Imugene Ltd · ASX:IMU
Imugene — Investor Presentation (January 2018)
34 slides from Imugene's investor presentation, Jan 9, 2018
Slide 1: Mimotope Induced B-Cell Antibodies for Immuno-Oncology
ASX:IMU For personal use only v MIMOTOPE INDUCED B-CELL ANTIBODIES FOR IMMUNO-ONCOLOGY Leslie Chong | Chief Executive Officer January/2018
Slide 2: Notice: Forward Looking Statements
NOTICE: FORWARD LOOKING STATEMENTS For personal use only Any forward looking statements in this presentation have been prepared on the basis of a number of assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about future events are subject to risks, unce
Slide 3: Executive Summary
EXECUTIVE SUMMARY For personal use only • Experienced management & board • Novel oncology platforms: Mimotopes: B cell peptide vaccines – IP protected to 2036 • Lead mimotope: HER-Vaxx Phase 1b/2 mimotope study in Her2+ gastric cancer (large unmet medical need by current existing therapies) • POC de
Slide 4: What Does Imugene Do?
WHAT DOES IMUGENE DO? For personal use only Imugene’s technology can induce a patient’s body v to make its own specific antibodies that target cancer. 4
Slide 5: A Team with Track Record in Drug Development
A TEAM WITH TRACK RECORD IN DRUG DEVELOPMENT Leslie Chong (Sydney, Australia) Prof Ursula Wiedermann (Vienna, Austria) For personal use only Chief Executive Officer Chief Scientific Officer • Over 19 years of oncology experience in Phase I - III of • Co-inventor of HER-Vaxx; clinical program develop
Slide 6: A Better Way to Make Antibodies to Treat Cancer?
A BETTER WAY TO MAKE ANTIBODIES TO TREAT CANCER? For personal use only IN A FACILITY USING B CELLS IN YOUR OWN BODY B Cells are cells in the human VSv body that naturally produce millions of antibodies Teaching B cells to make antibodies For example, Roche’s Herceptin using peptide mimotopes 6
Slide 7: Novel Mimotope Peptide Programs
NOVEL MIMOTOPE PEPTIDE PROGRAMS For personal use only • A mimotope is a small molecule, often a peptide, which mirrors the structure of an epitope, the specific target an Peptides identified antibody binds to. via computer aided • Because of this property, the mimotope induces an programs: HER-Vaxx
Slide 8: Mimotope: Platform Technology
MIMOTOPE: PLATFORM TECHNOLOGY SELECTION OF MIMOTOPES CREATION OF A VACCINE IMMUNIZATION ENDOGENOUS AB PRODUCTION For personal use only A library of mimotopes The selected mimotope or Immunization with the Successful delivery will result in can be interrogated with mimotopes can be used in peptide wi
Slide 9: Advantages of Mimotope Induced B-Cell Based Antibodies v. Synthetic Antibodies
ADVANTAGES OF MIMOTOPE INDUCED B-CELL BASED ANTIBODIES V. SYNTHETIC ANTIBODIES For personal use only Issue Natural B Cell Derived Antibodies Monoclonal Antibodies Safety Stimulates the immune system to produce natural Synthetic Ab, with side effects (including ventricular Abs, potentially safer, as
Slide 10: The Monoclonal Antibody (mAb) Market
THE MONOCLONAL ANTIBODY (mAb) MARKET For personal use only • Multiple antibody therapies are approved to treat cancer, for example: Sales in 2016 - Herceptin: >US$6.7 billion - Perjeta: >US$1.8 billion - Rituxan: >US$7.3 billion - YERVOY®: >US$1.0 billion - OPDIVO®: >US$3.7 billion - KEYTRUDA: >US$1
Slide 11: HER-Vaxx Mimotope: Mechanism of Action
HER-Vaxx MIMOTOPE: MECHANISM OF ACTION For personal use only Peptides “mimic” the HER-Vaxx epitope Antibody Secretion Tumor Cell 3 B-cell HER-2/neu EPITOPE = Peptides v Activation Antibody Via helper T- Binding Site cells B-Cell HER-Vaxx attacks the same target as the HER-Vaxx the world’s largest Im
