Corporate Presentation

Transcription

1 Corporate Presentation October 2017

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 Immunovaccine Founded in 2000 as a spin-off of Dalhousie University (Halifax) New management team in place since April CEO, CFO and Board chair are former Medicago (acquired by Mitsubishi Pharma in 2013) Immuno Oncology focus multiple Phase 2 combination studies ongoing with Merck and Incyte Proprietary drug delivery platforms and products covered by more than 200 patent and applications Listed on TSX and OTCQX (TSX: IMV; OTCQX: IMMVF) - Public since 2009 Raised $26M in last 18 months cash to cover current business plan until first half of 2019 Based in Halifax and Quebec City - 35 employees 3

4 Business Strategy Focusing on combination immunotherapy - Proprietary formulation/delivery platform (DepoVax TM ) and cancer target (survivin) - Phase 1/1b with DPX-Survivac + Metronomic Oral Cyclophosphamide completed in 56 patients - Combination trial collaborations with lead checkpoint inhibitors and partners (Incyte and Merck) - Current goal is to establish clinical proof of efficacy in Ovarian cancer showing that DPX-Survivac has antitumor activity - Next steps: - Accelerated path to market in Ovarian cancer - Expand DPX-Survivac clinical pipeline into top other 5 indications Partners - IO: Incyte, Merck, Dana Farber Cancer Institute, UConn Health - Other applications of the platform: Leidos, Zoetis 4

5 Management Team Frederic Ors, MSc/MA Pierre Labbé, CPA Gabriela Rosu, MD Stephan Fiset, MSc/MBA Leeladhar Sammatur, MSc Marianne Stanford, PhD Annie Tanguay, BSc Chief Executive Officer 20 years experience Chief Financial Officer 25 years experience Chief Medical Officer 23 years of experience Vice-President Clinical Research 17 years experience Vice-President of Manufacturing 25 years experience Vice-President of Research 17 years experience Senior Director of Quality Assurance 27 years experience 5

6 Pipeline 6

7 Platform Collaborations DEPOVAX PARTNERSHIPS Indication Candidate Progress Partners Malaria Multiple antigens in DepoVax Preclinical Ongoing Zika Peptides in DepoVax Preclinical Ongoing BVDV Antigens in DepoVax Animal trials Contraceptive Antigens in DepoVax Animal trials 7

8 A new way to deliver active ingredients to the immune system Immunotherapy $100B market opportunity Infectious diseases Immuno Oncology DPX - Survivac Ovarian DLBCL Breast Melanoma DPX - Neo DPX - RSV Malaria, Zika Veterinary vaccines New applications mrna, Allergies, Autoimmune, DepoVax TM 8

9 Platform & Product Encapsulate in a Liposome - Lyophilize - Suspend in oil Formulation: DepoVax - No water/no release: depot effect - Protects the antigens and forces active uptake by immune cells Tumor Antigen: Survivin - Not just a flag on cancer but essential for survival of cancer cells - Significant market potential across multiple indications Cancer Survivin % Ovarian 90 Breast 90 Melanoma 90 Lung 53 Colorectal 54 Gastric 94 Kidney Glioblastoma 80 ALL 70 CML 70 MDS 90 DLBCL 60 9

10 New approach to anti-cancer T cell activation Previous attempts at generating immune responses against cancer have not been successful in triggering significant anti-tumor activity Our approach is different and does not rely on the principles of vaccination which have inherent limitations - Vaccine approaches trigger short duration peak responses that cannot be sustained long enough to effect tumor shrinkages - The use of vectors (viral, bacterial, ) limit the possibility to repeat injections to maintain T cell activation We are pursuing an approach favoring duration of response. The use of DepoVax with minimal peptides for activation of T-cells combines multiple key features to deliver a sustained response: - Active process: no-release formulation forcing an active uptake by dendritic cells - Targeted delivery: 100% delivered to target Immune cells in the lymph nodes - Sustained delivery over a long period of time (weeks/month versus hours/day) - T-cell activation: minimal peptide to trigger T cell activation against the target and nothing else (no vector) Multiple clinical proof of concept: we have completed phase 1/phase 1b in 56 patients in Ovarian cancer and reported T cell responses to survivin in 87 percent of participants (47 of 54 evaluable patients) that was maintained for the duration of treatment (1 year) 10

11 Differentiation factor: Duration of response X X Vaccination Immunotherapy Boost 2 Months

12 Differentiation factor: Duration of response Phase 1b DPX-Survivac Ovarian Cancer (T cells) 6 Step 2: DPX-RSV(A) (n=8) Endpoint Log Titer Study Day: Vaccination: 12

13 Combination Immunotherapy Opportunity Anti PD-1 responders Non responders Lung Gastric Cancer Type Bladder Kidney Breast (TN) Ovarian Melanoma Colorectal 0 500,000 1,000,000 1,500,000 Global Number of Patients diagnosed every year 13

