2. Forward Looking Statements
Today’s 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
Oncolytics 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
the FDA/HPB/MHRA and those other factors detailed in the company’s filings with SEDAR
and the Securities and Exchange Commission. Oncolytics does not undertake an obligation
to update the forward looking statements, except as required by applicable laws.
3. Summary
REOLYSIN - A Broadly Active Novel Cancer Therapy
Focused Clinical Program
• lead product is REOLYSIN®
• SPA agreed with the FDA for first pivotal program –
Phase III REOLYSIN and paclitaxel/carboplatin in platinum-refractory
head and neck cancer patients
• this drug platform expanding to include NSCLC, melanoma and
squamous cell lung cancer
Growing Intellectual Property Portfolio
• broad patent coverage in US, Europe and Canada
Manufacturing at Commercial Scale
• 100L cGMP completed
4. Mode of Action
• REOLYSIN is a proprietary
isolate of the reovirus, a
replication competent virus
• asymptomatic in humans (does
not cause disease)
• replicates in Ras-activated
cancers
• at least 2/3 of carcinomas and
more than 90% of metastatic
disease has Ras involvement
• at least 5M new patients per
year are predicted to develop
cancers with Ras involvement
5. REOLYSIN Pipeline
Indication Preclinical Phase 1 Phase 2 Phase 3
Head & neck (REO 018)
in combination with carboplatin + paclitaxel
NSCLC (KRAS screened) (REO 016)
in combination with carboplatin + paclitaxel
Melanoma (REO 020)
in combination with carboplatin + paclitaxel
as monotherapy
Squamous cell carcinoma lung (REO 021)
in combination with carboplatin + paclitaxel
Pancreatic (REO 017)
in combination with gemcitabine
Sarcoma metastatic to lung (REO 014)
as monotherapy
Ovarian
as monotherapy
with carboplatin + paclitaxel
Colorectal (KRAS screened) (REO 022)
in combination with irinotecan
6. Pivotal (Phase III) Program for REOLYSIN
• Phase III trial examining REOLYSIN in combination with
paclitaxel/carboplatin in patients with platinum-refractory head and
neck cancers
• randomized, two-arm, double-blind, multicentre, two-stage, adaptive
trial
• first company to have an intravenously administered oncolytic virus
approved under the SPA program
• primary endpoint: overall survival
secondary endpoint: progression-free survival
pharmacodynamic endpoints: tumour Ras pathway status and
HPV status
• two-stage Phase III trial
- 80 patients in first stage
- adaptive design in second stage allows for detection of a range of
increases in overall survival by enrolling from 100 to 400 patients, with
the most probable being ~200
7. REOLYSIN clinical overview – Phase I/II
Combination Program
Phase I/II carboplatin/paclitaxel/REOLYSIN
Drug • REOLYSIN, d1-5, iv carboplatin (AUC5), d1, and paclitaxel (175mg/m2), d1,
Combination qw3. REOLYSIN was administered at a starting dose of 3x109 TCID50 and then
Program increased to 1x1010 and 3x1010 TCID50 in cohorts of 3 patients
(UK)
• there were no DLTs in the dose escalation. Toxicities were mainly grade 1 and 2
and included: nausea, fatigue, vomiting, myalgia, fever, neutropenia,
lymphopenia, thrombocytopenia and hypotension
• this combination resulted in a blunting of antiviral immune response as
compared to monotherapy virus
• response rates in 19 evaluable patients were partial response (PR) (5 pts),
stable disease (SD) (8 pts) and progressive disease (PD) (6 pts). Of note, all
PRs and 4/8 SDs were in H&N disease
• a total disease control rate (CR+PR+SD) of 68% was achieved to date
• positive results in head and neck disease led to the filing of two single arm
Phase II studies in refractory head and neck disease (US & UK)
8. Interim Results Compared to Historical Controls
Second-Line Other Therapies in Platinum Refractory Patients
Study Reference Response Rate Median TTP Median Survival
or PFS (months)
(months)
Various treatments or Léon et al., 2005 2.6% No Data 3
Best Supportive care
Various Vermorken, 2009 No data 1.9 4.5
Carboplatin/paclitaxel Vermorken’s 10% 2.0 4.5 (refractory)
