{"id":911640,"date":"2025-11-19T09:30:41","date_gmt":"2025-11-19T14:30:41","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/oncolytics-biotech-aligns-with-fda-on-pivotal-study-design-for-pelareorep-in-first-line-pancreatic-cancer\/"},"modified":"2025-11-19T09:30:41","modified_gmt":"2025-11-19T14:30:41","slug":"oncolytics-biotech-aligns-with-fda-on-pivotal-study-design-for-pelareorep-in-first-line-pancreatic-cancer","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/oncolytics-biotech-aligns-with-fda-on-pivotal-study-design-for-pelareorep-in-first-line-pancreatic-cancer\/","title":{"rendered":"Oncolytics Biotech\u00ae Aligns with FDA on Pivotal Study Design for Pelareorep in First-Line Pancreatic Cancer"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p class=\"bwalignc\"><b>Oncolytics Biotech<sup>\u00ae<\/sup> Aligns with FDA on Pivotal Study Design for Pelareorep in First-Line Pancreatic Cancer<\/b><\/p>\n<p class=\"bwalignc\"><i>Company to launch only current registration trial with an immunotherapy in first-line pancreatic cancer in first half of 2026<\/i><\/p>\n<p class=\"bwalignc\"><i>Trial design allows flexibility to include an experimental arm with checkpoint inhibitor combination<\/i><\/p>\n<p>SAN DIEGO&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nOncolytics Biotech<sup>\u00ae<\/sup> Inc. (Nasdaq: ONCY) (\u201cOncolytics\u201d or the \u201cCompany\u201d), a clinical-stage immunotherapy company developing pelareorep, today announced alignment with the U.S. Food and Drug Administration (\u201cFDA\u201d) regarding the design of its pivotal study of pelareorep in combination with standard-of-care therapy for the first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC).<\/p>\n<p>\nThe Company and the FDA completed a recent Type C meeting and have agreed on the key elements of the Phase 3 trial, which will evaluate pelareorep in combination with chemotherapy with or without a checkpoint inhibitor (\u201cCPI\u201d) compared to chemotherapy alone. As a result, Oncolytics now has a clear path to launch what it believes will be the only such pivotal study of an immunotherapy in mPDAC, an indication for which immunotherapies have provided very little benefit.<\/p>\n<p>\n\u201cWe now have regulatory clarity to allow us to start a pivotal study and ultimately the chance to bring the first approved immunotherapy treatment option to the pancreatic cancer treatment landscape,\u201d said Jared Kelly, Chief Executive Officer of Oncolytics Biotech. \u201cThe data speaks for itself, but we want to sincerely thank the FDA for its great work in helping us clear this initial regulatory hurdle. Although we still have work to do, we are laser-focused on bringing potential treatments to pancreatic cancer patients who desperately need more options.\u201d<\/p>\n<p>\nThe pivotal trial design includes a control arm of gemcitabine plus nab-paclitaxel (GnP), an experimental arm evaluating GnP plus pelareorep and an additional optional experimental arm evaluating GnP plus pelareorep plus a CPI. The primary endpoint of the study is overall survival. Progression-free survival and objective response rate are secondary endpoints. The trial will be statistically powered to demonstrate a clinically meaningful survival benefit and will potentially incorporate an interim analysis to support the option for an accelerated registration timeline. Either experimental arm or potentially both could meet the required success criteria.<\/p>\n<p>\nThe study protocol also permits flexibility in CPI selection for the triple-combination arm. Pelareorep has been combined successfully with multiple checkpoint inhibitors\u2014including atezolizumab, pembrolizumab, nivolumab, and retifanlimab\u2014in gastrointestinal and other tumor types. The final CPI choice will reflect ongoing discussions internally and with potential partners.<\/p>\n<p>\nDr. Thomas Heineman, Chief Medical Officer of Oncolytics, stated, \u201cThe FDA\u2019s feedback confirms that our design is appropriate to support registration if successful. We are now completing the administrative activities necessary to initiate the study, including finalizing the protocol, generation of supporting documents, and site selection. We also plan to announce the lead principal investigator once these preparations are complete.\u201d<\/p>\n<p>\nThe Company is engaged in study start-up activities, including protocol review and site selection, and will provide periodic updates on the trial initiation process.<\/p>\n<p><b>About Oncolytics Biotech Inc.<\/b><\/p>\n<p>\nOncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically \u201ccold\u201d tumors \u201chot\u201d through the activation of innate and adaptive immune responses.<\/p>\n<p>\nThe Company is advancing pelareorep in combination with chemotherapy and\/or checkpoint inhibitors in metastatic pancreatic and breast cancers, of which both development programs have received Fast Track designation from the FDA, and other gastrointestinal tumors. