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 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.
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 provides an overview of Cancer Genetics, Inc.'s presentation at the RedChip Global Conference on October 15, 2014. The presentation discusses CGI's business focus on developing genomic tests to assess and personalize cancer treatment. It highlights six proprietary diagnostic products that have been commercially launched, as well as CGI's product pipeline. The presentation also summarizes CGI's partnerships with academic and research institutions and its global operations across multiple locations.
The document discusses Cancer Genetics' focus on personalized cancer treatment through genomics. It provides an overview of Cancer Genetics' business model, which utilizes molecular diagnostic testing to support the cancer care continuum and improve outcomes. Key acquisitions are highlighted that expand Cancer Genetics' capabilities in clinical services, research, and pharmacogenomics.
This investor presentation by Cancer Genetics, Inc provides an overview of the company and its proprietary genomic testing programs. CGI has locations in the US, India, and China serving biopharma, clinical, and research clients. It has launched 7 proprietary diagnostic products focused on hematologic and urogenital cancers, and is working to validate additional next generation sequencing panels. CGI's tests provide information to aid in diagnosis, prognosis, and therapeutic decision making for cancers like CLL, cervical cancer, and kidney cancer. The company is collaborating with academic centers to further develop and validate its genomic tests.
This company presentation provides an overview of a cancer genetic testing services company. Key points include:
- The company has experienced strong and consistent growth in revenue and test volume over the past 10 years through both organic growth and acquisitions.
- It provides a broad menu of genetic and molecular testing services including next generation sequencing and is developing liquid biopsy tests.
- The company has an experienced management team with experience in large reference laboratories. It is focused on innovation, cost management, and expanding its commercial footprint.
- Financial results show increasing margins, productivity, and adjusted EBITDA despite lower average prices per test, demonstrating strong operating leverage as the business scales.
The presentation provides an overview of NeoGenomics, a cancer genetic testing company. It highlights the company's consistent historical growth in tests performed and revenue. The management team has significant experience in large cap clinical laboratories. The company aims to continue expanding its test menu and market share through new product development and partnerships within the fast-growing cancer genetic testing industry.
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 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.
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 provides an overview of Cancer Genetics, Inc.'s presentation at the RedChip Global Conference on October 15, 2014. The presentation discusses CGI's business focus on developing genomic tests to assess and personalize cancer treatment. It highlights six proprietary diagnostic products that have been commercially launched, as well as CGI's product pipeline. The presentation also summarizes CGI's partnerships with academic and research institutions and its global operations across multiple locations.
The document discusses Cancer Genetics' focus on personalized cancer treatment through genomics. It provides an overview of Cancer Genetics' business model, which utilizes molecular diagnostic testing to support the cancer care continuum and improve outcomes. Key acquisitions are highlighted that expand Cancer Genetics' capabilities in clinical services, research, and pharmacogenomics.
This investor presentation by Cancer Genetics, Inc provides an overview of the company and its proprietary genomic testing programs. CGI has locations in the US, India, and China serving biopharma, clinical, and research clients. It has launched 7 proprietary diagnostic products focused on hematologic and urogenital cancers, and is working to validate additional next generation sequencing panels. CGI's tests provide information to aid in diagnosis, prognosis, and therapeutic decision making for cancers like CLL, cervical cancer, and kidney cancer. The company is collaborating with academic centers to further develop and validate its genomic tests.
This company presentation provides an overview of a cancer genetic testing services company. Key points include:
- The company has experienced strong and consistent growth in revenue and test volume over the past 10 years through both organic growth and acquisitions.
- It provides a broad menu of genetic and molecular testing services including next generation sequencing and is developing liquid biopsy tests.
- The company has an experienced management team with experience in large reference laboratories. It is focused on innovation, cost management, and expanding its commercial footprint.
- Financial results show increasing margins, productivity, and adjusted EBITDA despite lower average prices per test, demonstrating strong operating leverage as the business scales.
