Immunovaccine Inc. (TSX: IMV) (OTCQX: IMMVF)

Transcription

1 November 2015 Immunovaccine Inc. (TSX: IMV) (OTCQX: IMMVF) Strong, Fast and Long Lasting Vaccines For Cancer and Infectious Diseases

2 FORWARD-LOOKING STATEMENTS Except for historical information, this presentation contains forward-looking statements, which reflect Immunovaccine s current expectations regarding future events. These forward-looking statements involve known and unknown risks and uncertainties that could cause Immunovaccine s actual results to differ materially from those statements. Those risks and uncertainties include, but are not limited to, our ability to access capital, the successful and timely completion of clinical trials, the receipt of all regulatory approvals and other risks detailed from time to time in our ongoing quarterly filings and annual information form. The forward-looking statements in this presentation are also based on a number of assumptions which may prove to be incorrect. Forward-looking statements contained in this presentation represent views only as of the date of this presentation and are presented for the purpose of assisting potential investors in understanding Immunovaccine s business, and may not be appropriate for other purposes. Immunovaccine does not undertake to update forward-looking statements, whether written or oral, that may be made from time to time by or on its behalf, except as required under applicable securities legislation. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read Immunovaccine s continuous disclosure documents, including its current annual information form, as well as its audited annual consolidated financial statements which are available on SEDAR at 2

3 THE DEPOVAX PLATFORM A patented oil-based formulation Creates powerful vaccines to treat cancer and protect against infectious diseases Lead cancer immunotherapy in phase 2 clinical trials Phase 1 study for Respiratory Syncytial Virus (RSV) planned Collaborations with the National Institutes of Health, the National Cancer Institute of Canada, and the Dana Farber Cancer Institute 3

4 STRATEGIC GOALS 2015 Immuno-oncology Open label phase 2 trials with DPX-Survivac in 2015 Sign partnerships for combination immunotherapy Infectious diseases Phase 1 trial of DPX-RSV for Respiratory Syncytial Virus Commercial partnership for anthrax 4

5 THE DEPOVAX ADVANTAGE Safe Based on animal and human tests Effective Rapid onset of immunity, lasting response Simple Easy to use, easy to manufacture controlled vaccine processing by the immune system 5

6 ID Cancer OUR PIPELINE Product Indication Preclinical Phase I/Ib Phase II DPX-Survivac Company-Sponsored DPX-Survivac Combination Trials DPX-Survivac Investigator-Sponsored Ovarian Lymphoma (recurrent) Ovarian (recurrent) with Incyte Ovarian (first line) with NCIC Glioblastoma ** ** * DPX-0907 Company-Sponsored DPX-E7 Academic collaboration DPX-RSV Company-Sponsored DPX-Anthrax Partnered Ovarian/Breast/Prostate HPV-cancers With Dana Farber Respiratory disease Adults/ Elderly PharmAthene ** 6 * ** planned for 2015 planned for 2016

7 THE BEGINNING OF THE END OF CANCER 7

8 RECENT DEALS- STRONG INTEREST Company Pfizer and Merck KGaA Announcement November 17, 2014: co-development deal for Merck KGaA s anti PDL- 1, Pfizer pays $850M +$2B in milestones + shares profits BMS Feb 23, 2015: Acquires Flexus Biosciences (IDO inhibitor), $800M upfront + $450M in milestones Cellectis AZ/ Medimmune Celgene March 25, 2015: Engineered CAR-T cell therapies, NASDAQ IPO, $1.5B valuation in debut April 24, 2015: enters deal with Innate Pharma (NK/ T cell checkpoint), $250M upfront, $1B in milestones and double digit royalty April 24, 2015: Enters deal with AZ/Medimmune to commercialize anti PDL-1 in hematology, pays $450M upfront+ shares profits 8

