{"id":451654,"date":"2021-03-05T07:33:31","date_gmt":"2021-03-05T12:33:31","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=451654"},"modified":"2021-03-05T07:33:31","modified_gmt":"2021-03-05T12:33:31","slug":"oncolytics-biotech-reports-fourth-quarter-and-full-year-2020-financial-results-and-operational-highlights","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/oncolytics-biotech-reports-fourth-quarter-and-full-year-2020-financial-results-and-operational-highlights\/","title":{"rendered":"Oncolytics Biotech\u00ae Reports Fourth Quarter and Full Year 2020 Financial Results and Operational Highlights"},"content":{"rendered":"
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PR Newswire<\/p>\n<\/p><\/div>\n

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\n – New clinical data highlight pelareorep’s potential to boost the effectiveness of checkpoint inhibitors<\/i>\n <\/p>\n

\n – Clinical demonstration of pelareorep reversing immunosuppressive tumor microenvironments<\/i>\n <\/p>\n

\n – On track to report clinical biomarker and safety data in breast cancer in 2021<\/i>\n <\/p>\n

\n – Strong financial foundation with approximately $50 million<\/span> in cash on hand and cash runway to\u00a0H2 2022<\/i>\n <\/p>\n

\n – Management hosting conference call and webcast today at 8:30 am ET<\/span><\/i>\n <\/p>\n

\n SAN DIEGO<\/span> and CALGARY, AB<\/span>, March 5, 2021<\/span> \/PRNewswire\/ — Oncolytics Biotech\u00ae<\/sup>\u00a0Inc. (NASDAQ: ONCY) (TSX: ONC) today announced its financial results and operational highlights for the quarter and year ended December 31, 2020<\/span>. All dollar amounts are expressed in Canadian currency unless otherwise noted. <\/p>\n

\n \"Oncolytics\n <\/div>\n

“We are beginning 2021 with strong momentum, bolstered by a robust clinical data set that demonstrates the potential of pelareorep to boost the effectiveness of immuno-oncology agents and address major unmet medical needs across multiple indications,” said Dr. Matt Coffey<\/span>, President and Chief Executive Officer of Oncolytics Biotech Inc. “Interim AWARE-1 results highlight pelareorep’s ability to train the immune system to target tumors and its potential to synergistically combine with checkpoint blockade therapy in HR+\/HER2- breast cancer patients. These findings reinforce the survival benefit observed in our prior phase 2 study and are suggestive of a successful outcome with our phase 2 BRACELET-1 trial, which evaluates pelareorep-checkpoint inhibitor therapy in the same breast cancer subtype. We look forward to reporting additional biomarker and safety data from our lead breast cancer program later this year and to the program’s continued advancement towards a registrational study.”<\/p>\n

Dr. Coffey continued, “Beyond our lead program, we continue to leverage our compelling data and collaborations with industry leaders to expand pelareorep’s commercial and business development potential. Pelareorep promotes tumor inflammation and upregulates PD-L1 expression in the clinic, positioning it to address unmet needs in triple-negative breast cancer (TNBC) and gastrointestinal (GI) cancers. In each of these indications, checkpoint inhibitors have had commercial success, but immunosuppressive tumor microenvironments (TMEs) and low PD-L1 expression severely limit their efficacy and the number of patients who can be successfully treated. Through our IRENE and GOBLET trials, we are collaborating with industry leaders to show that we can increase the percentage of TNBC and GI cancer patients responding to checkpoint blockade by taking advantage of pelareorep’s immunotherapeutic effects. Excitingly, pelareorep’s synergistic benefits appear to extend to immunomodulatory agents beyond checkpoint inhibitors, as recent preclinical results show that pelareorep may broaden the applicability of CAR T cells to solid tumors by improving their persistence and efficacy. Looking ahead, we will explore a partnership strategy to develop pelareorep as an enabling technology for CAR T cells and other immunotherapies while keeping our primary focus on our lead breast cancer program. We believe this strategy will drive and expand our sustained growth by allowing for the efficient development of pelareorep in a variety of difficult-to-treat indications. Finally, with our strengthened financial position, we look forward to accelerating these activities and delivering on our catalysts.” \u00a0\u00a0\u00a0\u00a0<\/p>\n