The presentation provides an overview of NeoGenomics, a cancer genetic testing company. It highlights the company's consistent historical growth in tests performed and revenue. The management team has significant experience in large cap clinical laboratories. The company aims to continue expanding its test menu and market share through new product development and partnerships within the fast-growing cancer genetic testing industry.
Cellgen Diagnostics is an early stage venture that is developing a break through Companion Diagnostic platform that will enable Precision Medicine by determining whether a patients genetic profile is a match for the prescribed cancer therapeutic.
NeoGenomics Company Overview 2014-09-12 includes the following sections:
-Forward-looking Statements
-Investment Highlights
-Experienced Management Team
-Company Overview
-Proven Track Record Of Consistent Growth
-U.S. Cancer Testing Market Size $10-12 Billion
-NeoGenomics' Cancer Testing Services
-Customer Targets
-Accelerating Pace of Innovation
-90+ New Assays Launched Since January 2012
-A Growing Commercial & Facility Footprint
-Acquisition of Path Logic
-Strategic Alliance
-2014 and 2015 Strategic Priorities
-Accelerating Cash Flow & Earnings
-Adjusted EBITDA Metrics
- And much more...
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 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.
NeoGenomics is a fast growing cancer genetics lab servicing Oncologists, Pathologists and Hospitals. This is August 2014 Company Overview Presentation.
This document discusses Biocept, Inc., a commercial-stage cancer diagnostics company. It provides an overview of Biocept's liquid biopsy platform and tests, including OncoCEE-BR, their first commercialized test for breast cancer. The document also summarizes Biocept's growth strategy, which includes expanding their test menu, improving operational efficiency, and increasing market penetration. It introduces Biocept's executive team and describes their extensive experience in cancer diagnostics, genomics, and life sciences.
Cancer Genetics provides personalized cancer treatment through molecular diagnostic testing. They have launched 6 proprietary diagnostic products targeting hematological and urogenital cancers. Their tests help determine cancer type and prognosis, guiding treatment selection. Recent acquisitions expand their capabilities and access to new markets in India. Their business model provides clinical testing services to oncologists and biopharma partnerships to support drug development.
This investor presentation summarizes the development of Oncolytics Biotech's lead product REOLYSIN, a therapeutic reovirus. Key points include:
1) REOLYSIN has demonstrated statistically significant improvements in overall survival for metastatic breast cancer and doubled two-year survival for metastatic pancreatic cancer.
2) The clinical development plan focuses on combination therapies with chemotherapy, immunotherapy agents like pembrolizumab, and targeted therapies/IMiDs to boost REOLYSIN's mechanism of action.
3) Over 1,100 patients have been treated with REOLYSIN which has shown a good safety profile with no maximum tolerated dose reached and mostly mild side effects.
Corporate Presentation TiGenix - September 2014TiGenix
This document does not constitute or form part of any offer or invitation to sell or issue, or any solicitation of any offer to purchase or subscribe for, any shares in the Company, nor shall any part of it nor the fact of its distribution form part of or be relied on in connection with any contract or investment decision relating thereto, nor does it constitute a recommendation regarding the securities of the Company.
This document may contain forward-looking statements and estimates made by the Company, including with respect to the anticipated future performance of TiGenix and the market in which it operates. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond the Company's control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Forward-looking statements, forecasts and estimates only speak as of the date of this document and no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in the Company’s expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based.
Drug manufacturers are looking to emerging markets like Latin America to fuel long-term success.
View this PAREXEL Consulting presentation to learn more.
Introducing Drugs & Trials for Cancer DiagnosticsGolden Helix
When interpreting a variant using the AMP/ASCO guidelines for somatic variant interpretation, clinicians must determine whether the variant can be considered a biomarker that affects clinical care by predicting sensitivity, resistance, or toxicity to a specific therapy. Such a determination requires the investigation of multiple evidence sources, including clinical trials, FDA approved therapies and peer-reviewed studies. Unfortunately, strong evidence linking specific genetic biomarkers to FDA-approved therapies only exists for a small number of cancers. Thus, most variants require an exploration of clinical practice guidelines, peer-reviewed literature, and large-scale cancer mutation databases to effectively assess the clinical significance of a given mutation.
