pipeline
IMUGENE HAS A DEVELOPING PIPELINE For personal use only Clinical Clinical Pre-Clinical development development Key Data / Results Key IP patents Phase 1 Phase 2 • CF33 has shown strong anti tumour responses in preclinical studies Intellectual property Vaxinia • Inhibition of tumour growth in nearly
Slide 34: Multiple Value Realisation Pathways
MULTIPLE VALUE REALISATION PATHWAYS For personal use only OR OR OR SALE OF COMPANY PARTNER WITH BIG LICENSE A TARGET DEVELOP PHARMA DISEASE INDEPENDENTLY Investor Presentation Nov 2019 34
Slide 35: Multiple Near & Medium Term Value Inflection Points
For personal use only PD ma 1-Va nu xx fac dru tur g Va ed xin ia M Co anu mp fac let tur PD e ing 1-V ax xC RO Va se xin lec ia ted CR Os CH ele EC cte KV d Cle axx ara FDA nc e IND PD 1-V a Cle xx F ara DA nc IND e HE R- V Int axx eri Ph m a Da se 2 PD ta 1-V Next 12 months ax xS it e PD Ac t iv 1
Slide 36: Financial Summary
For personal use only Financial Summary Public Market Overview Share Price Performance (last 6 months) Share Price 1 A$0.023 Market Capitalisation 2 A$83.1M IMU announced EGM and IMU announced proposed Clinical Development of Cash equivalents (30 Sep 19 acquistion of CF33 CF33 A$17.8M + R&D rebate)
Slide 37: Investment Highlights
INVESTMENT HIGHLIGHTS • Novel technology in one of the most sought-after areas of cancer immunotherapy For personal use only today: oncolytic viruses a.k.a. cancer killing viruses that stimulate immune recognition of cancer & our B-cell Immunotherapy pipeline • CF33 poised to enter into 2 x Phase 1
Slide 38: For personal use only
For personal use only 38
Slide 39: For personal use only
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Slide 40: Leslie Chong, Managing Director & CEO
For personal use only Leslie Chong Managing Director & CEO leslie.chong@imugene.com +61 458 040 433