corporate presentation - the life sciences report · phase 1b triple combination (dpx -survivac+...

© 2017 Immunovaccine Inc. All rights reserved.

Corporate Presentation

October 2017

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 www.sedar.com.

2 © 2017 Immunovaccine Inc. All rights reserved.

Immunovaccine

© 2017 Immunovaccine Inc. All rights reserved.3

• Founded in 2000 as a spin-off of Dalhousie University (Halifax)

• New management team in place since April 2016- CEO, CFO and Board chair are former Medicago (acquired by

Mitsubishi Pharma in 2013)

• Immuno Oncology focus – multiple Phase 2 combination studiesongoing with Merck and Incyte

• Proprietary drug delivery platforms and products covered by more than200 patent and applications

• Listed on TSX and OTCQX (TSX: IMV; OTCQX: IMMVF) - Public since2009

• 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

Business Strategy

• Focusing on combination immunotherapy - Proprietary formulation/delivery platform (DepoVaxTM) 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 anti-

tumor 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 © 2017 Immunovaccine Inc. All rights reserved.

Management Team


Frederic Ors, MSc/MA Chief Executive Officer20 years experience

Pierre Labbé, CPA Chief Financial Officer25 years experience

Gabriela Rosu, MD Chief Medical Officer23 years of experience

Stephan Fiset, MSc/MBA Vice-President Clinical Research17 years experience

Leeladhar Sammatur, MSc Vice-President of Manufacturing25 years experience

Marianne Stanford, PhD Vice-President of Research17 years experience

Annie Tanguay, BSc Senior Director of Quality Assurance27 years experience

Pipeline


DEPOVAX PARTNERSHIPS

Indication Candidate Progress Partners

Malaria Multiple antigens in DepoVaxPreclinical Ongoing

Zika Peptides in DepoVax Preclinical Ongoing

BVDV Antigens in DepoVax Animal trials

Contraceptive Antigens in DepoVax Animal trials

Platform Collaborations


A new way to deliver active ingredients to the immune system

Immunotherapy $100B market opportunity

DPX - Survivac

Infectious diseases

Malaria, Zika

New applications

mRNA, Allergies, Autoimmune,…

DPX - RSV

OvarianDLBCLBreast

Melanoma…


Immuno Oncology

DPX - Neo

DepoVaxTM

Veterinary vaccines

• 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

Platform & Product


Cancer Survivin %

Ovarian 90Breast 90Melanoma 90Lung 53Colorectal 54Gastric 94Kidney 23-82Glioblastoma 80ALL 70CML 70MDS 90DLBCL 60

Encapsulate in a Liposome - Lyophilize - Suspend in oil

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)


Differentiation factor: Duration of response


2Months 6 12

Boos

t

ImmunotherapyVaccination

X X

Differentiation factor: Duration of response


Step 2: DPX-RSV(A) (n=8)

0 100 200 300 400 5000

1

2

3

4

5

6

Study Day:

Vaccination:

Endp

oint

Log

Tite

r

• Phase 1b DPX-Survivac Ovarian Cancer (T cells)

Combination Immunotherapy Opportunity


Lung

Ovarian

Melanoma

Breast (TN)

Gastric

Bladder

Kidney

0 500,000 1,000,000 1,500,000

Anti PD-1 responders Non responders

Global Number of Patients diagnosed every year

Can

cer T

ype

Colorectal

Ovarian Cancer Program

Phase 1MonotherapyMaintenance

Strong sustained T cell activation

Best dose regimenPrime + boost

Increased expression of checkpoint inhibitors

Clinical benefit POC

Phase 1b and 2 Combination

Trials with IDO-1 and PD-1 inhibitors

Active Disease43% Tumor shrinkage

High Level T cells maintained for a year


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: Q1 2017- Top-line results 100mg: Q4 2017

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


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 140

- 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


Ovarian Cancer IO clinical trials (recurrent Phase (nb patients) DCR (SD, PD and CR) ORR (PR and CR)Checkpoint ImmunotherapyIpilumab-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-936559 (PD-L1) P1 (17) 17% (1 PR + 3 SD) 4% (1 PR)

Checkpoint + PARP inhibitorDurvalumab-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 ImmunotherapyEpacadostat+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)

Ovarian Cancer IO results

CONFIDENTIAL © 2017 Immunovaccine Inc. All rights reserved.17

* Study ongoing – incomplete results

Other Combination Clinical Trials

• 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: Q3 2017


Undisclosed Large Pharma

• 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: Q3 2017

Key Clinical Milestone Upcoming

• Q4 2017 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


corporate presentation - the life sciences report · phase 1b triple combination (dpx -survivac+...

Documents