This webcast explores this new incorporation of Drugs & Trials Annotations in VSClinical's AMP Workflow covering:
Identification of relevant clinical evidence for drug sensitivity and resistance based on patient biomarkers and tumor type
Review of clinical trial information including inclusion criteria, trial status, and contact information
Management of citations associated with relevant, targeted therapies
Evaluation of a biomarkers clinical evidence tier based on available evidence for drug sensitivity and resistance
This presentation provides an overview of a cancer genetics laboratory company. Key points include:
- The company has experienced strong and consistent revenue and test volume growth through strategic partnerships and an expanding test menu. An upcoming acquisition is expected to more than double revenue and more than triple adjusted EBITDA.
- The management team has extensive experience in large cap clinical laboratories.
- The company addresses a $5 billion clinical cancer testing market and has opportunities for further growth through innovation, such as liquid biopsy tests and partnerships with oncologists.
- Recent acquisitions and an expanding test menu have contributed to accelerating same store sales growth.
Avoiding Common Pitfalls in Cell and Gene Therapy TrialsMedpace
This webinar presentation discusses operationalizing advanced therapy clinical trials using lessons learned from past experiences. The webinar covers regulatory considerations, operational challenges, and case studies. Regulatory agencies require strategic engagement, assessment of regulatory readiness, and oversight of country requirements. Investigative sites face additional committee reviews and license applications. Manufacturing complex cell and gene therapies poses challenges around process transfer, scaling, and product availability. Aligning supply chain readiness, site capabilities, and an investigational product tracking process is key to avoiding delays. Developing a global strategy requires addressing requirements for manufacturing, stability data, labeling, and supply logistics early.
AV Therapeutics is a biotechnology company developing treatments for prostate cancer. It has developed Capridine, a patented drug that shows specificity for prostate cancer in pre-clinical studies. Capridine has minimal bone marrow toxicity and a wide therapeutic window. AV Therapeutics is also developing a peptide vaccine called Pros-Vax that is expected to eliminate micrometastatic disease. The company has a world-class team and plans to initiate phase I/II clinical trials for both Capridine and the peptide vaccine.
Next-Generation Immuno-Oncology Biomarkers: Insights for Developing Companion...Andrew Aijian
At DeciBio Consulting, we track the immuno-oncology (I/O) biomarker and technology landscape closely. Our analysis of biomarkers from ~1,000 immuno-oncology clinical trials and discussions with oncologists, pathologists, and KOLs reveals some key insights for diagnostic manufacturers to consider to address the I/O market.
This document provides a summary of Galena Biopharma's Q3 2016 financial results and corporate update. It discusses interim results from the Phase 3 PRESENT trial of NeuVax showing a potential delay in disease-free survival and highlights the risk of pseudoprogression in cancer immunotherapy trials. It also reviews the company's immunotherapy development pipeline, including NeuVax programs in breast and gastric cancer and GALE-301/302 programs in ovarian and breast cancer. Finally, it discusses the company's cash position and expected milestones for the remainder of 2016.
Unleash the real value of your corporate data with power bi luc labelleLuc Labelle
Luc Labelle presented on Power BI and provided an overview of its basic concepts such as datasets, reports, and dashboards. The presentation covered how to create reports from Excel spreadsheets and import existing Excel reports into Power BI. It also discussed creating and accessing organization content packs and dashboards for Office 365 groups using content packs. The presentation recommended resources for learning more about Power BI including its website, YouTube channel, Yammer group, and Jen Underwood's website.
Cellgen Diagnostics is an early stage venture that is developing a break through Companion Diagnostic platform that will enable Precision Medicine by determining whether a patients genetic profile is a match for the prescribed cancer therapeutic.
