Imugene Ltd · ASX:IMU
Imugene — JP Morgan Healthcare Conference 2023
38 slides from Imugene's conference presentation, Jan 9, 2023
Slide 1: Developing Cancer Immunotherapies
For personal use only ASX: IMU Developing Cancer Immunotherapies JP Morgan, January 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: Experienced Management Team with Significant Clinical Development Expertise
EXPERIENCED MANAGEMENT TEAM WITH SIGNIFICANT CLINICAL DEVELOPMENT EXPERTISE For personal use only Leslie Chong Dr Giovanni Dr Monil Shah Chief Executive Selvaggi, MD Chief Business Officer & Managing Director Chief Medical Officer Officer 4
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 Granted in IP TO 203
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: CF33 Oncolytic Virus
For personal use only CF33 Oncolytic Virus
Slide 8: 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 9: Major Advantages of VAXINIA CF33
MAJOR ADVANTAGES OF VAXINIA CF33 For personal use only Highly potent cancer killing Robust Efficacy Converts ‘cold’ tumors to responsive ‘warm’ tumors Direct intra-tumor and systemic anti-tumor activity Large therapeutic window Well-Tolerated Genetically stable Combinability with targeted therapies
Slide 10: CF33 Generation & Evaluation of Novel Chimeric Poxviruses
CF33 GENERATION & EVALUATION OF NOVEL CHIMERIC POXVIRUSES S T R AT E GY For personal use only VIRUS 1 VIRUS 2 …VIRUS 9 Engineer Novel Chimeric Viruses High Through-put Screening for Efficacy Against NCI60 Safe in Animals • Infection by 9 different pox vaccinia vaccine strains trading Arming with Add
Slide 11: Compelling Killing of Many Tumor Types at Low Doses
COMPELLING KILLING OF MANY TUMOR TYPES AT LOW DOSES For personal use only 11
Slide 12: 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 13: 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 14: 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 15: 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 16: VAXINIA Phase 1 MAST Study
VAXINIA PHASE 1 MAST STUDY (Metastatic Advanced Solid Tumors) For personal use only First Patient Enrolled May 2022, IV Cohort 1 Cleared Nov 2022 Dose Administration VAXINIA Monotherapy VAXINIA + Pembrolizumab Cohort Expansion (Parallel Groups) Dose Escalation Combination Dose Escalation* n=52-100 I
Slide 17: CF33-CD19
For personal use only CF33-CD19
Slide 18: 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 19: 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 20: 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 21: 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 22: 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 23: HER-Vaxx
For personal use only HER-Vaxx
Slide 24: B Cell Based Antibodies Have Distinct Competitive Advantages
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 25: HER-Vaxx: B-Cell Immunotherapy Vaccine Against HER-2
HER-Vaxx: B-CELL IMMUNOTHERAPY VACCINE AGAINST HER-2 For personal use only • B-cell cancer vaccine designed to stimulate a patient’s own immune system to repeatedly target the HER-2+ cancer with HER-2 directed antibodies • Stimulates a patient’s B cells to produce polyclonal antibodies that target c
Slide 26: HERIZON Phase 1b/2 Multicenter Open Label Study
HERIZON HERIZON Phase PHASE 1B/2 1b/2 MULTICENTER OPEN LABEL, open label,STUDY 26 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 27: 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 13.9 months 80 (7.5, 14.3) Sample Size 19 17 70 Overall Survival (%) Events 15 17 60 Median OS 13.9 months 8.3 months 50 (2-side
Slide 28: HER-Vaxx Phase 2: HERIZON Safety
HER-Vaxx PHASE 2: HERIZON SAFETY TREATMENT EMERGENT ADVERSE EVENTS For personal use only HER-Vaxx + CHEMOTHERAPY CHEMOTHERAPY ONLY ( N =1 9) ( N =1 7) n (%) n (%) Patients with at 18 (94.7%) 16 (94.1%) least one TEAE Grade 1 / 2 10 (52.6%) 9 (52.9%) Grade > 3 8 (42.1%) 7 (41.2%) Serious AE* 2 (10.5%
Slide 29: HER-Vaxx Phase 2: HERIZON HER-2 Antibody Levels Per Patient
HER-Vaxx PHASE 2: HERIZON HER-2 ANTIBODY LEVELS PER PATIENT For personal use only HER2-Specific IgG by Treatment Assignment and Study Visit - Logarithmic Scale 1,000,000 100,000 Anti-HER2 IgG Antibody Level (ng/ml) 10,000 1,000 IMU-131 PLUS HER-Vaxx PLUS CHEMOTHERAPY CHEMOTHERAPY CHEMOTHERAPY CHEMOT
Slide 30: nextHERIZON in Metastatic Gastric Cancer After Progression on Trastuzumab
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 31: 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 32: PD1-Vaxx
For personal use only PD1-Vaxx
Slide 33: PD1-Vaxx Stops Cancer Cells from Using PD1 to Stay Undetected
PD1-VAXX STOPS CANCER CELLS FROM USING PD1 TO STAY UNDETECTED BY THE IMMUNE SYSTEM For personal use only PD-L1 binding to PD-1 prevents T cell PD1-Vaxx stops cancer cells from staying recognition and killing of cancer cells undetected by T cells 2 P D 1 - VAXX B cell vaccine ANTI PD-1 pAb Anti-PD1 p
Slide 34: 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 35: Value Inflection Points Expected in the Next Months
VALUE INFLECTION POINTS EXPECTED IN THE NEXT 12 MONTHS For personal use only TECHNOLOGY MILESTONE VAXINIA MAST: Combination OBD IV onCARlytics FPI HER-Vaxx neoHERIZON: FPI HER-Vaxx nextHERIZON: Interim Data Readout VAXINIA MAST: Optimal Biological Dose (Monotherapy IV and/or IT) HER-Vaxx neoHERIZON:
Slide 36: Financial Summary
FINANCIAL SUMMARY PUBLIC MARKET OVERVIEW (January 4, 2023) SHARE PRICE PERFORMANCE For personal use only Share Price A$0.155 52 week range $0.13 - $0.43 Market Capitalisation1 A$995M Cash equivalents (30 September A$164M ‘22) Enterprise Value A$831M TOP 5 SHAREHOLDERS (as at January 4, 2023) JP Morg
Slide 37: Investment Highlights
INVESTMENT HIGHLIGHTS For personal use only MARKET CAPITALISATION 4th Jan 2023 A$995M CASH AS OF 30th Sep 2022 A$164M CF33 B-Cell CHECKvacc Oncolytic Virus onCARlytics Immunotherapies DISEASE AREAS HER-Vaxx 3 Breast (TNBC) PLATFORM Lung (NSCLC) TECHNOLOGIES Gastric VAXINIA CF33-CD19 Gastroesophageal
Slide 38: Contact
Contact For personal use only shareholderenquiries@imugene.com www.imugene.com ASX: IMU