Immunovaccine Inc. (TSX-V: IMV)

Transcription

1 May 2014 Immunovaccine Inc. (TSX-V: IMV) Targeted T cell Activation Immunotherapies

2 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. 2 Immunovaccine Proprietary Information

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 3 Immunovaccine Proprietary Information

4 NEXT-NEXT GENERATION IMMUNOTHERAPIES- COMBINING MONOCLONAL ANTIBODY T CELL THERAPY WITH ANTIGEN DIRECTED T CELL ACTIVATION Company Janssen (Johnson & Johnson) Roche Merck KGaA Pfizer GSK Announcement October 3, 2013: Research and option agreement with DCPrime BV to develop novel dendritic cell-based cancer vaccines October 3, 2013: Interest in clinical stage cancer vaccine partnerships as part of the new strategy at its early development group November 13, 2013: Deal with Immatics for antigen discovery, $17M upfront, research costs and up to $1B in milestones and royalties September 25, 2013: Vaccines one of four focused areas of R&D, continuing phase 3 development with Stimuvax September 11, 2013: Renewed vaccine pipeline includes preclinical cancer vaccines September 5, 2013: Multiple vaccine programs in development, continuing phase 3 development with MAGE-A3 vaccine 4 Immunovaccine Proprietary Information

5 CANCER IMMUNOTHERAPY OPPORTUNITY DPX-SURVIVAC 5

6 DPX-SURVIVAC- PRODUCING SURVIVIN SPECIFIC T CELLS Applicable to a wide range of solid tumors and hematological malignancies Entering large, randomized, controlled Phase 2 trials in ovarian cancer and glioblastoma with noted research organizations Phase 1 antigen-specific T cell activation data rivals all other known cancer immunotherapies Phase 1 signal of correlation between immune response and time to recurrence Strong partnering interest driven by rapidly disappearing available immunotherapy assets 6 Immunovaccine Proprietary Information

7 SURVIVIN A THERAPEUTIC TARGET FOR SOLID TUMORS AND HEMATOLOGICAL MALIGNANCIES Plays an important role in the control of apoptosis, cell division and metastasis Widely expressed in cancer patients >90% of ovarian cancer >80% of glioblastoma >70% of multiple myeloma and acute myeloid leukemia A prognostic factor associated with cancer progression A cancer Stem cell antigen (150 scientific references) An immunogenic antigen recognized by T cells 7 Immunovaccine Proprietary Information

8 SURVIVIN ANTIGENIC PEPTIDES CD8 specificity while overcoming limitation of HLA restriction Peptides identified based on spontaneous immune responses Peptides validated experimentally as naturally processed and presented Developed by Merck KgaA and exclusively licensed by Immunovaccine Inc Survivin Peptide A1 A2 A3 A24 B7 Sequence modified LMLGEFLKL modified unmodified unmodified 8 Immunovaccine Proprietary Information

9 DEPOVAX ADJUVANTING PLATFORM STABLE AND EASY TO USE Issued and pending patents provide broad protection Scalable GMP manufacturing process established Vial 1 Antigen(s) Proprietary adjuvant Liposomes Vial 2 Mineral-oil based diluent (Montanide ISA51 VG) 9 Immunovaccine Proprietary Information

10 DPX-SURVIVAC- OFF THE SHELF PRODUCT CREATING A STRONG DEPOT EFFECT Enabling strong immunity against the Cancer Signature Survivin Immune cells DepoVax TM - based deposit Histology of subcutaneous injection site in mouse Forcing prolonged vaccine processing by the immune system 10 Immunovaccine Proprietary Information

11 SFU per 10 6 PBMCs HIGH LEVELS OF SUSTAINED CD8 T CELLS INDUCED BY DPX-SURVIVAC THERAPY IN OVARIAN CANCER PATIENTS 0.5 ml Vaccine alone CY ml vaccine SFU (per 10 6 PBMC cells) Baseline 1 Dose 2 Doses 3 Doses Long Term Baseline (Day 0) After 1 Dose (3 wks) After 2 Doses (6 wks) After After 3 Doses 3 Doses (~2 mos.) (~4.5 mos.) Baseline 1 Dose 2 Doses 3 Doses Long Term Baseline (Day 0) After 1 Dose (21 days) After 2 Doses (42 days) After 3 Doses (70 days) After 3 Doses (126 days) Immunovaccine Proprietary Information

12 SFU per 10 6 PBMCs HIGH LEVELS OF SUSTAINED CD8 T CELLS INDUCED BY DPX-SURVIVAC THERAPY IN OVARIAN CANCER PATIENTS CY+Low dose vaccine (0.1 ml) CY+High dose vaccine (0.5mL) Baseline 1 Dose 2 Doses 3 Doses Long Term Baseline (Day 0) After 1 Dose (3 wks) After 2 Doses (6 wks) After After 3 Doses 3 Doses (~2 mos.) (~4.5 mos.) Baseline 1 Dose 2 Doses 3 Doses Long Term Baseline (Day 0) After 1 Dose (21 days) After 2 Doses (42 days) After 3 Doses (70 days) After 3 Doses (126 days) Immunovaccine Proprietary Information

13 CD8 SURVIVIN SPECIFIC CD8 + T CELLS DETECTED IN CANCER PATIENTS day 0 day 21 day 42 day 70 Ex vivo In vitro Stim Multimer 13 13

