- The presentation provides an overview of Oncolytics Biotech Inc. and its lead product candidate REOLYSIN®, an oncolytic virus being developed as a cancer therapeutic.
- Data is presented showing REOLYSIN®'s ability to reduce tumor burden through direct cytotoxic effects and stimulate anti-tumor immune responses, improving overall survival in clinical trials.
- Oncolytics has conducted over 30 clinical trials across many cancer types and is preparing registration trials in indications like pancreatic cancer based on favorable results. Manufacturing and a strong patent portfolio were also summarized.
2. Forward Looking Statements
This presentation contains certain forward looking statements relating to the
Company’s financial results, business prospects, and the development and
commercialization of REOLYSIN®, a therapeutic reovirus. These statements are based
on management’s current expectations and beliefs, and are subject to a number of
factors which involve known and unknown risks, delays, uncertainties and other
factors not under the Company’s control which may cause actual results, performance
or achievements of the Company to be materially different from the results,
performance or other expectations implied by these forward looking statements.
In any forward looking statement in which Oncolytic Biotech® Inc. expresses an
expectation or belief as to future results, such expectations or beliefs are expressed in
good faith and are believed to have a reasonable basis, but there can be no assurance
that the statement or expectation or belief will be achieved. These factors include
results of current or pending clinical trials, risks associated with intellectual property
protection, financial projections, market projections, actions by regulatory authorities
including but not limited to the FDA, HPB and MHRA, and those other factors detailed
in the Company’s filings with SEDAR and the Securities and Exchange Commission.
Oncolytics Biotech® Inc. does not undertake an obligation to update these forward
looking statements, except as required by applicable laws.
2
3. Oncolytics Overview
Conducted 30+ clinical
studies in 13 indications
400+ issued patents and
235 pending
applications worldwide
1,100+ patients treated;
strong safety profile
Developing REOLYSIN®
(oncolytic virus) as a
cancer therapeutic
$22.6 million total
current assets as at the
end of Q1, 2016
Manufacturing
at commercial scale
100L cGMP completed
3
4. What is REOLYSIN®?
A proprietary isolate
of wild-type reovirus
Serotype 3 Dearing
Non-pathogenic
Most humans show
evidence of exposure
by adulthood
4
5. Safety Profile of REOLYSIN®
General Safety
1,100+ patients treated, 1,000+ of these intravenously
No maximum tolerated dose (MTD) reached
Safety profile confirmed in a randomized setting
Monotherapy Safety
Mild toxicities (grade 1 or 2) including
Transient grade 3 and 4 toxicities included lymphopenia or
neutropenia – symptoms usually last < 6 hours
• Chills
• Fever
• Headache
• Cough
• Myalgia
• Runny nose
• Sore throat
• Fatigue
• Lymphopenia or neutropenia
5
6. Clinical Program for REOLYSIN®
GLIOMA
PROSTATE
OVARIAN
COLORECTAL
LUNG
PANCREATIC
MYELOMA
MELANOMA
HEAD AND NECK
BREAST
BLADDER
Indication Studies
Ongoing Study Completed Study
REO 001
PhaseI
REO 007
PhaseI/II
REO 002
PhaseI
REO 003
PhaseI/II
REO 004
PhaseI
REO 005
PhaseI
NCI-7848
PhaseII
REO 009
PhaseI
REO 011
PhaseI/II
MC-1472
PhaseI
REO 015
PhaseII
REO 017
PhaseI/II
REO 018
PhaseIII
REO 020
PhaseII
REO 022
PhaseII
GOG-0186H
PhaseII
REO 013 Brain
PhaseI
NCI-8601
PhaseII
IND 209
PhaseII
IND 210
PhaseII
NCI-7853
PhaseI/II
IND 213
PhaseII
NCI-9030
PhaseI
NCI-9603
Translational
REO 014
PhaseII
REO 016
PhaseII
REO 021
PhaseII
IND 211
PhaseII
REO 008
PhaseII
COG-ADVL1014
PhaseI Orphan Status
Orphan Status
Orphan Status
REO 023
Run-InStudy
REO 019
PhaseIb
REO 024
PhaseIb
6
7. REOLYSIN®: Two Mechanisms of Action
1. In cancer cells with Ras pathway activating
mutations (Braf, Kras and EGFR), REOLYSIN®
acts as a directed cytotoxin and thereby
reduces tumour burden.
