Slide 1: Proposed Acquisition of Oncolytic Chimeric Poxvirus known as CF33
Proposed Acquisition of Oncolytic Chimeric Poxvirus known as CF33
Slide 2: Disclaimer
DISCLAIMER 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). In preparing this pres
Slide 3: Introduction to Imugene
INTRODUCTION TO IMUGENE • Imugene is a biotech company headquartered in Australia and publicly traded on the Australian Securities Exchange (ASX:IMU) • B cell based technology originated from the Medical University of Vienna • Late 2013: Paul Hopper then built Imugene around this technology • 2017:
Slide 4: 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 SYDNEY, AU SYDNEY, AU PHILADELPHIA, USA BRISBANE, AU Managing Director & CEO Executive Chairman Non-Executive Director Non-Executive Director • 20+ years of
Slide 5: Experienced management team with significant clinical development expertise
Experienced management team which have significant clinical development expertise Dr Mark Marino Dr Nick Ede SAN DIEGO, USA MELBOURNE, AU Chief Medical Officer Chief Technology Officer • 28+ years of experience in drug • 25+ years peptide vaccine and development drug development • Former CMO of Cyto
Slide 6: Executive Summary
EXECUTIVE SUMMARY 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. 6
Slide 7: Investment Highlights
INVESTMENT HIGHLIGHTS • Novel technology in one of the most sought-after areas of cancer immunotherapy today – oncolytic viruses a.k.a. cancer killing viruses that stimulate immune recognition of cancer • Poised to enter Phase 1 clinical trials in 2020 • GMP Phase 1 virus material underway, addition
Slide 8: Landscape: Recent Oncolytic Virus Transactions
LANDSCAPE: RECENT ONCOLYTIC VIRUS TRANSACTIONS 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 Viralytics. 8
Slide 9: Viralytics Case Study
V I R A LY T I C S C A S E ST U DY ACQUIRED BY MERCK FOR $502M $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 trial with Raised $27m De
Slide 10: The Inventor & City of Hope
THE INVENTOR & CITY OF HOPE A pioneer both in the operating room and in the laboratory, Yuman Fong, M.D., The Sangiacomo Family Chair in Surgical Oncology and chair of The City of Hope Dept of Surgery is an internationally recognized expert in liver and pancreatic cancer. He has developed many new s
Slide 11: CF33 Mechanism of Action
CF33 MECHANISM OF ACTION HOW A VIRUS KILLS A CELL 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 increases local check point targets (PD
Slide 12: 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 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 impressing is that Importantly
Slide 13: Advantages of Oncolytic Viruses
ADVANTAGES OF ONCOLYTIC VIRUSES Synergy with Tumor standard-of- targeting care therapies and emerging Self- novel therapies amplification Stimulates immune system to recognise tumor Effective for First gene therapy both primary approved in USA: and metastatic Oncolytic virus tumors as well Talimogen
Slide 14: Why a Vaccinia Virus?
WHY A VACCINIA VIRUS? 1. Belongs to the genus Orthopoxvirus in the family Poxviridae 2. A large virus that contains a double stranded DNA genome & genetically very stable 3. Famous for use as a vaccine to eradicate the human deadly disease, smallpox. 4. The first oncolytic virus demonstrating viral
Slide 15: How Was CF33 Derived?
HOW WAS CF33 DERIVED? 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 chosen for further evaluat
Slide 16: CF33 Safety
CF33 SAFETY Figure 1. Day 7 biodistribution of the virus in Immune- • A number of studies have been completed with CF33 as well as some competent mice: Immune-competent BALB/c mice of the derivatives. It has proven very safe in nude mice and in bearing a single tumor in mammary fat-pad were immunoco
Slide 17: CF33 Shrinks Triple-Negative Breast Cancer
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 virus and IV 70 The viral dose used was 2-5 orders 50 of magnitude lower than doses used for oncolytic viruses under 30 clinical testing 10 0 Mol Ther O
Slide 18: CF33 Outperforms Amgen & Genelux Viruses
CF33 OUTPERFORMS AMGEN & GENELUX VIRUSES 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 Tumor volume (mm^3) 2000 G
