0
Corporate Presentation
January 2014
Forward Looking Statements
Today’s presentation contains certain forward looking statements relating to the
company’s fina...
Oncolytics Overview
•

Expanding Clinical Program
• Lead product is REOLYSIN , a broadly active novel cancer therapy
• Ong...
REOLYSIN® Overview
•

REOLYSIN® is a proprietary isolate of the reovirus
•

Reovirus is a replication competent virus and ...
REOLYSIN Mechanism of Action
®

Normal Cells

REOLYSIN®
infects both tumor
cells and normal,
healthy cells
REOLYSIN®
admin...
REO 013: REOLYSIN® Induced Tumour Responses
•

•

•

•

Image shows positive (red staining)
for reovirus in the metastatic...
Market for Ras Pathway Mediated Cancers
•

•

•

Estimated global cancer market was $77 billion in 2011; this is
expected ...
REOLYSIN® Clinical Program Overview
REOLYSIN® has been utilized in studies in over 620 patients
In total, nearly thirty on...
Selected REOLYSIN® Pipeline: Randomized Studies
Indication

Combination
Therapy

n

REO 018: Head & Neck Cancer

Carboplat...
Phase III (Pivotal) Program for REOLYSIN®
in Squamous Cell Head and Neck Cancers
•

In Q3 2012, Oncolytics completed enrol...
REO 018: Tumor Specific Response Data
•
•

Data announced December 13, 2012
Endpoint examines initial percentage tumor cha...
REO 018: Percentage Change in Metastatic Lesions
at First Post-Treatment Scan (Control vs. Test)
100.00%
80.00%

Percent C...
REO 018: Top-Line Efficacy Data
•
•

Data announced November 21, 2013
An analysis was performed on an intent-to-treat basi...
REO 018: Top-Line Safety Data
•

Data announced November 21, 2013 for all 167 patients enrolled

•

REOLYSIN was safe and ...
REO 016: Non-Small Cell Lung Cancer
•

•

Single-arm (up to 36 patients), open-label, two-stage US Phase II
study of intra...
REO 016: Biomarker Correlations with
®
REOLYSIN Efficacy
•

•
•

•

•

Of 36 evaluable patients, all of whom were Stage IV...
REO 016: Partial Response in Lung (EGFR
Over-Expression)

Pre-Treatment

Post Cycle 2
17
REO 021: Squamous Cell Carcinoma (SCC) of the Lungs
•

•

•

Single-arm (up to 36 patients), open-label US Phase II study ...
REO 021: Best Overall Percentage Response
in Target Lesions (Final Data)
40

Percent Change (Target Lesions)

20

0

-20

...
REO 021: Partial Response in Lung

Right Upper Lung Mass (8.3 cm)

Right Upper Lung Mass (4.1 cm)

Right Upper Lung Mass (...
Randomized Canadian Studies of REOLYSIN®
•

Patients are currently being enrolled in four randomized Phase II
studies in C...
Randomized U.S. Studies of REOLYSIN®
•

Patients are currently being enrolled in two randomized Phase II
studies in the Un...
REOLYSIN® and Safety
•

•
•

•

•

More than 620 patients treated, more than 530 intravenously at
doses up to 3x1010 TCID5...
Intellectual Property
•

•

More than 370 patents issued worldwide, including 51 US and 16
Canadian
Reovirus issue patent ...
Manufacturing

•

Now produced at 100L under cGMP with final formulation

•

Commercial manufacturing agreement with SAFC ...
Market & Capital Data
(all amounts in CAD)

Exchanges

NASDAQ:ONCY
TSX:ONC

Shares Outstanding (September
30, 2013)
Warran...
Oncolytics Summary
•

Expanding Clinical Program
• Lead product is REOLYSIN , a broadly active novel cancer therapy
• Ongo...
Corporate Presentation
January 2014
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Transcript of "January 2014 Corporate Presentation"

