Imugene Ltd · ASX:IMU
Imugene — Investor Presentation (November 2019)
31 slides from Imugene's investor presentation, Dec 2, 2019
Slide 1: CF33 Oncolytic Virus Acquisition
For personal use only ASX: IMU CF33 ONCOLYTIC VIRUS ACQUISITION November 2019 CONFIDENTIAL
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 For personal use only provide all information required by investors to make an informed decision on any investment in Imugene Limited (Company).
Slide 3: Investment Highlights
INVESTMENT HIGHLIGHTS For personal use only Ø Two novel technologies: CF33 oncolytic virus; and B-Cell immunotherapy Ø CF33 recently acquired from City of Hope Cancer Centre in Los Angeles Ø CF33 poised to enter two Phase 1 clinical trials in 2020 Ø CF33 has demonstrated single agent & combination a
Slide 4: Two Novel Technology Platforms
TWO NOVEL TECHNOLOGY PLATFORMS For personal use only CF33 B-Cell Oncolytic Vaccines Virus CHECKVacc Vaxinia HER-Vaxx PD1-Vaxx “Armed” Parental Virus Virus CONFIDENTIAL 4
Slide 5: Four Clinical Trials in 2020
FOUR CLINICAL TRIALS IN 2020 For personal use only ONCOLYTIC VIRUS B CELL IMMUNOTHERAPIES CHECKVacc Vaxinia HER-Vaxx PD1-Vaxx CF33+hNIS+ PD-L1 CF33+hNIS Phase 2 Phase 1 Triple Negative Breast Cancer Advanced Solid Tumors Gastric Cancer Lung Cancer Phase 1 Phase 1 / 2 Multi Centre Multi Centre City o
Slide 6: Imugene's Deep Pipeline
IMUGENE’S DEEP PIPELINE For personal use only Clinical Clinical Pre- Intellectual development development Key Data / Results Clinical Property Phase 1 Phase 2 • CF33 has shown strong anti tumour responses in preclinical studies Expiring 2037 Vaxinia Mixed Advanced • Inhibition of tumour growth in ne
Slide 7: Imugene's Estimated Timeline
IMUGENE’S ESTIMATED TIMELINE 2020 2021 2022 2023 For personal use only Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 HER- Vaxx Phase 2 Interim Data OS Enrollment PFS Readout Readout Completed Readout PD1- Phase 1 Expansion Vaxx IND OBD Expansion complete FPI Clearance CHECK Vacc TNBC IST Expansion
Slide 8: International Leadership Team
INTERNATIONAL LEADERSHIP TEAM For personal use only Leslie Chong Paul Hopper Dr Jens Eckstein Dr Lesley Russell Dr Axel Hoos Mr Charles Walker SYDNEY, AU SYDNEY, AU CAMBRIDGE, USA PHILADELPHIA, USA PHILADELPHIA, USA BRISBANE, AU Managing Director & CEO Executive Chairman Non-Executive Director Non-E
Slide 9: The Oncolytic Virus Inventor & City of Hope
THE ONCOLYTIC VIRUS INVENTOR & CITY OF HOPE A pioneer, both in the operating room and in the laboratory, Prof Yuman Fong, M.D., The Sangiacomo For personal use only Family Chair in Surgical Oncology and chair of The City of Hope Dept of Surgery is an internationally recognized expert in liver and pa
Slide 10: Oncolytic Virus Clinical Development Team – ex Viralytics
ONCOLYTIC VIRUS CLINICAL DEVELOPMENT TEAM – ex VIRALYTICS Paul Hopper For personal use only Chairman of Viralytics 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 Biostatistici
Slide 11: 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 12: Viralytics Case Study: Acquired by Merck for $502M
VIRALYTICS CASE STUDY 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 trial with Raise
Slide 13: CF33 Mechanism of Action
CF33 MECHANISM OF ACTION For personal use only 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 c
Slide 14: How Was the Virus Made?
