bloom burton & co. healthcare investor tsx: imv...immunovaccine’s business, and may not be...
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© 2017 Immunovaccine Inc. All rights reserved.
Bloom Burton & Co. Healthcare
Investor Conference
TSX: IMV
May 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.
DepoVaxTM
A new way to deliver messages to the immune sytem
Our approach fundamentally
transforms the way we
deliver messages to the
immune system
© 2017 Immunovaccine Inc. All rights reserved.3
Not the message but *how*
we deliver it is the key to
generating a pivotal immune
response against diseases
previously unresponsive to
immunotherapies
DepoVaxTM
has the potential to
revolutionize
Immunotherapy in
multiple areas
Value Proposition
Immunotherapy $100B market opportunity
Develop & Partner
Immuno Oncology Infectious diseases
Survivin
HPV E7
Malaria Zika
New applications
RSV
Head & Neck
Cervical
Ovarian
Anal
DLBCL
Melanoma
Lung…
© 2017 Immunovaccine Inc. All rights reserved.4
TSX: IMV Investment Opportunity
• Focusing in Immuno-oncology
- Formulation/delivery platform (DepoVaxTM) and cancer target (survivin)
- Phase 1/1b with DPX-Survivac + Metronomic Oral Cyclophosphamide completed in 56 patients
- We are in our industry’s ”race of all time,” to increase the number of patients responding to immuno-
therapy beyond the current 20 percent industry average
- Triple combination with checkpoints inhibitors from Incyte and Merck (IDO1, PD-1 inhibitors)
- Three Phase 2 clinical trials and one Phase 1b ongoing in ovarian cancer and DLBCL
- Potential expansion in multiple other indications: breast, melanoma, lung, colorectal…
5 © 2017 Immunovaccine Inc. All rights reserved.
Investment opportunity
• Partners: Incyte, Merck, Merck Kga, Dana Farber Cancer Institute, UConn Health, Leidos, Zoetis
• DepoVax provides multiple opportunities of partnering: neo epitopes, infectious diseases vaccines (RSV, Malaria, Zika)
• Potential new applications with different products and diseases (eg: DNA, mRNA delivery, Allergies,…)
• Strong financial position
- Three set of clinical results reported in 2016
- Five clinical milestones projected in 2017 including pivotal results with Incyte in Q4
- Raised $16m in 2016 – cash to cover current business plan well beyond major clinical milestones to H2 2018
- TSX IMV: $1.50 (52 weeks Low: 0.51 - High:1.53) – Market cap: $175M
6 © 2017 Immunovaccine Inc. All rights reserved.
Immuno-oncology Platform & Product
• 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
© 2017 Immunovaccine Inc. All rights reserved.7
Cancer Survivin %
Ovarian 90
Breast 90
Melanoma 90
Lung 53
Colorectal 54
Gastric 94
Kidney 23-82
Glioblastoma 80
ALL 70
CML 70
MDS 90
DLBCL 60
Encapsulate in a Liposome
+ Lyophilize + suspend in oil
Combination Immunotherapy Opportunity
• T cell infiltration has emerged as the key component of immunotherapy efficacy
• Combination immunotherapy: a road map, JITC 2017 5:16
- Patrick A. Ott, F. Stephen Hodi, Howard L. Kaufman, Jon M. Wigginton and Jedd D. Wolchok
- Immuno-oncology making significant impact on cancer but not sufficiently active for many patients
- Anti-PD-1 pathway backbone in many combination strategies
- Extensive clinical benefit and tolerable side effects is so far unparalleled; there are no other compounds on the horizon that could take the place of PD-1 pathway inhibition for this purpose
- Emerging evidence that immune checkpoint blockade is effective primarily in tumors that are already recognized by the immune system, as manifest by a pre-existing CD8+ T cell infiltrate
- T cell activation vaccines and IDO1 inhibitors highlitghed
© 2017 Immunovaccine Inc. All rights reserved.8
Combination Immunotherapy Opportunity
© 2017 Immunovaccine Inc. All rights reserved.9
TIL+
Most likely to
benefit from
single-agent anti–
PD-1/L1
TIL -
Poor prognosis
Non responders
to single agent
Combination Immunotherapy Opportunity
© 2017 Immunovaccine Inc. All rights reserved.10
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
ce
r T
yp
e
Colorectal
Clinical Strategy Ovarian Cancer
Phase 1
Phase 1b
Strong sustained T cell
activation
Best dose regimen
Prime + boost
Increased expression of
checkpoint inhibitors
Clinical benefit POC
Triple
Combination
Trials with IDO
and PD-1
inhibitors
43% Tumor
shrinkage
High Level T
cells maintained
for a year
