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.
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.
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.
The document summarizes the results of a clinical trial that found the drug Somatuline prolonged progression-free survival in patients with metastatic gastroenteropancreatic neuroendocrine tumors. The trial involved 204 patients across 14 countries and found that after 96 weeks, 65.1% of patients taking Somatuline had not seen disease progression compared to 33.0% of placebo patients. This represented a 53% reduced risk of progression or death. The results were published in the New England Journal of Medicine.
Treat the Patient: Not the Pregnancy April 2015PASaskatchewan
This document provides information on safely managing common medical conditions during pregnancy and lactation. It discusses medication classification systems and factors affecting drug transfer across the placenta and into breastmilk. Guidelines are presented for treating depression, diabetes, thyroid disorders, infections, pain, nausea, and other issues. Many prescription and over-the-counter drugs are deemed safe to use when necessary, such as most antibiotics, acetaminophen, ranitidine, and antidepressants. Untreated medical conditions pose greater risks than potential side effects of approved medications. Resources for further information and guidance are also referenced.
Medical complications in pregnancy cmt april 2010NESSlideShare
This document discusses three cases related to medical complications in pregnancy. Case 1 describes a woman who died of an undiagnosed pulmonary embolism during pregnancy. Case 2 involves a woman admitted with renal problems during pregnancy. The document then discusses prescribing medications during pregnancy, including the risks of certain anti-epileptic drugs. Case 3 presents a woman with epilepsy who is now pregnant.
Screening for and treatment of asymptomatic bacteriuria in high-risk pregnant women reduces the risk of preterm birth. However, routine screening of all pregnant women in the first trimester with urine culture is not currently recommended due to the low prevalence of asymptomatic bacteriuria in the general pregnant population and the costs of universal screening.
This document discusses the management of endometriosis from a primary healthcare perspective. It defines endometriosis and outlines its clinical symptoms. Treatment options are classified as symptomatic, medical, or surgical. Medical treatment aims to induce atrophy of ectopic endometrial tissue through hormone suppression. Common medical treatments include combined estrogen-progestogen contraceptives, progestogen-only methods like the Mirena IUD, GnRH agonists, and dienogest. Surgical treatment includes procedures like laparoscopy to treat endometriotic lesions. Overall management focuses on alleviating symptoms through lifestyle changes and a combination of medical and surgical therapies depending on the severity of disease.
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.
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.
The document summarizes the results of a clinical trial that found the drug Somatuline prolonged progression-free survival in patients with metastatic gastroenteropancreatic neuroendocrine tumors. The trial involved 204 patients across 14 countries and found that after 96 weeks, 65.1% of patients taking Somatuline had not seen disease progression compared to 33.0% of placebo patients. This represented a 53% reduced risk of progression or death. The results were published in the New England Journal of Medicine.
Treat the Patient: Not the Pregnancy April 2015PASaskatchewan
This document provides information on safely managing common medical conditions during pregnancy and lactation. It discusses medication classification systems and factors affecting drug transfer across the placenta and into breastmilk. Guidelines are presented for treating depression, diabetes, thyroid disorders, infections, pain, nausea, and other issues. Many prescription and over-the-counter drugs are deemed safe to use when necessary, such as most antibiotics, acetaminophen, ranitidine, and antidepressants. Untreated medical conditions pose greater risks than potential side effects of approved medications. Resources for further information and guidance are also referenced.
Medical complications in pregnancy cmt april 2010NESSlideShare
This document discusses three cases related to medical complications in pregnancy. Case 1 describes a woman who died of an undiagnosed pulmonary embolism during pregnancy. Case 2 involves a woman admitted with renal problems during pregnancy. The document then discusses prescribing medications during pregnancy, including the risks of certain anti-epileptic drugs. Case 3 presents a woman with epilepsy who is now pregnant.
Screening for and treatment of asymptomatic bacteriuria in high-risk pregnant women reduces the risk of preterm birth. However, routine screening of all pregnant women in the first trimester with urine culture is not currently recommended due to the low prevalence of asymptomatic bacteriuria in the general pregnant population and the costs of universal screening.