14 (% of CD4 + or CD8 + Phenotype) DPX-SURVIVAC THERAPY INDUCES SEVERAL IMPORTANT CD4 + AND CD8 + T CELL PHENOTYPES IN CANCER PATIENTS "Total" IFNg Cohort C Mean values of all cohort C patients Study Day Immunovaccine Proprietary Information CD4 + Effector Memory CD4+ EM CD8 + Central Memory CD8+ CM CD8 + Effector Memory CD8+ EM CD8 + Late Differentiated CD8+ LD "Total" I Background subtracted Background on all samples <0.02%

15 Proportion of Progression-Free Patients POSITIVE TREND FOR DELAYED PROGRESSION IN PATIENTS RESPONDING TO DPX-SURVIVAC 1 Time to Progression (n=18) Strong Responders Low and Negative Responders Time (Days) The two groups are balanced immunologically based on age, lymphocyte counts, WBC counts and DPX-Survivac specific antibody responses 15 Immunovaccine Proprietary Information

16 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 Efficacy of DPX-Survivac in combination with metronomic cyclophosphamide Designed to assess progression free survival Glioblastoma A multi-center randomized controlled phase 2 study in Italy Up to 50 patients with newly diagnosed maximally resected (>90%) brain cancer to be initiated in 1H2014 Efficacy of DPX-Survivac in combination with temozolomide 16 Immunovaccine Proprietary Information

17 IMV AND PROFILE OF SELECT NASDAQ LISTED COMPANIES

18 PUBLICLY TRADED BIOTECH COMPANIES WITH CANCER VACCINE PROGRAMS Company Immunovaccine TSXV: IMV Galena Biopharma, Inc NASDAQ:GALE Immunocellular Therapeutics NYSE:IMUC NewLink Genetics Corp NASDAQ:NLNK Northwest Biotherapeutics Inc NASDAQ:NWBO Agenus, Inc. NASDAQ:AGEN Stemline Therapeutics, Inc. NASDAQ:STML Celldex Therapeutics, Inc. NASDAQ:CLDX Market Cap ($M) May 2, 2014 Vaccines 92 DPX-Survivac, DPX Nelipepimut-s (NeuVax) 68 ICT-107 ICT-121 ICT-140 Folate binding protein (E39) 589 HyperAcute- Pancreas HyperAcute- Lung Cancer HyperAcute- Prostate Cancer 317 DCVax- L DCVax- Prostate DCVax- Direct DCVax- Head&Neck 170 R-100 G-100/G-200 R-200 Indication (Phase) Ovarian (Phase 1-2) GBM (Phase 1-2) Breast Cancer (Phase 3) Prostate Cancer (Phase 1) Ovarian Cancer (Phase 1) GBM (Phase 2) GBM (Phase 2) Ovarian Cancer (IND) Pancreatic Ca (Phase 3) NSCLC (Phase 2) Prostate Cancer (Phase 1) GBM (Phase 3) Prostate Ca (Phase 3) Colon Ca (Phase 1) Head and Neck Ca (Phase 1) RCC (Phase 3) GBM (Phase 2) RCC (Phase 2) 193 SL-701 Glioma (Phase 1) 1,297 Rindopepimut CDX-1401 GBM (Phase 3) AML, solid tumor (Phase 1) 18 Immunovaccine Proprietary Information

19 IMMUNOVACCINE S FUNDING HISTORY (Immunovaccine Technologies Inc., Private company) Equity Grants License Fees from Zoetis (formerly Pfizer Animal Health) $ 19.8 million $ 9.4 million $ 1.8 million (Immunovaccine Inc., TSXV: IMV) Equity Grants Government loan (up to $5 M available) $ 15.9 million $ 2.9 million $ 1.25 million 19 Immunovaccine Proprietary Information

20 IMMUNOVACCINE (TSXV: IMV) TODAY (MAY 2, 2014) Share price week range Market cap 66.8M Shares outstanding 79.5M Avg. volume 108,000 Insider s 25% Stock options & warrants outstanding (as at Dec. 31, 2013) 3,844,610 (share weighted-average exercise price of $0.67) 20 Immunovaccine Proprietary Information

21 IMMUNOVACCINE S PIPELINE PRODUCTS BASED ON THE DEPOVAX PLATFORM 21 Immunovaccine Proprietary Information

22 IMMUNOVACCINE GOALS Capitalize on the potential of DepoVax in cancer immunotherapy Diversify by pursuing select applications and licensing opportunities Rapidly advance a sophisticated clinical pipeline Transform into a mid-stage clinical development company 22 Immunovaccine Proprietary Information

23 WHY WILL DPX-SURVIVAC BE A PARADIGM-SHIFTING PRODUCT? Broadly applicable to many cancer types, targets cancer stem cells A positive clinical signal in phase 1 provides rationale for phase 2 development in combination with immune modulation Strong T cell activation data with confirmed dose response clearly demonstrates the product s MOA Stable and easy to use off the shelf product Well suited for combo immunotherapy regimens including checkpoint blockade 23 Immunovaccine Proprietary Information

24 LEADERSHIP AND EXPERIENCE MANAGEMENT & BOARD Management: Albert Scardino, Executive Chairman Marc Mansour, Ph.D., Chief Operating Officer & Director Kimberly Stephens, CA, Chief Financial Officer Board Members: James W. Hall, CA 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) 24 Immunovaccine Proprietary Information

25 IMMUNOVACCINE INC. (TSX-V: IMV) For more information: Albert Scardino Executive Chairman T: E: