REOLYSIN® shows promise as a cancer therapeutic through two mechanisms of action. It acts as a directed cytotoxin against cancer cells with Ras pathway mutations, reducing tumor burden in clinical trials. It also stimulates anti-tumor immune responses, improving overall survival in some studies compared to chemotherapy alone. Oncolytic Biotech is conducting additional registration trials with tumor reduction and overall survival endpoints to confirm these findings and seek approvals.
REOLYSIN is an oncolytic virus being developed as a cancer therapeutic. It selectively replicates in and kills Ras activated tumor cells. Over 1,100 patients have been treated with REOLYSIN which has shown a good safety profile and evidence of tumor reduction. Clinical trials are ongoing in various cancer types, both as a monotherapy and in combination with chemotherapy and immunotherapy. The goal is to demonstrate tumor reduction and improved overall survival to support regulatory approval. Oncolytics Biotech has a strong patent portfolio and manufactures REOLYSIN at commercial scale.
- The presentation provides an overview of Oncolytics Biotech Inc. and its lead product candidate REOLYSIN®, an oncolytic virus being developed as a cancer therapeutic.
- Data is presented showing REOLYSIN®'s ability to reduce tumor burden through direct cytotoxic effects and stimulate anti-tumor immune responses, improving overall survival in clinical trials.
- Oncolytics has conducted over 30 clinical trials across many cancer types and is preparing registration trials in indications like pancreatic cancer based on favorable results. Manufacturing and a strong patent portfolio were also summarized.
This corporate presentation provides an overview of Oncolytics Biotech and their lead product REOLYSIN. Key points include:
- REOLYSIN is a proprietary reovirus being studied in five randomized phase 2 clinical trials for various cancers.
- Preclinical research shows REOLYSIN selectively replicates in cancer cells with Ras pathway activation. Over 1,000 patients have been treated safely.
- The company has a strong patent portfolio with over 370 patents worldwide and manufacturing capacity at commercial scale.
- Ongoing studies are evaluating REOLYSIN alone or in combination with chemotherapy to show improved survival outcomes and tumor response rates.
The corporate presentation summarizes Oncolytics Biotech's lead product REOLYSIN, a therapeutic reovirus being studied in multiple clinical trials. Key points include:
- REOLYSIN has been administered to over 1,000 patients safely and shows efficacy against Ras-activated cancers.
- A randomized Phase II trial of REOLYSIN in head and neck cancer, REO 018, showed improved tumor stabilization and shrinkage for those receiving REOLYSIN compared to the control arm.
- Oncolytics intends for REO 018 to support a planned Phase III registration trial of REOLYSIN in head and neck cancer.
This document provides an overview of Oncolytics Biotech and their lead product, REOLYSIN.
It discusses three clinical development pathways for REOLYSIN: 1) Combinations with chemotherapy to directly lyse tumor cells, 2) Combinations with immunotherapy to activate immune responses, and 3) Combinations with targeted therapies to modulate innate immunity.
For pathway 1, a phase 2 trial showed REOLYSIN in combination with paclitaxel significantly improved overall survival over paclitaxel alone in metastatic breast cancer patients. This provides the basis for a planned 400-patient phase 3 registration study in this indication.
This presentation provides an overview of Oncolytics Biotech and its lead product candidate REOLYSIN. Key points include:
- REOLYSIN is a first-in-class immuno-oncolytic virus being developed for solid tumors and blood cancers. It has a dual mechanism of action selectively killing cancer cells while activating the immune system.
- In a phase 2 trial in metastatic breast cancer, REOLYSIN combined with paclitaxel more than doubled overall survival compared to paclitaxel alone in ER+/PR+/HER2- patients.
- The clinical development plan is pursuing combinations with chemotherapy, immunotherapy agents like Keytruda, and targeted therapies. This includes an ongoing myel
This corporate presentation provides an overview of Oncolytics Biotech Inc. and its lead product REOLYSIN®, a cancer therapy. It discusses ongoing randomized phase II clinical trials in ovarian, colorectal, lung, prostate and breast cancers. Previous clinical trials have shown REOLYSIN® to be generally safe and well-tolerated, with the potential to reduce tumour burden and improve survival. The company has a strong intellectual property portfolio with over 370 patents worldwide and manufacturing capacity at commercial scale. Top-line data readouts from the ongoing randomized studies are anticipated in 2015 which could support preparation for a registration study.
- The document outlines Oncolytics Biotech's corporate presentation from September 2016. It discusses the company's oncolytic virus REOLYSIN, its two mechanisms of action, positive clinical trial data showing increased progression-free and overall survival for certain patient groups, evidence of tumor responses including reductions in liver metastases, an upcoming colorectal cancer study, potential in multiple myeloma based on preclinical data, commercial-scale manufacturing, and a strong intellectual property portfolio with over 400 issued patents worldwide. The presentation positions REOLYSIN as a promising cancer therapeutic prepared for late-stage clinical trials.
REOLYSIN is an oncolytic virus being developed as a cancer therapeutic. It selectively replicates in and kills Ras activated tumor cells. Over 1,100 patients have been treated with REOLYSIN which has shown a good safety profile and evidence of tumor reduction. Clinical trials are ongoing in various cancer types, both as a monotherapy and in combination with chemotherapy and immunotherapy. The goal is to demonstrate tumor reduction and improved overall survival to support regulatory approval. Oncolytics Biotech has a strong patent portfolio and manufactures REOLYSIN at commercial scale.
- The presentation provides an overview of Oncolytics Biotech Inc. and its lead product candidate REOLYSIN®, an oncolytic virus being developed as a cancer therapeutic.
- Data is presented showing REOLYSIN®'s ability to reduce tumor burden through direct cytotoxic effects and stimulate anti-tumor immune responses, improving overall survival in clinical trials.
- Oncolytics has conducted over 30 clinical trials across many cancer types and is preparing registration trials in indications like pancreatic cancer based on favorable results. Manufacturing and a strong patent portfolio were also summarized.
This corporate presentation provides an overview of Oncolytics Biotech and their lead product REOLYSIN. Key points include:
- REOLYSIN is a proprietary reovirus being studied in five randomized phase 2 clinical trials for various cancers.
- Preclinical research shows REOLYSIN selectively replicates in cancer cells with Ras pathway activation. Over 1,000 patients have been treated safely.
- The company has a strong patent portfolio with over 370 patents worldwide and manufacturing capacity at commercial scale.
- Ongoing studies are evaluating REOLYSIN alone or in combination with chemotherapy to show improved survival outcomes and tumor response rates.