This document discusses the management of endometriosis from a primary healthcare perspective. It defines endometriosis and outlines its clinical symptoms. Treatment options are classified as symptomatic, medical, or surgical. Medical treatment aims to induce atrophy of ectopic endometrial tissue through hormone suppression. Common medical treatments include combined estrogen-progestogen contraceptives, progestogen-only methods like the Mirena IUD, GnRH agonists, and dienogest. Surgical treatment includes procedures like laparoscopy to treat endometriotic lesions. Overall management focuses on alleviating symptoms through lifestyle changes and a combination of medical and surgical therapies depending on the severity of disease.
The Women's Health Initiative (WHI) was a 15-year study from 1991-2010 that examined the effects of postmenopausal hormone therapy (HT) and lifestyle interventions on health outcomes in postmenopausal women. The WHI hormone therapy trials found that estrogen plus progestin therapy increased risks of heart disease, stroke, blood clots and breast cancer. Estrogen-alone therapy increased risks of stroke and blood clots but did not change heart disease risk. Subsequent research has found that risks may depend on factors like age at start of therapy, duration of use, and type of progestin used. Current recommendations are to use the lowest effective dose of HT for the shortest time to treat menop
This document summarizes a pilot study that evaluated the safety and effectiveness of an alternative therapy for polycystic ovary syndrome (PCOS) using natural minerals. 20 women with PCOS received weekly treatments involving wrapping the body in bandages soaked in a mineral solution for 1 hour. Hormone levels were measured before and after treatment. Results found that treatment significantly improved levels of luteinizing hormone, prolactin, anti-Mullerian hormone, fasting insulin, and liver enzymes. No adverse events occurred. The study suggests this natural mineral treatment may be a safe and effective approach for managing symptoms of PCOS.
This document summarizes evidence on the use of antenatal corticosteroids (ACS) to improve outcomes for preterm infants. It finds that a single course of betamethasone or dexamethasone between 23-34 weeks reduces rates of respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, and mortality. Multiple courses increase risks of fetal growth restriction. Benefits are seen 1-7 days after treatment. ACS is now recommended for women at risk of preterm birth from 24-34 weeks to improve neonatal outcomes.
This study compared the efficacy of double-dose and single-dose methotrexate protocols for treating ectopic pregnancies. It found:
1. The overall success rate was higher but not significantly different for the double-dose protocol (88%) compared to the single-dose protocol (82%).
2. The double-dose protocol had significantly higher success rates than the single-dose protocol for patients with initial β-hCG levels between 3600-5500 mIU/ml and ectopic mass diameters between 2.7-3.5 cm.
3. The double-dose protocol may be more effective for patients with higher β-hCG levels and larger ectopic mass sizes because the closer proximity
The herbal formulation Hyponidd was found to be as effective as metformin in managing anovulatory PCOS women with insulin resistance by lowering insulin resistance and hyperandrogenemia without side effects. A comparison study found that both Hyponidd and metformin significantly reduced fasting insulin levels, insulin resistance indicators, and hyperandrogenemia markers. However, Hyponidd resulted in fewer side effects like nausea and diarrhea than metformin.
1. The document provides information on the emergency contraceptive ulipristal acetate (UPA), including its mechanism of action, pharmacokinetics, clinical evaluations in randomized studies, contraindications, precautions, adverse reactions and drug interactions.
2. Key points include that UPA prevents pregnancy by inhibiting or delaying ovulation and altering the endometrium; clinical trials found it to be over 99% effective in preventing pregnancy when taken as directed within 120 hours of intercourse.
3. Common adverse reactions included headache, nausea and menstrual irregularities. UPA should not be used by women with current or history of certain cancers, liver disease or high risk of arterial or venous thrombotic diseases.
The document provides plinth area rates for construction works in India as of 1 October 2012. It includes rates for RCC framed structures and load bearing constructions for buildings like offices, colleges, hospitals, schools and hostels. Rates are provided per square meter for various elements like additional floors, heights, foundations, firefighting systems, operation theatres etc. Specifications and rules for adopting these rates are provided in annexures. The rates are based on recent actual expenditure data from field formations and aim to account for price rises in last 5 years and latest construction practices.
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.
The document discusses a front cover, double page spread, and contents page for a book, mentioning that the female artist who created them depicted beauty as most female artists do today. It also mentions that Jessica wore a sparkly dress and heels for the Enigma code.