Slide 12: HER-Vaxx Is a Phase 1b/2 Stage Mimotope Peptide Therapy for HER2+ Gastric Cancer
ASX:IMU For personal use only v HER-Vaxx IS A PHASE 1B/2 STAGE MIMOTOPE PEPTIDE THERAPY BEING DEVELOPED FOR HER2+ GASTRIC CANCER 12
Slide 13: Phase 1 in Breast Cancer, Completed at Medical University of Vienna
PHASE 1 IN BREAST CANCER, COMPLETED AT MEDICAL UNIVERSITY OF VIENNA- SINGLE AGENT, NO CHEMO For personal use only DESIGN *RESULTS CLINICAL ENDPOINTS • 10 patients • Patients developed anti-HER-2 antibodies 1 Safety and Tolerability • All late stage breast cancer • Induction of cytokines (Th1 biased;
Slide 14: HER-Vaxx Inhibits HER-2 Expressing Cells
HER-VAXX INHIBITS HER-2 EXPRESSING CELLS HER-Vaxx antibodies demonstrate anti-tumour effect Combination with Herceptin shows significantly For personal use only by inhibiting validated HER-2+ gastric cell line higher inhibition than Herceptin alone. Percentage of Inhibition Percentage of Inhibition
Slide 15: Phase 1b/2 Enhanced Gastric Formulation
PHASE 1B/2 ENHANCED GASTRIC FORMULATION For personal use only Her-2/neu specific IgG kinetic, after last immunization 1.60 3 w. after 3 doses vacc. 1.40 1.14 1.18 8 w. after 3 doses vacc. 1.20 1.00 0.94 OD 0.89 0.84 0.80 0.81 16 w. after 3 doses 0.73 0.80 0.67 0.63 0.62 v vacc. 0.60 6 mo. after 3 do
Slide 16: Phase 1b/2 in Gastric Cancer
PHASE 1B/2, IN GASTRIC CANCER Phase 1b lead-in Phase 2 For personal use only • Open label • Open label • ~70 patients from sites in Asia • ~Up to 18 patients in 3 cohorts of up to 6 pts per cohort • Combination with chemo • Combination with chemo/cisplatin • Randomized • Primary Endpoints: • Endpoin
Slide 17: Our Investigators and Study Centers
OUR INVESTIGATORS AND STUDY CENTERS For personal use only CHINA THOMAS YAU YEE CHAO Taipei Veterans Queen Mary Hospital General Hospital The University of Hong Kong) MYANMAR TAIWAN CHAIYUT CHIA-JUI YEN National Cheng CHAROENTUM LAOS Kung University Maharaj Nakorn Hospital Chiang Mai Hospital JEDZADA
Slide 18: Gastric Market Opportunity
GASTRIC MARKET OPPORTUNITY For personal use only • Asia is the largest market for gastric cancer globally • Gastric cancer is the second leading cause of cancer mortality in the world & its management, especially in advanced stages, has evolved Chemotherapy relatively little • ~1 million gastric can
Slide 19: Market Opportunity
MARKET OPPORTUNITY Indications Gastric Cancer Breast Cancer For personal use only 1 million cases of newly diagnosed cases, 1.67m cases of newly diagnosed cases; Incidence ~190k are HER2+* ~418k are HER2+* Varies in breast cancer type. 0.5m Prognosis Poor. Median survival is 7-10 months deaths per y
Slide 20: Imugene Pipeline
IMUGENE PIPELINE For personal use only HER-Vaxx (IMU-131) Discovery Pre-Clinical Phase IB Phase 2 Open Label Randomized, Chemotherapy Controlled Study in Gastric Cancer + or - HER-Vaxx *Combination Study in breast HER-Vaxx + cancer Herceptin *Herceptin Resistant/Failed Study HER-Vaxx + Chemotherapy
Slide 21: Mimotope B-Cell Peptide Therapy
ASX:IMU For personal use only v MIMOTOPE B-CELL PEPTIDE THERAPY 21
Slide 22: Mimotope Proposed Development Path 2017-2018
MIMOTOPE PROPOSED DEVELOPMENT PATH 2017-2018 2H, 2018:Toxicology, For personal use only 2H, 2018: GMP Mimotope #1: 1H, 18:Formal pre- immunotox, safety manufacturing clinical pharmacology candidate 1H, 2018: CMC Identified manufacturing v Proposed Phase l Expansions Assumption Mimotope #1 Design Coh
Slide 23: Imugene Discovery Pipeline