The corporate presentation summarizes Oncolytics Biotech's lead product REOLYSIN, a therapeutic reovirus being studied in multiple clinical trials. Key points include:
- REOLYSIN has been administered to over 1,000 patients safely and shows efficacy against Ras-activated cancers.
- A randomized Phase II trial of REOLYSIN in head and neck cancer, REO 018, showed improved tumor stabilization and shrinkage for those receiving REOLYSIN compared to the control arm.
- Oncolytics intends for REO 018 to support a planned Phase III registration trial of REOLYSIN in head and neck cancer.
This document provides an overview of Oncolytics Biotech and their lead product, REOLYSIN.
It discusses three clinical development pathways for REOLYSIN: 1) Combinations with chemotherapy to directly lyse tumor cells, 2) Combinations with immunotherapy to activate immune responses, and 3) Combinations with targeted therapies to modulate innate immunity.
For pathway 1, a phase 2 trial showed REOLYSIN in combination with paclitaxel significantly improved overall survival over paclitaxel alone in metastatic breast cancer patients. This provides the basis for a planned 400-patient phase 3 registration study in this indication.
This presentation provides an overview of Oncolytics Biotech and its lead product candidate REOLYSIN. Key points include:
- REOLYSIN is a first-in-class immuno-oncolytic virus being developed for solid tumors and blood cancers. It has a dual mechanism of action selectively killing cancer cells while activating the immune system.
- In a phase 2 trial in metastatic breast cancer, REOLYSIN combined with paclitaxel more than doubled overall survival compared to paclitaxel alone in ER+/PR+/HER2- patients.
- The clinical development plan is pursuing combinations with chemotherapy, immunotherapy agents like Keytruda, and targeted therapies. This includes an ongoing myel
This corporate presentation provides an overview of Oncolytics Biotech Inc. and its lead product REOLYSIN®, a cancer therapy. It discusses ongoing randomized phase II clinical trials in ovarian, colorectal, lung, prostate and breast cancers. Previous clinical trials have shown REOLYSIN® to be generally safe and well-tolerated, with the potential to reduce tumour burden and improve survival. The company has a strong intellectual property portfolio with over 370 patents worldwide and manufacturing capacity at commercial scale. Top-line data readouts from the ongoing randomized studies are anticipated in 2015 which could support preparation for a registration study.
- The document outlines Oncolytics Biotech's corporate presentation from September 2016. It discusses the company's oncolytic virus REOLYSIN, its two mechanisms of action, positive clinical trial data showing increased progression-free and overall survival for certain patient groups, evidence of tumor responses including reductions in liver metastases, an upcoming colorectal cancer study, potential in multiple myeloma based on preclinical data, commercial-scale manufacturing, and a strong intellectual property portfolio with over 400 issued patents worldwide. The presentation positions REOLYSIN as a promising cancer therapeutic prepared for late-stage clinical trials.
Drug Information Association Clinical Forum Presentationdneasha
Pharmacoepidemiology studies were performed on YASMIN and CRESTOR to better understand safety risks in real-world use. For YASMIN, a large database study found no increased risks of hyperkalemia or blood clots compared to other oral contraceptives. For CRESTOR, a global program using multiple databases evaluated safety outcomes like rhabdomyolysis. Future directions may include using health databases and electronic records in large simple trials to efficiently answer safety questions.
This document discusses the presentation, testing, and management of pituitary adenomas and hypothalamic syndromes. It provides guidance on testing a 66-year-old man with a confirmed pituitary adenoma discovered on MRI after presenting with stroke symptoms. Testing strategies and their limitations are reviewed. Factors affecting decisions around intervention and appropriate follow-up strategies are also discussed, drawing on literature to support recommendations. Long-term management of patients with prolactinomas on dopamine agonists is explored, including monitoring, treatment withdrawal, and surveillance of side effects.
Analyzing ASCO 2016: Developments, takeaways, and implications from the confe...Pharma Intelligence
In conjunction with a Key Opinion Leader, Dr. Peter Lee MD Chair, Department of Immuno-Oncology at City of Hope Comprehensive Cancer Center, CA, several Informa analysts discuss the major developments of the conference and key take-aways via a Webinar.
Watch our recording of Biomedtracker's Robert Jeng, Ph,D., Citeline's Allison Bruce, Scrip's Mary Jo Laffler, and Datamonitor Healthcare's Zachary McLellan as they download and debrief following the always-exciting ASCO weekend.
View and listen to the full webinar here https://www.youtube.com/watch?v=7yMsCb3R5X8
Advances in induction in Acute Lymphocytic Leukemiaspa718
This document summarizes key findings from recent studies on improving induction therapy for acute lymphocytic leukemia (ALL). It describes trials showing that intensified chemotherapy regimens based on pediatric protocols improved outcomes for young adults compared to historical regimens. A trial incorporating the targeted therapy ponatinib into frontline therapy for Philadelphia chromosome-positive ALL achieved high rates of complete response and molecular response. Combining the epigenetic agents decitabine and vorinostat with chemotherapy showed tolerability and clinical benefit for relapsed/refractory ALL. Overall, the document discusses advances demonstrating that pediatric-inspired and targeted regimens are feasible and effective for certain adult ALL patients.
Your fast-pass to the news, insights, and storylines you need to know.
Watch the full webinar here http://ow.ly/4mOGmk
Hosted by Master of Ceremonies Ian Lloyd, senior director of Pharmaprojects and data integration, this webinar spotlights the blockbuster trends and rising stars of global R&D 2016 as seen in this year’s Annual Review.
During this presentation, Ian Lloyd & Scrip Managing Editor, Alex Shimmings cover:
>> Year-on-year growth
>> Clinical phases trends
>> Top companies and the shape of the industry
>> Mergers and acquisitions
>> Trending therapies, diseases, drug types and delivery routes
>> Mechanisms and drug targets
This webinar is the essential pharma R&D trend and forecast overview you need to be positioned for success in 2016.
Watch the full webinar here http://ow.ly/4mOGmk
This document discusses a case of a 64-year-old man presenting with right flank pain and a history of smoking who is found to have clear-cell renal cell carcinoma (RCC). He undergoes a right radical nephrectomy and pathology confirms grade 3 clear-cell RCC without margins or lymph node involvement. Small lung nodules are detected 18 months later and biopsy confirms metastatic clear cell RCC. Systemic therapy options for the metastatic disease are discussed, including tyrosine kinase inhibitors, immunotherapy, and their combinations. Ongoing trials of immunotherapy in the adjuvant and metastatic settings are also summarized. Risk stratification models and their impact on treatment selection are reviewed.
