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Reolysin

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Reolysin

  1. 1. TSX:ONC NASDAQ:ONCY Investor Presentation February 2009 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®. These statements are based on management’s current e pectat o s and beliefs and are expectations a d be e s a d a e subject to a number o factors which involve known and u be of acto s c oe o ad 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 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 trials 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.
  2. 2. Oncolytics Biotech Inc. • corporate focus is on the development of oncolytic viruses for the treatment of cancer • lead product is REOLYSIN® Mode of Action • REOLYSIN contains the reovirus, a naturally occurring, 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
  3. 3. Reovirus Growth in a Ras Activated Cell Intellectual Property • More than 200 patents issued worldwide including 31 U.S. and 9 CDN • reovirus issued patent claims cover p - 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
  4. 4. Manufacturing • successful development of a proprietary cell growth medium • cGMP material now produced at p 40L with Sigma Aldrich • 100L scale-up work completed SAFC Pharma Carlsbad • leading CMO for viral intermediates and final drug product • commercial capabilities planned for 2009 Clinical Trial Program- Strategic Direction • perform parallel studies in a number of indications either as a monotherapy or in combination y • determine the most promising indications of efficacy and safety [signal] • use data from these trials to make strategic decisions regarding pivotal studies • first pivotal trial will be a Phase II/III randomized trial using REOLYSIN + paclitaxel/carboplatin for patients with refractory head and neck cancers
  5. 5. REOLYSIN Clinical Trial Program 2009 Clinical Sites - Oncolytics + NCI Albert Einstein College of The University of Mayo Clinic Rochester, Medicine/Montefiore Karmanos Cancer Michigan Comprehensive The Ohio State USA Beatson Oncology Medical Center, Institute, Wayne State Cancer Center, USA University, Centre, USA University, USA USA Minnesota Oncology UK Hematology, USA St. James’s Hospital, UK Tom Baker C T B k Cancer Southampton Hospital, Center, Canada UK University of Wisconsin, The Royal Marsden USA Hospital Sutton, UK University of California The Royal Marsden San Francisco, USA Hospital London, UK Cedars-Sinai Medical Prince of Wales Center, USA Hospital, Hong Kong Mayo Clinic Guy’s Hospital, UK Scottsdale, USA Institute of Drug The Churchill Hospital, Development/Cancer UK Therapy Research Center, USA The Royal Surrey Hospital and Mt. The Center for Cancer Alvernia, UK Care and Research, USA Sidney Kimmel Howard University, University of Alabama at Comprehensive Cancer USA Birmingham, Christie Hospital, UK Center at Johns Hopkins, Mayo Clinic Jacksonville, Washington University, USA USA USA USA Oncolytics sites NCI sites
  6. 6. Safety • >250 patients now treated, >160 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, 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 Systemic (IV) Administration • largest potential patient population • well tolerated in 51 patients in two completed Phase I studies • demonstrable tumour regressions in a number of different cancer indications
  7. 7. Clinical Overview - Systemic Monotherapy Trial Patient Population Tumour Response Phase I systemic Late-stage or 30% showed stable disease or better administration (UK) advanced cancer - Colorectal cancer 2 patients : Stable disease at 3 and 6 patients who have ti t h h months; CEA tumor marker reduction of 27% and 68% failed all other therapies. (N=33) - Metastatic prostate cancer one patient: Stable disease at 4 months 50% decrease in PSA. Biopsy lymph node – EM: Viral replication. Pathology - Necrosis - Metastatic bladder cancer one patient: Stable disease at 4 months. Minor tumor response (24% tumor reduction) in metastatic lesion (lymph node); patient later reported as disease free. - Pancreatic cancer one patient: Stable disease at 4 months. - NSC Lung Cancer one patient: Stable disease at 4 months. - Endometrial cancer one patient: Stable disease at 5 months. Clinical Overview - Systemic Monotherapy Trial Patient Population Tumour Response Phase I systemic Late-stage or 44% showed stable disease or better administration (US) advanced cancer -One partial response i progressive b O ti l in i breast cancer (K t (Kras patients who have mutated patient) failed all other therapies. (N=18)
