July 2014 Immunovaccine Inc. (TSX-V: IMV) Targeted T cell Activation Immunotherapies FORWARD-LOOKING STATEMENTS This document contains forward-looking information pursuant to applicable securities law. All information that addresses activities or developments that we expect to occur in the future are forward-looking statements. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. However, they should not be regarded as a representation that any of the plans or objectives will be achieved. Actual results may differ materially from those expressed or implied by the forward-looking information set forth in this document due to risks and uncertainties affecting the Company, including access to capital, the successful completion of clinical trials and receipt of all regulatory approvals. The forward-looking statements in this document are based on a number of assumptions which may prove to be incorrect, including assumptions concerning general business and economic conditions, positive clinical trials and the availability of financing. Immunovaccine assumes no responsibility to update forward-looking statements in this document. Additional information about Immunovaccine, including risks and uncertainties that could cause actual results to differ from those implied or inferred from any forward-looking statements in this presentation, are contained in our various securities filings, including our current Annual Information Form, as well as our audited annual consolidated financial statements which are available on SEDAR at www.sedar.com. 2 IMMUNOVACCINE SNAPSHOT A vaccine platform technology company with a product pipeline Capitalizing on the potential of DPX-Survivac in cancer immunotherapy Diversifying by pursuing select applications and licensing opportunities Moving rapidly toward mid-stage clinical development 3 CANCER IMMUNOTHERAPY- “BREAKTHROUGH OF THE YEAR” • Intra-tumoral T cell infiltration is an established positive prognostic marker for increased overall survival in cancer patients • Dramatic clinical responses achieved with T cell activation therapies – Checkpoint inhibitors “taking the brakes off” T cells – T cells Engineered to “home” to cancer • Cancer immunotherapies including vaccines: – To become treatment of choice for up to 60% of cancers – To exceed $35 billion/ year in the next decade 4 EVOLUTION OF CANCER IMMUNOTHERAPIES 2020 – Global immunotherapy market forecasted to reach $35 billion (Andrew Baum, Citigroup) June 2, 2014 – GSK focuses on immuno oncology, deal with Adaptimmune for $ 350 million April 21, 2014 – Company: Pfizer attempts its first bid for AstraZeneca for $101 billion (cancer immunotherapy pipeline) September 11, 2013 – Company: Pfizer – Sets its sight on therapeutic cancer vaccines. October 3, 2013 – Company: Roche – Targets Cancer Vaccine Partnerships. November 13, 2013 – Company: Roche – Deal with Immatics for antigen discovery, $17 million upfront, research costs and up to $1B in milestones and royalties. October 3, 2013 – Company: Janssen (Johnson & Johnson) Research and option agreement with DCPrime BV to develop novel dendritic cell-based cancer vaccines. 