NeoGenomics Company Overview 2014-09-12 includes the following sections:
-Forward-looking Statements
-Investment Highlights
-Experienced Management Team
-Company Overview
-Proven Track Record Of Consistent Growth
-U.S. Cancer Testing Market Size $10-12 Billion
-NeoGenomics' Cancer Testing Services
-Customer Targets
-Accelerating Pace of Innovation
-90+ New Assays Launched Since January 2012
-A Growing Commercial & Facility Footprint
-Acquisition of Path Logic
-Strategic Alliance
-2014 and 2015 Strategic Priorities
-Accelerating Cash Flow & Earnings
-Adjusted EBITDA Metrics
- And much more...
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 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.
NeoGenomics is a fast growing cancer genetics lab servicing Oncologists, Pathologists and Hospitals. This is August 2014 Company Overview Presentation.
This document discusses Biocept, Inc., a commercial-stage cancer diagnostics company. It provides an overview of Biocept's liquid biopsy platform and tests, including OncoCEE-BR, their first commercialized test for breast cancer. The document also summarizes Biocept's growth strategy, which includes expanding their test menu, improving operational efficiency, and increasing market penetration. It introduces Biocept's executive team and describes their extensive experience in cancer diagnostics, genomics, and life sciences.
Cancer Genetics provides personalized cancer treatment through molecular diagnostic testing. They have launched 6 proprietary diagnostic products targeting hematological and urogenital cancers. Their tests help determine cancer type and prognosis, guiding treatment selection. Recent acquisitions expand their capabilities and access to new markets in India. Their business model provides clinical testing services to oncologists and biopharma partnerships to support drug development.
This investor presentation summarizes the development of Oncolytics Biotech's lead product REOLYSIN, a therapeutic reovirus. Key points include:
1) REOLYSIN has demonstrated statistically significant improvements in overall survival for metastatic breast cancer and doubled two-year survival for metastatic pancreatic cancer.
2) The clinical development plan focuses on combination therapies with chemotherapy, immunotherapy agents like pembrolizumab, and targeted therapies/IMiDs to boost REOLYSIN's mechanism of action.
3) Over 1,100 patients have been treated with REOLYSIN which has shown a good safety profile with no maximum tolerated dose reached and mostly mild side effects.
Corporate Presentation TiGenix - September 2014TiGenix
This document does not constitute or form part of any offer or invitation to sell or issue, or any solicitation of any offer to purchase or subscribe for, any shares in the Company, nor shall any part of it nor the fact of its distribution form part of or be relied on in connection with any contract or investment decision relating thereto, nor does it constitute a recommendation regarding the securities of the Company.
This document may contain forward-looking statements and estimates made by the Company, including with respect to the anticipated future performance of TiGenix and the market in which it operates. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond the Company's control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Forward-looking statements, forecasts and estimates only speak as of the date of this document and no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in the Company’s expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based.
Drug manufacturers are looking to emerging markets like Latin America to fuel long-term success.
View this PAREXEL Consulting presentation to learn more.
Introducing Drugs & Trials for Cancer DiagnosticsGolden Helix
When interpreting a variant using the AMP/ASCO guidelines for somatic variant interpretation, clinicians must determine whether the variant can be considered a biomarker that affects clinical care by predicting sensitivity, resistance, or toxicity to a specific therapy. Such a determination requires the investigation of multiple evidence sources, including clinical trials, FDA approved therapies and peer-reviewed studies. Unfortunately, strong evidence linking specific genetic biomarkers to FDA-approved therapies only exists for a small number of cancers. Thus, most variants require an exploration of clinical practice guidelines, peer-reviewed literature, and large-scale cancer mutation databases to effectively assess the clinical significance of a given mutation.