2. REOLYSIN® also interacts with the immune
system in at least two known ways, thereby
functioning as an immune therapy that
extends overall survival.
7
9. Neoadjuvant Treatment of Muscle-Invasive Bladder Cancer
Prior studies in other indications have indicated that REOLYSIN® may be an effective
neoadjuvant agent due to its ability to rapidly reduce tumour burden (e.g. the REO 018
head and neck study)
We are initiating a study to confirm clinical response rates in muscle-invasive bladder
cancer and, once confirmed, will proceed to a registration study
Multiple Myeloma
We have completed and/or initiated three studies of REOLYSIN® in multiple myeloma
patients
These studies have confirmed very high response rates in patients who have failed, or
are refractory to, standard of care
We are preparing to file for a registration study in this indication of the basis of results
from studies in this indication to date
Registration Program for REOLYSIN®: Studies
with Tumour Reduction Endpoints
9
10. Days after REOLYSIN® administration:
0 3 43 88 167 537
REO 003: REOLYSIN® Intratumoural
Monotherapy Anaplastic Astrocytoma
Early Cytotoxic Activity Followed by Late Stage Immune-Mediated
Response Against the Residual Tumour
Viral replication mediated
tumour response
Post debulking Immune mediated tumour response
10
11. REO 021: Partial Response in Patient with
Squamous Cell Carcinoma of the Lung
Right Upper Lung Mass (8.3 cm)
Pre-Treatment
Right Pleural Met (2.2 cm)
Right Upper Lung Mass (4.1 cm)
Post-Cycle 2
Right Pleural Met (0.8 cm)
Right Upper Lung Mass (3.6 cm)
Post-Cycle 4
Right Pleural Met (0.4 cm)
11
12. REOLYSIN® Plus Carfilzomib Response Data in
Multiple Myeloma
-100
-90
-80
-70
-60
-50
-40
-30
-20
-10
0
5 8 4 7 6 3 1 2
%CHANGEOFMONOCLONALPROTEIN
PATIENTS EVALUABLE FOR RESPONSE
Responses evaluated using International Myeloma Working Group (IMWG) Criteria :
• Patients 1 & 2 = Very Good Partial Response (VGPR)
• Patients 3, 6 & 7 = Partial Response (PR)
• Patients 4, 5 & 8 = Minor Response (MR)
12
13. Colorectal Cancer: Randomized Tumour
Specific Data
Patients were treated with FOLFOX 6/Avastin® plus or
minus REOLYSIN®
Female patients with or without metastases on the test
arm had a 63.2% objective response rate (n=19) versus
23.8% on the control arm (n=21) (p=0.0054)
If patients had liver metastases (with or without other
metastases), patients in the test arm had a 55%
objective overall response rate (n=40) versus 28.6% in
the control arm (n=42) (p=0.0077)
A 51% increased reduction in median total liver
metastatic tumour volume in the test arm versus the
control arm(Kaplan-Meier curve, p= 0.0378, n=27)
13
14. Post-Cycle 2
14
Post-Cycle 6
Partial Response in Metastatic Liver Tumors –
REOLYSIN®/Paclitaxel/Carboplatin (Phase 1)
Pre-Treatment
• Diagnosis: Metastatic sinu-nasal carcinoma with marked progression of pelvic and hepatic disease
• Prior Treatment: Radiotherapy
15. Pre-Treatment Post-Cycle 3
• Treatment History: Radiation (2 cycles); cisplatin, gemcitabine/carboplatin,
carboplatin/5-FU (6 cycles); docetaxel (3 cycles)
• Liver metastases reduced from 59.4 mm at baseline to 19 mm post-Cycle 3
15
Partial Response in Metastatic Nasopharyngeal Cancer
– REOLYSIN®/Paclitaxel/Carboplatin (Phase 2)