  1. 1. Corporate Presentation January 2014
  2. 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. 2
  3. 3. Oncolytics Overview • Expanding Clinical Program • Lead product is REOLYSIN , a broadly active novel cancer therapy • Ongoing clinical trials include seven randomized studies: • Enrollment complete randomized international study (REO 018) of REOLYSIN in combination with carboplatin and pactliaxel in platinum-refractory recurrent head and neck cancer patients – the supportive study to a planned Phase III registration study in this indication • Six sponsored Phase II studies announced or ongoing in the US and Canada – breast, non-small cell lung, colorectal, prostate, pancreatic and ovarian cancers ® ® • • Strong Intellectual Property Portfolio • More than 370 patents issued worldwide Manufacturing at Commercial Scale • 100L cGMP completed, commercial manufacturing agreement in place 3
  4. 4. REOLYSIN® Overview • REOLYSIN® is a proprietary isolate of the reovirus • Reovirus is a replication competent virus and is considered safe to humans • REOLYSIN® has been safely administered to patients via intravenous, intratumoral and intrathecal injection • Mechanism of Action: • • • • In Ras-activated cells, one of the key cellular defence mechanisms against doublestranded RNA viral infection, Protein Kinase-R (PKR), is deactivated This specific vulnerability of constitutive Ras-activated cancer cells to the reovirus is the basis of REOLYSIN®’s activity and specificity Reovirus oncolysis is seen in cancer cells with constitute Ras pathway activation; susceptible cancer cells therefore include those with either: • EGFR overexpression or mutation1; or • Ras mutation, which includes Kras mutation2 Both of these mutations lead to activation of the Ras pathway 1 Evidence that the epidemal growth factor receptor on host cells confers reovirus infection efficiency. Strong et al. Virology 1993; 197(1): 405 2 The molecular basis of viral oncolysis: usurpation of the Ras signalling pathway by reovirus. Strong et al. EMBO J 1998; 17(12): 3351 4
  5. 5. REOLYSIN Mechanism of Action ® Normal Cells REOLYSIN® infects both tumor cells and normal, healthy cells REOLYSIN® administered to patients via IV REOLYSIN® is a virus whose replication is stopped in a nonRas-activated cell Healthy cell remains undamaged Ras-Activated Cells REOLYSIN® infects both tumor cells and normal, healthy cells REOLYSIN® replicates in Rasactivated tumor cells 5 Tumor cells rupture to release progeny virus Replicated viruses repeat cell lysis cycle in nearby tumor cells
  6. 6. REO 013: REOLYSIN® Induced Tumour Responses • • • • Image shows positive (red staining) for reovirus in the metastatic lesions (yellow arrow) and negative for reovirus in the normal cells (red arrow) Nine out of ten patients showed the same pattern, i.e. targeted delivery to metastatic tumor lesions of the liver In addition, two of the ten patients had complete tumor necrosis This demonstrates that REOLYSIN® specifically accesses and replicates in metastatic colorectal cancer when delivered as a monotherapy 6
  7. 7. Market for Ras Pathway Mediated Cancers • • • Estimated global cancer market was $77 billion in 2011; this is expected to rise to $105 billion in 2016 At least five million new patients per year are expected to develop cancers with a Ras pathway involvement In the developed world alone, at least 2.6 million patients per year die of cancers that have metastasized 7
  8. 8. REOLYSIN® Clinical Program Overview REOLYSIN® has been utilized in studies in over 620 patients In total, nearly thirty ongoing or completed clinical trials including: • • Seven randomized Phase II and Phase III clinical trials, including Phase III head and neck cancer and Phase II trials for ovarian, pancreatic, prostate, colorectal, non-small cell lung and breast cancers Nine single arm studies in the following indications: • Phase II trials: • • Company sponsored: pancreatic cancer, non-small cell lung cancer, head and neck carcinoma, metastatic melanoma and squamous cell carcinoma Phase I trials: • Company sponsored: colorectal cancer and advanced malignancies • Investigator sponsored: multiple myeloma and relapsed or refractory solid tumors 8
  9. 9. Selected REOLYSIN® Pipeline: Randomized Studies Indication Combination Therapy n REO 018: Head & Neck Cancer Carboplatin + paclitaxel 167 n/a GOG-0186H: Ovarian, Fallopian Tube & Primary Peritoneal Cancers Paclitaxel 110 NCI/ GOG OSU-10045: Pancreatic Cancer Carboplatin + paclitaxel 70 NCI IND 209: Prostate Cancer Docetaxel 80 NCIC IND 210: Colorectal Cancer FOLFOX-6 + Avastin® 100 NCIC IND 211: Non-Small Cell Lung Cancer Docetaxel or pemetrexed 150 NCIC IND 213: Breast Cancer Paclitaxel 100 NCIC Preclinical 9 Phase I Phase II Phase III Sponsor