This webcast explores this new incorporation of Drugs & Trials Annotations in VSClinical's AMP Workflow covering:
Identification of relevant clinical evidence for drug sensitivity and resistance based on patient biomarkers and tumor type
Review of clinical trial information including inclusion criteria, trial status, and contact information
Management of citations associated with relevant, targeted therapies
Evaluation of a biomarkers clinical evidence tier based on available evidence for drug sensitivity and resistance
This presentation provides an overview of a cancer genetics laboratory company. Key points include:
- The company has experienced strong and consistent revenue and test volume growth through strategic partnerships and an expanding test menu. An upcoming acquisition is expected to more than double revenue and more than triple adjusted EBITDA.
- The management team has extensive experience in large cap clinical laboratories.
- The company addresses a $5 billion clinical cancer testing market and has opportunities for further growth through innovation, such as liquid biopsy tests and partnerships with oncologists.
- Recent acquisitions and an expanding test menu have contributed to accelerating same store sales growth.
Avoiding Common Pitfalls in Cell and Gene Therapy TrialsMedpace
This webinar presentation discusses operationalizing advanced therapy clinical trials using lessons learned from past experiences. The webinar covers regulatory considerations, operational challenges, and case studies. Regulatory agencies require strategic engagement, assessment of regulatory readiness, and oversight of country requirements. Investigative sites face additional committee reviews and license applications. Manufacturing complex cell and gene therapies poses challenges around process transfer, scaling, and product availability. Aligning supply chain readiness, site capabilities, and an investigational product tracking process is key to avoiding delays. Developing a global strategy requires addressing requirements for manufacturing, stability data, labeling, and supply logistics early.
AV Therapeutics is a biotechnology company developing treatments for prostate cancer. It has developed Capridine, a patented drug that shows specificity for prostate cancer in pre-clinical studies. Capridine has minimal bone marrow toxicity and a wide therapeutic window. AV Therapeutics is also developing a peptide vaccine called Pros-Vax that is expected to eliminate micrometastatic disease. The company has a world-class team and plans to initiate phase I/II clinical trials for both Capridine and the peptide vaccine.
Next-Generation Immuno-Oncology Biomarkers: Insights for Developing Companion...Andrew Aijian
At DeciBio Consulting, we track the immuno-oncology (I/O) biomarker and technology landscape closely. Our analysis of biomarkers from ~1,000 immuno-oncology clinical trials and discussions with oncologists, pathologists, and KOLs reveals some key insights for diagnostic manufacturers to consider to address the I/O market.
This document provides a summary of Galena Biopharma's Q3 2016 financial results and corporate update. It discusses interim results from the Phase 3 PRESENT trial of NeuVax showing a potential delay in disease-free survival and highlights the risk of pseudoprogression in cancer immunotherapy trials. It also reviews the company's immunotherapy development pipeline, including NeuVax programs in breast and gastric cancer and GALE-301/302 programs in ovarian and breast cancer. Finally, it discusses the company's cash position and expected milestones for the remainder of 2016.
Unleash the real value of your corporate data with power bi luc labelleLuc Labelle
Luc Labelle presented on Power BI and provided an overview of its basic concepts such as datasets, reports, and dashboards. The presentation covered how to create reports from Excel spreadsheets and import existing Excel reports into Power BI. It also discussed creating and accessing organization content packs and dashboards for Office 365 groups using content packs. The presentation recommended resources for learning more about Power BI including its website, YouTube channel, Yammer group, and Jen Underwood's website.
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.
The document discusses distances between locations in Spain. It states that the distance from Valdepeñas to Galicia is approximately 747 km. It also mentions that Pena Trevinca is 2,124 km from an unspecified location. Sources listed are Google Maps, Google Pictures, and Atlas Science 5 Primary.
Therapists should evaluate patients before virtual reality treatment by administering questionnaires to assess death anxiety and conducting interviews to understand fears and triggers. Therapists then customize the virtual environments to each patient, including adjusting parameters and allowing patients to experience modules on the anxiety of others' and one's own death. The virtual reality application contains four customizable environments - a park, room, funeral home and cemetery - to help patients gradually confront death symbols and concepts.