16. Other Randomized Clinical Trial Data:
Tumour-Specific Responses
Head and Neck Cancer (REO 018)
Velocityof Tumour Shrinkage: An analysis of 105 patients showed that 86%
of the test arm (n=50) versus 67% of the control arm (n=55) had tumour
stabilization or shrinkage (p = 0.025)
Volumetric Tumour Reduction:
• An analysis of 118 loco-regional patients with or without distal metastases
showed that the test arm had a 23% greater volumetric reduction than the
control arm (p = 0.076)
• An analysis of 47 patients with distal metastases only showed that the test
arm had a 30% greater volumetric reduction than the control arm (p = 0.021)
Ovarian Cancer (GOG-0186H)
The rate of full response was 9.26% in the test arm versus 1.85% in the
control arm (p = 0.0196)
The rate of stable disease or better was 44.44% in the test arm versus
24.08% in the control arm (p = 0.0096)
16
18. Advanced Gliomas
We have completed and/or initiated/about to initiate five studies of REOLYSIN® in
glioma patients including an ongoing Phase 1 IV combined with GM-CSF in pediatric
patients, and a study assessing response in patients receiving REOLYSIN® and the
standard of care (surgery followed by radiation and temozolomide)
Subject to confirmation of best approach, we will proceed to a pivotal trial, which will
also measure overall survival
Patients With Metastases to the Liver
We have completed enrolment in studies with head and neck cancer and colorectal
cancer (CRC), both with significant metastases of the liver.
Subject to confirmation of results from the CRC study, we will proceed to a pivotal trial,
which will also measure overall survival
Registration Program for REOLYSIN®: Studies
with Overall Survival Endpoints
18
19. Days after REOLYSIN® administration:
0 3 43 88 167 537
REO 003: REOLYSIN® Intratumoural
Monotherapy Anaplastic Astrocytoma
Early Cytotoxic Activity Followed by Late Stage Immune-Mediated
Response Against the Residual Tumour
Viral replication mediated
tumour response
Post debulking Immune mediated tumour response
16
20. Patient Outcomes Are Influenced By
Immune Status
The survival rate of ovarian cancer patients with high PD-L1 expression on
entry is statistically significantly worse than that of patients with low PD-L1
expression on entry
Five year survival was 80.2% for patients with low PD-L1 expression on entry and 52.6% for
those with high PD-L1 expression on entry (p = 0.016)
Mean survival was 9.56 years for patients with low PD-L1 expression on entry and 6.48 years
for those with high PD-L1 expression on entry1
The survival rate of ovarian cancer patients with high intraepithelial CD8+ T
lymphocyte counts on entry is statistically significantly better than that of
patients with low CD8+ T lymphocyte counts
Five year survival was 86.9% for patients with high CD8+ T lymphocyte counts on entry and
39% for those with low CD8+ T lymphocyte counts on entry (p < 0.001)
Mean survival was 9.6 years for patients with high CD8+ T lymphocyte counts on entry and 4.7
years for those with low CD8+ T lymphocyte counts on entry1
1 Hamanishi et al. 2007. Programmed cell death 1 ligand 1 and tumor-infiltrating CD8+ T lymphocytes are prognostic
factors of human ovarian cancer. PNAS 104(9):3360-3365.
