Imugene Ltd · ASX:IMU
Imugene — NWR Healthcare Conference 2023
34 slides from Imugene's conference presentation, Mar 22, 2023
Slide 1: Developing Cancer Immunotherapies
For personal use only ASX: IMU Developing Cancer Immunotherapies NWR Healthcare Conference March 22, 2023 Release authorised by the Managing Director and Chief Executive Officer Imugene Limited.
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: 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 5: Imugene's deep immunotherapy pipeline for the treatment of solid tumors
IMUGENE’S DEEP IMMUNOTHERAPY PIPELINE FOR THE TREATMENT OF SOLID TUMORS PROGRAM/ COMBINATION FDA 2023 EXPECTED For personal use only PLATFORM TARGET APPROACH INDICATION IND PRECLINICAL IND PHASE 1 PHASE 2 MILESTONES onCARlytics CD19 targeted Metastatic (CF33-CD19) therapies Solid Tumors PHASE 1 FDA
Slide 6: CF33 Oncolytic Virus
For personal use only CF33 Oncolytic Virus
Slide 7: 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 8: CF33-hNIS: tumor tracking and tropism
CF33-hNIS: TUMOR TRACKING AND TROPISM Genetic modification enables tumor tracking and tumor tropism • hNIS (human sodium iodide symporter) protein is expressed on the tumor cell surface For personal use only • hNIS transgene inserted within J2R locus (Tk) to transport radioactive iodine for imaging
Slide 9: 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 10: CHECKvacc (CF33-hNIS-antiPD-L1) tumor tracking
CHECKvacc (CF33-hNIS-antiPD-L1) TUMOR TRACKING For personal use only • hNIS 99m uptake in SPECT scan • Immune activation- increase in PD-L1 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 sig
Slide 11: 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 12: CF33-CD19
For personal use only CF33-CD19
Slide 13: The cell therapy solid tumor challenge and 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 14: 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 15: 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 16: Published front cover of Science Translational Medicine journal in 2020
PUBLISHED FRONT COVER OF SCIENCE TRANSLATIONAL MEDICINE JOURNAL IN 2020 For personal use only Effective combination immunotherapy using oncolytic viruses to deliver CAR targets to solid tumors Park AK, Fong Y, Kim SI, Yang J, Murad JP, Lu J, Jeang B, Chang WC, Chen NG, Thomas SH, Forman SJ, Priceman
Slide 17: 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 18: HER-Vaxx
For personal use only HER-Vaxx
Slide 19: B cell based antibodies have distinct competitive advantages to existing treatments
B CELL BASED ANTIBODIES HAVE DISTINCT COMPETITIVE ADVANTAGES TO EXISTING TREATMENTS For personal use only B cell vaccines offer a unique opportunity to intervene at multiple points in the immune system and create immune memory which NATURAL B CELL MONOCLONAL ANTIBODIES enhances durability of respons
Slide 20: HERIZON Phase 1b/2 study
HERIZON HERIZON Phase PHASE 1B/2 1b/2 MULTICENTER OPEN LABEL, open label,STUDY 20 multicenter study For personal use only PATIENTS 50 µg HER-Vaxx (IMU-131) + TREAT • Treatment- • HER-2 +++ SOC Chemo x 6 UNTIL PD FOLLOW- naive stage or HER-2++ UP III/IV GC FISH/CISH+ve RANDOMISE 1:1 FOR OS Stratified
Slide 21: HER-Vaxx significantly prolongs overall survival in 1L HER-2+ gastric cancer
HER-Vaxx SIGNIFICANTLY PROLONGS OVERALL SURVIVAL IN 1L PATIENTS WITH HER-2+ GASTRIC CANCER For personal use only 100 HER-Vaxx + Chemotherapy 90 HER-Vaxx+Chemo Chemotherapy 14.0 months 80 (11.1, 14.3) Sample Size 19 17 70 Overall Survival (%) Events 15 17 60 Median OS 14.0 months 8.3 months 50 (2-sid
Slide 22: HERIZON in the news!
HERIZON IN THE NEWS ! For personal use only
Slide 23: HER-Vaxx Studies
For personal use only HER-Vaxx Studies
Slide 24: HER-Vaxx Phase 2: nextHERIZON in metastatic gastric cancer
HER-Vaxx PHASE 2: nextHERIZON IN METASTATIC GASTRIC CANCER AFTER PROGRESSION ON TRASTUZUMAB For personal use only TRIAL PATIENTS STUDY ENDPOINTS • Phase 2 • > 1L • Non-Randomised Primary • Open label • Advanced or metastatic • HER-Vaxx in combination • Objective Response Rate • USA, Australia, Asia
Slide 25: HER-Vaxx Phase 2: neoHERIZON in resectable gastric cancer
HER-Vaxx PHASE 2: neoHERIZON IN RESECTABLE GASTRIC CANCER For personal use only TRIAL PATIENTS STUDY ENDPOINTS • Phase 2 • Neoadjuvant Gastric • Arm 1 – FLOT + HER-Vaxx Primary • Open label Cancer • Arm 2 – FLOT + Avelumab + • Pathological Complete Response • Randomised • HER-2+++/HER-2++ HER-Vaxx S
Slide 26: PD1-Vaxx
For personal use only PD1-Vaxx
Slide 27: IMPRINTER: PD1-Vaxx NSCLC Phase 1 study design
IMPRINTER: PD1-Vaxx NSCLC PHASE 1 STUDY DESIGN Phase 1: PD1-Vaxx Monotherapy Dose Escalation & Expansion For personal use only 2L+ NSCLC Progressed on/after ICI MONOTHERAPY Cohort 1 Cohort 2 Cohort 3 Expansion 10 µg 50 µg 100 µg mOBD OBD PD1-Vaxx PD1-Vaxx PD1-Vaxx PD1-Vaxx n = 3-6 n = 3-6 n = 3-6 n
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: Financial summary
FINANCIAL SUMMARY PUBLIC MARKET OVERVIEW (March 21, 2023) SHARE PRICE PERFORMANCE For personal use only Share Price A$0.13 52 week range A$0.12 - A$0.32 Market Capitalisation1 A$835M Cash equivalents (31 December A$162M ‘22) Enterprise Value A$673M TOP 5 SHAREHOLDERS (as at March 21, 2023) JP Morgan
Slide 30: Investment highlights
INVESTMENT HIGHLIGHTS MARKET For personal use only CAPITALISATION 21st March 2023 A$835M CASH AS OF 31st December 2022 A$162M CF33 B-Cell CHECKvacc Oncolytic Virus onCARlytics Immunotherapies DISEASE AREAS HER-Vaxx 3 Breast (TNBC) PLATFORM Lung (NSCLC) TECHNOLOGIES Gastric VAXINIA CF33-CD19 Gastroes
Slide 31: Contact
Contact For personal use only shareholderenquiries@imugene.com www.imugene.com ASX: IMU
Slide 32: International leadership team with extensive commercialisation expertise
INTERNATIONAL LEADERSHIP TEAM WITH EXTENSIVE COMMERCIALISATION EXPERTISE IN THE SECTOR Imugene has a team with oncology drug development experience 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
Slide 33: 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 34: 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