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TSX:ONC NASDAQ:ONCY
Investor PresentationJanuary 2010
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 factorswhich 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.
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
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
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
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 survivalsecondary endpoint: progression-free survivalpharmacodynamic endpoints: tumour Ras pathway status andHPV 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
REOLYSIN clinical overview – Phase I/II Combination Program
Phase I/II Drug Combination Program (UK)
carboplatin/paclitaxel/REOLYSIN• REOLYSIN, d1-5, iv carboplatin (AUC5), d1, and paclitaxel (175mg/m2), d1,
qw3. REOLYSIN was administered at a starting dose of 3x109 TCID50 and then increased to 1x1010 and 3x1010 TCID50 in cohorts of 3 patients
• 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)
Second-Line Other Therapies in Platinum Refractory Patients
Study Reference Response Rate Median TTP or PFS (months)
Median Survival(months)
Various treatments or Best Supportive care
Léon et al., 2005 2.6% No Data 3
Various Vermorken, 2009 No data 1.9 4.5
Carboplatin/paclitaxel Vermorken’sEstimate for controlarm in REO 018Personal communication
10% 2.0 4.5 (refractory)6.5 (pt failed)
REOLYSIN + carboplatin/paclitaxelH&N patients (N=19)November 17, 2009
RR 42% (8 PRs), CBR 74%(8 PRs, 6 SDs)
N/A N/A
Interim Results Compared to Historical Controls
Pre-treatment Pre-treatment
Post 6 Cycles Post 6 Cycles
Phase I REOLYSIN/Paclitaxel/Carboplatin – Lung and Head & Neck Tumours – Response Maintained for 8 Cycles
Prior treatment: radiotherapy; cisplatin/fluorouracil – 6 cycles
Phase II REOLYSIN/Paclitaxel/Carboplatin Combination Metastatic Nasopharyngeal
Pre-treatment Post cycle 3prior treatment • radiation - 2 cycles• cisplatin, gemcitabine/carboplatin,
carboplatin/5-FU - 6 cycles• docetaxel - 3 cycles
results•target lesion - liver metastases
baseline - 59.4 mm•post cycle 3-19 mm•response maintained through 8 cycles
Treatment history:palliative RT cisplatin + 5FU carboplatin + 5FU
Pre-treatment
UK Phase II REOLYSIN/Carbo/Taxol Combination Partial Response in Poorly Differentiated SCC H&N
Post Cycle 3
Pre-treatmentRapid progression in <3 weeks before Study
After 3 cycles
Treatment history: cisplatin + 5 FU; RT/cisplatin;
UK Phase II REOLYSIN/Carbo/Taxol Combination Partial Response in SCC H&N
REOLYSIN: A Broader Market Opportunity
Tumors with Ras pathway activation
Erbitux - $1.7BTarceva - $457M
2008 Sales
Vectibix - $153 M
EGFR Inhibitorscontra-indicated:KRas mutated- NSCLC- Colorectal
cancer
REOLYSIN is effective in both situations
Tumors with Ras Mutation
No ApprovedTherapies
Tumors with EGFR
Overexpressedor
Mutated
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
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
Increasing Vascular Efflux Through Manipulation of VEGF Signalling
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 tumors
Sunitinib
Avastin
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
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
Manufacturing
• successful development of a proprietary cell growth medium• commercial cGMP process established• cGMP now produced at 100L
Market & Capital Data
Exchanges NASDAQ:ONCYTSX:ONC
Shares Outstanding (Dec. 9, 2009) 61,549,969
Warrants PriceExpiring:
Feb. 22, 2010 $3.50 2,300,000Nov. 23, 2014 $3.50 1,700,000Dec. 2, 2014 $3.50 255,000
Options $4.72 (average) 3,936,893
Fully Diluted (Dec. 9, 2009) 69,741,862
Est. Cash/Cash Equivalents C$36.0 M (Dec. 6, 2009)
Monthly Burn Rate 2009 (Approx.) C$1.3 M
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
TSX:ONC NASDAQ:ONCY
Investor PresentationJanuary 2010