14 Ovarian Cancer Program Strong sustained T cell activation High Level T cells maintained for a year Phase 1 Monotherapy Maintenance Best dose regimen Prime + boost Clinical benefit POC 43% Tumor shrinkage Phase 1b and 2 Combination Trials with IDO-1 and PD-1 inhibitors Active Disease Increased expression of checkpoint inhibitors 14

15 Phase 1b Combination Trial with Incyte Phase 1b triple combination (DPX-Survivac + mcpa + Epacadostat IDO inhibitor) in recurrent Ovarian cancer - Platinum resistant and sensitive subjects who have completed first-line treatment and have evidence of measurable disease - Up to 40 evaluable patients, one arm, open-label, safety and efficacy study - Dose escalation from 100 mg BID epacadostat to 300 mg BID - Sites in US and Canada - Interim results: Q Top-line results 100mg: Q Endpoints Primary: Safety, cell-mediated immunity, changes in immune cell infiltration from baseline tumor biopsy to post-treatment tumor biopsies Secondary: Response rate, time to progression, overall survival, biomarkers of immune and clinical response 15

16 Phase 1b Combination Trial with Incyte Q2 2017: Interim results on first 4 patients assessed after 2-3 months of treatment - Safety (first in human triple combination with DPX-Survivac): no SAE - Response Rate: 3 out of 4 with stable disease one with progressive disease - 75% Disease Control Rate - Tumor shrinkage reported at day Survivin antigen-specific CD8 + T cell immune responses in the blood demonstrated - Tumor immune profiling conducted on pre- and post-treatment biopsies - Demonstrate increases in T cell infiltration in the tumors - Markers of immune activation in the tumors including checkpoint inhibitors 16

17 Ovarian Cancer IO results Ovarian Cancer IO clinical trials (recurrent Phase (nb patients) DCR (SD, PD and CR) ORR (PR and CR) Checkpoint Immunotherapy Ipilumab-BMS (CTLA-4) P1 (9) 44% (1 PR + 3 SD) 11% (1 PR) Epacadostat-Incyte (IDO1) P2 (20) 0% (1 CA 125 reduction) 0% Keytruda-Merck (PD-1) P1b (26) 34.6% (6 SD + 3PR) 11.5% (3 PR) Nivolumab-BMS (PD-1) P2 (20) 45% (2 CR +1 PR + 5 SD) 15% (2 CR +1 PR) Avelumab-Merck KgA (PD-L1) P1b (124) 54% (12 PR + 55 SD) 9.7% (12 PR) BMS (PD-L1) P1 (17) 17% (1 PR + 3 SD) 4% (1 PR) Checkpoint + PARP inhibitor Durvalumab-AZ (PD-L1) + Olaparib (PARP) P1/2 (13) 79% (2 PR + 9 SD) 14% (2 PR) Keytruda-Merck (PD-1) + Niraparib -TESARO (PARP)* P2 (29) 50% (9 SD + 6 PR) 21% (6 PR) Combination Immunotherapy Epacadostat+Keytruda P2 (37) 35% (10 SD + 3 PR) 8% (3 PR) Epacadostat 100mg + Nivolumab P1/2 (18) 28% (3 SD + 2 PR) 11% (2 PR) Epacadostat 300mg + Nivolumab P1/2 (11) 36% (2 SD + 1 PR + 1 CR) 18% (1 PR + 1 CR) * Study ongoing incomplete results 17 CONFIDENTIAL

18 Other Combination Clinical Trials Undisclosed Large Pharma Phase 2 combination (DPX-Survivac +mcpa+ pembrolizumab (anti-pd-1)) in recurrent Ovarian cancer Platinum resistant subjects who have completed first-line treatment and have evidence of measurable disease 42 subjects Initiation: Q Phase 2 combination DPX-Survivac + mcpa + anti- PD-1 in Patients with Measurable or Recurrent Diffuse Large B-Cell Lymphoma (DLBCL) Subjects with histologically proven recurrent DLBCL after one, two or three lines of chemotherapy 25 subjects Initiation: Q

19 Key Clinical Milestone Upcoming Q Top-line results Phase 1b with Incyte - Cohort of patients in the 100mg dose of Epacadostat - First report of efficacy results with DPX Survivac looking at the impact on active tumors - Will report response rate (CR and PR) - Correlation of clinical benefits and responses in the tumors based on biopsy analysis Followed by - Additional data in first half 2018 on Incyte/Epacadostat 300mg dose cohort - Combination with Merck/Pembrolizumab Other Milestones: Additional combination trials with partners (basket trial and others) - Interim results with Merck - Interim results with Dana Farber Cancer Institute - DPX Neo collaborations and clinical trials - Additional RSV data on mechanism of action - New collaborations 19

20 Immunovaccine Inc Summer Street, Suite 412 Halifax, Nova Scotia, B3H 0A8 Tel: Fax: