Imugene Ltd · ASX:IMU
Imugene — Non-Deal Roadshow (March 2023)
32 slides from Imugene's roadshow presentation, Mar 15, 2023
Slide 1: Imugene Non-Deal Roadshow March 2023
For personal use only ASX: IMU Developing Cancer Immunotherapies Imugene Non-Deal Roadshow March, 2023
Slide 2: Disclaimer
DISCLAIMER For personal use only 1. The information in this presentation does not constitute personal 4. Neither the Company nor any of its directors, officers, employees, investment advice. The presentation is not intended to be advisers, associated persons or subsidiaries are liable for any direct
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) For personal use only PD1-Vaxx Leslie Chong Licensed PD1-Vaxx from Strategic Clinical Trial Strategic from OSU & PD1-Vaxx Partnership Strategic Supply V
Slide 4: Investment Highlights
INVESTMENT HIGHLIGHTS MARKET For personal use only 9th March 2023 A$835M CASH AS OF 31st December 2022 A$162M CAPITALISATION CF33 B-Cell CHECKvacc Oncolytic Virus onCARlytics Immunotherapies DISEASE AREAS HER-Vaxx 3 Breast (TNBC) PLATFORM Lung (NSCLC) TECHNOLOGIES Gastric VAXINIA CF33-CD19 Gastroeso
Slide 5: Three Unique Technology Platforms Maximize Opportunities in Solid Tumors
THREE UNIQUE TECHNOLOGY PLATFORMS MAXIMIZE OPPORTUNITIES IN SOLID TUMORS Therapeutic approaches with combination potential with existing standards of care For personal use only PLATFORM CF33-CD19 CAR T Combination Therapy CHECKvacc VAXINIA HER-Vaxx PD1-Vaxx IP TO 2036 IP TO 2037 IP TO 2037 Granted i
Slide 6: Imugene's Deep Immunotherapy Pipeline for the Treatment of Solid Tumors
IMUGENE’S DEEP IMMUNOTHERAPY PIPELINE FOR THE TREATMENT OF SOLID TUMORS PROGRAM/ COMBINATION 2023 EXPECTED For personal use only PLATFORM TARGET APPROACH INDICATION IND PRECLINICAL IND PHASE 1 PHASE 2 MILESTONES onCARlytics CD19 targeted Metastatic FDA IND (CF33-CD19) therapies Solid Tumors PHASE 1
Slide 7: Industry Leader & Non-Executive Director
INDUSTRY LEADER & NON-EXECUTIVE DIRECTOR Dr. Dupont is a renowned expert in the fields of cell therapy and oncology, with long-standing and For personal use only deep experience in developing therapies and programs dedicated to addressing high unmet medical needs. Dr. Dupont serves as Global Head of
Slide 8: Immunotherapy Is a Pillar in Cancer Care
IMMUNOTHERAPY IS A PILLAR IN CANCER CARE Immunotherapy stimulates a patient’s own immune system to fight cancer For personal use only CANCER CARE TARGETED THERAPY IMMUNOTHERAPY CHEMOTHERAPY RADIOTHERAPY MOLECULARLY CYTOTOXIC SURGERY Ancient Times – Present 1890s - Present 1940s - Present 1990s - Pre
Slide 9: First Immune Checkpoint Inhibitors Were Approved in 2014 for Melanoma
FIRST IMMUNE CHECKPOINT INHIBITORS WERE APPROVED IN 2014 FOR THE TREATMENT OF MELANOMA For personal use only 33 16 21 11 Approvals Types of advanced Approvals Types of advanced cancers cancers While highly successful in some patients, not all respond to immune checkpoint therapy https://www.opdivohc
Slide 10: Immunotherapy Unleashes the Immune System to Fight Cancer
IMMUNOTHERAPY UNLEASHES THE IMMUNE SYSTEM TO FIGHT CANCER For personal use only Cellular Therapy Transfer of human cells to find and fight cancer (CAR-T) or replace diseased cells Medications that regulate and boost part of the immune system (ex, Immunomodulators immune checkpoint inhibitors) Modifi
Slide 11: CAR-T Therapy Successes in Hematological Malignancies
CAR-T THERAPY SUCCESSES IN HEMATOLOGICAL MALIGNANCIES For personal use only FIRST FDA APPROVED OVERALL BRAND COMPANY APPROVAL CANCERS RESPONSE RATE 2017 3 53-86% 2017 3 72-91% 2020 2 65*-87% 2021 1 73-87% 2021 1 72% 2022 1 98% https://www.hcp.novartis.com/products/kymriah/; *Overall complete remissi
Slide 12: Mechanism of Action: How Does It Work?
MECHANISM OF ACTION: HOW DOES IT WORK? onCARlytics makes For personal use only solid tumors “seen” by CD19 targeting therapies 1. OnCARlytics infects Tumor cells 2. Virus replication and production of CF33-CD19 on the cell surface enabling CD19 cell targeting 3. Tumor cell lysis leads to viral parti
Slide 13: 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 of The City of Hope Dept of Surgery is an internationally recognized expert in liver For personal use only and pancreatic cancer. He has developed many new surgical t
Slide 14: CF33 Oncolytic Virus
For personal use only CF33 Oncolytic Virus
Slide 15: Oncolytic Viruses Offer a Selective Immunogenic Approach to Kill Tumor Cells
ONCOLYTIC VIRUSES OFFER A SELECTIVE IMMUNOGENIC APPROACH TO EFFECTIVELY KILL TUMOR CELLS For personal use only HOW A VIRUS KILLS A CELL Step 1: Step 2: Step 3: Virus enters Virus duplicates Cell explodes, cell itself releasing thousands of brand new virus particles Engineering enhancements Multiple
Slide 16: Safely Delivered Routes: IT, IP, IV
SAFELY DELIVERED ROUTES: IT, IP, IV ENABLES LARGE THERAPEUTIC INDEX IN PATIENTS For personal use only No toxicity across tumor models in over 1,000 mice until over 109 Tumor restricted viral delivery # OF VIRUS MOUSE DOSE DELIVERY TOXICITY MICE CF33-NIS Nude 73 1e3-1e5 IT No findings CF33-miR Nude 4
Slide 17: CF33-hNIS: Tumor Tracking and Tropism
CF33-hNIS: TUMOR TRACKING AND TROPISM For personal use only Genetic modification enables tumor tracking and tumor tropism • hNIS (human sodium iodide 124I PET Imaging of CF33-hNIS-infected HCT116 (colon cancer) from symporter) protein is expressed on the tumor cell surface flank xenografts in nude m
Slide 18: CHECKvacc Phase 1 TNBC Study
CHECKvacc PHASE 1 TNBC STUDY CF33+hNIS+aPD-L1 (“Armed” Virus) For personal use only Presented at SABC 2022 COHORT 8 | 3-6 PATIENTS Identify: Metastatic Triple Negative Breast … Recommended Phase 2 Dose (RP2D) RP2D Expansion Cancer Based on: COHORT 2 | 3-6 PATIENTS 12 Patients • Safety - 2 prior line
Slide 19: CHECKvacc (CF33-hNIS-antiPD-L1) hNIS Tumor Tracking
CHECKvacc (CF33-hNIS-antiPD-L1) hNIS TUMOR TRACKING For personal use only hNIS 99m uptake in SPECT scan SPECT imaging of patient using Technetium- 99m (C1D8): Patient COH-004 received CHECKvacc at Dose Level 2 (3x105 PFU). Injected lesion was left axilla showed significant enhancement of injected ly
Slide 20: CHECKvacc: Infection Leads to Anti-Cancer Immunologic Changes
CHECKvacc (CF33-hNIS-antiPD-L1) INFECTION LEADS to ANTI-CANCER IMMUNOLOGIC CHANGES For personal use only A B C Multiplex immunofluorescence (mIF) of COH – 004 Multi-color immunohistochemistry tumor: C&D immune infiltrates shows increase density demonstrating not only expression of PD- of PD – L1+ ce
Slide 21: VAXINIA Phase 1 MAST Study
VAXINIA PHASE 1 MAST STUDY (Metastatic Advanced Solid Tumors) First Patient Enrolled for IT and IV combination in March 2023 For personal use only Dose Administration VAXINIA Monotherapy VAXINIA + Pembrolizumab Cohort Expansion (Parallel Groups) Dose Escalation Combination Dose Escalation* n=52-100
Slide 22: CF33-CD19
For personal use only CF33-CD19
Slide 23: The Cell Therapy Solid Tumor Challenge & Imugene's Solution
THE CELL THERAPY SOLID TUMOR CHALLENGE & IMUGENE’S SOLUTION For personal use only Cell therapy, including Chimeric Antigen Receptor (CAR) T cell therapy, has had limited activity in solid tumors, largely due to a lack of IMUGENE’S APPROACH selectively and highly expressed surface antigens, such as t
Slide 24: How Does the CD19 Oncolytic Virus Work?