2010 - $1.6 billion global cancer vaccine market 5 CANCER IMMUNOTHERAPY OPPORTUNITY DPX-SURVIVAC 6 DPX-SURVIVAC- THERAPEUTIC VACCINE PRODUCING SURVIVIN SPECIFIC T CELLS • Applicable to a wide range of solid tumors and hematological malignancies • Entering multiple phase 2 studies including a large, randomized, controlled Phase 2 trials in ovarian cancer with NCIC • Exploring combination trials with compounds such as Anti-PD-1 • Strong Phase 1 antigen-specific T cell activation data supporting mechanism of action in cancer patients • Phase 1 signal of clinical activity • Stable and easy to use “off the shelf” product • Strong partnering interest driven by rapidly disappearing available immunotherapy assets 7 EVOLUTION OF CANCER IMMUNOTHERAPY USING DEPOVAX™ (DPX) FORMULATION • Issued patents provide broad protection – Any antigen, any adjuvant, any indication – Initial patent protection through 2021 – Additional pending patents extend protection to 2028 and 2033 • Scalable GMP manufacturing process established – Meets FDA and EU standards – Methods fully transferable Vial 1 Antigen(s) Proprietary adjuvant Liposomes comprised of phospholipids and cholesterol 8 Vial 2 Mineral-oil based diluent (Montanide ISA51 VG) DPX-SURVIVAC - CREATING A STRONG IMMUNITY DUE TO “DEPOT” EFFECT Immune cells DepoVaxTM- based deposit Histology of subcutaneous injection site in mouse Forcing prolonged vaccine processing by the immune system 9 DPX-SURVIVAC USES AN IMPORTANT THERAPEUTIC TARGET: SURVIVIN – FOR SOLID TUMORS AND HEMATOLOGICAL MALIGNANCIES • Plays an important role in the control of apoptosis, cell division and metastasis Survivin Peptide • A prognostic factor associated with cancer progression A1 modified • A cancer stem cell antigen (150 scientific references) A2 LMLGEFLKL • An immunogenic antigen recognized by T cells • Peptides identified based on spontaneous immune responses A3 modified A24 unmodified B7 unmodified • 10 Developed by Merck KgaA and exclusively licensed to Immunovaccine Inc Sequence SURVIVIN IS ONE OF THE MOST BROADLY EXPRESSED TUMOR ASSOCIATED ANTIGENS Found in a majority of Cancer Patients NY-ESO-1 Survivin MAGE-A3 Red line represents background mRNA expression levels found in normal cells specific to that antigen 11 DPX-SURVIVAC PHASE I DESIGN – OVARIAN Screening Study Day: -7 Treatment 0 Follow up 7 14 21 28 35 42 49 56 70 98 119 126 210 DPX-Survivac: Cyclophosphamide: PBMC Collection: Non-randomized, Dose Finding: Cohort A: 0.5 mL DPX-Survivac (N=7) Cohort B: 0.1 mL DPX-Survivac + low dose Cyclophosphamide (N=6) Cohort C: 0.5 mL DPX-Survivac + low dose Cyclophosphamide (N=6) 12 Immune Monitoring: • • • • Antigen specific IFNg ELISpot CD8+ Tetramer Polyfunctionality by ICS Gene up-regulation by exploratory mRNA analysis • Markers (CA-125, MDSC, Treg, B cells) HIGH LEVELS OF SUSTAINED IMMUNITY INDUCED BY DPXSURVIVAC THERAPY IN OVARIAN CANCER PATIENTS Individual patient immune responses by ELISPOT assay Cohort A 0.5mL DPX-SVV 13 Cohort B 0.1mL DPX-SVV + CPA Cohort C 0.5mL DPX-SVV + CPA Cohort 1 & 2 (phase 1b) 0.25mL DPX-SVV + CPA 0.1mL DPX-SVV + CPA SURVIVIN SPECIFIC CD8+ T CELLS DETECTED IN THE BLOOD OF CANCER PATIENTS day 0 day 21 0.006 0.085 day 42 0.043 day 70 0.199 Ex vivo 0.064 CD8 In vitro Stim. Multimer 14 14 22.4 4.25 8.24 DPX-SURVIVAC THERAPY INDUCES SEVERAL IMPORTANT CD4+ AND CD8+ POLYFUNCTIONAL T CELL PHENOTYPES IN CANCER PATIENTS (% of CD4+ or CD8+ Phenotype) "Total" IFNg Cohort C Mean values of all cohort C patients 1.00 0.90 0.80 0.70 0.35 + CD4EMEffector Memory CD4+ + CD8CM Central Memory CD8+ + CD8EM Effector Memory CD8+ + CD8LD Late Differentiated CD8+ 0.30 "Total" I 0.25 1.00 0.90 0.80 Background subtracted 0.70 Background on all samples <0.02% 0.35 0.20 0.15 0.10 