- 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 document provides information about the Sub-betic Mountain range in Spain. It notes that the distance from Valdepeñas to the Sub-betic Range is 209km and that the autonomous community is Andalusia. It also lists the peak of La Sagra at 2,381 meters and names the most important areas as Sierra Cazorla, Sierra Magina and Sierra Segura.
The document repeatedly lists the website "zula-eri.com" over 50 times without any other text or context. It appears to solely consist of the repetitive listing of this single website address.
Badrinath is located in the Garhwal hills of Uttarakhand on the banks of the Alaknanda River between the Nar and Narayana mountain ranges. Dwarka is located in Gujarat and was the dwelling place of Lord Krishna. Jagannath Puri is located in Odisha and its main 1000 year old temple was constructed by kings Choda Ganga Deva and Tritiya Ananga Bhima Deva. Rameswaram is located in Tamil Nadu. These four pilgrimage sites make up the Char Dham pilgrimage circuit in India.
The document appears to contain a list of 10 items with various numbers, dates, and other data points. It is difficult to discern any clear meaning or narrative from the numerical values alone. More context would be needed to understand the purpose or subject of the list.
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 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.
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.
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
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
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 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 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.
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
- 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.
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
1) CytoDyn is developing the monoclonal antibody leronlimab as a treatment for multiple indications including HIV, cancer, and immunological diseases.
2) Clinical trials show promise for leronlimab as a HIV combination therapy and monotherapy, as well as for cancer, GvHD, and NASH.
3) The company is pursuing partnerships, manufacturing agreements, and commercialization plans to bring leronlimab to market for patients.
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.
Specialized oncology reference laboratory providing the latest testing technologies, global/tech-only options, and interactive education to the pathology community
Offer the complete spectrum of diagnostic services through nationwide network of laboratories
Dedicated to providing superior service, faster turn-around times, and complete attention to the needs of our clients and their patients
Similar to November 2013 Corporate Presentation (20)
“Psychiatry and the Humanities”: An Innovative Course at the University of Mo...Université de Montréal
“Psychiatry and the Humanities”: An Innovative Course at the University of Montreal Expanding the medical model to embrace the humanities. Link: https://www.psychiatrictimes.com/view/-psychiatry-and-the-humanities-an-innovative-course-at-the-university-of-montreal
The skin is the largest organ and its health plays a vital role among the other sense organs. The skin concerns like acne breakout, psoriasis, or anything similar along the lines, finding a qualified and experienced dermatologist becomes paramount.
Nano-gold for Cancer Therapy chemistry investigatory projectSIVAVINAYAKPK
chemistry investigatory project
The development of nanogold-based cancer therapy could revolutionize oncology by providing a more targeted, less invasive treatment option. This project contributes to the growing body of research aimed at harnessing nanotechnology for medical applications, paving the way for future clinical trials and potential commercial applications.
Cancer remains one of the leading causes of death worldwide, prompting the need for innovative treatment methods. Nanotechnology offers promising new approaches, including the use of gold nanoparticles (nanogold) for targeted cancer therapy. Nanogold particles possess unique physical and chemical properties that make them suitable for drug delivery, imaging, and photothermal therapy.
Travel Clinic Cardiff: Health Advice for International TravelersNX Healthcare
Travel Clinic Cardiff offers comprehensive travel health services, including vaccinations, travel advice, and preventive care for international travelers. Our expert team ensures you are well-prepared and protected for your journey, providing personalized consultations tailored to your destination. Conveniently located in Cardiff, we help you travel with confidence and peace of mind. Visit us: www.nxhealthcare.co.uk
Summer is a time for fun in the sun, but the heat and humidity can also wreak havoc on your skin. From itchy rashes to unwanted pigmentation, several skin conditions become more prevalent during these warmer months.
- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
PGx Analysis in VarSeq: A User’s PerspectiveGolden Helix
Since our release of the PGx capabilities in VarSeq, we’ve had a few months to gather some insights from various use cases. Some users approach PGx workflows by means of array genotyping or what seems to be a growing trend of adding the star allele calling to the existing NGS pipeline for whole genome data. Luckily, both approaches are supported with the VarSeq software platform. The genotyping method being used will also dictate what the scope of the tertiary analysis will be. For example, are your PGx reports a standalone pipeline or would your lab’s goal be to handle a dual-purpose workflow and report on PGx + Diagnostic findings.
The purpose of this webcast is to:
Discuss and demonstrate the approaches with array and NGS genotyping methods for star allele calling to prep for downstream analysis.
Following genotyping, explore alternative tertiary workflow concepts in VarSeq to handle PGx reporting.
Moreover, we will include insights users will need to consider when validating their PGx workflow for all possible star alleles and options you have for automating your PGx analysis for large number of samples. Please join us for a session dedicated to the application of star allele genotyping and subsequent PGx workflows in our VarSeq software.
Travel vaccination in Manchester offers comprehensive immunization services for individuals planning international trips. Expert healthcare providers administer vaccines tailored to your destination, ensuring you stay protected against various diseases. Conveniently located clinics and flexible appointment options make it easy to get the necessary shots before your journey. Stay healthy and travel with confidence by getting vaccinated in Manchester. Visit us: www.nxhealthcare.co.uk
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. Oncolytics Overview
•
•
•
Expanding Clinical Program
®
• Lead product is REOLYSIN , a broadly active novel cancer therapy
• Ongoing clinical trials include seven randomized studies:
• Enrollment complete in randomized international study (REO 018)
of REOLYSIN® with carboplatin and paclitaxel in platinumrefractory 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 U.S.
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. 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,
intratumoural 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. REOLYSIN Mechanism of Action
®
Normal Cells
REOLYSIN®
infects both tumour
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 tumour
cells and normal,
healthy cells
REOLYSIN®
replicates in Rasactivated tumour
cells
5
Tumour cells
rupture to release
progeny virus
Replicated viruses
repeat cell lysis cycle in
nearby tumour cells
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 tumour lesions of the liver
In addition, two of the ten patients
had complete tumour necrosis
This demonstrates that REOLYSIN®
specifically accesses and replicates in
metastatic colorectal cancer when
delivered as a monotherapy
6
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. 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 tumours
8
9. Ongoing Randomized Studies of REOLYSIN®
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. 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
•
•
•
•
EGOC 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
patient with metastatic disease only)
REO 018 Endpoints:
•
•
•
•
The study was approved and run in fourteen countries in North America and Europe
Patients in the REO 018 study were stratified for:
•
•
®
Primary Endpoint: Overall Survival (OS)
Secondary Endpoints: Progression-Free Survival (PFS), best response and tumour-specific response
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. REO 018: Tumour-Specific Response Data
•
•
Data announced December 13, 2012
Endpoint examines initial percentage tumour 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 tumour
specific differential activity in metastatic and loco-regional disease in a
randomized setting
®
Of the total 105 patients with evaluable metastatic tumours, 86% (n=50)
of those in the test, and 67% (n=55) in the control arm, arm had tumour
stabilization (0% growth) or shrinkage
•
This is a statistically significant difference, with a p-value of 0.025
11
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. 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)
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
15. REO 016: Non-Small Cell Lung Cancer
•
•
Single-arm (up to 36 patients), open-label, two-stage U.S. 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 EGFRmutated or -overexpressed, all of which cause Ras pathway
activation
• First-line therapy study, i.e. patients will be offered REOLYSIN® in
combination with carboplatin and paclitaxel instead of standard of
care if they are Kras- or EGFR-mutated or EGFR-overexpressed
15
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
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
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. 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 with 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. 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. 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. 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. Manufacturing
•
Now produced at 100L under cGMP with final formulation
•
Commercial manufacturing agreement with SAFC in place
25
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 in randomized international study (REO 018)
of REOLYSIN® with carboplatin and paclitaxel in platinumrefractory 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 U.S.
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