This document provides tips on using social media channels like LinkedIn, Facebook, Twitter, and Google+ to market yourself professionally. It reviews the key social media platforms and encourages sharing content that highlights your work, education, philanthropic efforts, and examples of professional accomplishments in order to maintain a positive online image. The document concludes by soliciting any examples of effectively using social media for professional purposes and providing contact information for further questions.
Pusat Grosir Solo (PGS) adalah pusat perbelanjaan batik terbesar di Kota Solo yang menyediakan berbagai produk tekstil dan pakaian batik untuk pedagang grosir dan eceran. PGS berlokasi di pusat kota Solo dekat komplek Keraton Surakarta dan Mangkunegaran, sehingga menarik banyak pengunjung dan meningkatkan penjualan produk batik. Fasilitas lengkap dan kenyamanan berbelanja di PGS menunjang k
The Women's Health Initiative (WHI) was a 15-year study from 1991-2010 that examined the effects of postmenopausal hormone therapy (HT) and lifestyle interventions on health outcomes in postmenopausal women. The WHI hormone therapy trials found that estrogen plus progestin therapy increased risks of heart disease, stroke, blood clots and breast cancer. Estrogen-alone therapy increased risks of stroke and blood clots but did not change heart disease risk. Subsequent research has found that risks may depend on factors like age at start of therapy, duration of use, and type of progestin used. Current recommendations are to use the lowest effective dose of HT for the shortest time to treat menop
This document summarizes a pilot study that evaluated the safety and effectiveness of an alternative therapy for polycystic ovary syndrome (PCOS) using natural minerals. 20 women with PCOS received weekly treatments involving wrapping the body in bandages soaked in a mineral solution for 1 hour. Hormone levels were measured before and after treatment. Results found that treatment significantly improved levels of luteinizing hormone, prolactin, anti-Mullerian hormone, fasting insulin, and liver enzymes. No adverse events occurred. The study suggests this natural mineral treatment may be a safe and effective approach for managing symptoms of PCOS.
This document summarizes evidence on the use of antenatal corticosteroids (ACS) to improve outcomes for preterm infants. It finds that a single course of betamethasone or dexamethasone between 23-34 weeks reduces rates of respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, and mortality. Multiple courses increase risks of fetal growth restriction. Benefits are seen 1-7 days after treatment. ACS is now recommended for women at risk of preterm birth from 24-34 weeks to improve neonatal outcomes.
This study compared the efficacy of double-dose and single-dose methotrexate protocols for treating ectopic pregnancies. It found:
1. The overall success rate was higher but not significantly different for the double-dose protocol (88%) compared to the single-dose protocol (82%).
2. The double-dose protocol had significantly higher success rates than the single-dose protocol for patients with initial β-hCG levels between 3600-5500 mIU/ml and ectopic mass diameters between 2.7-3.5 cm.
3. The double-dose protocol may be more effective for patients with higher β-hCG levels and larger ectopic mass sizes because the closer proximity
The herbal formulation Hyponidd was found to be as effective as metformin in managing anovulatory PCOS women with insulin resistance by lowering insulin resistance and hyperandrogenemia without side effects. A comparison study found that both Hyponidd and metformin significantly reduced fasting insulin levels, insulin resistance indicators, and hyperandrogenemia markers. However, Hyponidd resulted in fewer side effects like nausea and diarrhea than metformin.
1. The document provides information on the emergency contraceptive ulipristal acetate (UPA), including its mechanism of action, pharmacokinetics, clinical evaluations in randomized studies, contraindications, precautions, adverse reactions and drug interactions.
2. Key points include that UPA prevents pregnancy by inhibiting or delaying ovulation and altering the endometrium; clinical trials found it to be over 99% effective in preventing pregnancy when taken as directed within 120 hours of intercourse.
3. Common adverse reactions included headache, nausea and menstrual irregularities. UPA should not be used by women with current or history of certain cancers, liver disease or high risk of arterial or venous thrombotic diseases.
The document provides plinth area rates for construction works in India as of 1 October 2012. It includes rates for RCC framed structures and load bearing constructions for buildings like offices, colleges, hospitals, schools and hostels. Rates are provided per square meter for various elements like additional floors, heights, foundations, firefighting systems, operation theatres etc. Specifications and rules for adopting these rates are provided in annexures. The rates are based on recent actual expenditure data from field formations and aim to account for price rises in last 5 years and latest construction practices.