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\n Select highlights from 2020 and early 2021<\/u>
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\n Breast Cancer Program<\/b>\n <\/p>\n

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\n Reported AWARE-1 Data Demonstrating Pelareorep’s Ability to Reverse Immunosuppressive TMEs and Potential to Boost the Effectiveness of Checkpoint Inhibitors<\/i>
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AWARE-1 data presented at the 2020 San Antonio Breast Cancer Symposium (SABCS) showed that systemic pelareorep treatment increased tumor PD-L1 expression by an average of 105-fold in early-stage breast cancer patients, thereby making tumors more amenable to checkpoint inhibitor therapy. Data also showed that 72% of patients \u00a0saw an increase in CelTIL (the study’s primary endpoint), a measure of tumor-associated cellularity and tumor-infiltrating lymphocytes that is associated with favorable clinical response. These data add to prior AWARE-1 results showing that systemic pelareorep treatment led to the generation of new anti-viral and anti-tumor T cell clones and an average 14-fold increase in intratumoral CD8+ T cells. Together, these data support the results of a prior successful phase 2 trial (IND-213<\/a>) that showed a near doubling of overall survival with pelareorep treatment by demonstrating pelareorep’s ability to induce robust and potentially long-lasting anti-tumor immune responses in HR+\/HER2- breast cancer patients (link<\/a>\u00a0to PR,\u00a0link<\/a>\u00a0to poster).<\/p>\n

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\n Initiated Dosing in Phase 2 BRACELET-1 Study and Successfully Completed Safety Run-in<\/i>
\n <\/b>\n <\/p>\n

Oncolytics advanced its lead breast cancer program with the initiation of dosing in BRACELET-1, a randomized phase 2 study being conducted under a co-development agreement with Merck KGaA (Darmstadt, Germany<\/span>) and Pfizer. BRACELET-1 is designed to generate mechanistic data supporting the results of IND-213<\/a>\u00a0and to evaluate pelareorep’s ability to synergistically combine with anti-PD-L1 therapy. The study also seeks to validate peripheral T cell clonality as a biomarker of pelareorep response in HR+\/HER2- metastatic breast cancer, which may improve the patient selection process in future registration studies and increase their likelihood of success. The trial’s safety run-in has been successfully completed, with the Data and Safety Monitoring Board verifying pelareorep’s outstanding safety profile. <\/p>\n

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\n Initiated Dosing in Phase 2 IRENE Study<\/i>
\n <\/b>\n <\/p>\n

Oncolytics expanded its lead breast cancer program into a new disease subtype through the initiation of dosing in IRENE, a phase 2 investigator-sponsored study investigating the use of pelareorep in combination with Incyte’s anti-PD-1 checkpoint inhibitor retifanlimab (INCMGA00012) in patients with unresectable locally advanced or metastatic TNBC. In addition to investigating the safety and efficacy of pelareorep-anti-PD-1 combination treatment in TNBC patients, the study also evaluates changes in PD-L1 expression and correlations between treatment outcomes and peripheral T cell clonality.\u00a0<\/p>\n

\n Gastrointestinal Cancer Program<\/b>\n <\/p>\n

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\n Announced Phase 1\/2 GOBLET Study in Collaboration with Roche and AIO<\/i>
\n <\/b>\n <\/p>\n

GOBLET is a phase 1\/2 multi-center trial designed to investigate the use of pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab (Tecentriq\u00ae<\/sup>) in patients with metastatic pancreatic, metastatic colorectal and advanced anal cancers. The trial is being managed by AIO, a leading academic cooperative medical oncology group based in Germany<\/span>. GOBLET builds on previously reported early clinical data showing that pelareorep-based combination treatments stimulated an adaptive immune response and led to a greater than 90% clinical benefit rate in KRAS mutated colorectal cancer patients (link<\/a>\u00a0to PR,\u00a0link<\/a>\u00a0to study), as well as a greater than 80% increase in progression-free survival (PFS) in pancreatic cancer patients with low levels of CEACAM6 expression (link<\/a>\u00a0to PR,\u00a0link<\/a>\u00a0to poster). In addition to evaluating the safety and efficacy of pelareorep-atezolizumab treatment, the trial also seeks to validate CEACAM6 and T cell clonality as predictive biomarkers, which may improve the patient selection process in future registration studies and increase their likelihood of success.<\/p>\n