Merck presented at the 2016 ASCO conference on their oncology strategy and KEYTRUDA program. Key points include:
1) Merck's strategy is to identify patients most likely to benefit from KEYTRUDA, establish KEYTRUDA as a foundation for cancer treatment in monotherapy and combinations, and improve long-term disease control and survival across cancers.
2) KEYTRUDA has shown clinical activity in over 20 tumor types and has over 30 ongoing registration-enabling studies and 100 combination trials. Data at ASCO 2016 showed further progress in combinations and predictive biomarkers.
3) Merck is pursuing a combination strategy with KEYTRUDA and targeted therapies, immunomodulators
Kimberly Halla, MSN, FNP-C, Paula J. Anastasia, RN, MN, AOCN, and Nelli Zafman, MSN, CRNP, AOCNP prepared useful Practice Aids pertaining to PARP inhibitor therapy for this CNE activity titled, "Realizing the Promise of PARP Inhibitors in Solid Tumor Therapy: Guiding Oncology Nurses on the Advances and Challenges." For the full presentation, monograph, complete CNE information, and to apply for credit, please visit us at http://bit.ly/2EkO5Ij. CNE credit will be available until May 22, 2020.
Gene therapy using an AAV vector was tested in 6 males with severe hemophilia B. The vector encoded Factor IX and was administered via peripheral vein infusion. No safety issues were found regarding germline transmission or formation of antibodies against FIX. Mild, transient elevations in liver enzymes occurred in some subjects. FIX levels increased in a dose-dependent manner, allowing 4 subjects to stop prophylactic FIX treatment without bleeding. While the study demonstrated proof-of-concept for hemophilia B gene therapy, larger trials are needed to further evaluate safety and efficacy.
This document describes a quality improvement initiative to reduce the incidence of postoperative nausea and vomiting (PONV) at a hospital. It developed new guidelines and an order set for managing PONV based on literature reviews. All clinical staff were educated on these tools. Data on order set use and PONV rates will be collected and charted weekly to evaluate the impact and allow adjustments to the intervention. The goal is to implement evidence on PONV into practice to improve patient outcomes and experience by decreasing this common complication.
Roy H. Decker, MD, PhD, and Sarah B. Goldberg, MD, MPH, prepared useful practice aids pertaining to lung cancer for this CME activity titled "The Era of Immunotherapy in Stage III NSCLC: Exploring the Evidence and Practicalities of Integrating Checkpoint Inhibition Into the Multimodal Treatment Arsenal." For the full presentation, monograph, complete CME information, and to apply for credit, please visit us at http://bit.ly/2PU3iaZ. CME credit will be available until December 6, 2019.
1. Lung neuroendocrine tumors (NETs) have been increasing in incidence and include typical carcinoid (TC), atypical carcinoid (AC), large-cell neuroendocrine carcinoma (LCNEC), and small-cell lung cancer (SCLC).
2. Diagnosis of lung NETs can be difficult due to non-specific symptoms and frequently involves histopathological examination. Treatment depends on tumor grade and stage.
3. For localized disease, surgery is the primary treatment. For advanced or metastatic NETs, options include somatostatin analogues, targeted therapies like everolimus, chemotherapy, and peptide receptor radionuclide therapy.
Coles alemtuzumab camm223 10yr efficacy safety aan 2016_poster p3.053BartsMSBlog
Alemtuzumab demonstrated durable efficacy and a consistent safety profile over 10 years in patients with relapsing-remitting multiple sclerosis (RRMS) from the CAMMS223 study. Most patients maintained a low annualized relapse rate and experienced stabilization or improvement in disability scores. While adverse events were most common in the first year, serious safety issues were rare, with infections declining over time and no deaths occurring. Alemtuzumab provided sustained benefit for RRMS with limited additional treatment for many patients over 10 years.
This study examined the significance of HER-2 and hormonal receptor status in patients with locally advanced breast cancer treated with neoadjuvant systemic therapy. It found that hormonal receptor status has a significant prognostic effect on both overall survival and progression-free survival. HER-2 receptor status was found to have a significant prognostic effect on overall survival. No significant association was found between receptor status and clinical response to neoadjuvant chemotherapy. The study was limited by its small sample size and retrospective design.
The document outlines a student's strategy to become famous at their business school by getting a girlfriend within their first month of studying. It details their plan to reveal their crush during an icebreaker activity and lists the attractive female students they find at the school. The student hopes this "love story" will end with the girl of their dreams accepting their proposal, though they anticipate being rejected. They also share their habit of drinking frequently and invite all girls to socialize with them at their dorm. The document provides a lighthearted look at one student's unrealistic goals and observations during their early time at business school.
This corporate presentation provides an overview of Oncolytics Biotech and their lead product REOLYSIN. Key points include:
- REOLYSIN is a proprietary reovirus being tested in combination with chemotherapy in seven randomized clinical trials for various cancers. Completed trials show signs of efficacy and a favorable safety profile.
- Preclinical evidence suggests REOLYSIN selectively replicates in Ras-activated cancer cells. Ongoing trials are exploring this mechanism of action and correlating outcomes with Ras pathway biomarkers.
- A randomized Phase 3 trial in head and neck cancer showed increased progression-free and overall survival for patients receiving REOLYSIN plus chemotherapy compared to chemotherapy alone.
Drug Information Association Clinical Forum Presentationdneasha
Pharmacoepidemiology studies were performed on YASMIN and CRESTOR to better understand safety risks in real-world use. For YASMIN, a large database study found no increased risks of hyperkalemia or blood clots compared to other oral contraceptives. For CRESTOR, a global program using multiple databases evaluated safety outcomes like rhabdomyolysis. Future directions may include using health databases and electronic records in large simple trials to efficiently answer safety questions.
This document discusses the presentation, testing, and management of pituitary adenomas and hypothalamic syndromes. It provides guidance on testing a 66-year-old man with a confirmed pituitary adenoma discovered on MRI after presenting with stroke symptoms. Testing strategies and their limitations are reviewed. Factors affecting decisions around intervention and appropriate follow-up strategies are also discussed, drawing on literature to support recommendations. Long-term management of patients with prolactinomas on dopamine agonists is explored, including monitoring, treatment withdrawal, and surveillance of side effects.
Analyzing ASCO 2016: Developments, takeaways, and implications from the confe...Pharma Intelligence
In conjunction with a Key Opinion Leader, Dr. Peter Lee MD Chair, Department of Immuno-Oncology at City of Hope Comprehensive Cancer Center, CA, several Informa analysts discuss the major developments of the conference and key take-aways via a Webinar.