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.
The document discusses a front cover, double page spread, and contents page for a book, mentioning that the female artist who created them depicted beauty as most female artists do today. It also mentions that Jessica wore a sparkly dress and heels for the Enigma code.
This document provides tips on using social media channels like LinkedIn, Facebook, Twitter, and Google+ to market yourself professionally. It reviews the key social media platforms and encourages sharing content that highlights your work, education, philanthropic efforts, and examples of professional accomplishments in order to maintain a positive online image. The document concludes by soliciting any examples of effectively using social media for professional purposes and providing contact information for further questions.
Pusat Grosir Solo (PGS) adalah pusat perbelanjaan batik terbesar di Kota Solo yang menyediakan berbagai produk tekstil dan pakaian batik untuk pedagang grosir dan eceran. PGS berlokasi di pusat kota Solo dekat komplek Keraton Surakarta dan Mangkunegaran, sehingga menarik banyak pengunjung dan meningkatkan penjualan produk batik. Fasilitas lengkap dan kenyamanan berbelanja di PGS menunjang k
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.
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
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.
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.
- 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 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 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.
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 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 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.
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
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.
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 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 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.
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 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.
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 document provides an investor presentation for Oncolytics Biotech regarding their clinical development program and progress with REOLYSIN, an investigational immuno-oncology viral therapy. Recent progress includes statistically significantly increased overall survival in a phase 2 trial of REOLYSIN in combination with paclitaxel in metastatic breast cancer patients. The clinical development plan focuses on evaluating REOLYSIN in combination with chemotherapy, immunotherapy agents, and targeted therapies to potentially boost multiple aspects of REOLYSIN's mechanism of action. Upcoming milestones include an end-of-phase 2 meeting to discuss the registration pathway in metastatic breast cancer.
This document provides an investor presentation for Oncolytics Biotech Inc. summarizing recent progress and the clinical development plan for REOLYSIN, an immuno-oncology viral agent. Key points include:
- REOLYSIN showed statistically significant increased overall survival in a phase 2 trial in metastatic breast cancer when combined with paclitaxel chemotherapy.
- The clinical development plan focuses on combining REOLYSIN with chemotherapy, immunotherapy agents, and targeted therapies to boost its immune-activating mechanism of action.
- Upcoming milestones include presenting pancreatic cancer data at ASCO and holding an end-of-phase 2 meeting to discuss the metastatic breast cancer registration pathway.
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.
This corporate presentation summarizes Oncolytics Biotech's lead product REOLYSIN, a novel cancer therapy. It discusses ongoing clinical trials of REOLYSIN in combination with chemotherapy in various cancer indications. Positive results are shown reducing tumor burden and improving survival outcomes. Future registration pathways are outlined based on reducing tumor size prior to standard therapies or improving survival when combined with chemotherapy and immune therapies. Over 1,000 patients have been treated with REOLYSIN which has shown to be generally safe and well tolerated.
This presentation provides an overview of Oncolytics Biotech and their lead product REOLYSIN®, a therapeutic reovirus being studied for various cancer indications. Key points include:
- REOLYSIN® has shown selective cytotoxicity against cancer cells with Ras pathway activation and is currently in six phase II randomized clinical trials in cancers like breast, lung, colorectal, prostate, pancreatic, and ovarian.
- Early clinical data shows REOLYSIN® may have immune-mediated anti-tumor activity in addition to direct cytotoxic effects. Combinations with immunotherapy agents are being explored.
- Over 1,000 patients have been treated with REOLYSIN® which has shown a good safety profile with mostly
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.
World economy charts case study presented by a Big 4
World economy charts case study presented by a Big 4
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World economy charts case study presented by a Big 4
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World economy charts case study presented by a Big 4
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The E-Way Bill revolutionizes logistics by digitizing the documentation of goods transport, ensuring transparency, tax compliance, and streamlined processes. This mandatory, electronic system reduces delays, enhances accountability, and combats tax evasion, benefiting businesses and authorities alike. Embrace the E-Way Bill for efficient, reliable transportation operations.
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).
Cleades Robinson, a respected leader in Philadelphia's police force, is known for his diplomatic and tactful approach, fostering a strong community rapport.
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.