20
21. REOLYSIN® in Multiple Myeloma
Variable
REOLYSIN®
Monotherapy,
Pre-Treatment
REOLYSIN®
Monotherapy,
Post-Treatment
Statistics
REOLYSIN® +
Carfilzomib,
Pre-
Treatment
REOLYSIN® +
Carfilzomib,
Post-
Treatment
Statistics
CD8 58.0 (21.5) 63.9 (18.3)
not
significant
37.8 (8.5) 84.6 (26.8) p=0.060
PD-L1 20.8 (9.2) 30.6 (11.5)
not
significant
74.2 (49.5) 208.2 (31.1) p=0.005
caspase-3 5.4 (0.6) 6.2 (0.9)
not
significant
6.2 (0.8) 24.8 (4.3) p=0.005
Data supplied by Dr. G. Nuovo
21
22. Top-Line Overall Survival (OS) Results
REO 017 (Pancreatic Cancer) – Comparison with ACCORD 11 and MPACT Studies:
Treatment n
CA19.9 ≥20%
Decrease from
Baseline
Median
PFS
(months)
Median OS
(months)
1-Year
Survival
(%)
2-Year
Survival
(%)
Gemcitabine (ACCORD 11)
(Conroy et al., 2011)
171 N/A 3.3 6.8 20 2
Gemcitabine (MPACT)
(Van Hoff et al., 2013)
(Goldstein et al., 2015)
430 44 3.7 6.6 22 5
Gemcitabine/REOLYSIN®
(REO 017)
33 70 4.0 10.2 45 24
22
23. Top Line Overall Survival (OS) Results
23
REO 016 (Non-Small Cell Lung Cancer) – Comparison with Schiller et al., 2002:
Treatment n
Median PFS
(months)
Median OS
(months)
1-Year
Survival (%)
2-Year
Survival
(%)
Carboplatin and paclitaxel
(Schiller et al., 2002)
290 3.1 8.1 34 11
Carboplatin, paclitaxel and
REOLYSIN® (REO 016)
37 4.0 13.1 57 30
24. Enhancing Immune Responses to
Improve Overall Survival
Ongoing preclinical and clinical research has led to
three clinical programs:
1. Gemcitabine in combination with REOLYSIN® (REO 009
and REO 017);
2. GM-CSF in combination with REOLYSIN® (Mayo
(pediatric) and Leeds (adult)); or
3. Checkpoint inhibitors in combination with REOLYSIN®
(first study: pancreatic cancer, standard of care plus
REOLYSIN® plus pembrolizumab)
24
26. Manufacturing
Now produced at commercial scale (100L) under cGMP with final formulation
Commercial manufacturing agreement in place with Sigma-Aldrich® Fine
Chemicals (SAFC)
26
27. Patent Portfolio
More than 400 patents issued worldwide,
including 56 US and 20 Canadian
Approximately 235 pending patent
applications worldwide
Issued patent claims for reovirus cover:
Compositions of matter comprising
reovirus
Pharmaceutical use of reoviruses to
treat neoplasia and cellular
proliferative diseases
Combination therapy with radiation,
chemotherapy and/or immune
suppressants
Methods for manufacturing reovirus
and screening for susceptibility to
reovirus
Pharmaceutical use of reoviruses in
transplantation procedures
24
29. Market & Capital Data
(all amounts in CAD)
Exchanges OTCQX:ONCYF
TSX:ONC
FRA:ONY
Shares Outstanding (March 31,
2016)
118,697,122
Price
Options Outstanding (March 31,
2016)
$2.17
(weighted
average)
8,561,394
Fully Diluted (March 31, 2016) 127,258,516
Total Current Assets (March 31,
2016)
$22.6 M
29
30. Investment Highlights
Five ongoing randomized Phase II studies
Ovarian, colorectal, non-small cell lung, prostate and breast cancers
Recently initiated first checkpoint inhibitor study
in patients with pancreatic cancer
Preparing for registration study
Positive safety data for 1,100+ patients
Strong intellectual property portfolio
More than 400 issued patents worldwide
Manufacturing at commercial scale
30