ONCY Oncolytics Biotech Inc.

3.21
-0.26  -7%
Previous Close 3.47
Open 3.41
52 Week Low 0.94
52 Week High 4.7
Market Cap $133,718,964
Shares 41,656,998
Float 18,751,875
Enterprise Value $64,314,648
Volume 1,836,512
Av. Daily Volume 1,779,183
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Upcoming Catalysts

Drug Stage Catalyst Date
Pelareorep with Keytruda (NU 18I01)
Pancreatic cancer
Phase 2
Phase 2
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Pelareorep and Opdivo (WINSHIP 4398-18)
Multiple myeloma
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
Pelareorep and Carfilzomib /Dexamethasone
Multiple myeloma
Phase 1
Phase 1
Phase 1 interim data noted ORR 50% - May 29, 2020 at ASCO.
Pelareorep, paclitaxel and avelumab - BRACELET-1
HR+ / HER2- breast cancer
Phase 2
Phase 2
Phase 2 trial ongoing.
Pelareorep and retifanlimab (INCMGA00012) - IRENE
Triple-negative breast cancer.
Phase 2
Phase 2
Phase 2 trial ongoing.
Pelareorep and atezolizumab (Tecentriq) - GOBLET
Colorectal and advanced anal cancers
Phase 1/2
Phase 1/2
Phase 1/2 initiation of dosing due 1H 2021.
Pelareorep and Tecentriq - AWARE-1
Breast cancer
Phase 1b
Phase 1b
Phase 1b data presented at SITC November 2020.

Latest News

  1. SAN DIEGO, Calif. and CALGARY, AB, Feb. 26, 2021 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC) today announced that it will host a conference call and webcast on Friday, March 5, 2021, at 8:30 am ET to discuss a corporate update and financial results for the fourth quarter and full year 2020.

    Conference Call & Webcast

    Date: Friday, March 5, 2021
    Time: 8:30 am ET
    Dial In – North American Toll-Free: (888) 231-8191
    Dial In – International: (647) 427-7450
    Conference ID (if needed): 569-6653
    Webcast: please click here

    A live webcast of the call will also be available on the Investor Relations page of Oncolytics' website, available by clicking here and will be archived for three months. A dial in replay will be available for one…

    SAN DIEGO, Calif. and CALGARY, AB, Feb. 26, 2021 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC) today announced that it will host a conference call and webcast on Friday, March 5, 2021, at 8:30 am ET to discuss a corporate update and financial results for the fourth quarter and full year 2020.

    Conference Call & Webcast

    Date: Friday, March 5, 2021

    Time: 8:30 am ET

    Dial In – North American Toll-Free: (888) 231-8191

    Dial In – International: (647) 427-7450

    Conference ID (if needed): 569-6653

    Webcast: please click here

    A live webcast of the call will also be available on the Investor Relations page of Oncolytics' website, available by clicking here and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (855) 859-2056 (North America) or (416) 849-0833 (International) and using reference code: 569-6653.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

    Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies of pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic, the company's intentions regarding a potential phase 3 study involving pelareorep; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

    Company Contact

    Kirk Look

    Chief Financial Officer

    +1-403-670-7658

    Investor Relations for Oncolytics

    Timothy McCarthy

    LifeSci Advisors

    +1-917-679-9282

     

    Cision View original content:http://www.prnewswire.com/news-releases/oncolytics-biotech-to-host-conference-call-to-discuss-fourth-quarter-and-full-year-financial-results-and-operational-highlights-301236150.html

    SOURCE Oncolytics Biotech® Inc.

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  2. Mayo Clinic shows pelareorep vastly improved persistence and efficacy of CAR T cell therapy leading to cures in this model

    Pelareorep's synergistic effects with CAR T therapy appear to be specific and were not observed with the oncolytic virus VSV

    Results demonstrate the potential of pelareorep to broaden the applicability of CAR T cells to solid tumors

    SAN DIEGO, Calif. and CALGARY, AB, Feb. 23, 2021 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC) announced publication of an electronic poster at the CAR-TCR Summit Europe 2021 with data from a preclinical study evaluating pelareorep and chimeric antigen receptor (CAR) T cell combination therapy in solid tumors.