Watch our recording of Biomedtracker's Robert Jeng, Ph,D., Citeline's Allison Bruce, Scrip's Mary Jo Laffler, and Datamonitor Healthcare's Zachary McLellan as they download and debrief following the always-exciting ASCO weekend.
View and listen to the full webinar here https://www.youtube.com/watch?v=7yMsCb3R5X8
Advances in induction in Acute Lymphocytic Leukemiaspa718
This document summarizes key findings from recent studies on improving induction therapy for acute lymphocytic leukemia (ALL). It describes trials showing that intensified chemotherapy regimens based on pediatric protocols improved outcomes for young adults compared to historical regimens. A trial incorporating the targeted therapy ponatinib into frontline therapy for Philadelphia chromosome-positive ALL achieved high rates of complete response and molecular response. Combining the epigenetic agents decitabine and vorinostat with chemotherapy showed tolerability and clinical benefit for relapsed/refractory ALL. Overall, the document discusses advances demonstrating that pediatric-inspired and targeted regimens are feasible and effective for certain adult ALL patients.
Your fast-pass to the news, insights, and storylines you need to know.
Watch the full webinar here http://ow.ly/4mOGmk
Hosted by Master of Ceremonies Ian Lloyd, senior director of Pharmaprojects and data integration, this webinar spotlights the blockbuster trends and rising stars of global R&D 2016 as seen in this year’s Annual Review.
During this presentation, Ian Lloyd & Scrip Managing Editor, Alex Shimmings cover:
>> Year-on-year growth
>> Clinical phases trends
>> Top companies and the shape of the industry
>> Mergers and acquisitions
>> Trending therapies, diseases, drug types and delivery routes
>> Mechanisms and drug targets
This webinar is the essential pharma R&D trend and forecast overview you need to be positioned for success in 2016.
Watch the full webinar here http://ow.ly/4mOGmk
This document discusses a case of a 64-year-old man presenting with right flank pain and a history of smoking who is found to have clear-cell renal cell carcinoma (RCC). He undergoes a right radical nephrectomy and pathology confirms grade 3 clear-cell RCC without margins or lymph node involvement. Small lung nodules are detected 18 months later and biopsy confirms metastatic clear cell RCC. Systemic therapy options for the metastatic disease are discussed, including tyrosine kinase inhibitors, immunotherapy, and their combinations. Ongoing trials of immunotherapy in the adjuvant and metastatic settings are also summarized. Risk stratification models and their impact on treatment selection are reviewed.
Merck presented at the 2016 ASCO conference on their oncology strategy and KEYTRUDA program. Key points include:
1) Merck's strategy is to identify patients most likely to benefit from KEYTRUDA, establish KEYTRUDA as a foundation for cancer treatment in monotherapy and combinations, and improve long-term disease control and survival across cancers.
2) KEYTRUDA has shown clinical activity in over 20 tumor types and has over 30 ongoing registration-enabling studies and 100 combination trials. Data at ASCO 2016 showed further progress in combinations and predictive biomarkers.
3) Merck is pursuing a combination strategy with KEYTRUDA and targeted therapies, immunomodulators
Kimberly Halla, MSN, FNP-C, Paula J. Anastasia, RN, MN, AOCN, and Nelli Zafman, MSN, CRNP, AOCNP prepared useful Practice Aids pertaining to PARP inhibitor therapy for this CNE activity titled, "Realizing the Promise of PARP Inhibitors in Solid Tumor Therapy: Guiding Oncology Nurses on the Advances and Challenges." For the full presentation, monograph, complete CNE information, and to apply for credit, please visit us at http://bit.ly/2EkO5Ij. CNE credit will be available until May 22, 2020.
Gene therapy using an AAV vector was tested in 6 males with severe hemophilia B. The vector encoded Factor IX and was administered via peripheral vein infusion. No safety issues were found regarding germline transmission or formation of antibodies against FIX. Mild, transient elevations in liver enzymes occurred in some subjects. FIX levels increased in a dose-dependent manner, allowing 4 subjects to stop prophylactic FIX treatment without bleeding. While the study demonstrated proof-of-concept for hemophilia B gene therapy, larger trials are needed to further evaluate safety and efficacy.
This document describes a quality improvement initiative to reduce the incidence of postoperative nausea and vomiting (PONV) at a hospital. It developed new guidelines and an order set for managing PONV based on literature reviews. All clinical staff were educated on these tools. Data on order set use and PONV rates will be collected and charted weekly to evaluate the impact and allow adjustments to the intervention. The goal is to implement evidence on PONV into practice to improve patient outcomes and experience by decreasing this common complication.
Roy H. Decker, MD, PhD, and Sarah B. Goldberg, MD, MPH, prepared useful practice aids pertaining to lung cancer for this CME activity titled "The Era of Immunotherapy in Stage III NSCLC: Exploring the Evidence and Practicalities of Integrating Checkpoint Inhibition Into the Multimodal Treatment Arsenal." For the full presentation, monograph, complete CME information, and to apply for credit, please visit us at http://bit.ly/2PU3iaZ. CME credit will be available until December 6, 2019.
1. Lung neuroendocrine tumors (NETs) have been increasing in incidence and include typical carcinoid (TC), atypical carcinoid (AC), large-cell neuroendocrine carcinoma (LCNEC), and small-cell lung cancer (SCLC).
2. Diagnosis of lung NETs can be difficult due to non-specific symptoms and frequently involves histopathological examination. Treatment depends on tumor grade and stage.
3. For localized disease, surgery is the primary treatment. For advanced or metastatic NETs, options include somatostatin analogues, targeted therapies like everolimus, chemotherapy, and peptide receptor radionuclide therapy.
Coles alemtuzumab camm223 10yr efficacy safety aan 2016_poster p3.053BartsMSBlog
Alemtuzumab demonstrated durable efficacy and a consistent safety profile over 10 years in patients with relapsing-remitting multiple sclerosis (RRMS) from the CAMMS223 study. Most patients maintained a low annualized relapse rate and experienced stabilization or improvement in disability scores. While adverse events were most common in the first year, serious safety issues were rare, with infections declining over time and no deaths occurring. Alemtuzumab provided sustained benefit for RRMS with limited additional treatment for many patients over 10 years.
This study examined the significance of HER-2 and hormonal receptor status in patients with locally advanced breast cancer treated with neoadjuvant systemic therapy. It found that hormonal receptor status has a significant prognostic effect on both overall survival and progression-free survival. HER-2 receptor status was found to have a significant prognostic effect on overall survival. No significant association was found between receptor status and clinical response to neoadjuvant chemotherapy. The study was limited by its small sample size and retrospective design.
