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Corporate presentation-(september-2015-corrected)

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Corporate presentation-(september-2015-corrected)

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Corporate presentation-(september-2015-corrected)

  1. 1. Corporate Presentation September 2015
  2. 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 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. 2
  3. 3. 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 $32.1 million cash as at the end of Q2, 2015 Manufacturing at commercial scale 100L cGMP completed
  4. 4. What is REOLYSIN®? Proprietary isolate of the reovirus Widely found Non-pathogenic Widespread human exposure 4
  5. 5. REOLYSIN® Mechanism of Action REOLYSIN® infects both tumour cells and normal healthy cells REOLYSIN® does not replicate in cells that are not Ras activated Healthy cells remain undamagedREOLYSIN® Administered to patients PRE-SCREENED for RAS, EGFR, BRAF and others Normal Cells REOLYSIN® infects both tumour cells and normal healthy cells REOLYSIN® replicates in Ras-activated tumour cells Tumour cells then rupture to release progeny virus Progeny viruses repeat cell infection cycle in nearby tumour cells Ras–Activated Cells Productively infected cells upregulate interferon and others, including PD-1 and PD-L1, and induce an anti- tumour specific immune response mediated by NK and T cells 5
  6. 6. REOLYSIN® and Safety General Safety 1,100+ patients treated, 1,000+ intravenously No MTD reached Safety profile confirmed in a randomized setting 6 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
  7. 7. 7 REOLYSIN® Clinical Program 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 (MAYO –MC0672 ) PhaseII REO 009 PhaseI REO 011 PhaseI/II MAY0 (MC-1472) PhaseI REO 015 PhaseII REO 017 PhaseI/II REO 018 PhaseIII REO 020 PhaseII REO 022 PhaseII NCI (GOG-0186H) PhaseII REO 013 Brain PhaseI NCI 8601 PhaseII IND 209 PhaseII IND 210 PhaseII NCI (OSU-07022) PhaseI/II IND 213 PhaseII NCI (OSU-11148) PhaseI NCI 9603 Translational REO 014 PhaseII REO 016 PhaseII REO 021 PhaseII IND 211 PhaseII REO 008 PhaseII NCI (COG-ADVL1014) PhaseI Orphan Status Orphan Status Orphan Status REO 019 Run-InStudy
  8. 8. REOLYSIN® Addressable Market Breast 140,514 Ovarian 12,774 Soft tissue 7,158 Brain 13,710 Head & Neck 27,468 Pancreas 29,376 Prostate 132,480 Melanoma 44,322 Myeloma 16,110 Colon & Rectum 79,620 Lung & Bronchus 132,720 1,000,000+ new U.S. cases a year in studied indications, of which REOLYSIN® conservatively addresses 60% Source: American Cancer Society – Cancer Facts and Figures 2015 Estimated New Cases per Indication in the U.S. in 2015 8
  9. 9. Orphan Drug Designations Orphan Drug Designations obtained for REOLYSIN®: Potential benefits of Orphan Drug Designation: A period of market exclusivity (US and EU) Potential tax credits for certain activities (US) Eligibility for orphan drug grants (US) Potential fee waivers and/or reductions (US and EU) Protocol assistance (EU) 9 FDA EMA • ovarian • primary peritoneal • ovarian • pancreatic • fallopian tube • pancreatic • malignant gliomas • gastric
  10. 10. What Does REOLYSIN® Do? Reduces Tumour Burden
  11. 11. 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 11
  12. 12. 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) 12
  13. 13. REO 018 Head and Neck Cancer: Randomized Tumour-Specific Response Data First Endpoint: Velocity o 105 patients o 86% of test arm (n=50) had tumour stabilization or shrinkage o 67% of control arm (n=55) had tumour stabilization or shrinkage o p-value 0.025 Second Endpoint: Volume Loco-regional patients with or without distal metastases o 23% improvement in test arm vs. control for tumour volume decrease o p-value 0.076, n=118 Patients with distal metastases only o 30% improvement in test arm vs. control for tumour volume decrease o p-value 0.021, n=47 Study demonstrated that REOLYSIN® increased both the magnitude and velocity of tumour shrinkage 13
  14. 14. Registration Program for REOLYSIN® Short-Term: Tumour Reduction Endpoints: Neoadjuvant treatment of muscle-invasive bladder cancer Neoadjuvant = therapy used prior to a major therapeutic intervention (usually surgery) in order to improve outcome Next Steps: IND has been filed to conduct a small “run-in” study assessing histopathological response in muscle invasive bladder cancer o REOLYSIN® in combination with gemcitabine and cisplatin Subject to confirmation of response – proceed to pivotal trial 14
  15. 15. Studies demonstrate that REOLYSIN® increases both the magnitude and velocity of tumor shrinkage Muscle invasive bladder cancer is the only cancer indication in which US regulators have accepted histopathological response as a registration endpoint in a neoadjuvant study to date Each patient enrolled in the study will be assessable for this endpoint at a maximum of nine weeks after starting treatment 15 Why Muscle Invasive Bladder Cancer?
  16. 16. What Does REOLYSIN® Do? Improves Overall Survival