    Newly published results show that loading CAR T cells with pelareorep…

    Mayo Clinic shows pelareorep vastly improved persistence and efficacy of CAR T cell therapy leading to cures in this model

    Pelareorep's synergistic effects with CAR T therapy appear to be specific and were not observed with the oncolytic virus VSV

    Results demonstrate the potential of pelareorep to broaden the applicability of CAR T cells to solid tumors

    SAN DIEGO, Calif. and CALGARY, AB, Feb. 23, 2021 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC) announced publication of an electronic poster at the CAR-TCR Summit Europe 2021 with data from a preclinical study evaluating pelareorep and chimeric antigen receptor (CAR) T cell combination therapy in solid tumors.

    Newly published results show that loading CAR T cells with pelareorep vastly improved their persistence and efficacy in a murine solid tumor model, in stark contrast to preclinical studies using intratumoral infection with the VSV oncolytic virus that weakened CAR T cells. Efficacy of pelareorep-loaded CAR T cell ("CAR/Pela") therapy was further enhanced by boosting mice 8 days later with a single intravenous dose of pelareorep ("pelareorep boost"), generating highly persistent CAR T cells, inhibition of recurrent tumor growth, and ultimately tumor cures. These synergistic immune effects were specific to pelareorep, as intravenous boosting with VSV did not augment CAR/Pela therapy or prevent the growth of recurrent tumors. Survival data from the preclinical study are shown below:

    Therapy

    Survival Rate at End of Study

    PBS (vehicle)

    0% (0/7)

    CAR T

    14% (1/7)

    Pelareorep

    0% (0/7)

    Pelareorep + Pelareorep boost

    0% (0/7)

    CAR/Pela

    57% (4/7)

    CAR/Pela + pelareorep boost

    100% (7/7)

    CAR/Pela + VSV boost

    42% (3/7)

    "These very exciting data demonstrate pelareorep's ability to overcome major shortcomings of CAR T cells," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "Despite commercial success in hematological cancers, CAR T therapies have limited efficacy against solid tumors due to immunosuppressive tumor microenvironments (TMEs) that promote T cell exhaustion and exclusion. Pelareorep's ability to reverse immunosuppressive TMEs has been well documented in the clinic, and combining CAR T cells with pelareorep may enable their success against solid cancers. This would be a major advancement, as it would substantially broaden the applicability of CAR T cells to a variety of highly prevalent and difficult-to-treat indications."

    Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development, added, "While our primary focus is on advancing our lead breast cancer program to a registrational trial, we continue to evaluate additional opportunities to expand pelareorep's business development and partnership potential. In clinical studies, pelareorep recruited high concentrations of T cells to solid tumors, positioning it to synergistically interact with checkpoint inhibitors. In this newly published study, we show the synergistic benefits of pelareorep can be extended to additional cutting-edge immunotherapeutic agents. Based on these findings, we are specifically exploring a partnership strategy to further the development of pelareorep as an enabling technology for CAR T cells and additional immunotherapies that require immune effector cell infiltration in solid tumors."

    The electronic poster titled "Combination Therapy with Oncolytic Viruses and CAR T Cells," was developed in collaboration with researchers from the Mayo Clinic, Duke University, and Oncolytics. It is available on the Posters & Publications page of Oncolytics' website (LINK).

    About CAR T cells and CAR T therapy

    The CAR T process begins when blood is drawn from a patient and their T cells are separated so they can be genetically engineered to produce chimeric antigen receptors (CARs). These receptors enable the T cells to recognize and attach to a specific protein or antigen on tumor cells. Once the engineering process is complete, a laboratory can increase the number of CAR T cells into the hundreds of millions. Finally, the CAR T cells will be infused back into the patient where, ideally, the engineered cells further multiply, and recognize and kill cancer cells. Historically, solid tumors have been considered beyond the reach of CAR T therapy due to their tumor microenvironment, which is detrimental to CAR T cell entry and activity, amongst other challenges.1

    About Pelareorep

    Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

    Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies of pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    References:

    1.  National Cancer Institute. CAR T Cells: Engineering Patients' Immune Cells to Treat Their Cancers. Updated July 31, 2019. Accessed February 18, 2021. https://www.cancer.gov/about-cancer/treatment/research/car-t-cells

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic, potential commercial opportunities for pelareorep; the Company's primary focus on advancing its lead breast cancer program to a registrational trial; the Company's evaluation and pursuit of business development and partnership potential opportunities; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. In any forward-looking statement in which Oncolytics 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. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

    Company Contact

    Kirk Look

    Chief Financial Officer

    +1-403-670-7658

    Investor Relations for Oncolytics

    Timothy McCarthy

    LifeSci Advisors

    +1-917-679-9282

     

    Cision View original content:http://www.prnewswire.com/news-releases/oncolytics-biotech-reports-preclinical-data-demonstrating-the-synergistic-anti-cancer-activity-of-pelareorep-combined-with-car-t-cell-therapy-in-solid-tumors-301232827.html

    SOURCE Oncolytics Biotech® Inc.

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  3. - Pelareorep strongly increases CelTIL score, the primary endpoint and a measure of tumor cellularity and inflammation associated with favorable clinical outcomes

    - Pelareorep increased tumor PD-L1 expression 105-fold, thereby making the tumors more amenable to immuno-checkpoint inhibitor treatment

    SAN DIEGO and CALGARY, AB, Dec. 9, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC) and SOLTI-Innovative Breast Cancer Research today published an electronic poster at the 2020 San Antonio Breast Cancer Symposium (SABCS) with data from the AWARE-1 window-of-opportunity study in patients with early-stage breast cancer showing pelareorep delivers a significant boost known to increase the effectiveness of checkpoint inhibitors…

    - Pelareorep strongly increases CelTIL score, the primary endpoint and a measure of tumor cellularity and inflammation associated with favorable clinical outcomes

    - Pelareorep increased tumor PD-L1 expression 105-fold, thereby making the tumors more amenable to immuno-checkpoint inhibitor treatment

    SAN DIEGO and CALGARY, AB, Dec. 9, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC) and SOLTI-Innovative Breast Cancer Research today published an electronic poster at the 2020 San Antonio Breast Cancer Symposium (SABCS) with data from the AWARE-1 window-of-opportunity study in patients with early-stage breast cancer showing pelareorep delivers a significant boost known to increase the effectiveness of checkpoint inhibitors.

    Oncolytics_Logo

    In the AWARE-1 study, a collaboration between Oncolytics Biotech and SOLTI, early-stage breast cancer patients are treated with pelareorep, with or without atezolizumab (Tecentriq®), plus an appropriate therapy for each patient's breast cancer subtype, followed by surgery. The SABCS poster includes 17 out of the 20 HR+/HER2- breast cancer patients comprising the study's first two cohorts, the targeted patient population for our intended phase 3 study. Treatment with pelareorep increased the CelTIL score in tumor biopsies, which has been associated with improved clinical outcomes. In addition, pelareorep treatment dramatically upregulated PD-L1 expression in the tumor microenvironment (TME). These findings highlight the potential of pelareorep to act synergistically with checkpoint inhibitors and also provides a basis for the near doubling of overall survival observed in a prior phase 2 trial when pelareorep was added to chemotherapy in HR+/HER2- breast cancer patients (link to PR, link to poster).

    "AWARE-1 data demonstrate pelareorep's consistent remodeling of the tumor immune environment," said Dr. Aleix Prat, M.D., Ph.D., Translational Investigator of AWARE-1, SOLTI President and Head of the Medical Oncology Department at Hospital Clinic in Barcelona. "Pelareorep seems to train the immune system to target cancer cells while simultaneously promoting tumor inflammation and priming a response to immune checkpoint blockade. This demonstrates pelareorep's potential to overcome the immunosuppressive nature of the tumor microenvironment which could limit checkpoint inhibitor efficacy."