HOW WAS THE VIRUS MADE? • This is a unique “designer virus” which does not exist in nature For personal use only • Nine viruses selected: six vaccinia (smallpox); cowpox; rabbit; and racoon • All inserted in a cancer cell, where they traded DNA • Hundreds of new virus resulted and were isolated for
Slide 15: 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 16: CF33 Safety
CF33 SAFETY Figure 1. Day 7 biodistribution of the virus in For personal use only Immune-competent mice: Immune-competent • A number of studies have been completed with CF33 as BALB/c mice bearing a single tumor in mammary well as some of the derivatives. It has proven very safe in fat-pad were inje
Slide 17: 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 18: Compelling Single Agent Tumour Inhibition in Multiple Cancers
COMPELLING SINGLE AGENT TUMOUR INHIBITION IN MULTIPLE CANCERS For personal use only CONFIDENTIAL 18
Slide 19: CF33 Shrinks Triple-Negative Breast Cancer
CF33 SHRINKS TRIPLE-NEGATIVE BREAST CANCER 130 Mice treated with both For personal use only PBS intratumoral virus and IV 110 #33, 10^3 pfu 90 #33, 10^4 pfu The viral dose used was 2-5 % change in tumor volume 70 orders of magnitude lower than doses used for oncolytic viruses 50 under clinical testi
Slide 20: CHECKvacc: CF33 + hNIS + PD-L1 (Armed Virus)
CHECKvacc: CF33 +hNIS+PD-L1 (“Armed” Virus) Qtr 2 2020 Phase 1 Triple Negative Breast Cancer Study – GMP Manufacturing Complete For personal use only COHORT | 3-6 PATIENTS IDENTIFY COHORT | 3-6 PATIENTS Recommended Metastatic Triple Phase 2 Dose Negative Breast COHORT | 3-6 PATIENTS (RP2D) RP2D EXPA
Slide 21: Phase 1/2 Vaxinia MAST Study
PHASE 1/2 VAXINIA MAST STUDY (Mixed Advanced Solid Tumours Advanced NSCLC, TNBC, For personal use only Melanoma Urothelial, Gastric GMP manufacturing complete TNBC, Urothelial IT Administration IV Administration PHASE 1 STUDY: DOSE SEEKING/SIGNAL FINDING PHASE 2 – DOSE EXPANSION Part 1 Part 2 Vaxini
Slide 22: Vaxinia: CF33 + hNIS (Parental Virus)
Vaxinia: CF33 + hNIS (Parental Virus) Proposed Phase 1 & 2 MAST STUDY For personal use only MAST Study Phase 1 MAST Study Phase 2 Dose Seeking/Signal Finding Vaxinia + ICI Lung, TNBC, Melanoma, Bladder, Indication Indication Select tumors from Phase 1 Gastric, Colorectal 1.Vaxinia: CF33-hNIS monothe
Slide 23: Multiple Near & Medium Term Value Inflection Points
MULTIPLE NEAR & MEDIUM TERM VALUE INFLECTION POINTS For personal use only HER-Vaxx Phase 2 Enrollment completed Vaxinia 1st Patient Dosed CheckVacc TNBC IST 1st Patient Dosed Vaxinia FDA IND Clearance PD1-Vaxx 1st Patient Dosed PD1-Vaxx Site Active HER-Vaxx Phase 2 Independent Data Look PD1-Vaxx FDA
Slide 24: B-Cell Immunotherapy
For personal use only B-Cell Immunotherapy
Slide 25: B Cell Based Antibodies Have Distinct Advantages to Existing Treatments
B CELL BASED ANTIBODIES HAVE DISTINCT ADVANTAGES TO EXISTING TREATMENTS B cell Vaccines offer a unique For personal use only opportunity to intervene at multiple points in the immune system and create immune memory which N AT U R A L B C E L L DE R I V E D MONOCLONAL enhances durability of response.
Slide 26: B-Cell Immunotherapy Vaccine Against HER-2
B-CELL IMMUNOTHERAPY VACCINE AGAINST HER-2 For personal use only • HER-Vaxx is a B-cell immunotherapy designed to treat tumours that over-express the HER2/neu receptor, HER-Vaxx stimulates the patients B cells to produce including gastric and breast cancer antibodies that target only those cancer ce
Slide 27: 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 28: HER-Vaxx Phase 1b: Clinical Response
HER-Vaxx PHASE 1B: CLINICAL RESPONSE 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 observed, no significant i
Slide 29: Going Forward: HER-Vaxx Phase 2 Recruiting
GOING FORWARD: HER-Vaxx PHASE 2 RECRUITING 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 E
Slide 30: 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 31: PD-1/HER-2 Combination: Potential to Increase Response Rates in HER-2+ Cancers
PD-1/HER-2 COMBINATION: POTENTIAL TO INCREASE RESPONSE RATES IN HER-2+ CANCERS For personal use only % CANCER GROWTH INHIBITION IN COLORECTAL CANCER MODEL Immuno-oncology combinations are driving value • Combining drugs for better immuno-oncology PD-1 vaccine plus Her-2 vaccine 90% outcome is drivin