9 COMBINATIONS - THE NEW PARADIGM Partners AZ / Advaxis Merck / Advaxis BMS / Incyte Merck / Incyte Pfizer and Merck KgaA Incyte / Agenus BMS / BMS Combination Therapies AZ/ Medimmune collaborates with Advaxis for combination of anti- PDL-1 and a Listeria based vaccine for cervical cancer Merck collaborates with Advaxis for combination of anti-pd-1 and a Listeria based vaccine for prostate cancer BMS collaborates with Incyte for combination of anti-pd-1 and an IDO- 1 inhibitor Merck collaborates with Incyte for combination of anti-pd-1 and an IDO-1 inhibitor A joint development program combining anti-pdl-1 with several Pfizer compounds in multiple cancer indications Incytes licenses Agenus checkpoint blockade discovery platform with the goal of combination therapy with an IDO-1 inhibitor Combination of anti PD-1 and anti-ctla-4 showed a marked increase in response rate in melanoma 9

10 SURVIVIN A COMMON TARGET ACROSS MANY CANCERS Present in solid tumors and blood cancers Controls important cancer processesapoptosis, cell division and metastasis A biomarker of cancer progression A cancer stem cell antigen (150 scientific references) Recognized by killer T cells Survivac- Developed by Merck KgaA, licensed to IMV % of patients Indication expressing survivin Ovarian Cancer 90 Breast Cancer 90 Melanoma 90 Lung Cancer 53 Colorectal Cancer 54 Glioblastoma 80 AML 60 MDS 90 ALL 70 CML 70 FL 20 DLBCL 60 10

11 STRONG IMMUNE RESPONSE WITH DPX-SURVIVAC IN OVARIAN CANCER Rapid, strong and durable T cells induced Vaccine schedule Vaccine schedule Phase 1 Phase 1b 11

12 CLINICAL RESULTS OF DPX-SURVIVAC IN OVARIAN CANCER Patient with stable tumor and rising CA-125 experienced a 43% reduction in tumor size and a drop in CA-125 following vaccination Immune response CA-125 level 9 Sep cm Dec 5 Nov cm 2.96 cm Feb cm 3.07 cm May cm 12

13 OUR THERAPEUTIC APPROACH FOR CANCER Disease Burden DPX-Survivac Therapy Checkpoint Inhibitor No evidence of disease Minimal residual disease Measurable disease Recurrent disease P P P P P P 13

14 Tumor Volume (mm 3 ) COMBINATION THERAPY TO CONTROL AGGRESSIVE TUMORS Animal results support testing combinations in the clinic Untreated Cyclophos + anti-pd1 Cyclophos + vaccine Cyclophos + anti-pd1 + vaccine Study Day Post Tumor Implantation 14

15 DPX-SURVIVAC UPCOMING CLINICAL TRIALS Open label phase 2 in Lymphoma (company sponsored) A multi-center trial enrolling up to 24 patients with recurrent DLBCL Cleared by Health Canada Primary objective is to determine the objective response rate (ORR) Designed with ability to amend the trial to include a checkpoint inhibitor Combination trial in recurrent ovarian cancer (co-funded) Open label phase 1b with Incyte s IDO1 inhibitor Epacadostat Randomized phase 2 in ovarian cancer (NCIC collaboration) A multi-center randomized controlled phase 2 in US/ Canada Enrolling 250 patients with stage III/ IV ovarian cancer (first line) Designed to assess progression free survival (PFS) Investigator sponsored trials Glioblastoma (Italy): Primary endpoint is immune response rate 15

16 INCYTE COLLABORATION A STRONG SCIENTIFIC AND BUSINESS RATIONALE DPX-Survivac/ IDO combination IDO acts to create a suppressive milieu in tumor and tumor draining lymph node IDO promotes Treg activation which suppress vaccine induced T cells when they reach established tumors IDO inhibitor has the potential to open a window of opportunity for DPX- Survivac to attack established tumors more effectively Partnership with Incyte Epacadostat: first in class IDO1 inhibitor with 10+ P1 & 2 clinical trials completed or ongoing (Merck, BMS, AZ, Genentech, Celldex, Advaxis) Co-development agreement (50/50 cost-sharing) to evaluate DPX- Survivac/ Epacadostat combination in a P1b in Ovarian cancer Epacadostat is an orally bioavailable small molecule making the triple combination (DPX-Survivac/ Cyclophosphamide/ Epacadostat) a fully synthetic and off the shelf IO therapy solution 16