    Key data and conclusions from the SABCS poster include:

    • 72% of evaluated patients (n=18) saw an increase in CelTIL, the study's primary endpoint that is associated with favorable clinical outcomes.
    • The maximum percentage increase in CelTIL (~300%) was achieved in a cohort 2 patient receiving pelareorep in combination with checkpoint blockade therapy.
    • On average, there was a 105-fold increase in TME PD-L1 expression (n=13) from baseline (pre-pelareorep administration) to surgery (21-days post-administration).
    • Tumor microenvironment PD-L1 expression increased in all evaluated patients (n=13).
    • Preliminary imaging mass cytometry analysis showed pelareorep treatment promoted broad anti-tumor changes in the TME, including enhanced CD8+ T cell activation and the recruitment of memory T cells.

    Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics, commented, "In the AWARE-1 study, pelareorep delivered consistent increases in tumor PD-L1 expression and recruitment of anti-cancer immune cells into tumors, as well as increases in CelTIL score for over 70% of the patients. This is highly encouraging given the association between CelTIL and clinical outcomes, and we hope to observe the same success from our phase 2 BRACELET-1 trial, which is  exclusively enrolling HR+/HER2- breast cancer patients."

    Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development, added, "Immune deserts or immunosuppressive tumor microenvironments limit tumor PD-L1 expression levels and thereby limit regulatory approval and commercial success of checkpoint inhibitors in certain breast and other malignancies. AWARE-1 data show that pelareorep can alter the tumor microenvironment and induce robust PD-L1 expression, highlighting the potential of pelareorep to boost the efficacy of checkpoint inhibitors and increase the proportion of patients eligible for these therapies. We expect this synergistic potential to enable the continued execution of our strategy to develop pelareorep-based therapies in collaboration with industry leaders."

    The electronic poster, titled "A window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer (REO-027, AWARE-1)" is available in the SABCS virtual poster hall and on the Posters & Publications page of Oncolytics' website (LINK).

    Ongoing 'trial-in-progress' posters giving an overview of Oncolytics' IRENE and BRACELET-1 study designs were also presented at SABCS and are available at the same locations.

    About AWARE-1

    AWARE-1 is an open-label window-of-opportunity study in early-stage breast cancer enrolling 38 patients into five cohorts:

    • Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)
    • Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)
    • Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)
    • Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)
    • Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)

    The study combines pelareorep, with or without atezolizumab, and the standard of care therapy according to breast cancer subtype. Patients are biopsied as part of their initial breast cancer evaluation, then again on day three following initial treatment, and a final tissue sample after three weeks, on the day of their mastectomy. Data generated from this study are intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive biomarker data by breast cancer subtype. The primary endpoint of the study is overall CelTIL (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety, and tumor and blood-based biomarkers.

    For more information about the AWARE-1 study, refer to https://clinicaltrials.gov/ct2/show/NCT04102618.

    Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

    About Breast Cancer

    Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

    Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

    About Pelareorep

    Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

    About SOLTI

    SOLTI is a leading cooperative group in the field of clinical cancer research. With its academic and translational core, the group is committed to designing and executing clinical trials based on the molecular biology of tumors. Its focus is on breast cancer, but it also explores other kinds of tumors. The main goal of SOLTI is to promote through disruptive means the development of innovative research that will improve the well-being and future outcomes of cancer patients. Since its creation in 1995, SOLTI's purpose has been to bring about a paradigm shift in clinical and translational cancer research from within academia. With 77 clinical trials under their belt and more than 30 ongoing investigations, SOLTI counts on the work of more than 400 researchers from a network comprising more than 100 hospitals in Spain and Portugal, all coordinated by the team of 50 workers from the head office. SOLTI is a member of the Spanish Society of Medical Oncology (SEOM).

