Oncolytics Biotech Inc. · NASDAQ:ONCY
Oncolytics Biotech — Investor Presentation (November 2010)
18 slides from Oncolytics Biotech's investor presentation, Nov 10, 2010
Slide 1: Investor Presentation November 2010 / Forward Looking Statements
TSX:ONC NASDAQ:ONCY Investor Presentation November 2010 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 st
Slide 2: Summary / Mode of Action
Summary REOLYSIN - A Broadly Active Novel Cancer Therapy Focused Clinical Program • d t iis REOLYSIN® l d product lead • Phase III REOLYSIN and paclitaxel/carboplatin in platinum-refractory head and neck cancer patients (US, UK, Belgium, and Canada) • Randomized Phase II REOLYSIN and paclitaxel in o
Slide 3: REOLYSIN Pipeline / Pivotal (Phase III) Program
REOLYSIN Pipeline Indication Preclinical Phase 1 Phase 2 Phase 3 Head & neck (REO 018) in combination with carboplatin + paclitaxel Recurrent ovarian, fallopian tube , or primary peritoneal in combination with paclitaxel (randomized, GOG-0186H) NSCLC (Kras screened) (REO 016) in combination with car
Slide 4: Interim Results Compared to Historical Controls
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 Docetaxel Specenier et al., 6.7% <
Slide 5: Phase II REOLYSIN/Paclitaxel/Carboplatin Combination Metastatic Nasopharyngeal
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 • do
Slide 6: UK Phase II Combination Partial Response in SCC H&N
UK Phase II REOLYSIN/Carbo/Taxol Combination Partial Response in SCC H&N Pre-treatment Rapid After 3 cycles progression i <3 in 3 weeks k before Study Treatment history: cisplatin + 5 FU; RT/cisplatin; REOLYSIN Pipeline Indication Preclinical Phase 1 Phase 2 Phase 3 Head & neck (REO 018) in combinat
Slide 7: US Phase 2 Ovarian: REOLYSIN/Paclitaxel Combination
US Phase 2 Ovarian: REOLYSIN/Paclitaxel Combination • Phase 2 trial examining REOLYSIN in combination with paclitaxel in the treatment of recurrent or p persistent ovarian,, fallopian p tube or primary peritoneal cancer • 150 patient randomized, two-arm, multicentre study • Sponsored by the NCI, und
Slide 8: REOLYSIN: Targeting Tumours With Ras Pathway Activation
US Phase 2 SCCLC: REOLYSIN/Carbo/Taxol Combination Pt 0001 – Partial Response (PR) in Lung Pre-treatment Post 2 Cycles Post 4 Cycles Right Upper Lung Mass (8.3 cm) Right Upper Lung Mass (4.1cm) Right Upper Lung Mass (3.6cm) Right pleural met (2.2cm) Right pleural met (0.8cm) Right pleural met (0.4cm
Slide 9: Phase II NSCLC and Kras/EGFR
REOLYSIN Pipeline Indication Preclinical Phase 1 Phase 2 Phase 3 Head & neck (REO 018) in combination with carboplatin + paclitaxel Recurrent ovarian, fallopian tube , or primary peritoneal in combination with paclitaxel (randomized, GOG-0186H) NSCLC (Kras screened) (REO 016) in combination with car
Slide 10: Colorectal Cancer and Kras / Pancreatic Cancer Phase II
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 • Phase I study using REOLYSIN/FOLFIRI combination in second line patients prescreened for Kras mutations Phase II Study of REOLYS
Slide 11: Safety / Intellectual Property
Safety • >330 patients treated, >240 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 lym
Slide 12: Manufacturing / Market & Capital Data
Manufacturing • successful development of a proprietary cell growth medium • commercial cGMP process established • now produced at 100L under cGMP with final formulation Market & Capital Data Exchanges NASDAQ:ONCY TSX:ONC Shares Outstanding (Nov 9, 2010) 67,842,669 Warrants Expiring Price Nov 8, 201
Slide 13: Summary / Previous Clinical Progress Appendix
Summary REOLYSIN - A Broadly Active Novel Cancer Therapy Focused Clinical Program • d t iis REOLYSIN® l d product lead • Phase III REOLYSIN and paclitaxel/carboplatin in platinum-refractory head and neck cancer patients (US, UK, Belgium, and Canada) • Randomized Phase II REOLYSIN and paclitaxel in o
Slide 14: Local and Systemic Monotherapy Trials
Local Monotherapy Trials Study Title Status Results REO 001 Phase I trial for various Complete Safe, well tolerated. 11 of 18 pts had tumour subcutaneous tumours regression of 32% to 100%. (Canada) REO 002 T2 prostate cancer (Canada) Complete Safe, well tolerated. Evidence of viral activity in 5 of
Slide 15: Adenocarcinoma (endometrium) / Case for Drug/Radiation Combinations
Adenocarcinoma (endometrium) A 30.03.2006 • Refractory, heavily pretreated patient 201.1 - radiotherapy (pelvis 45Gy; VV mm brachytherapy (12Gy) - chemotherapy (paclitaxel/carbo 6 cycles; doxorubicin 3 cycles) B 12.06.2006 • Patient had a 20% reduction in the 209.0 mm sum of the longest diameters of
Slide 16: REOLYSIN and Drug Synergy / Increasing Vascular Efflux
REOLYSIN and Drug Synergy – Increased Potency • Combinations with cisplatin, gemcitabine, mitomycin or vinblastine were, in general, synergistic against g NSCLC cell lines known to be sensitive to the anticancer drugs g except p in those cells with high level resistance to the agent • The combinatio
Slide 17: Combination Trials
Combination Trials Study Title Status Results REO 006 Phase I various metastatic Complete 7 evaluable pts. in low dose (20Gy) group, 2 PRs tumours. Local therapy in (esophageal adenocarcinoma & SCC skin), 5 combination with radiation SD. 7 evaluable pts. in high dose (36Gy) group, (U K ) (U.K.) 5 PR
Slide 18: Combination Trials
Combination Trials Study Title Status Results REO 017 Phase II advanced pancreatic Approved Single arm, open-label, Phase II study of carcinoma. With gemcitabine REOLYSIN given intravenously with (U.S.) gemcitabine. Up to 33 pt. REO 020 Phase II metastatic melanoma. Enrolling Single arm, open-label,
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