The document outlines a student's strategy to become famous at their business school by getting a girlfriend within their first month of studying. It details their plan to reveal their crush during an icebreaker activity and lists the attractive female students they find at the school. The student hopes this "love story" will end with the girl of their dreams accepting their proposal, though they anticipate being rejected. They also share their habit of drinking frequently and invite all girls to socialize with them at their dorm. The document provides a lighthearted look at one student's unrealistic goals and observations during their early time at business school.
This corporate presentation provides an overview of Oncolytics Biotech and their lead product REOLYSIN. Key points include:
- REOLYSIN is a proprietary reovirus being tested in combination with chemotherapy in seven randomized clinical trials for various cancers. Completed trials show signs of efficacy and a favorable safety profile.
- Preclinical evidence suggests REOLYSIN selectively replicates in Ras-activated cancer cells. Ongoing trials are exploring this mechanism of action and correlating outcomes with Ras pathway biomarkers.
- A randomized Phase 3 trial in head and neck cancer showed increased progression-free and overall survival for patients receiving REOLYSIN plus chemotherapy compared to chemotherapy alone.
Founded in 1976, Apple Inc. began as a computer company founded by Steve Jobs and Steve Wozniak. Some of Apple's seminal early products included the Apple I computer in 1976 and the Apple II in 1977, which was a unique and colorful personal computer. Throughout the 1980s, Apple launched other computers like the Apple III and Lisa, and in 1984, the groundbreaking Macintosh, the first computer with a graphical user interface. In later decades, Apple introduced many successful consumer electronics including the iPod in 2001, iPhone in 2007 which pioneered the touchscreen smartphone, and iPad tablet in 2010. Apple has continued innovating with new versions of its products and aims to focus on customer satisfaction and performance stability for the
The document provides observations of communication skills for 4 individuals at an organization.
For Person 1, their key strengths are listed as a pleasing personality and being assertive, while their limitation is noted as being prejudiced at times.
Person 2 is described as having simplicity as a strength, but sometimes being shy as a limitation.
The strengths of Person 3 are said to be leading by example, while their limitation is described as sometimes being indifferent and arrogant.
Finally, Person 4's strengths are identified as frankness and being assertive, while their limitation is stated as working on instinct at times.
Adobe SiteCatalyst is a software-as-a-service solution that collects web analytics data like page views and visits from website visitors. It processes and reports this data. SiteCatalyst collects data through JavaScript tagging, which embeds SiteCatalyst code onto web pages to send visitor data to Adobe's data collection layer. SiteCatalyst provides both traffic and conversion variables to track visitor behavior. Traffic variables count events like page views, while conversion variables track persistent information like login status. SiteCatalyst also supports custom events to track specific user actions. Tagging is the process of adding the SiteCatalyst JavaScript code to web pages so analytic data is collected as pages load.
This document outlines plans for a Multi Art Informal Learning (MAIL) complex that aims to improve art education through a constructivist and informal learning approach. It would provide teenagers with convenient access to high-quality art facilities and activities to encourage voluntary participation and make learning enjoyable. The complex would include various art rooms, performance spaces, and technology like VR and AR. Specialists in different art forms would guide students. The goal is to help students' emotional and cognitive development through a more flexible educational experience.
Browser hijacking is a serious nuisance in today’s web surfing experience. Fortunately, avoiding a browser hijacking is not impossible if you stay aware, and take a few simple precautions.
Vektor adalah besaran yang mempunyai besar dan arah, seperti perpindahan, kecepatan, gaya, dan percepatan.
Skalar adalah besaran yang mempunyai besar tetapi tanpa arah, seperti massa, panjang, waktu, suhu, dan sebarang bilangan riil
This document is about a presentation given by Luc Labelle at the SharePoint Saturday event in New Hampshire on October 24th 2015. The presentation discussed how Power BI can help unleash the value of corporate data by allowing users to gather, clean, transform, explore, visualize and share data. It provided an overview of the basic concepts in Power BI like datasets, reports and dashboards as well as licensing information and the ecosystem supporting Power BI.
How a Credit Union Can Stay Off the CFPB's RadarSilver cloud
Learn what it takes to align consumer expectations, CFPB expectations and your business. SilverCloud, Inc. will take you through the evolving consumer behaviors, the current regulatory landscape and where you want to be to stay off the radar. Learn what your financial institution needs to be doing to have happier consumers, drive more revenue, lower costs, and stay compliant.
The document summarizes the health effects of smoking. It causes irritation and damage to the lungs leading to reduced lung function, excess mucus, and increased risk of infection. Smoking also constricts blood vessels, raises blood pressure, reduces oxygen in the blood, and damages artery walls increasing risks of conditions like heart attack and stroke. It weakens the immune system making smokers more vulnerable to infections.
1. The presentation discusses a corporate overview of Oncolytics Biotech including their clinical programs investigating REOLYSIN, a proprietary reovirus, as a cancer therapeutic.
2. Data is presented showing REOLYSIN can reduce tumor burden through direct cytotoxic effects and enhance long-term immune responses. Studies also indicate it may improve overall survival.
3. Oncolytics is developing REOLYSIN for registration in muscle invasive bladder cancer based on ability to show histopathological response. They are also investigating its use in gliomas and other cancers.
1) The document contains forward-looking statements about Oncolytics Biotech's financial results, business prospects, and the development of REOLYSIN, noting inherent risks and uncertainties.
2) REOLYSIN is a proprietary reovirus isolate that selectively replicates in and lyses tumor cells with an activated Ras pathway. Over 1,100 patients have been treated with REOLYSIN, demonstrating a strong safety profile and evidence of anti-tumor activity.
3) Clinical studies show REOLYSIN can reduce tumor burden, improve overall survival rates compared to standard therapies, and enhance long-term immune responses against residual tumor cells through viral replication and immune-mediated effects.
This presentation provides an overview of Oncolytics Biotech Inc. and its lead product REOLYSIN®, a novel cancer therapy. Key points include:
- REOLYSIN® is a proprietary reovirus being studied in five randomized Phase II clinical trials for various cancer indications. Interim data has shown increased progression-free and overall survival compared to controls.
- Preclinical research demonstrates REOLYSIN®'s ability to directly kill tumor cells and stimulate anti-tumor immune responses. Combinations with immunotherapies are being explored.
- Over 1,100 patients have been treated with REOLYSIN® to date, which has shown a favorable safety profile both as monotherapy and in
Corporate Presentation August 24, 2015
1) Oncolytics Biotech is developing the oncolytic virus REOLYSIN® as a cancer therapeutic. REOLYSIN® has shown to selectively replicate in and kill Ras-activated tumor cells while sparing normal cells.