    To find out more about SOLTI, visit www.gruposolti.org / Twitter: @SOLTI / LinkedIn / Youtube 

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

    Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies of pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic, the Company's intentions regarding a potential phase 3 study involving pelareorep; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact

    Kirk Look

    Chief Financial Officer

    +1-403-670-7658

     

    Investor Relations for Oncolytics

    Timothy McCarthy

    LifeSci Advisors

    +1-917-679-9282

     

    Cision View original content:http://www.prnewswire.com/news-releases/oncolytics-and-solti-report-clinical-synergy-of-pelareorep-with-checkpoint-inhibitors-at-the-2020-san-antonio-breast-cancer-symposium-301189190.html

    SOURCE Oncolytics Biotech® Inc.

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  4. SAN DIEGO, Calif. and CALGARY, Alberta, Nov. 19, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC) today announced positive results from ReoGlio, an investigator-sponsored, phase 1b trial evaluating the combination of pelareorep and granulocyte-macrophage colony-stimulating factor (GM-CSF) alongside standard chemoradiotherapy and adjuvant temozolomide for the treatment of glioblastoma multiforme (GBM). The results, which were featured in a podium presentation at the 2020 Society of Neuro-Oncology Annual Meeting, show a compelling signal of efficacy and demonstrate the safety and tolerability of the pelareorep-based combination therapy in newly diagnosed GBM patients.

    "The ReoGlio trial results add to a robust set of clinical…

    SAN DIEGO, Calif. and CALGARY, Alberta, Nov. 19, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC) today announced positive results from ReoGlio, an investigator-sponsored, phase 1b trial evaluating the combination of pelareorep and granulocyte-macrophage colony-stimulating factor (GM-CSF) alongside standard chemoradiotherapy and adjuvant temozolomide for the treatment of glioblastoma multiforme (GBM). The results, which were featured in a podium presentation at the 2020 Society of Neuro-Oncology Annual Meeting, show a compelling signal of efficacy and demonstrate the safety and tolerability of the pelareorep-based combination therapy in newly diagnosed GBM patients.

    "The ReoGlio trial results add to a robust set of clinical data supporting the safety, tolerability, and efficacy of pelareorep in a broad range of indications," said Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics. "The median progression-free survival (PFS) of approximately eight months is encouraging in this challenging indication, particularly considering the improved median PFS correlated with the dose of pelareorep administered. Together, these results drive momentum to develop pelareorep across a spectrum of cancer indications."

    The podium presentation, Pelareorep and granulocyte-macrophage colony-stimulating factor (GM-CSF) with standard chemoradiotherapy/adjuvant temozolomide for glioblastoma multiforme (GBM) patients: ReoGlio phase I trial results, was given by Susan Short, M.R.C.P., Ph.D., Professor of Clinical Oncology and Neuro-Oncology at the University of Leeds. Key data and conclusions from the presentation include:

    • Evaluable patients treated at pelareorep dose level-2 (3x1010 TCID50) had an estimated median PFS of 9.4 months (n=6; 95% CI: 4.2-10.6)
    • Evaluable patients treated at pelareorep dose level-1 (1x1010 TCID50) had an estimated median PFS of 6.1 months (n=6; 95% CI: 4.9-9.2)
    • The estimated median PFS of all evaluable patients, regardless of pelareorep dose level, was 7.8 months (n=12; 95% CI: 4.9-9.7)
    • Pelareorep, in addition to GM-CSF, standard chemoradiotherapy, and adjuvant temozolomide, was safe and well-tolerated

    Oncolytics remains focused on the clinical advancement of pelareorep and will continue evaluating new commercial opportunities for pelareorep, while prioritizing the current programs and achieving the expected milestones for those in breast, gastrointestinal, and hematological malignancies. Oncolytics thanks the University of Leeds, Cancer Research UK, and The Brain Tumor Charity for designing, managing, and funding the ReoGlio trial.