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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 Oncolytics Biotech® Inc. expresses an
expectation or belief as to future results, such expectations or beliefs are expressed in
good faith and are believed to have a reasonable basis, but there can be no assurance
that the statement or expectation or belief will be achieved. These factors include results
of current or pending clinical trials, risks associated with intellectual property protection,
financial projections, market projections, actions by the FDA/HPB/MHRA and those other
factors detailed in the company’s filings with SEDAR and the Securities and Exchange
Commission. Oncolytics does not undertake an obligation to update the forward looking
statements, except as required by applicable laws.
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3. 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
$32.1 million cash as at
the end of Q2, 2015
Manufacturing
at commercial scale
100L cGMP completed
4. What is REOLYSIN®?
Proprietary isolate
of the reovirus
Widely found
Non-pathogenic
Widespread human
exposure
4
5. REOLYSIN® Mechanism of Action
REOLYSIN®
infects both
tumour cells
and normal
healthy cells
REOLYSIN®
does not
replicate in
cells that are
not Ras
activated
Healthy cells
remain
undamagedREOLYSIN®
Administered to
patients
PRE-SCREENED
for RAS, EGFR,
BRAF and others
Normal Cells
REOLYSIN®
infects both
tumour cells
and normal
healthy cells
REOLYSIN®
replicates in
Ras-activated
tumour cells
Tumour cells then
rupture to release
progeny virus
Progeny viruses repeat cell
infection cycle in nearby
tumour cells
Ras–Activated Cells
Productively infected cells upregulate interferon and
others, including PD-1 and PD-L1, and induce an anti-
tumour specific immune response mediated by NK and
T cells
5
6. REOLYSIN® and Safety
General Safety
1,100+ patients treated, 1,000+ intravenously
No MTD reached
Safety profile confirmed in a randomized setting
6
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
7. 7
REOLYSIN® Clinical Program
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 019
Run-InStudy
9. REOLYSIN®
Addressable
Market
Breast
140,514
Ovarian
12,774
Soft tissue
7,158
Brain
13,710
Head & Neck
27,468
Pancreas
29,376
Prostate
132,480
Melanoma
44,322
Myeloma
16,110
Colon & Rectum
79,620
Lung & Bronchus
132,720
1,000,000+ new U.S. cases a year
in studied indications,
of which REOLYSIN®
conservatively addresses 60%
Source: American Cancer Society – Cancer Facts and
Figures 2015 Estimated New Cases per Indication in
the U.S. in 2015
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10. Orphan Drug Designations
Orphan Drug Designations obtained for REOLYSIN®:
Potential benefits of Orphan Drug Designation:
A period of market exclusivity (US and EU)
Potential tax credits for certain activities (US)
Eligibility for orphan drug grants (US)
Potential fee waivers and/or reductions (US and EU)
Protocol assistance (EU)
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FDA EMA
• ovarian • primary peritoneal • ovarian
• pancreatic • fallopian tube • pancreatic
• malignant gliomas • gastric
12. 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
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13. 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)
13
14. REO 018 Head and Neck Cancer: Randomized
Tumour-Specific Response Data
First Endpoint: Velocity
o 105 patients
o 86% of test arm (n=50) had
tumour stabilization or shrinkage
o 67% of control arm (n=55) had
tumour stabilization or shrinkage
o p-value 0.025
Second Endpoint: Volume
Loco-regional patients with or without
distal metastases
o 23% improvement in test arm vs.
control for tumour volume decrease
o p-value 0.076, n=118
Patients with distal metastases only
o 30% improvement in test arm vs.
control for tumour volume decrease
o p-value 0.021, n=47
Study demonstrated that REOLYSIN® increased both the
magnitude and velocity of tumour shrinkage
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15. Registration Program for REOLYSIN®
Short-Term: Tumour Reduction Endpoints:
Neoadjuvant treatment of muscle-invasive bladder cancer
Neoadjuvant = therapy used prior to a major therapeutic intervention
(usually surgery) in order to improve outcome
Next Steps:
IND has been filed to conduct a small “run-in” study assessing
histopathological response in muscle invasive bladder cancer
o REOLYSIN® in combination with gemcitabine and cisplatin
Subject to confirmation of response – proceed to pivotal trial
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16. Studies demonstrate that REOLYSIN® increases both the
magnitude and velocity of tumor shrinkage
Muscle invasive bladder cancer is the only cancer indication in
which US regulators have accepted histopathological response
as a registration endpoint in a neoadjuvant study to date
Each patient enrolled in the study will be assessable for this
endpoint at a maximum of nine weeks after starting
treatment
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Why Muscle Invasive Bladder Cancer?