2) Clinical trials involving over 1,100 patients have demonstrated REOLYSIN®'s favorable safety profile and ability to reduce tumor burden and improve overall survival rates.
3) Ongoing randomized phase 2 studies in ovarian, colorectal, breast, lung, and prostate cancers are evaluating REOLYSIN®'s ability to enhance immune responses and improve long-term clinical outcomes.
This corporate presentation provides an overview of Oncolytics Biotech and its lead product REOLYSIN. Key points include:
- REOLYSIN is a proprietary reovirus being tested in combination with chemotherapy in multiple randomized phase 2 clinical trials for various cancers.
- Completed phase 2 trial REO 018 in head and neck cancer showed increased progression-free and overall survival when combined with chemotherapy.
- Ongoing trials include studies sponsored by the NCI in pancreatic, ovarian, lung, and breast cancers.
- REOLYSIN works by selectively replicating in Ras-activated cancer cells and is believed to have a favorable safety profile.
This document summarizes an investor presentation by Oncolytics Biotech regarding their immuno-oncology agent REOLYSIN. It discusses 3 key points:
1. REOLYSIN's dual mechanism of action turns "cold" tumors "hot" by selectively lysing cancer cells and activating the innate and adaptive immune system.
2. Clinical trials showed REOLYSIN in combination with chemotherapy significantly improved overall survival in patients with metastatic breast cancer and doubled 2-year survival in pancreatic cancer.
3. The company's development plan focuses on combination trials with chemotherapy, immunotherapy agents like Keytruda, and targeted therapies through collaborations with Celgene to advance their lead program in registration trials for metastatic breast cancer
This investor presentation summarizes Oncolytics Biotech's clinical development plan for REOLYSIN, a viral immunotherapy for cancer. It discusses three pathways: 1) chemotherapy combinations, which are the basis for the first registration pathway in pancreatic cancer. Survival data from several phase 2 studies is expected in 2017. 2) Immunotherapy combinations, including an ongoing study of REOLYSIN with pembrolizumab. 3) Targeted agent/IMiD combinations, such as a collaboration using REOLYSIN with pomalidomide in multiple myeloma. The presentation outlines the mechanism of action of REOLYSIN and how combinations can enhance innate and adaptive immune responses against cancer.
This presentation provides an overview of Oncolytics Biotech and its lead product candidate REOLYSIN. Key points include:
- REOLYSIN is an immuno-oncolytic virus that has demonstrated a statistically significant improvement in overall survival for patients with metastatic breast cancer.
- The clinical development plan focuses on combining REOLYSIN with chemotherapy or immunotherapy agents to boost its dual mechanism of action. This includes an ongoing phase 3 study in metastatic breast cancer.
- If approved, REOLYSIN would address a large market as the first systemically delivered oncolytic virus for solid tumors. Oncolytics is preparing for commercial-scale manufacturing.
Oncolytics Biotech presented their investor presentation which included the following key points:
1) Oncolytics is developing REOLYSIN, a novel immuno-oncology viral agent for systemic administration that exploits cancer cell lysis and anti-tumor immunity.
2) Additional randomized phase 2 clinical trials in 2017 are expected to generate overall survival data in breast cancer, ovarian cancer, non-small cell lung cancer, and colorectal cancer.
3) The clinical development plan focuses on combining REOLYSIN with chemotherapy for late-stage development and establishing it as a backbone agent combined with immunotherapy.
4) Over 900 patients have been treated with REOLYSIN intravenously with no drug
This presentation provides an overview of Oncolytics Biotech and its lead product REOLYSIN®, a proprietary reovirus for the treatment of cancers. Key points include:
- REOLYSIN® shows efficacy in Ras-activated cancers and has a favorable safety profile. It is being studied in 7 randomized clinical trials in various cancer types.
- Data from a randomized phase 2 trial in head and neck cancer (REO 018) showed improved progression-free survival and tumor responses with the combination of REOLYSIN®, carboplatin and paclitaxel.
- Additional phase 2 studies in lung, prostate, colorectal and other cancers are ongoing to further evaluate REOLYS
This presentation provides an overview of Oncolytics Biotech and its lead product REOLYSIN®, a proprietary reovirus for the treatment of cancers. Key points include:
- REOLYSIN® selectively replicates in and kills Ras-activated cancer cells through a mechanism of action that deactivates the cellular defense protein PKR.
- Oncolytics has an expanding clinical program testing REOLYSIN® across several cancer types both as a monotherapy and in combination with chemotherapy.
- A randomized Phase II head and neck cancer study (REO 018) showed increased progression-free and overall survival for patients receiving REOLYSIN® plus chemotherapy compared to chemotherapy alone.
This presentation provides an overview of Oncolytics Biotech Inc. and its lead product REOLYSIN®. REOLYSIN® is a first-in-class immuno-oncology viral therapy for solid tumors and blood cancers. Recent clinical trials showed REOLYSIN® statistically significantly increased overall survival when combined with chemotherapy for metastatic breast cancer. The company has defined a clinical development plan targeting registration in metastatic breast cancer and is pursuing combination trials to further develop REOLYSIN®'s mechanism of action. Oncolytics Biotech has strengthened its leadership team and secured manufacturing agreements to support late-stage trials and early commercialization.
Oncolytics Biotech presented an investor presentation that summarized their progress with REOLYSIN, a therapeutic reovirus for treating cancer. Key points included:
- REOLYSIN showed statistically significant increased overall survival in a phase 2 trial for metastatic breast cancer.
- The FDA granted REOLYSIN Fast Track designation and the clinical development plan focuses on combinations with chemotherapy, immunotherapy, and targeted therapies.
- Safety data has shown REOLYSIN to be well-tolerated with no maximum tolerated dose reached. Manufacturing is established at commercial scale.
- The patent portfolio and leadership team provide a strong foundation to further develop REOLYSIN as a potential treatment for multiple cancer types.
This investor presentation summarizes Oncolytics Biotech's progress developing its lead product REOLYSIN, a proprietary reovirus for treating cancer. Key points include:
- REOLYSIN showed statistically significant increased overall survival in a phase 2 trial combining it with paclitaxel for metastatic breast cancer.
- The company is preparing for regulatory meetings to discuss a potential registration pathway in breast cancer based on these results.
- Additional clinical studies are investigating REOLYSIN in combination with chemotherapy for pancreatic cancer, immunotherapy with pembrolizumab, and targeted therapies from Celgene.