  10. 10. Phase III (Pivotal) Program for REOLYSIN® in Squamous Cell Head and Neck Cancers • In Q3 2012, Oncolytics completed enrollment in REO 018, a randomized, two stage, two-arm, double-blind, multi-center trial examining REOLYSIN® in combination with carboplatin and paclitaxel in taxane-naïve patients with platinum-refractory recurrent head and neck cancers • • The study was approved and run in fourteen countries in North America and Europe Patients in the REO 018 study were stratified for: • ECOG performance status (0-1 versus 2) • Time of progression/relapse after prior platinum-based chemotherapy • • Disease location (patients with locally recurrent disease, with or without distal metastases, versus patients with metastatic disease only) REO 018 Endpoints: • • Secondary Endpoints: Progression-Free Survival (PFS), best response and tumour-specific response • • Primary Endpoint: Overall Survival (OS) Pharmacodynamic Endpoints: Tumour Ras pathway status and HPV status The Company intends to treat REO 018 as a separate supportive study to a planned randomized, follow-on international Phase III head and neck registration study in patients with loco-regional head and neck cancer 10
  11. 11. REO 018: Tumor Specific Response Data • • Data announced December 13, 2012 Endpoint examines initial percentage tumor changes between baseline and first post treatment scans in all patients, differentiating between loco-regional tumours and metastatic tumours • • • This is a measure of rate or velocity of response, not magnitude of response The endpoint was introduced to determine if REOLYSIN adds tumor specific differential activity in metastatic and loco-regional disease in a randomized setting ® Of the total 105 patients with evaluable metastatic tumors, 86% (n=50) of those in the test, and 67% (n=55) in the control arm, arm had tumor stabilization (0% growth) or shrinkage • This is a statistically significant difference, with a p-value of 0.025 11
  12. 12. REO 018: Percentage Change in Metastatic Lesions at First Post-Treatment Scan (Control vs. Test) 100.00% 80.00% Percent Change (Target Lesions) 60.00% 40.00% 20.00% 0.00% Control 0 0.1 0.2 0.3 0.4 0.5 -20.00% -40.00% -60.00% -80.00% -100.00% p=0.03 12 0.6 0.7 0.8 0.9 1 Test
  13. 13. REO 018: Top-Line Efficacy Data • • Data announced November 21, 2013 An analysis was performed on an intent-to-treat basis of the 118 patients with loco-regional disease, with or without metastases • • Patients in the test arm (n=62) showed a median PFS of 94 days (13.4 weeks), versus 50 days (7.1 weeks) in the control arm (n=56) • • At the time of reporting, there had not been a sufficient number of events to conduct a survival analysis of patients in the metastatic-only group Patients who received REOLYSIN® had increased benefit through five cycles of therapy Of 88 patients who did not receive additional therapy following discontinuation of study treatment, those in the test arm (n=50) showed a median OS of 150 days (21.4 weeks), versus 115 days (16.4 weeks) in the control arm (n=38) 13
  14. 14. REO 018: Top-Line Safety Data • Data announced November 21, 2013 for all 167 patients enrolled • REOLYSIN was safe and well-tolerated by patients • Patients on the test arm of the study experienced a higher incidence of flu-like symptoms consistent with earlier clinical trials of REOLYSIN® and treatment with a virus • • Most commonly mild fever, chills, nausea and diarrhea Fewer patients required dose reductions of paclitaxel due to neuropathy or neurotoxicity on the test arm than the control arm (zero in the test arm versus six in the control; p=0.028) • On this basis, Oncolytics intends to explore the potential chemoprotective and neuroprotective properties of REOLYSIN® in future clinical studies 14
  15. 15. REO 016: Non-Small Cell Lung Cancer • • Single-arm (up to 36 patients), open-label, two-stage US Phase II study of intravenously-administered REOLYSIN® in combination with carboplatin and paclitaxel For non-small cell lung cancer (NSCLC) patients who have been prescreened for Kras and EGFR mutation status • 15-20% of NSCLC is Kras mutated, while up to 50% is EGFR mutated or overexpressed, all of which cause Ras pathway activation • First-line therapy study, i.e. patients will be offered REOLYSIN® / carboplatin / paclitaxel instead of standard of care if they are Kras or EGFR mutated or EGFR overexpressed 15
  16. 16. REO 016: Biomarker Correlations with ® REOLYSIN Efficacy • • • • • Of 36 evaluable patients, all of whom were Stage IV on entry, 89% exhibited SD or better (11 PR, 21 SD and 4 PD by RECIST) 20 of these 36 patients (56%) had one year or more of survival Of 24 patients with at least an EGFR mutation or amplification, 16 (66.7%) had one year or more of survival Of 13 patients with only an EGFR mutation or amplification, 9 (69.2%) had one year or more of survival Of 4 patients with BRAF and EGFR amplifications, 4 (100%) had one year or more of survival