17 OPPORTUNITIES IN INFECTIOUS DISEASE DPX-RSV (company controlled) A preventative vaccine for respiratory syncytial virus Initially targeting the elderly population Entering a phase 1 study in older healthy volunteers (50-64 yrs) DPX- Anthrax (collaboration with the NIH) A recombinant PA based rapid response vaccine enabled by DepoVax Demonstrated single dose rapid protection potential in animal challenge studies (rabbits and non-human primates) Studies conducted by the NIAID of the National Institutes of Health (NIH) DepoVax licensed to PharmAthene for single dose DPX-rPA development and commercialization 17

18 OUR FIRST INFECTIOUS DISEASE TRIAL RSV causes severe respiratory illness Affects the elderly and young children There is currently no vaccine Initially developing DPX-RSV for the elderly Phase 1 trial to establish safety and activity Small hydrophobic protein (SH) 18

19 ANTHRAX VACCINE STRATEGY A deadly bacterial Infection Anthrax spores can be weaponized Part of the Strategic National Stockpile (SNS) of the US US government seeks better anthrax solutions DepoVax licensed to PharmAthene for single dose anthrax vaccine development and commercialization 19

20 2015 CATALYSTS Catalyst Expected Date Initiation of Phase II DPX-Survivac Lymphoma Study Q Initiation of Phase I DPX-RSV Study Q Establish a co-development agreement with a partner for DPX-Anthrax Q2/Q Clinical Collaborations with commercial partner in oncology Q2/Q Initial Data from Phase I DPX-RSV Trial Q Initial Data from Phase II DPX-Survivac Lymphoma Study Q

21 IMMUNOVACCINE TODAY (NOVEMBER 2, 2015) (TSX: IMV; OTCQX: IMMVF) Share price $ week range $ $1.36 Market cap $70.8M Shares outstanding 92.0M 3 months Avg. volume 46,000 Insider s (approx) 28% Stock options & warrants outstanding (as at August 12, 2015) 11.79M (average exercise price of $0.94) 21

22 PUBLICLY TRADED BIOTECH COMPANIES WITH CANCER VACCINE PROGRAMS Company Immunovaccine TSX: IMV Market Cap ($M) Nov 2, * Advaxis, Inc. NASDAQ: ADXS 413 Inovio Pharmaceuticals NASDAQ:INO 480 Agenus, Inc. NASDAQ:AGEN 401 Stemline Therapeutics, Inc. NASDAQ:STML 160 Celldex Therapeutics, Inc. NASDAQ:CLDX 1,171 Vaccines DPX-Survivac, DPX-0907 ADXS-HPV HPV cancers ADXS-PSA Prostate ADXS-HER2 - overexpressing VGX-3100 INO-3112 INO-1400 R-100 G-100/G-200 R-200 Indication (Phase) Ovarian (Phase 1-2) GBM (Phase 1-2) HPV cancers (combo) (Phase 2) Prostate (combo) (Phase 1-2) HER2 overexpressing (Phase 1) Cervical Displasia (Phase 2) HPV cancers (Phase 1) BrCa, Lung, Prostate (Phase 1) RCC (Phase 3) GBM (Phase 2) RCC (Phase 2) SL-701 Glioma (Phase 1) Rindopepimut CDX-1401 GBM (Phase 3) AML, solid tumor (Phase 1) * In Canadian dollars 22

23 EXPERIENCED LEADERSHIP Executive team: Marc Mansour, Ph.D., MBA, Chief Executive Officer & Board Member Kimberly Stephens, CPA, CA, Chief Financial Officer Frederic Ors, BSc, MScM, Chief Business Officer Neil Berinstein, M.D., Medical Affairs Advisor Irene Clement, Regulatory Affairs Advisor Board of Directors: Albert Scardino, Chairman James W. Hall, CPA, CA, Former Senior VP of Investments GrowthWorks Wayne Pisano, Former President and CEO of Sanofi Pasteur Brad Thompson, Ph.D., CEO of Oncolytics Wade Dawe, CEO of Fortune Bay Corp. Fred Smithers, President of IONA Resources Holdings 23

24 Immunovaccine Inc. (TSX: IMV) (OTCQX: IMMVF) For more information: Marc Mansour, Ph.D., MBA Chief Executive Officer T: ext. 3 E: mmansour@imvaccine.com