18. Top-Line Overall Survival (OS) Results:
REO 018 (Head and Neck Cancer)
An intent-to-treat analysis of 118 patients with loco-
regional disease showed a statistically significant
improvement in the OS of the test arm versus that of
the control arm1
p=0.0146
hazard ratio=0.5099
1
Overall survival was measured to the median PFS in each arm, censoring any patients who received
post-discontinuation therapy from the date on which they commenced the first of these therapies.
18
19. Top-Line Overall Survival (OS) Results
REO 017 (Pancreatic Cancer) – Comparison with ACCORD 11 and MPACT Studies:
19
21. Days Post Treatment:
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
21
22. REOLYSIN®: Enhancing Immune Response
REOLYSIN® acts as a selective cytotoxin – killing the
tumour cells in which it replicates
We now know that administration of REOLYSIN®
also:
Causes the immune system to recognize
and kill tumour cells as well
Causes up-regulation of PD-1 and PD-L1
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23. REOLYSIN®: Immunology & Anti-PD-1 / PD-L1
In some types of cancer (including pancreatic
cancer, glioblastoma and metastatic brain
lesions), REOLYSIN® has been shown to
upregulate PD-1 and PD-L1 (Appendix A)
In cancers with low PD-1 and PD-L1 upregulation,
this enhances the activity of checkpoint inhibitors
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24. Immune Preclinical Research
In ovarian cancer models in mice:
Combination of gemcitabine and reovirus type 3 improved
overall survival
In melanoma models in mice:
Combination of GM-CSF with REOLYSIN® improved overall
survival
In brain cancer models in mice:
Combination of a checkpoint inhibitor (anti-PD-1) with
REOLYSIN® improved overall survival
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25. 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®
(studies pending)
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26. Registration Program for REOLYSIN®
Medium-Term: intravenous treatment of advanced
gliomas
Long-Term: to be determined upon receipt of data
from ongoing single-arm and randomized studies in a
range of indications
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27. Medium-Term – Overall Survival Endpoints
A key finding from REO 013 was that REOLYSIN® can cross the blood brain barrier
and subsequently infect and kill tumour in the brain, as well as primary gliomas and
metastatic lesions from other primary cancers outside brain
We have completed and initiated four studies of REOLYSIN® in glioma patients:
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• REO 003 – Ph 1/2 local mono-therapy
• REO 007 – Phase 1/2 infusion mono-
therapy
• REO 013 – Ph 1 IV prior to surgical resection
• MC1374 – Ph 1 IV combined with GM-CSF -
pediatric (ongoing)
Registration Program for REOLYSIN®
28. Registration Program for REOLYSIN®
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Next Steps
A small “run-in” study assessing response in gliomas has been initiated
(Mayo Clinic’s MC1374)
o Pediatric patients being treated with REOLYSIN® in combination with GM-CSF
Second study assessing response in adult patients receiving REOLYSIN® and
the standard of care (surgery followed by radiation and temozolomide)
Subject to confirmation of best approach – proceed to pivotal trial
30. Manufacturing
Now produced at 100L (commercial scale) under cGMP with
final formulation
Commercial manufacturing agreement in place with Sigma-
Aldrich® Fine Chemicals (SAFC)
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31. Patent Portfolio
More than 400 patents issued
worldwide, including 56 US and
20 Canadian
Reovirus issue patent claims cover:
o Compositions of matter comprising reovirus
o Pharmaceutical use of reoviruses to treat
neoplasia and cellular proliferative diseases
o Combination therapy with radiation,
chemotherapy and/or immune suppressants
o Methods for manufacturing reovirus and
screening for susceptibility to reovirus
o Pharmaceutical use of reoviruses in
transplantation procedures
Approximately 235 pending
applications worldwide
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34. Investment Highlights
Five ongoing randomized Phase II studies
Ovarian, colorectal, non-small cell lung, prostate and breast cancers
Preparing for registration study
Safety data for 1,100+ patients
Strong intellectual portfolio
More than 400 patents worldwide
Manufacturing at commercial scale
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