For personal use only IMUGENE DISCOVERY PIPELINE MIMOTOPE IMMUNE ID OF PROGRAM PRE-IND WORK CLINICAL DEVELOPMENT IDENTIFICATION CHARACTERIZATION CANDIDATE HER-Vaxx /Her2 Combo *Mimotope #2 *Mimotope #3 v Her2 / *Mimotope Combo Combo #3? TBD 23
Slide 24: Financial Summary
FINANCIAL SUMMARY ASX:IMU Top 5 shareholders (as at Dec. 2017) For personal use only Market Cap No. of Shares % Capital $42.8M AUD, $33.3M USD (28/Dec/17) Platinum Asset Ordinary Shares 2.855 billion 276,874,515 9.70% Management 12 month price National Nominees 1.2 cents – 2.8 cents AUD 125,895,033
Slide 25: Executive Summary
EXECUTIVE SUMMARY For personal use only • Experienced management & board • Novel oncology platforms: Mimotopes: B cell peptide vaccines – IP protected to 2036 • Lead mimotope: HER-Vaxx Phase 1b/2 mimotope study in Her2+ gastric cancer (large unmet medical need by current existing therapies) • POC de
Slide 26: Appendix
26 For personal use only ASX:IMU v APPENDIX
Slide 27: Phase 1a Study Design
PHASE IA STUDY DESIGN* For personal use only ADMINISTRATION & READOUT SCHEDULE Patient inclusion criteria • Metastatic breast cancer • HER2 +, ++ • ER/PR pos. • Life expectance > 4 mo v Primary endpoint D0 D28 D56 D84 • Safety & Tolerability Secondary endpoint Vaccination with 10µg • Immunogenicity
Slide 28: Patient Characteristics – Ages 55-84
PATIENT CHARACTERISTICS – AGES 55-84 * For personal use only Patient ID Age Metastatic disease since Prior chemotherapy Current antihormonal therapy 1 55 Oct. 2006 no Anastrozol 2 66 May 2004 yes (1 adj) Fulvestrant 3 84 Mar. 1999 no Anastrozol 4 79 Sept. 2003 no Anastrozol 5 67 Apr. 2004 no Fulvest
Slide 29: Safety and Tolerability – Few Grade 1 Local Reactions, None Systemic
SAFETY AND TOLERABILITY – FEW GRADE 1 LOCAL REACTIONS, NONE SYSTEMIC* For personal use only Patient ID Local vaccination reaction grade Systemic grade 3/4 toxicity 1 1 no 2 0 no 3 0 no 4 1 no 5 1 v no 6 0 no 7 0 no 8 0 no 9 1 no 10 0 no * Breast Cancer Res Treat. 2010 Feb;119(3):673-83. 29
Slide 30: Phase 1 Secondary Endpoint – Immunologic Responses
PHASE 1 SECONDARY ENDPOINT – IMMUNOLOGIC RESPONSES For personal use only Western blot analysis demonstrating increase of Her-2/neu-specific IgG post- vaccination in patient: ANTIBODY (lane 1) Polyclonal rabbit anti Her-2/neu antibody was used as positive control RESPONSES (lane 2) serum of a healthy
Slide 31: Phase 1 – Reduction in Regulatory T Cells
Cancer PatientsPhase vs. Healthy Controls I - Regulatory T cells: Cancer Patients vs. Healthy Controls REDUCTION IN REGULATORY T CELLS* For personal use only p=0.033 pre-vaccination post-vaccination p=0.033 pre-vaccination post-vaccination CD4+Foxp3+ Data.026 CD4+Foxp3+ Data.026 10.0 p=0.007 p=0.007
Slide 32: Encouraging Immunogenicity, Even at Low Dose, with No Cardiotoxicity
ENCOURAGING IMMUNOGENICITY, EVEN AT LOW DOSE, AND IN PATIENTS AGES UP TO 84 YEARS, WITH NO CARDIOTOXICITY For personal use only Antibody and cellular responses in human Pat. # Peptide-specific ab P4, P6, P7 HER2- specific ab Infl. HIT IL-2, IFNγ, TNF T reg • Immunogenicity in 8/10 patients in Phase
Slide 33: Tumor Growth Inhibition In Vivo
TUMOR GROWTH INHIBITION IN VIVO* Time to disease progression For personal use only • Prolonged time to Cumulative proportion tumor-free Untreated Tentanus toxoid disease progression Peptide Peptide + IL12 • Immunization of c-neu transgenic mice IL12 (recognized HER2 cancer model) with tetanus toxoid
Slide 34: Leslie Chong, Chief Executive Officer
For personal use only Leslie Chong Chief Executive Officer leslie.chong@imugene.com v +61 458 040 433