  8. 8. Monotherapy Systemic Administration Treatment Indication Status Phase II IV REOLYSIN (ONC) Sarcoma Ongoing Phase II IV REOLYSIN (NCI) Metastatic melanoma Ongoing Phase I/II IV and IP REOLYSIN Ovarian, peritoneal Ongoing (NCI) and fallopian tube cancer Translational IV REOLYSIN Metastatic colorectal Ongoing (University of Leeds) Interim Results Phase II Sarcoma Study • Exceeded primary statistical endpoint of Baseline Cycle 10 study in December 2008 • promising interim results; of the 33 pts evaluable for response: - 5 pts with SD for more than 6 mos including 1 pt with SD for more than 17 mos - 10 pts with SD for 3-6 cycles • mild toxicity with constitutional “flu-like” symptoms the most commonly reported toxicity • 43 patients treated to date
  9. 9. Systemic Administration Combination REOLYSIN Chemotherapy Program Treatment combination Indication Status Phase I/II REOLYSIN + gemcitabine (UK) advanced ongoing cancers Phase I/II REOLYSIN + docetaxel (UK) advanced complete cancers Phase I REOLYSIN + cyclophosphamide (UK) advanced ongoing cancers Phase I/II REOLYSIN + carboplatin/paclitaxel (UK) advanced ongoing cancers Phase II REOLYSIN + carboplatin/paclitaxel (UK) H&N ongoing Phase II REOLYSIN + carboplatin/paclitaxel (US) H&N ongoing Phase II REOLYSIN + carboplatin/paclitaxel (US) NSCLC approved prescreened for Kras/EGFR Phase II/III REOLYSIN + carboplatin/paclitaxel H&N pending REOLYSIN/Gemcitabine Combination – Metastatic Nasopharangeal Post 8 cycles Baseline
  10. 10. REOLYSIN/Docetaxel Combination • 16 patients evaluable for response - 2 significant partial responses - 10 stable di t bl disease, i l di 8 stable di including t bl disease f more th 4 cycles for than l • of note, a breast cancer patient with a CR in the liver, and prolonged stabilization for 7 cycles in a pancreatic cancer patient • enrolment completed Dec. 08 REOLYSIN/Docetaxel Combination- Metastatic Breast Cancer CR after 6 cycles Liver mets at baseline prior treatment results • radiation - 4 cycles • target lesion- liver metastases • paclitaxel - 24 cycles • baseline - 28 mm, post cycle 6 - 0 mm, CR • capecitabine - 8 cycles maintained for all 8 cycles • zoladex • non target bone metastases- no change, stable after all 8 cycles
  11. 11. U.K./U.S. Combination REOLYSIN/Paclitaxel/Carboplatin Trial Results • 22 patients treated to date, 19 evaluable • 1 endometrial patient SD after all 8 cycles • 1 melanoma patient has shown response after 3 cycles • 12 head and neck cancer patients (11 platinum-failed) - 5 durable partial responses; (4 platinum-failed) - 4 stable disease • combination resulted in disease control in the majority of the p patients • expected response rate in platinum-failed H&N - 10% • ONCY response rate in platinum-failed H&N - 36%, clinical benefit rate – 73% Phase II REOLYSIN/Paclitaxel/Carboplatin Combination Metastatic Nasopharyngeal Post cycle 3 Pre-treatment results prior treatment • target lesion- liver metastases • radiation - 2 cycles baseline - 59.4 mm • cisplatin, gemcitabine/carboplatin, • post cycle 3 -19 mm carboplatin/5-FU - 6 cycles • Response maintained through 8 cycles • docetaxel - 3 cycles
  12. 12. REOLYSIN + Paclitaxel/Carboplatin Combination– Nasopharynx – Continuing Response After 8 Cycles Post Cycle 3 Pre-treatment Post Cycle 3 Pre-treatment Treatment history: Radiotherapy; 6 cycles of cisplatin; 3 cycles of 5-FU/cisplatin and; Zalutulumab Pivotal (Phase II/III) Program for REOLYSIN • first pivotal program announced November 2008 • randomized Phase II/III trial using REOLYSIN in combination with paclitaxel/carboplatin in patients with refractory head and neck cancers • expected filing date – early 2009
  13. 13. Reolysin: A Treatment For Tumours With RAS Pathway Activation Tumours with RAS pathway p y Activation EGFR Inhibitor 2008 Sales Erbitux - $1.7Bn Tumours with Tumours with Tarceva - $457mm EGFR kRAS Mutation Overexpression Vectibix - $153mm 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 ie. 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 t b i ff ti i K b h to be ineffective in Kras mutated patients t t d ti t • A similar opportunity exists in second line colorectal cancer where 45% of patients have Kras mutations
  14. 14. Market & Capital Data Exchanges NASDAQ:ONCY TSX:ONC Shares Outstanding 43,830,748 Warrants Price Expiring: Dec. 29, 2009 1.80 320,000 Dec. 29, 2011 1.80 2,915,000 Feb. 22, 2010 3.50 2,300,000 Options 4.61 (average) 3,885,993 Fully Diluted (Dec 31 2008) (Dec. 31, 53,251,741 53 251 741 Est. Cash/Cash Equivalents C$12.7 M (Sept. 30, 2008) Monthly Burn Rate 2009 (Approx.) C$1.0 M Summary REOLYSIN - A Broadly Active Novel Cancer Therapy Focused Clinical Program • 10 clinical trials enrolling or approved (inc 5 Phase II trials) (inc. • positive interim and final data emerging including durable clinical responses in lung, liver, and nodal metastatic disease • first pivotal program - Phase II/III REOLYSIN and paclitaxel/carboplatin in refractory head and neck patients Growing Intellectual Property Portfolio • broad t t b d patent coverage in US E i US, Europe and C d Canada d Manufacturing at Commercial Scale • 40L GMP production completed, 100L GMP underway
  15. 15. TSX:ONC NASDAQ:ONCY Investor Presentation February 2009

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