This document provides an investor presentation for Oncolytics Biotech Inc. summarizing recent progress and the clinical development plan for REOLYSIN, an immuno-oncology viral agent. Key points include:
- REOLYSIN showed statistically significant increased overall survival in a phase 2 trial in metastatic breast cancer when combined with paclitaxel chemotherapy.
- The clinical development plan focuses on combining REOLYSIN with chemotherapy, immunotherapy agents, and targeted therapies to boost its immune-activating mechanism of action.
- Upcoming milestones include presenting pancreatic cancer data at ASCO and holding an end-of-phase 2 meeting to discuss the metastatic breast cancer registration pathway.
11. Path 1: Chemo-Combo / Breast Cancer
• Randomized, non-blinded study, with IV
administered REOLYSIN® given in
combination with paclitaxel versus
paclitaxel alone
• Patients with advanced or metastatic breast
cancer
• Paclitaxel weekly, on days 1, 8 and 15 of a
28-day cycle and test arm with the addition
of REOLYSIN® on days 1, 2, 8, 9, 15 and 16
• 74 patients; powered to 90%
• Endpoints:
• Primary: PFS
• Secondary: OS
• Secondary : ORR
• Secondary: Safety
(IND-213) Phase 2 Data(IND-213) Phase 2 Design
• Statistically significant improvement
in median OS:
• 10.4 months to 17.4 months
• 61 patients presented p53 mutations
• OS more than doubled from 10.4
months to 20.9 months
• First immuno-oncology viral-agent to
demonstrate a statistically significant
median OS advantage in a
randomized clinical study
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18. Path 3: Targeted/IMiD Combinations
REO + Pomalidomide in multiple myeloma
o Establish safety profile
o Ongoing collaboration with Celgene
& Myeloma UK
o Combined with Revlimid® & Imnovid® as a
rescue treatment in myeloma patients
Enhancement of Innate
Immune Response:
REOLYSIN® + IMiDs
REOLYSIN® alone
REOLYSIN® + IMiDs
Release of
inflammatory
cytokines
Increased
activation of
NK cells
Release of
inflammatory
cytokines
Activation of
NK cells
+ IMiDs
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22. Patent Portfolio
¡ More than 415 patents issued
worldwide, including 61 US and
20 Canadian
¡ Reovirus issue patent claims cover:
• Compositions of matter comprising reovirus
• Through 2028
• 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
¡ Over 60 pending
applications worldwide
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28. Investment Highlights
¡ REOLYSIN® statistically significantly increased overall survival
in metastatic breast cancer
¡ More than doubled overall survival in patients with p53 mutation
¡ Strengthened management team: C-Suite and Business Development
¡ Unpartnered immuno-oncology viral agent for systemic
administration exploiting dual activity by cancer cell lysis and anti-
tumor immunity
¡ Defined Clinical Development Program and registration pathway
¡ Extensive patient safety data showing no added significant toxicity
when used as combination with chemotherapy
¡ Manufacturing at commercial scale with sufficient supplies on hand to
support late- stage development and early commercialization
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