Reolysin

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  • 1. TSX:ONC NASDAQ:ONCY Investor Presentation January 2010
  • 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
  • 20. Market & Capital Data Exchanges NASDAQ:ONCY TSX:ONC Shares Outstanding (Dec. 9, 2009) 61,549,969 Warrants Price Expiring: Feb. 22, 2010 $3.50 2,300,000 Nov. 23, 2014 $3.50 1,700,000 Dec. 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
  • 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
  • 22. TSX:ONC NASDAQ:ONCY Investor Presentation January 2010