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Oncolytics
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Investor Presentation
August 17, 2014
Forward Looking StatementsThis 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.
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Oncolytics Overviewo Expanding Clinical Program
o Lead product is REOLYSIN®, a broadly active novel cancer therapy
o Ongoing clinical trials include six randomized studies:o Phase II studies ongoing in the US and Canada – breast, non‐small cell lung, colorectal, prostate, pancreatic and ovarian cancers
o Strong Intellectual Property Portfolioo More than 370 patents issued worldwide (27 of which were issued on or after July 1, 2013)
o Manufacturing at Commercial Scaleo 100L cGMP completed, commercial manufacturing agreement in place
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REOLYSIN®: An Overviewo REOLYSIN® is a proprietary isolate of the reovirus
o Reovirus is considered safe to humanso REOLYSIN® has been safely administered to patients via intravenous, intratumoral and intrathecal injection
o Mechanism of Action (MoA):o Primary MoA is as a selective cytotoxin, where selectivity is based on whether cancer cells have constituative Raspathway activation; susceptible cancer cells therefore include those with either:
o EGFR overexpression or mutation; oro Ras mutation, which includes Kras mutation
o Secondary MoAs may include interferon up regulation in target tissues, and tumour directed immune response
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Market for Ras Pathway Mediated Cancers
o Estimated global cancer market was US$85 billion in 2013; this is expected to rise to US$109 billion in 2018
o At least five million new patients per year are expected to develop cancers with a Ras pathway involvement
o In the developed world alone, at least 2.6 million patients per year die of cancers that have metastasized
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REOLYSIN®: Clinical History
o To date, over 1,000 patients have been treated with REOLYSIN®
o Over 30 ongoing and completed studies of REOLYSIN® in North America and Europe examining a variety of:o Modes of administrationo Therapeutic combinations o Cancer indications and patient populations
o Ongoing preclinical research to bolster clinical program strategy, trial design, intellectual property portfolio and regulatory submissions
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Registration Pathway for REOLYSIN®
1) Studies where REOLYSIN® therapy will be used before standard efficacy‐based therapies (surgery, radical radiotherapy and chemotherapy) in order to reduce tumour burden
2) Studies based on progression‐free survival endpoints (EU) and overall survival endpoints (US) of REOLYSIN® in combination with chemotherapy and/or radiotherapy
3) Studies based on exploiting secondary immune based MoA
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Registration Pathway for REOLYSIN® (I)
REO 013: REOLYSIN® Intravenous Monotherapy Metastatic Liver Lesiono Image shows positive (red
staining) for reovirus in the metastatic lesions (blue arrow) and negative for reovirus in the normal cells (red arrow)
o Nine out of ten patients showed the same pattern, i.e. targeted delivery to metastatic tumor lesions of the liver
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REO 018 Head and Neck Cancer: Randomized Tumor Specific Response DataTwo endpoints:o The first endpoint examined initial percentage tumor changes between
baseline and first post treatment scans in all patients, differentiating between loco‐regional tumours and metastatic tumours
o This is a measure of rate or velocity of response, not magnitude of responseo 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
o This is a statistically significant difference, with a p‐value of 0.025o The second endpoint compared percentage tumour shrinkage at the same
time pointso Patients with loco‐regional disease with or without distal metastases on the
test arm had a decrease in tumor volume of an average of 23% over control (p=0.076, n = 118)
o Patients with distal metastases only on the test arm had a decrease in tumor volume of an average of 30% over control (p=0.021, n=47)
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REO 011: Head & Neck Cancer Patient with Partial Response in Liver Metastases
Prior treatment: radiationResponse maintained through 8 cycles
Pre‐Treatment Post‐Cycle 6
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Registration Pathway for REOLYSIN® (II)
REO 018 Head and Neck Cancer: Top‐Line Efficacy Datao Data announced November 21, 2013 and April 8, 2014o Patients with loco‐regional disease with or without distal metastases 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)
o Patients who received REOLYSIN® demonstrated increased benefit through five cycles of therapy
o An intent‐to‐treat analysis of the 118 loco‐regional patients using Type II censoring from the median PFS of each arm showed a statistically significant improvement in PFS of the test arm versus that of the control arm (p=0.0072, hazard ratio=0.5360)
o An intent‐to‐treat analysis of the 118 loco‐regional patients performed on all patients to the median PFS in each arm, censoring any patients who received post‐discontinuation therapy at the date at which they commenced the first of these therapies showed a statistically significant improvement in OS of the test arm versus the control arm (p=0.0146, hazard ratio=0.5099)
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Randomized Clinical Trial Program for REOLYSIN®: Active Studies
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Trial Phase Sponsor n Enrollment Status
IND 213: Intravenous REOLYSIN® in Combination with Paclitaxel in Patients with Advanced or Metastatic Breast
CancerII NCIC CTG 100 >50% complete
IND 211: Intravenous REOLYSIN® in Combination with Docetaxel or Pemetrexed in Patients with Previously‐Treated Advanced or Metastatic Non‐Small Cell Lung
Cancer (NSCLC)
II NCIC CTG 150 >75% complete
IND 210: Intravenous REOLYSIN® in Combination with FOLFOX‐6 Plus Bevacizumab (Avastin®) in Patients with
Advanced or Metastatic Colorectal CancerII NCIC CTG 100 >90% complete
IND 209: Intravenous REOLYSIN® in Combination with Docetaxel in Patients with Recurrent or Metastatic
Castration‐Resistant Prostate CancerII NCIC CTG 80 >75% complete
OSU‐10045: Intravenous REOLYSIN® in Combination with Paclitaxel and Carboplatin for Patients with Metastatic
Pancreatic CancerII NCI 70 complete
GOG‐0186H: Intravenous REOLYSIN® in Combination with Paclitaxel for Patients with Persistent or Recurrent Ovarian,
Fallopian Tube or Primary Peritoneal CancerII NCI/GOG 110 >95% complete
Registration Pathway for REOLYSIN® (III)
Days after REOLYSIN® administration:
0 3 43 88 167 537(Post Debulking)
REO 003: REOLYSIN® IntratumouralMonotherapy Anaplastic Astrocytoma
Early Cytotoxic Activity Followed by Late Stage Immune-Mediated Response Against the Residual Tumour
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Exploiting Immune Based MoA
Ongoing preclinical research conducted after immune responses were noted in early monotherapy studies has led to two clinical candidate programs: GM‐CSF in combination with REOLYSIN®; or A checkpoint inhibitor in combination with REOLYSIN®
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GM‐CSF + REOLYSIN®: Effect on Overall Survival
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REOLYSIN® and Safety
o More than 1,000 patients treated, more than 900 intravenously at doses up to 3x1010 TCID50 daily
o No maximum tolerated dose (MTD) reached to dateo 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
o Transient grade 3 and 4 toxicities included lymphopenia and neutropenia
o These symptoms were more frequently observed from day 2 of treatment and usually lasted less than 6 hours
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REO 018: Top‐Line Safety Datao Data announced November 21, 2013 for all 167 patients enrolledo REOLYSIN® was safe and well‐tolerated by patientso 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
o Most commonly mild fever, chills, nausea and diarrheao 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)
o On this basis, Oncolytics intends to explore the potential chemoprotective and neuroprotective properties of REOLYSIN® in future clinical studies
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Intellectual Propertyo More than 370 patents issued worldwide, including 56 US
and 20 Canadiano Reovirus issue patent claims cover:
o Compositions of matter comprising reoviruso Pharmaceutical use of reoviruses to treat neoplasia and cellular
proliferative diseaseso Combination therapy with radiation, chemotherapy and/or
immune suppressantso Methods for manufacturing reovirus and screening for
susceptibility to reoviruso Pharmaceutical use of reoviruses in transplantation procedures
o Approximately 235 pending applications worldwide
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Manufacturing
o Now produced at 100L under cGMP with final formulationo Commercial manufacturing agreement with SAFC in place
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Market & Capital Data (allamountsinCAD)
Exchanges NASDAQ:ONCYTSX:ONC
SharesOutstanding(June30,2014)
88,247,844
Price
OptionsOutstanding(June30,2014)
$3.49(weightedaverage)
5,987,844
FullyDiluted(June30,2014) 94,235,688
Cash/CashEquivalents(June30,2014)
$18.9M
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Oncolytics Overviewo Expanding Clinical Program
o Lead product is REOLYSIN®, a broadly active novel cancer therapy
o Ongoing clinical trials include six randomized studies:o Phase II studies ongoing in the US and Canada – breast, non‐small cell lung, colorectal, prostate, pancreatic and ovarian cancers
o Strong Intellectual Property Portfolioo More than 370 patents issued worldwide (27 of which were issued on or after July 1, 2013)
o Manufacturing at Commercial Scaleo 100L cGMP completed, commercial manufacturing agreement in place
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Investor Presentation
August 17, 2014