© 2017 Immunovaccine Inc. All rights reserved.11
Phase 1b Combination Trial with Incyte
• Phase 1b combination (DPX-Survivac + epacadostat) in recurrent ovarian cancer
- Platinum resistant and sensitive subjects who have completed first-line treatment and have evidence of measurable disease
- Up to 40 with minimum of 16 evaluable patients, one arm, open-label, safety and efficacy study
- Company sponsored – Immunovaccine leading the trial with sites in US and Canada
- Interim results by the end of March
- Expected Completion: Q4 2017 (top-line results)
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
Immunovaccine Goal
Demonstrate DPX-Survivac can send CD8+ T cell to the tumor which with the help of IDO inhibitor can
be effective in reducing or eliminating the tumor
© 2017 Immunovaccine Inc. All rights reserved.12
Phase 1b Combination Trial with Incyte
• Last week of March: Interim results on first 4 patients
• Patients with recurrent progressive disease - CT scans over one year with mandatory biopsies before and aftertreatment
© 2017 Immunovaccine Inc. All rights reserved.13
Biopsies
CT Scan
Interim
Results
Anti PD-1
window of
Response
Phase 1b Combination Trial with Incyte
• 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
© 2017 Immunovaccine Inc. All rights reserved.14
Phase 2 Combination Trial with Merck
• Phase 2 combination (DPX-Survivac + pembrolizumab (anti-PD-1)) in recurrent ovarian cancer
- Platinum resistant subjects who have completed first-line treatment and have evidence of measurable disease
- 42 patients
- Funded by Merck - Investigator sponsored (Princess Margaret Hospital) - sites in Canada
- Initiation: Q2 2017
© 2017 Immunovaccine Inc. All rights reserved.15
Endpoints
Primary: Overall response rate (ORR)
Secondary: Progression free survival (PFS) rate, overall survival (OS) rate, Number of side effects
IMV Goal
Demonstrate to Merck DPX-Survivac can send CD8+ T cells to the tumor and make it more responsive
to pembrolizumab – pembrolizumab has an efficacy (ORR) of 11% in ovarian cancer
Indication Product Trials Timing Partners
Ovarian DPX Survivac + mCPA Completed
DPX Survivac + mCPA + IDO1 Ongoing
DPX Survivac + mCPA + PD-1 Ongoing
DLBCL DPX Survivac + mCPAOngoing
DPX Survivac + mCPA + PD-1 Q1 2017 Large Pharma
HPV cervical
cancerDPX E7 First patient Q1
Pipeline
© 2017 Immunovaccine Inc. All rights reserved.16
Phase 1/1b
Phase 2
Phase 2
Phase 1b
Phase 2
Phase 1/2
Indication Product Trials Timing Partners
RSV DPX-SHe AntigenTop line Results
October 2016
ZIKA/MALARIA Antigen Preclinical
Vet vaccines Contraception, BVDV Animal trials 2021 market
Partnering
© 2017 Immunovaccine Inc. All rights reserved.17
Phase 1
RSV Phase 1 Clinical Results (12 Month Data)
• 23 amino acid peptide, Elderly population, 50ul dose volume
© 2017 Immunovaccine Inc. All rights reserved.18
Step 2: DPX-RSV(A) (n=8)
0 100 200 300 400 5000
1
2
3
4
5
6
Study Day:
Vaccination:
En
dp
oin
t L
og
Tit
er
2017 Milestones
© 2017 Immunovaccine Inc. All rights reserved.
Milestones Expected date
RSV Phase 1 interim results July 2016
Phase 1/1b clinical results in ovarian cancer August 2016
First patient with Incyte in Ovarian cancer Sept 2016
RSV Phase 1 Final results 6 month data Oct. 2016
DPX-Neo (Uconn Health) preclinical results Oct. 2016
Combination trial with Merck Q1 2017
Interim clinical results with Incyte in Ovarian cancer Q1 2017
RSV Phase 1 Final results 12 month data Q2 2017
Interim clinical results from Dana Farber Cancer Institute in HPV cancers Q4 2017
Interim clinical results with Merck in Ovarian cancer Q4 2017
Top line clinical results with Incyte in Ovarian cancer Q4 2017
19
Management Team
© 2017 Immunovaccine Inc. All rights reserved.20
Pierre Labbé, CPA Chief Financial Officer
25 years experience
Gabriela Rosu, MD Chief Medical Officer
16 years of experience
Rita Nigam, PhD Vice-President of Clinical
21 years experience
Leeladhar Sammatur, MSc Vice-President of Manufacturing
19 years experience
Marianne Stanford, PhD Vice-President of Research
13 years experience
Annie Tanguay, BSc Senior Director of Quality Assurance
15 years experience
Frederic Ors, MSc/MA Chief Executive Officer
19 years experience
© 2017 Immunovaccine Inc. All rights reserved.
Immunovaccine Inc.
1344 Summer Street, Suite 412
Halifax, Nova Scotia, B3H 0A8
Tel: 902.492.1819
Fax: 902.492.0888