    About ReoGlio

    The ReoGlio trial was an investigator-sponsored phase 1b, open-label trial evaluating the combination of pelareorep and GM-CSF, alongside standard chemoradiotherapy and adjuvant temozolomide, for the treatment of newly diagnosed GBM. Fifteen patients were treated in the trial, twelve of which were evaluable for efficacy analyses.  The primary objective of the study was to determine the maximum tolerated dose of pelareorep and GM-CSF with standard chemoradiotherapy. Secondary objectives were to gain a preliminary assessment of the activity of the pelareorep-GM-CSF combination and to assess treatment compliance. The trial was designed and managed by the University of Leeds and funded through grants provided by Cancer Research UK and The Brain Tumor Charity.

    About Pelareorep

    Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

    Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic; the safety and tolerability of pelareorep-based combination therapy in newly diagnosed GBM patients; the Company's focus and strategies; the Company's plans to pursue future registrational studies; the Company's evaluation of new commercial opportunities for pelareorep; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact :

    Kirk Look

    Chief Financial Officer

    403.670.7658

       

    Investor Relations for Oncolytics : 

    Timothy McCarthy

    LifeSci Advisors

    917.679.9282

    Cision View original content:http://www.prnewswire.com/news-releases/oncolytics-biotech-announces-positive-clinical-results-against-glioblastoma-multiforme-at-the-2020-society-of-neuro-oncology-annual-meeting-301176875.html

    SOURCE Oncolytics Biotech® Inc.

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  5. SAN DIEGO, Calif. and CALGARY, Alberta, Nov. 17, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC) today announced the publication of three abstracts for electronic poster presentations to be given as part of the 2020 San Antonio Breast Cancer Symposium, which is being held virtually from December 8-11, 2020.

    Oncolytics

    Details on the abstracts and corresponding electronic posters are shown below. All posters will be available in a virtual poster hall beginning Wednesday, December 9, 2020 at 9:00 AM ET.

    Poster Number: PS12-08
    Title: A window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer (REO-027, AWARE-1)
    Session Name: Poster Session 12
    Presenter: Dr. Luis Manso

    Poster Number: OT-13-02…

    SAN DIEGO, Calif. and CALGARY, Alberta, Nov. 17, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC) today announced the publication of three abstracts for electronic poster presentations to be given as part of the 2020 San Antonio Breast Cancer Symposium, which is being held virtually from December 8-11, 2020.

    Oncolytics

    Details on the abstracts and corresponding electronic posters are shown below. All posters will be available in a virtual poster hall beginning Wednesday, December 9, 2020 at 9:00 AM ET.

    Poster Number: PS12-08

    Title: A window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer (REO-027, AWARE-1)

    Session Name: Poster Session 12

    Presenter: Dr. Luis Manso

    Poster Number: OT-13-02

    Title: Bracelet-1 (pre0113): a study to assess overall response rate by inducing an inflammatory phenotype in metastatic breast cancer with the oncolytic reovirus pelareorep in combination with anti-PD-L1 avelumab and paclitaxel

    Session Name: Ongoing Trials Posters

    Presenter: Dr. Kathy Miller

    Poster Number: OT-32-02

    Title: Irene study: phase 2 study of incmga00012 (retifanlimab) and the oncolytic virus pelareorep in metastatic triple negative breast cancer

    Session Name: Ongoing Trials Posters

    Presenter: Dr. Mridula George

    About Pelareorep

    Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

    Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic; the timing of the presentations to be given as part of the 2020 San Antonio Breast Cancer Symposium; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

     

    Company Contact

    Kirk Look

    Chief Financial Officer

    +1-403-670-7658

    Investor Relations for Oncolytics

    Timothy McCarthy

    LifeSci Advisors

    +1-917-679-9282

     

     

    Cision View original content:http://www.prnewswire.com/news-releases/oncolytics-biotech-to-present-aware-1-data-and-provide-updates-on-phase-2-bracelet-1-and-irene-trials-at-the-2020-san-antonio-breast-cancer-symposium-301174275.html

    SOURCE Oncolytics Biotech® Inc.

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