0.05 0.00 0 21 42 84 63 Study Day 105 126 0.30 0.25 0.20 15 0.15 POSITIVE TREND FOR DELAYED PROGRESSION IN PATIENTS RESPONDING TO DPX-SURVIVAC Proportion of Progression-Free Patients Time to Progression (N=18) 1 0.9 0.8 0.7 0.6 0.5 Strong Responders 0.4 Low and Negative Responders 0.3 0.2 0.1 0 0 100 200 300 Time (Days) 400 500 • Groups are immunologically balanced: age, lymphocyte counts, WBC counts and survivin antibody responses 16 CLINICAL RESPONSE (SUBJECT 01-04) CORRELATES WITH CA125 DECREASE AND IMMUNE RESPONSE INCREASE • • • Initial disease: Stage 3c epithelial ovarian cancer: Aug 2011; Surgery followed by IV chemo (Complete Response) Recurrent disease: Stage 3c: Nov 2012; IV chemo (Partial response) Phase 1b DPX-Survivac clinical trial: 24 Sep 2013; Cohort 1 – 43% reduction in tumor size achieved in February 2014 5000 Cx (PR) DPX (0.25 mL) CA-125 (U/ml) 4000 3000 DPX (0.1 mL) 2000 no Tx 1000 400 300 200 100 0 11 11 20 t20 g c O Au 9 Sep 2013 r Ap 12 20 2 01 l2 u J 12 12 20 c20 ct O De SFU (per 10 6 PBMC cells) IFN-g ELISpot Sx, Cx (CR) 4096 2048 1024 512 256 128 64 32 0 3 13 21 42 77 05 33 61 89 17 01 20 SD SD SD D1 D1 D1 D1 D2 l2 t u S S S S S p J Se 5.61 cm Dec 2013 5 Nov 2013 4.00 cm 4.45 2.96 cm cm Feb 2014 21 42 63 84 105 126 147 168 189 Study Day 3.15 cm 3.07 cm May 2014 3.30 cm 01-04 17 Immunovaccine Proprietary Information DPX-SURVIVAC UPCOMING CLINICAL TRIALS • Ovarian cancer – A multi-center randomized controlled phase 2 in US/ Canada • 250 patients with stage III/ IV ovarian cancer (first line) • Efficacy of DPX-Survivac in combination with metronomic cyclophosphamide • Designed to assess progression free survival – Currently exploring additional trials • Glioblastoma – An open label multi-center phase 2 trial in Italy in maximally resected brain cancer patients • Exploring additional trials in a variety of indications, including Lymphoma • Exploring combination trials with anti-PD1 in existing and new indications 18 PHASE II OVARIAN CANCER TRIAL DESIGN (FIRST LINE MAINTENANCE) Priming Phase Study Day -8 0 21 Boosting Phase… 42 77 133 189 245 DPX-Survivac Prime DPX-Survivac Boost CTX (BID for 1 week) PBMC collection CA-125 (repeat measures) CT/MRI Scans: 2:1 Randomization RECIST 1.1 DPX-Survivac (8 doses) + Cyclophosphamide (50 mg bid) Placebo (8 doses) + Cyclophosphamide (50 mg bid) 19 301 357 413 DPX-SURVIVAC- A PARADIGM SHIFTING PRODUCT 20 • Applicable to a wide range of solid tumors and hematological malignancies • Entering multiple phase 2 trials including a large randomized study in ovarian cancer with the national Cancer Institute of Canada Clinical Trials Group (NCIC CTG) • Strong Phase 1 antigen-specific T cell activation data clearly demonstrates the product’s MOA • Phase 1 signal of correlation between immune response and time to recurrence • Documented clinical activity in ovarian cancer highlight a potentially durable effect of the therapy • Stable and easy to use “off the shelf” product • Well suited for combo immunotherapy regimens including checkpoint blockade • Strong partnering interest driven by clinical data and rapidly dwindling immunotherapy assets RATIONALE FOR NEXT GENERATION COMBINATION THERAPY METRONOMIC CYCLOPHOSPHAMIDE SYNERGIZES WITH VACCINE IN A PRE-CLINICAL MODEL (EARLY TREATMENT) 3 Tumor Volume (mm ) 2500 PBS DPX-R9F mCPA DPX + mCPA 2000 1500 1000 500 0 0 20 40 mCPA: DPX-R9F: Study Day 22 60 80 ENHANCED ANTI-TUMOR ACTIVITY ACHIEVED WITH ANTI-PD-1 