  17. 17. Top-Line Overall Survival (OS) Results: REO 018 (Head and Neck Cancer) An intent-to-treat analysis of 118 patients with loco- regional disease showed a statistically significant improvement in the OS of the test arm versus that of the control arm1 p=0.0146 hazard ratio=0.5099 1 Overall survival was measured to the median PFS in each arm, censoring any patients who received post-discontinuation therapy from the date on which they commenced the first of these therapies. 17
  18. 18. Top-Line Overall Survival (OS) Results REO 017 (Pancreatic Cancer) – Comparison with ACCORD 11 and MPACT Studies: 18
  19. 19. What Does REOLYSIN® Do? Enhances Long-Term Immune Responses
  20. 20. Days Post Treatment: 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 20
  21. 21. REOLYSIN®: Enhancing Immune Response REOLYSIN® acts as a selective cytotoxin – killing the tumour cells in which it replicates We now know that administration of REOLYSIN® also: Causes the immune system to recognize and kill tumour cells as well Causes up-regulation of PD-1 and PD-L1 21
  22. 22. REOLYSIN®: Immunology & Anti-PD-1 / PD-L1 In some types of cancer (including pancreatic cancer, glioblastoma and metastatic brain lesions), REOLYSIN® has been shown to upregulate PD-1 and PD-L1 (Appendix A) In cancers with low PD-1 and PD-L1 upregulation, this enhances the activity of checkpoint inhibitors 22
  23. 23. Immune Preclinical Research In ovarian cancer models in mice: Combination of gemcitabine and reovirus type 3 improved overall survival In melanoma models in mice: Combination of GM-CSF with REOLYSIN® improved overall survival In brain cancer models in mice: Combination of a checkpoint inhibitor (anti-PD-1) with REOLYSIN® improved overall survival 23
  24. 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® (studies pending) 24
  25. 25. Registration Program for REOLYSIN® Medium-Term: intravenous treatment of advanced gliomas Long-Term: to be determined upon receipt of data from ongoing single-arm and randomized studies in a range of indications 25
  26. 26. Medium-Term – Overall Survival Endpoints A key finding from REO 013 was that REOLYSIN® can cross the blood brain barrier and subsequently infect and kill tumour in the brain, as well as primary gliomas and metastatic lesions from other primary cancers outside brain We have completed and initiated four studies of REOLYSIN® in glioma patients: 26 • REO 003 – Ph 1/2 local mono-therapy • REO 007 – Phase 1/2 infusion mono- therapy • REO 013 – Ph 1 IV prior to surgical resection • MC1472 – Ph 1 IV combined with GM-CSF - pediatric (ongoing) Registration Program for REOLYSIN®
  27. 27. Registration Program for REOLYSIN® 27 Next Steps A small “run-in” study assessing response in gliomas has been initiated (Mayo Clinic’s MC1472) o Pediatric patients being treated with REOLYSIN® in combination with GM-CSF Second study assessing response in adult patients receiving REOLYSIN® and the standard of care (surgery followed by radiation and temozolomide) Subject to confirmation of best approach – proceed to pivotal trial
  28. 28. Manufacturing & Intellectual Property
  29. 29. Manufacturing Now produced at 100L (commercial scale) under cGMP with final formulation Commercial manufacturing agreement in place with Sigma- Aldrich® Fine Chemicals (SAFC) 29
  30. 30. Patent Portfolio More than 400 patents issued worldwide, including 56 US and 20 Canadian Reovirus issue patent claims cover: o Compositions of matter comprising reovirus o Pharmaceutical use of reoviruses to treat neoplasia and cellular proliferative diseases o Combination therapy with radiation, chemotherapy and/or immune suppressants o Methods for manufacturing reovirus and screening for susceptibility to reovirus o Pharmaceutical use of reoviruses in transplantation procedures Approximately 235 pending applications worldwide 30
  31. 31. Corporate & Financial
  32. 32. Market & Capital Data (all amounts in CAD) Exchanges NASDAQ:ONCY TSX:ONC Shares Outstanding (June 30, 2015) 117,710,372 Price Options Outstanding (June 30, 2015) $3.16 (weighted average) 5,531,394 Fully Diluted (June 30, 2015) 123,241,766 Cash/Cash Equivalents (June 30, 2015) $32.1 M 32
  33. 33. Investment Highlights Five ongoing randomized Phase II studies Ovarian, colorectal, non-small cell lung, prostate and breast cancers Preparing for registration study Safety data for 1,100+ patients Strong intellectual portfolio More than 400 patents worldwide Manufacturing at commercial scale 33
  34. 34. Corporate Presentation September 2015
  35. 35. Appendix A: Presence of Reoviral Protein, PD-1 & PD-1 (REO 013b Study) Case Diagnosis Reoviral Protein PD-L1 PD-1 1 glioblastoma 1+ 2+ 2+ 2 adenocarcinoma (colon metastasis) 1+ 2+ 2+ 3 glioma, grade 3 1+ 2+ 2+ 4 glioma, grade 3 negative 0 1+ 5 melanoma metastasis negative 1+ 2+ 6 glioblastoma 1+ 2+ 2+ 7 glioblastoma negative weak 0 8 glioblastoma 1+ 1+ 2+ 9 melanoma metastasis 2+ 3+ 2+ 10 (control) adenocarcinoma (breast metastasis) negative 0 0 11 (control) glioblastoma negative 0 0 12 (control) glioblastoma negative 0 0 13 (control) glioblastoma negative 0 0 14 (control) glioblastoma negative 0 0 15 (control) adenocarcinoma (ovarian metastasis) negative 0 weak