- REOLYSIN's mechanism of action involves direct killing of cancer cells, stimulation of innate and
Targovax presentation december 2017 carnegietargovax2017
Targovax provided an overview of its clinical programs for its two immuno-oncology platforms: ONCOS oncolytic virus and TG mutRAS neoantigen vaccine. For ONCOS, interim data from ongoing phase I/II trials in several solid tumors was highlighted. For TG, encouraging survival data from a phase I/II trial in resected pancreatic cancer was summarized. Upcoming clinical readouts and trial initiations in 2017-2018 were outlined for both platforms.
Targovax has two immuno-oncology programs - ONCOS, an oncolytic virus, and TG, a RAS neoantigen vaccine. TG has shown promising results in pancreatic cancer trials, with 20% 10-year survival in previous trials. An ongoing phase I/II trial is validating these results with adjuvant chemotherapy. ONCOS has demonstrated the ability to increase tumor-infiltrating T-cells in early trials. Targovax has a broad clinical program with several upcoming data readouts in 2017-2018 from trials in melanoma, mesothelioma, ovarian/colorectal, prostate, and pancreatic/colorectal cancers.
This investor presentation summarizes Oncolytics Biotech's REOLYSIN viral therapy program. It highlights statistically significant increases in overall survival seen in phase 2 trials in metastatic breast cancer and pancreatic cancer. The clinical development plan focuses on three pathways: chemotherapy combinations as the first registration pathway, immunotherapy combinations with agents like pembrolizumab, and targeted therapy combinations using agents like pomalidomide. Safety data from over 1,100 patients shows a good toxicity profile. Manufacturing is established at commercial scale and the company has a strong patent portfolio. The leadership team has extensive experience in oncology drug development.
1) The document discusses Targovax's clinical programs targeting cancer through immune activation, including their ONCOS oncolytic virus and TG RAS neoantigen vaccine.
2) Early clinical trials of ONCOS-102 demonstrated immune activation and clinical activity in patients with various solid tumors.
3) Targovax is conducting additional trials of ONCOS-102 in combination with checkpoint inhibitors in indications like mesothelioma and peritoneal cancers.
4) The TG vaccine targets mutated RAS neoantigens, which are present in many cancer types, and aims to induce T-cell responses against patient-specific tumors.
Targovax presented highlights from Q1 2017, including encouraging survival data from a phase I/II trial of TG01 in pancreatic cancer. 68% of patients were still alive after 2 years, compared to historical rates of 30-53%. Targovax will present further clinical data on TG01 at ASCO in June. The company initiated an exploratory trial of TG01 in colorectal cancer and has six clinical trials ongoing or planned in 2017-2018 across cancer indications. Financially, Targovax has cash of NOK 147M and an operating expenses run rate of NOK 104M annually based on the last four quarters.
This corporate presentation summarizes PharmaMar's pipeline and strategy:
- PharmaMar is a biotech company focused on developing marine-derived oncology drugs. It has a fully integrated platform from discovery to commercialization.
- The pipeline includes Yondelis® for soft tissue sarcoma and ovarian cancer, Aplidin® for multiple myeloma, and PM1183 which is being studied in small cell lung cancer, platinum-resistant ovarian cancer, and BRCA breast cancer.
- PM1183 has shown promising results in early clinical trials, achieving a 67% response rate in small cell lung cancer. Phase III trials are ongoing in platinum-resistant ovarian cancer.
Methanex is the world's largest producer and supplier of methanol. We create value through our leadership in the global production, marketing and delivery of methanol to customers. View our latest Investor Presentation for more details.
UnityNet World Environment Day Abraham Project 2024 Press ReleaseLHelferty
June 12, 2024 UnityNet International (#UNI) World Environment Day Abraham Project 2024 Press Release from Markham / Mississauga, Ontario in the, Greater Tkaronto Bioregion, Canada in the North American Great Lakes Watersheds of North America (Turtle Island).
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ZKsync airdrop of 3.6 billion ZK tokens is scheduled by ZKsync for next week.pdfSOFTTECHHUB
The world of blockchain and decentralized technologies is about to witness a groundbreaking event. ZKsync, the pioneering Ethereum Layer 2 network, has announced the highly anticipated airdrop of its native token, ZK. This move marks a significant milestone in the protocol's journey, empowering the community to take the reins and shape the future of this revolutionary ecosystem.
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Cleades Robinson, a respected leader in Philadelphia's police force, is known for his diplomatic and tactful approach, fostering a strong community rapport.
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 Oncolytic 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 regulatory authorities
including but not limited to the FDA, HPB and MHRA, and those other factors detailed
in the Company’s filings with SEDAR and the Securities and Exchange Commission.
Oncolytics Biotech® Inc. does not undertake an obligation to update these forward
looking statements, except as required by applicable laws.
2
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
$26.9 million total
current assets as at the
end of Q4, 2015
Manufacturing
at commercial scale
100L cGMP completed
3
4. What is REOLYSIN®?
A proprietary isolate
of wild-type reovirus
Serotype 3 Dearing
Non-pathogenic
Most humans show
evidence of exposure
by adulthood
4
5. Safety Profile of REOLYSIN®
General Safety
1,100+ patients treated, 1,000+ of these intravenously
No MTD reached
Safety profile confirmed in a randomized setting
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
5
6. Clinical Program for REOLYSIN®
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 023
Run-InStudy
REO 019
PhaseIb
REO 024
PhaseIb
6
7. REOLYSIN®: Two Mechanisms of Action
1. In cancer cells with Ras pathway activating
mutations (Braf, Kras and EGFR), REOLYSIN®
acts as a directed cytotoxin and thereby
reduces tumour burden.
2. REOLYSIN® also interacts with the immune
system in at least two known ways, thereby
functioning as an immune therapy that
extends overall survival.
7
9. Neoadjuvant Treatment of Muscle-Invasive Bladder Cancer
Prior studies in other indications have indicated that REOLYSIN® may be an effective
neoadjuvant agent due to its ability to rapidly reduce tumour burden (e.g. the REO 018
head and neck study)
We are initiating a study to confirm clinical response rates in muscle-invasive bladder
cancer and, once confirmed, will proceed to a registration study
Multiple Myeloma
We have completed and/or initiated three studies of REOLYSIN® in multiple myeloma
patients
These studies have confirmed very high response rates in patients who have failed, or
are refractory to, standard of care
We are preparing to file for a registration study in this indication of the basis of results
from studies in this indication to date
Registration Program for REOLYSIN®: Studies
with Tumour Reduction Endpoints
9
10. 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
10
11. 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)
11
12. REOLYSIN® Plus Carfilzomib Response Data in
Multiple Myeloma
-100
-90
-80
-70
-60
-50
-40
-30
-20
-10
0
5 8 4 7 6 3 1 2
%CHANGEOFMONOCLONALPROTEIN
PATIENTS EVALUABLE FOR RESPONSE
Responses evaluated using International Myeloma Working Group (IMWG) Criteria :
• Patients 1 & 2 = Very Good Partial Response (VGPR)
• Patients 3, 6 & 7 = Partial Response (PR)
• Patients 4, 5 & 8 = Minor Response (MR)
12
13. Randomized Clinical Trial Data: Tumour-
Specific Responses
Head and Neck Cancer (REO 018)
Velocityof Tumour Shrinkage: An analysis of 105 patients showed that 86%
of the test arm (n=50) versus 67% of the control arm (n=55) had tumour
stabilization or shrinkage (p = 0.025)
Volumetric Tumour Reduction:
• An analysis of 118 loco-regional patients with or without distal metastases
showed that the test arm had a 23% greater volumetric reduction than the
control arm (p = 0.076)
• An analysis of 47 patients with distal metastases only showed that the test
arm had a 30% greater volumetric reduction than the control arm (p = 0.021)
Ovarian Cancer (GOG-0186H)
The rate of full response was 9.26% in the test arm versus 1.85% in the
control arm (p = 0.0196)
The rate of stable disease or better was 44.44% in the test arm versus
24.08% in the control arm (p = 0.0096)
13
15. Advanced Gliomas
We have completed and/or initiated/about to initiate five studies of REOLYSIN® in
glioma patients including an ongoing Phase 1 IV combined with GM-CSF in pediatric
patients, and a study assessing response in patients receiving REOLYSIN® and the
standard of care (surgery followed by radiation and temozolomide)
Subject to confirmation of best approach, we will proceed to a pivotal trial, which will
also measure overall survival
Patients With Metastases to the Liver
We have completed enrolment in studies with head and neck cancer and colorectal
cancer (CRC), both with significant metastases of the liver.
Subject to confirmation of results from the CRC study, we will proceed to a pivotal trial,
which will also measure overall survival
Registration Program for REOLYSIN®: Studies
with Overall Survival Endpoints
15
16. 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
16
17. Patient Outcomes Are Influenced By
Immune Status
The survival rate of ovarian cancer patients with high PD-L1 expression on
entry is statistically significantly worse than that of patients with low PD-L1
expression on entry
Five year survival was 80.2% for patients with low PD-L1 expression on entry and 52.6% for
those with high PD-L1 expression on entry (p = 0.016)
Mean survival was 9.56 years for patients with low PD-L1 expression on entry and 6.48 years
for those with high PD-L1 expression on entry1
The survival rate of ovarian cancer patients with high intraepithelial CD8+ T
lymphocyte counts on entry is statistically significantly better than that of
patients with low CD8+ T lymphocyte counts
Five year survival was 86.9% for patients with high CD8+ T lymphocyte counts on entry and
39% for those with low CD8+ T lymphocyte counts on entry (p < 0.001)
Mean survival was 9.6 years for patients with high CD8+ T lymphocyte counts on entry and 4.7
years for those with low CD8+ T lymphocyte counts on entry1
1 Hamanishi et al. 2007. Programmed cell death 1 ligand 1 and tumor-infiltrating CD8+ T lymphocytes are prognostic
factors of human ovarian cancer. PNAS 104(9):3360-3365.
17
18. REOLYSIN® in Multiple Myeloma
Variable
REOLYSIN®
Monotherapy,
Pre-Treatment
REOLYSIN®
Monotherapy,
Post-Treatment
Statistics
REOLYSIN® +
Carfilzomib,
Pre-
Treatment
REOLYSIN® +
Carfilzomib,
Post-
Treatment
Statistics
CD8 58.0 (21.5) 63.9 (18.3)
not
significant
37.8 (8.5) 84.6 (26.8) p=0.060
PD-L1 20.8 (9.2) 30.6 (11.5)
not
significant
74.2 (49.5) 208.2 (31.1) p=0.005
caspase-3 5.4 (0.6) 6.2 (0.9)
not
significant
6.2 (0.8) 24.8 (4.3) p=0.005
Data supplied by Dr. G. Nuovo
18
19. Top-Line Overall Survival (OS) Results
REO 017 (Pancreatic Cancer) – Comparison with ACCORD 11 and MPACT Studies:
Treatment n
CA19.9 ≥20%
Decrease from
Baseline
Median
PFS
(months)
Median OS
(months)
1-Year
Survival
(%)
2-Year
Survival
(%)
Gemcitabine (ACCORD 11)
(Conroy et al., 2011)
171 N/A 3.3 6.8 20 2
Gemcitabine (MPACT)
(Van Hoff et al., 2013)
(Goldstein et al., 2015)
430 44 3.7 6.6 22 5
Gemcitabine/REOLYSIN®
(REO 017)
33 70 4.0 10.2 45 24
19
20. Top Line Overall Survival (OS) Results
20
REO 016 (Non-Small Cell Lung Cancer) – Comparison with Schiller et al., 2002:
Treatment n
Median PFS
(months)
Median OS
(months)
1-Year
Survival (%)
2-Year
Survival
(%)
Carboplatin and paclitaxel
(Schiller et al., 2002)
290 3.1 8.1 34 11
Carboplatin, paclitaxel and
REOLYSIN® (REO 016)
37 4.0 13.1 57 30
21. 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®
(first study: pancreatic cancer, standard of care plus
REOLYSIN® plus pembrolizumab)
21
23. Manufacturing
Now produced at commercial scale (100L) under cGMP with final formulation
Commercial manufacturing agreement in place with Sigma-Aldrich® Fine
Chemicals (SAFC)
23
24. Patent Portfolio
More than 400 patents issued worldwide,
including 56 US and 20 Canadian
Approximately 235 pending patent
applications worldwide
Issued patent claims for reovirus 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
24
26. Market & Capital Data
(all amounts in CAD)
Exchanges OTCQX:ONCYF
TSX:ONC
FRA:ONY
Shares Outstanding (December 31,
2015)
118,151,622
Price
Options Outstanding (December 31,
2015)
$2.17
(weighted
average)
8,561,394
Fully Diluted (December 31, 2015) 126,713,016
Total Current Assets (December 31,
2015)
$26.9 M
26
27. Investment Highlights
Five ongoing randomized Phase II studies
Ovarian, colorectal, non-small cell lung, prostate and breast cancers
Recently initiated first checkpoint inhibitor study
in patients with pancreatic cancer
Preparing for registration study
Positive safety data for 1,100+ patients
Strong intellectual property portfolio
More than 400 issued patents worldwide
Manufacturing at commercial scale
27