Slide 1: ASX Announcement: Investor presentation at Bioshares Biotech Summit 2019
ASX Announcement Investor presentation at Bioshares Biotech Summit 2019 _________________________________________________________________________________ For personal use only SYDNEY, Australia, 26 July 2019: Imugene Limited (ASX:IMU), a clinical stage immuno-oncology company, today announced its Ch
Slide 2: For personal use only
immunotherapy B-cell vaccine candidates and an oncolytic virotherapy (CF33) aimed at treating a variety of cancers in combination with standard of care drugs and emerging immunotherapies. We are supported by a leading team of international cancer experts with extensive experience in developing new c
Slide 3: An Emerging Leader in Cancer Immuno-Oncology
For personal use only AN EMERGING LEADER IN CANCER IMMUNO-ONCOLOGY Bioshares Presentation Dr Nick Ede, CTO July 2019
Slide 4: Disclaimer
2 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 5: Introduction to Imugene
3 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) • B cell vaccine based technology originated from the Medical University of Vienna • 2017: HER-Vaxx, our anti HER2 B cell canc
Slide 6: Imugene has a developing pipeline
4 IMUGENE HAS A DEVELOPING PIPELINE Clinical Clinical Pre-Clinical development development Key Data / Results Key IP patents For personal use only Phase 1 Phase 2 CF33 • CF33 has shown strong anti tumour responses in preclinical studies Intellectual property • Inhibition of tumour growth in nearly a
Slide 7: International leadership team with extensive commercialisation expertise
International leadership team with extensive commercialisation 5 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
Slide 8: IMU.ACS.001 Phase 1B Study of IMU-131, a HER2 Targeting B-Cell Vaccine
For personal use only IMU.ACS.001 PHASE 1B STUDY OF IMU-131, A HER2 TARGETING B-CELL VACCINE
Slide 9: HER-Vaxx (IMU-131) is a therapeutic B-cell peptide vaccine
7 HER-Vaxx (IMU-131) IS A THERAPEUTIC B-CELL PEPTIDE VACCINE COMPOSED OF 3 EPITOPES FROM THE EXTRACELLULAR DOMAIN OF HER2/NEU CONJUGATED TO CRM197 For personal use only Peptides “mimic” HER-Vaxx ANTIBODY TUMOR the epitope SECRETION CELL Via helper T-cells HER-2/NEU 3 PEPTIDES HER-Vaxx B-CELL IMMUNOT
Slide 10: IMU.ACS.001 Phase 1B: Design & Results
8 IMU.ACS.001 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
Slide 11: IMU.ASC.001 Phase 1B: Clinical Response & Conclusions
9 IMU.ASC.001 PHASE 1B: CLINICAL RESPONSE & CONCLUSIONS For personal use only • The preliminary immunology and clinical response data are promising. • Safety data indicate that IMU-131 is well-tolerated with no significant local or systemic reactions. • There were no dose-limiting toxicities observe
Slide 12: Phase 2 commenced
10 …and commenced Phase 2 For personal use only Phase 2 commenced - First patients dosed March 2019 Trial Patients Study Primary Endpoints • Phase 2 • Gastric Cancer Randomized • Overall survival • Open label • Up to 70 patients HER-Vaxx in combination • Progression-free • Asia with standard of care
Slide 13: Imugene announces HER-Vaxx to the world 2019
11 Imugene announces HER-Vaxx to the world 2019 For personal use only With a proactive approach to business development and brand awareness through participation in key conferences and acceptance in peer reviewed journals
Slide 14: HER-Vaxx Combinations: Potential to increase response rates in HER-2+ cancers
12 HER-Vaxx Combinations: Potential to increase response rates in HER-2+ cancers For personal use only % CANCER GROWTH INHIBITION IN COLORECTAL CANCER MODEL (OSU) Immuno-oncology combinations driving value • Combining drugs for better immuno-oncology PD-1 vaccine plus Her-2 vaccine 90% outcome is dr
Slide 15: A New Hope for Cancer Therapy
13 A NEW HOPE FOR CANCER THERAPY 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
Slide 16: Landscape: Recent Oncolytic Virus Transactions
14 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 Viral
Slide 17: 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 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 t
Slide 18: Compelling tumour inhibition in multiple cancers
16 Compelling tumour inhibition in multiple cancers For personal use only Pancreatic Colorectal J Transl Med. 2018, 16, 110 Mol Ther Oncolytics. 2018, 9, 13 PBS. For i.v. treatment, eight mice received 105 PFU of CF33-Fluc, Statistical Analy and four mice received PBS via tail-vein injection. Two an
Slide 19: CF33 Outperforms Amgen & Genelux Viruses
17 CF33 OUTPERFORMS AMGEN & GENELUX VIRUSES For personal use only MICE BEARING THE A549 LUNG 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
Slide 20: CF33 Safety
18 CF33 SAFETY For personal use only 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 mamm
Slide 21: CF33 Proposed Phase 1/2 Clinical Development Plan
19 CF33 PROPOSED PHASE 1/2 CLINICAL DEVELOPMENT PLAN MAST Study Phase 1 MAST Study Phase 1/2 For personal use only “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
Slide 22: Intellectual Property
20 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
Slide 23: Core Science Published in Leading Peer Publications
21 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 Onc
Slide 24: Why CF33?
22 • Novel technology in one of the most sought-after areas of cancer For personal use only 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 • Potentia
Slide 25: Nick Ede, Chief Technology Officer
For personal use only Nick Ede Chief Technology Officer Imugene (ASX:IMU) nede@imugene.com +61 400 642 254