  17. 17. REO 016: Partial Response in Lung (EGFR Over-Expression) Pre-Treatment Post Cycle 2 17
  18. 18. REO 021: Squamous Cell Carcinoma (SCC) of the Lungs • • • Single-arm (up to 36 patients), open-label US Phase II study of intravenously-administered REOLYSIN® in combination with carboplatin and paclitaxel Final results in 25 evaluable patients (all with metastatic disease) demonstrated that 92% (23 patients) exhibited overall tumour shrinkage, with mean shrinkage of 32.7% Of the 25 evaluable patients who received more than one cycle of therapy, 10 (40%) showed partial responses by RECIST, and a further 12 (48%) showed stable disease by RECIST, for a disease control rate (CR + PR + SD) of 92% 18
  19. 19. REO 021: Best Overall Percentage Response in Target Lesions (Final Data) 40 Percent Change (Target Lesions) 20 0 -20 -40 -60 -80 -100 Patients by Increasing Overall Percentage Tumour Shrinkage 19
  20. 20. REO 021: Partial Response in Lung Right Upper Lung Mass (8.3 cm) Right Upper Lung Mass (4.1 cm) Right Upper Lung Mass (3.6 cm) Right Pleural Met (2.2 cm) Right Pleural Met (0.8 cm) Right Pleural Met (0.4 cm) Pre-Treatment Post Cycle 2 20 Post Cycle 4
  21. 21. Randomized Canadian Studies of REOLYSIN® • Patients are currently being enrolled in four randomized Phase II studies in Canada: • • • • • IND 209: Intravenous Administration of REOLYSIN® in Combination with Docetaxel for Patients with Recurrent or Metastatic Castration Resistant Prostate Cancer IND 210: Intravenous Administration of REOLYSIN® in Combination with FOLFOX-6 Plus Avastin® versus FOLFOX-6 Plus Avastin® Alone in Patients with Advanced or Metastatic Colorectal Cancer IND 211: Intravenous Administration of REOLYSIN® in Combination with Docetaxel or Pemetrexed for Patients with Previously-Treated Advanced or Metastatic Non-Small Cell Lung Cancer IND 213: Intravenous Administration of REOLYSIN® in Combination with Paclitaxel for Patients with Advanced or Metastatic Breast Cancer All four studies are sponsored by the National Cancer Institute of Canada’s Clinical Trials Group (NCIC CTG) 21
  22. 22. Randomized U.S. Studies of REOLYSIN® • Patients are currently being enrolled in two randomized Phase II studies in the United States: • • • OSU-10045: Intravenous Administration of REOLYSIN® in Combination with Paclitaxel and Carboplatin for Patients with Metastatic Pancreatic Cancer GOG-0186H: Intravenous Administration of REOLYSIN® in Combination with Paclitaxel for Patients with Persistent or Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer Both studies are sponsored by the U.S. National Cancer Institute (NCI), with GOG-0186H being conducted by the Gynecologic Oncology Group (GOG) 22
  23. 23. REOLYSIN® and Safety • • • • • More than 620 patients treated, more than 530 intravenously at doses up to 3x1010 TCID50 daily No maximum tolerated dose (MTD) reached to date Monotherapy toxicities have generally been mild (grade 1 or 2) and included chills, fever, headache, cough, myalgia, runny nose, sore throat, 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 23
  24. 24. Intellectual Property • • More than 370 patents issued worldwide, including 51 US and 16 Canadian Reovirus issue 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 Approximately 235 pending applications worldwide 24
  25. 25. Manufacturing • Now produced at 100L under cGMP with final formulation • Commercial manufacturing agreement with SAFC in place 25
  26. 26. Market & Capital Data (all amounts in CAD) Exchanges NASDAQ:ONCY TSX:ONC Shares Outstanding (September 30, 2013) Warrants Expiring Feb 8, 2014 Options 84,758,818 Price $4.20 303,945 $4.40 (average) 6,076,844 Fully Diluted (September 30, 2013) 91,139,607 Cash/Cash Equivalents (September 30, 2013) $29.5M 26
  27. 27. Oncolytics Summary • Expanding Clinical Program • Lead product is REOLYSIN , a broadly active novel cancer therapy • Ongoing clinical trials include seven randomized studies: • Enrollment complete randomized international study (REO 018) of REOLYSIN in combination with carboplatin and pactliaxel in platinum-refractory recurrent head and neck cancer patients – the supportive study to a planned Phase III registration study in this indication • Six sponsored Phase II studies announced or ongoing in the US and Canada – breast, non-small cell lung, colorectal, prostate, pancreatic and ovarian cancers ® ® • • Strong Intellectual Property Portfolio • More than 370 patents issued worldwide Manufacturing at Commercial Scale • 100L cGMP completed, commercial manufacturing agreement in place 27
  28. 28. Corporate Presentation January 2014
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