IN COMBINATION WITH CYCLOPHOSPHAMIDE AND VACCINE C3 Tumor Challenge mCPA, anti-PD1 mCPA, vaccine, isotype mCPA, vaccine, anti-PD1 PBS 3 Tumor Volume (mm ) 1500 1000 500 0 Study Day: 0 mCPA: -PD1: DPX-R9F: 23 10 20 30 40 50 DEPOVAX PLATFORM ENABLING MULTIPLE PRODUCT OPPORTUNITIES IN CANCER AND INFECTIOUS DISEASE IMMUNOVACCINE’S PIPELINE PRODUCTS BASED ON THE DEPOVAX™ PLATFORM 25 COMPLETED, ONGOING, AND FUTURE STUDIES 2011 2012 Therapeutic Cancer DPX-Survivac (company controlled) Phase 1 Ovc Phase 1b Ovc Phase 2 Ovc (N=250) (US/Canada, NCIC) Phase 2a GBM (Italy) Exploring trials in various indications including Ovc and Lymphoma Exploring combination trials with anti-PD1 DPX-0907 (company controlled) Phase 1 BC, Ovc, PC (N=21) Phase 2 BC, Ovc (Italy) Exploring additional trials DPX-E7 (collaboration with Dana-Farber) Phase 1 HPV related head & neck, anal, cervical (US) Infectious Disease DPX-RSV(A) (company controlled) Phase 1 Healthy adults (Canada) DPX-rPA Anthrax (collaboration with NIH) 26 2013 2014 2015 2016 IMV AND PROFILE OF SELECT NASDAQ LISTED COMPANIES IMV LEADERSHIP & BOARD 28 • Leadership team: – Marc Mansour, Ph.D., MBA, Chief Executive Officer & Director – Kimberly Stephens, CA, Chief Financial Officer – Neil Berinstein, M.D., Medical Affairs Advisor – Irene Clement, Regulatory Affairs Advisor – Llew Keltner, M.D., Ph.D, Business Development Advisor • Board Members: – Albert Scardino • Chairman – James W. Hall, CA • Former Senior VP of Investments GrowthWorks – Llew Keltner, M.D., Ph.D. • Chairman of Raptor (NASDAQ: RPTP), Former CEO of AgonOx – Stephanie Léouzon • Senior Advisor to Torreya Partners, formerly Credit Suisse – Wayne Pisano • Former President and CEO of Sanofi Pasteur – Brad Thompson, Ph.D. • CEO of Oncolytics (TSX: ONC, NASDAQ: ONCY) IMMUNOVACCINE (TSXV: IMV) TODAY (JULY 3, 2014) Share price $0.65 52 week range $0.24 - $1.50 Market cap $51.7M Shares outstanding 79.5M Avg. volume 85,700 Insider’s (approx) 25% Stock options & warrants outstanding 5.05M (as at March. 31, 2014) 29 (share weighted-average exercise price of $0.73) PUBLICLY TRADED BIOTECH COMPANIES WITH CANCER VACCINE PROGRAMS Company Market Cap ($M) Vaccines Indication (Phase) July 3, 2014 Immunovaccine TSXV: IMV 52* DPX-Survivac, DPX-0907 Ovarian (Phase 1-2) GBM (Phase 1-2) Galena Biopharma, Inc NASDAQ:GALE 369 Nelipepimut-s (NeuVax) Folate binding protein (E39) Breast Cancer (Phase 3) Prostate Cancer (Phase 1) Ovarian Cancer (Phase 1) ICT-107 ICT-121 ICT-140 GBM (Phase 2) GBM (Phase 2) Ovarian Cancer (IND) Immunocellular Therapeutics NYSE:IMUC NewLink Genetics Corp NASDAQ:NLNK 777 HyperAcute- Pancreas HyperAcute- Lung Cancer HyperAcute- Prostate Cancer Pancreatic Ca (Phase 3) NSCLC (Phase 2) Prostate Cancer (Phase 1) Northwest Biotherapeutics Inc NASDAQ:NWBO 408 DCVax- L DCVax- Prostate DCVax- Direct DCVax- Head&Neck GBM (Phase 3) Prostate Ca (Phase 3) Colon Ca (Phase 1) Head and Neck Ca (Phase 1) Agenus, Inc. NASDAQ:AGEN 246 R-100 G-100/G-200 R-200 RCC (Phase 3) GBM (Phase 2) RCC (Phase 2) Stemline Therapeutics, Inc. NASDAQ:STML 197 SL-701 Glioma (Phase 1) Celldex Therapeutics, Inc. NASDAQ:CLDX 1,540 Rindopepimut CDX-1401 GBM (Phase 3) AML, solid tumor (Phase 1) * In Canadian dollars 30 65 IMMUNOVACCINE INC. (TSX-V: IMV) For more information: Marc Mansour, Ph.D., MBA Chief Executive Officer T: 902-421-5735 ext. 3 E: [email protected] www.imvaccine.com
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