Slide 19: CF33 Abscopal Effects
CF33 ABSCOPAL EFFECTS The abscopal effect describes a situation whereby shrinkage of untreated or distant tumors occurs concurrently with IMPACT OF CF33 ON UN-INJECTED shrinkage of tumors directly treated with the drug. TUMORS Inhibition of un-injected tumors by both CF33 § Effective for killing can
Slide 20: Phase 1 GMP Manufacturing at City of Hope
PHASE 1 GMP-MANUFACTURING AT CITY OF HOPE 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 ISO 7 production rooms in three product type
Slide 21: CF33 Proposed Phase 1/2 Clinical Development Plan
CF33 PROPOSED PHASE 1/2 CLINICAL DEVELOPMENT PLAN MAST Study Phase 1 MAST Study Phase 1/2 “Mixed Advanced Solid Tumors” “Mixed Advanced Solid Tumors” Lung, TNBC, melanoma, bladder, Select tumors from Phase Indication Indication GI 1 cohorts 15 – Single Agent CF33 Combination with ICI FDA IND 15 – Co
Slide 22: CF33 MAST (Mixed Advanced Solid Tumours) Study
CF33 MAST (MIXED ADVANCED SOLID TUMOURS) STUDY CF33 Proposed Phase 1 / 2 Clinical Development Plan Phase 1 – Dose Seeking /Signal Finding Phase 2 – Expansions Assumption CF33 + Immune CF33 + ICI in various CF33 Dose Escalation tumour indications Checkpoint Inhibitor (ICI) IDENTIFY Indication (30 pat
Slide 23: Intellectual Property
INTELLECTUAL PROPERTY F O U N D AT I O N PAT E N T ( 2 0 37 ) 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 8/9/2017, and estimated e
Slide 24: Core Science Published in Leading Peer Publications
CORE SCIENCE PUBLISHED IN LEADING PEER PUBLICATIONS 2018 2018 2018 2018 Mol Ther Oncolytics. 2018 Jun 29;9 Mol Ther Oncolytics. 2018 Jun 29;9 J Transl Med. 2018 Apr 26;16:110 Surgery. 2018 Feb;163(2) A Novel Oncolytic Chimeric Endogenous AKT Activity Promotes Novel Oncolytic Chimeric Orthopoxvirus N
Slide 25: M&A Frenzy for Oncolytic Viruses
M&A FRENZY FOR ONCOLYTIC VIRUSES 25
Slide 26: M&A Frenzy for Oncolytic Viruses… Continued
M&A FRENZY FOR ONCOLYTIC VIRUSES… CONTINUED 26
Slide 27: Selected Oncolytic Virus Deals
SELECTED ONCOLYTIC VIRUS DEALS Date Source Buyer Deal type Up-front (US$m) Note 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 Acquisition 394 Cavatak, phas
Slide 28: The Vaxinia Team: Plug & Play
THE VAXINIA TEAM: PLUG & PLAY D E E P O N C O LY T I C V I R U S E X P E R I E N C E Va x i n i a Paul Hopper Dr Len Post Mark Grose Dr Seymour Fein Dr Evan Siegal Dr Mike White Senior Scientific Clinical Trials IND Lead on Vaxinia Executive Chairman Medical Monitor Biostatistician Advisor Manager I
Slide 29: Oncolytic Virus Scientific Advisors
ONCOLYTIC VIRUS SCIENTIFIC ADVISORS Professor Ulrich Lauer Prasad S. Adusumilli Dr. Rebecca Auer Professor James Market Head of Virotherapy Research bei Deputy Chief, Thoracic Service; Associate Scientist Cancer James Garber Galbraith University of Tuebingen Germany. Co-Director, Mesothelioma Therap
Slide 30: Multiple Value Realisation Pathways
MULTIPLE VALUE REALISATION PATHWAYS OR OR OR SALE OF COMPANY PARTNER WITH BIG LICENSE A TARGET DEVELOP PHARMA DISEASE INDEPENDENTLY 30
Slide 31: Why CF33?
• Novel technology in one of the most sought-after areas of cancer immunotherapy today – oncolytic viruses a.k.a. cancer killing viruses WHY • Compelling pre-clinical data & safety • GMP manufacturing has commenced • Poised to enter Phase 1 clinical trials in 2020 • Potential applications across man
Slide 32: Estimated Timetable
ESTIMATED TIMETABLE • 15th July: Announce transaction to ASX • 7th of August: Dispatch Notice of Meeting to Shareholders • 9th September: Extraordinary General Meeting of Imugene shareholders 32
Slide 33: Imugene Has a Developing Pipeline
IMUGENE HAS A DEVELOPING PIPELINE Clinical Clinical Pre-Clinical development development Key Data / Results Key IP patents Phase 1 Phase 2 CF33 • CF33 has shown strong anti tumour responses in preclinical studies Intellectual property • Inhibition of tumour growth in nearly all NCI60 models in TNBC,
Slide 34: Imugene Discovery Pipeline
IMUGENE DISCOVERY PIPELINE Program Pre-clinical ID of candidate Oncolytic Virus Her-1 (EGFR) Her-3 IGF-1R VEGF Combination (numerous) PD-L1 34
Slide 35: Leslie Chong, Managing Director & CEO
Leslie Chong Managing Director & CEO leslie.chong@imugene.com +61 458 040 433