\n Hematologic Malignancies Program<\/b>\n <\/p>\n

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\n Announced Clinical Proof-of-Concept Data at the ASCO Virtual Meeting<\/i>
\n <\/b>\n <\/p>\n

Phase 1b<\/span> data presented at the American Society of Clinical Oncology (ASCO) meeting\u00a0showed that pelareorep, when combined with carfilzomib, activated a profound inflammatory response accompanied by a 50% overall response rate and an 83% clinical benefit rate in patients with challenging-to-treat carfilzomib-refractory multiple myeloma (link<\/a>\u00a0to the PR, link<\/a>\u00a0to the poster).\u00a0The data also showed the first reported incidence of cytokine stimulation associated with tumor response in multiple myeloma, highlighting the ability of pelareorep to induce robust immune cell activation and tumor lysis. Together with earlier trial data showing pelareorep-induced upregulation of PD-L1 expression, these data highlight the potential of pelareorep to synergistically combine with checkpoint inhibitors in hematologic cancers.\u00a0 <\/p>\n

\n Opportunities to Further Expand the Clinical Benefits of Pelareorep to Additional Indications<\/b>\n <\/p>\n

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\n Reported Positive Clinical Results Against Glioblastoma Multiforme<\/i>
\n <\/b>\n <\/p>\n

Oncolytics announced positive results from ReoGlio, an investigator-sponsored phase 1b<\/span> 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) at the 2020 Society of Neuro-Oncology Annual Meeting (link<\/a>\u00a0to the PR). The results showed a compelling signal of efficacy and demonstrated the safety and tolerability of the pelareorep-based combination therapy in newly diagnosed GBM patients. Notably, observed improvements in median PFS correlated with the dose of pelareorep administered. Oncolytics thanks the University of Leeds, Cancer Research UK, and The Brain Tumor Charity for designing, managing, and funding the ReoGlio trial.<\/p>\n

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\n Demonstrated the Potential of Pelareorep to Broaden the Applicability of CAR T Cells to Solid Tumors<\/i>
\n <\/b>\n <\/p>\n

A recent preclinical study from the Mayo Clinic showed that loading chimeric antigen receptor (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 (link<\/a>\u00a0to the PR, link<\/a>\u00a0to the poster). The 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, which led to the generation of highly persistent CAR T cells, the 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. Together, these data demonstrate the potential of pelareorep to broaden the applicability of CAR T cells to solid tumors, an area where CAR T cell efficacy is currently limited due to immunosuppressive TMEs that promote T cell exhaustion and exclusion. <\/p>\n

\n Corporate Highlights<\/b>\n <\/p>\n

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\n Appointed Richard Vile<\/span>, Ph.D., to Scientific Advisory Board<\/i>
\n <\/b>\n <\/p>\n

Dr. Vile, a Professor of Immunology at the Mayo Clinic, is a world-renowned scientist and long-time collaborator of Oncolytics with extensive experience studying pelareorep, and led the Mayo Clinic CAR T preclinical study mentioned above. Dr. Vile is a recognized key opinion leader whose research focuses on several areas of immuno-oncology, including oncolytic viruses, adoptive cell therapies (ACTs) such as CAR T cells, and potential synergistic interactions between oncolytic viruses and ACTs. In addition to his role as a professor at the Mayo Clinic (“Mayo”), Dr. Vile is the Director of Mayo’s Immuno-oncology and Gene and Virus Therapy programs and Co-Director of the Cancer Immunology and Immunotherapy program. He also serves on the editorial board of several prestigious scientific journals, including\u00a0Molecular Therapy,\u00a0Gene Therapy,\u00a0The Journal of Gene Medicine<\/span>, and\u00a0OncoImmunology.<\/i><\/b><\/p>\n

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\n Financial Highlights<\/i>
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