Estimate for 6.5 (pt failed)
control
arm in REO 018
Personal
communication
REOLYSIN + RR 42% (8 PRs), N/A N/A
carboplatin/paclitaxel CBR 74%
H&N patients (N=19) (8 PRs, 6 SDs)
November 17, 2009
9. Phase I REOLYSIN/Paclitaxel/Carboplatin – Lung and Head &
Neck Tumours – Response Maintained for 8 Cycles
Pre-treatment Pre-treatment
Post 6 Cycles Post 6 Cycles
Prior treatment: radiotherapy; cisplatin/fluorouracil – 6 cycles
10. Phase II REOLYSIN/Paclitaxel/Carboplatin
Combination Metastatic Nasopharyngeal
Pre-treatment Post cycle 3
prior treatment results
• radiation - 2 cycles •target lesion - liver metastases
• cisplatin, gemcitabine/carboplatin, baseline - 59.4 mm
carboplatin/5-FU - 6 cycles •post cycle 3-19 mm
• docetaxel - 3 cycles •response maintained through 8 cycles
11. UK Phase II REOLYSIN/Carbo/Taxol Combination
Partial Response in Poorly Differentiated SCC H&N
Pre-treatment
Post Cycle 3
Treatment history:
palliative RT
cisplatin + 5FU
carboplatin + 5FU
12. UK Phase II REOLYSIN/Carbo/Taxol Combination
Partial Response in SCC H&N
Pre-treatment
Rapid After 3 cycles
progression
in <3 weeks
before Study
Treatment history: cisplatin + 5 FU; RT/cisplatin;
13. REOLYSIN: A Broader Market Opportunity
EGFR Inhibitors
contra-indicated: Tumors with Ras pathway
KRas mutated
activation
- NSCLC
- Colorectal
cancer
2008 Sales
Tumors with Tumors with Erbitux - $1.7B
Ras Mutation EGFR
Tarceva - $457M
Overexpressed
No Approved or Vectibix - $153 M
Therapies Mutated
REOLYSIN is effective in both situations
14. Phase II NSCLC and Kras/EGFR
U.S. Phase II
• for NSCLC prescreened for Kras and EGFR mutation status
• 15 to 20% of NSCLC is Kras mutated and up to 50% is EGFR
mutated or over expressed
• first line therapy study i.e. patients will be offered
REOLYSIN/paclitaxel/carboplatin instead of standard of care
if they are Kras or EGFR mutated or EGFR over expressed,
all of which cause Ras pathway activation
• current standard of care includes EGFR inhibitors which have
been shown to be ineffective in Kras mutated patients
15. Colorectal Cancer and Kras
• current standard of care for second-line patients also includes
EGFR inhibitors
• 45% of second-line colorectal patients have Kras mutations
• preclinical work completed using reovirus in combination with
irinotecan
16. Increasing Vascular Efflux Through
Manipulation of VEGF Signalling
Sunitinib
B-16 Melanoma Mouse Model
• transient destabilization and
permeabilization of tumor vasculature
enhances localization of circulating
REOLYSIN
• therapy is associated with increased
vascular permeability to circulating
virus and increased virus recovery from
Avastin tumors
17. Safety
• >285 patients treated, >200 intravenously at doses up to 3x1010
TCID50 daily
• no maximum tolerated dose (MTD) reached to date
• toxicities have been generally mild (grade 1 or 2) and included
chills, fever, headache, cough, myalgia, runny nose, sore throat
and fatigue, and grade 1 or 2 lymphopenia and neutropenia.
Transient grade 3 and 4 toxicities included lymphopenia and
neutropenia. These symptoms were more frequently observed
from day 2 of treatment and usually lasted less than 6 hours
18. Intellectual Property
• more than 200 patents issued worldwide including
33 U.S. and 11 CDN
• reovirus issued patent claims 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
• more than 180 pending applications worldwide
19. Manufacturing
• successful development of a proprietary cell growth medium
• commercial cGMP process established
• cGMP now produced at 100L
21. Summary
REOLYSIN - A Broadly Active Novel Cancer Therapy
Focused Clinical Program
• lead product is REOLYSIN®
• SPA agreed with the FDA for first pivotal program - Phase III
REOLYSIN and paclitaxel/carboplatin in platinum-refractory head and
neck cancer patients
• this drug platform expanding to include NSCLC, melanoma and
squamous cell lung cancer
Growing Intellectual Property Portfolio
• broad patent coverage in US, Europe and Canada
Manufacturing at Commercial Scale
• 100L cGMP completed