HOW DOES THE CD 19 ONCOLYTIC VIRUS WORK? €D19 ONCOLYTIC VIRUS ‘5 CANCER CELL CANCER CELL 1. 2. 3. 4. CD19 ONCOLYTIC VIRUS CD19 ONCOLYTIC VIRUS CAUSES CD19 CAR-T CELL RECOGNISE CANCER CELL INFECTS SOLID CANCER THE SOLID CANCER TO GROW > THE CD19 FLAGS AND » DIES “CD 19 FLAGS" ATTACKS THE CANCER CELL
Slide 25: onCARlytics Delivers Targets to Targetless Solid Tumors
onCARLYTICS DELIVERS TARGETS TO “TARGETLESS” SOLID TUMORS For personal use only Combination of onCARlytics (CF33-CD19) and CD19-CAR T cells promotes tumor regression in xenograft model of TNBC i.t.10M i.t. 5M Mock or pfu OV19t CD19-CAR T cells s.c. MDA-MB-468 onCARlytics (CF33-CD19) infects a wide a
Slide 26: onCARlytics Combination with CD19 Targeting Therapies
onCARLYTICS COMBINATION WITH CD19 TARGETING THERAPIES Collaboration with Celularity, Eureka and Arovella for combination with onCARlytics For personal use only AUG 2021 NOV 2021 SEP 2022 Strategic Strategic Strategic Partnership Partnership Partnership with Celularity with Eureka with Arovella Allog
Slide 27: Investment Highlights
INVESTMENT HIGHLIGHTS MARKET For personal use only 9th March 2023 A$835M CASH AS OF 31st December 2022 A$162M CAPITALISATION CF33 B-Cell CHECKvacc Oncolytic Virus onCARlytics Immunotherapies DISEASE AREAS HER-Vaxx 3 Breast (TNBC) PLATFORM Lung (NSCLC) TECHNOLOGIES Gastric VAXINIA CF33-CD19 Gastroeso
Slide 28: Value Inflection Points Expected in the Next Months
VALUE INFLECTION POINTS EXPECTED IN THE NEXT 12 MONTHS For personal use only VAXINIA MAST: Combination OBD IV onCARlytics FPI HER - Vaxx neoHERIZON: FPI RECENTLY ACHIEVED VAXINIA MAST: Combination FPI IT and IV HER - Vaxx nextHERIZON: Interim Data Readout VAXINIA MAST: IV Cohort 2 Cleared VAXINIA MA
Slide 29: International Leadership Team with Extensive Commercialisation Expertise
INTERNATIONAL LEADERSHIP TEAM WITH EXTENSIVE COMMERCIALISATION EXPERTISE IN THE SECTOR For personal use only Leslie Chong Paul Hopper Charles Walker Dr Lesley Russell Dr Jens Eckstein Dr Jakob Dupont SYDNEY, AU SYDNEY, AU PHILADELPHIA, USA CAMBRIDGE, USA CALIFORNIA, USA BRISBANE, AU Managing Directo
Slide 30: Imugene's Management Team
IMUGENE’S MANAGEMENT TEAM Experienced management team with significant clinical development expertise For personal use only Leslie Chong Dr Nick Ede Dr Giovanni Dr Monil Shah Mike Tonroe Paul Wright Ursula McCurry Chief Executive Chief Technology Selvaggi Chief Business Chief Financial Officer VP of
Slide 31: Imugene Scientific Advisory Board
IMUGENE SCIENTIFIC ADVISORY BOARD For personal use only Dr Prasad Adusumilli Dr Rebecca Auer Prof Tanios BekaiI Saab Prof Pravin Kaumaya Prof Yuman Fong Dr Yelina Janjigian Memorial Sloan Kettering University of Ottawa, CAN Mayo Clinic, USA Ohio State University, USA City of Hope, USA Memorial Sloan
Slide 32: Contact
For personal use only CONTACT shareholderenquiries@imugene.com www.imugene.com ASX: IMU