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.oncolyticsbiotech.com%2F&amp;esheet=54360682&amp;newsitemid=20251119471276&amp;lan=en-US&amp;anchor=www.oncolyticsbiotech.com&amp;index=1&amp;md5=3644bcf014f23f77e046079b867a02f0\">www.oncolyticsbiotech.com<\/a> or follow the Company on social media on <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Foncolytics-biotech-inc.%2F&amp;esheet=54360682&amp;newsitemid=20251119471276&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=2&amp;md5=f22d8efe97dac2486e9bdf61de76cbf9\">LinkedIn<\/a> and on X @<a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fx.com%2Foncolytics&amp;esheet=54360682&amp;newsitemid=20251119471276&amp;lan=en-US&amp;anchor=oncolytics&amp;index=3&amp;md5=89d4c57dcfdf59b4451f03f279293c71\">oncolytics<\/a>.<\/p>\n<p><b>Forward-looking statements<\/b><\/p>\n<p><i>This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. 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 \u201cforward-looking statements\u201d). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; expectations regarding the initiation, design, protocol, lead principal investigator, and outcomes of a planned study of pelareorep in combination with standard-of-care therapy for the first-line treatment of metastatic pancreatic ductal adenocarcinoma; expectations relating to outcomes of ongoing and future studies; Oncolytics\u2019 plan to continue actively pursuing strategic partnerships; its goals, strategies and objectives; and its belief in the clinical promise of pelareorep in metastatic pancreatic and other gastrointestinal cancers. 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. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics\u2019 public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.<\/i><\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20251119471276r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20251119471276\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20251119471276\/en\/<\/a><\/span><\/p>\n<p><b>Company Contact<br \/>\n<\/b><br \/>Jon Patton<br \/>\n<br \/>Director of IR &amp; Communication<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:jpatton@oncolytics.ca\">jpatton@oncolytics.ca<br \/>\n<\/a><\/p>\n<p><b>Investor Relations for Oncolytics<br \/>\n<\/b><br \/>Mike Moyer<br \/>\n<br \/>LifeSci Advisors<br \/>\n<br \/>+1-617-308-4306<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:mmoyer@lifesciadvisors.com\">mmoyer@lifesciadvisors.com<br \/>\n<\/a><\/p>\n<p><b>Media Contact for Oncolytics<br \/>\n<\/b><br \/>Owen Blaschak<br \/>\n<br \/>LifeSci Communications<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:oblaschak@lifescicomms.com\">oblaschak@lifescicomms.com<\/a><\/p>\n<p><b>KEYWORDS:<\/b> California United States North America<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Science Biotechnology Research Pharmaceutical Oncology Health FDA Clinical Trials<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20251119471276\/en\/2649107\/3\/Oncolytics_Biotech_Inc_Logo_%281%29.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>Oncolytics Biotech\u00ae Aligns with FDA on Pivotal Study Design for Pelareorep in First-Line Pancreatic Cancer Company to launch only current registration trial with an immunotherapy in first-line pancreatic cancer in first half of 2026 Trial design allows flexibility to include an experimental arm with checkpoint inhibitor combination SAN DIEGO&#8211;(BUSINESS WIRE)&#8211; Oncolytics Biotech\u00ae Inc. (Nasdaq: ONCY) (\u201cOncolytics\u201d or the \u201cCompany\u201d), a clinical-stage immunotherapy company developing pelareorep, today announced alignment with the U.S. Food and Drug Administration (\u201cFDA\u201d) regarding the design of its pivotal study of pelareorep in combination with standard-of-care therapy for the first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). The Company and the FDA completed a recent Type C meeting and have agreed on the key elements of the &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/oncolytics-biotech-aligns-with-fda-on-pivotal-study-design-for-pelareorep-in-first-line-pancreatic-cancer\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Oncolytics Biotech\u00ae Aligns with FDA on Pivotal Study Design for Pelareorep in First-Line Pancreatic Cancer&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-911640","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Oncolytics Biotech\u00ae Aligns with FDA on Pivotal Study Design for Pelareorep in First-Line Pancreatic Cancer - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/oncolytics-biotech-aligns-with-fda-on-pivotal-study-design-for-pelareorep-in-first-line-pancreatic-cancer\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Oncolytics Biotech\u00ae Aligns with FDA on Pivotal Study Design for Pelareorep in First-Line Pancreatic Cancer - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Oncolytics Biotech\u00ae Aligns with FDA on Pivotal Study Design for Pelareorep in First-Line Pancreatic Cancer Company to launch only current registration trial with an immunotherapy in first-line pancreatic cancer in first half of 2026 Trial design allows flexibility to include an experimental arm with checkpoint inhibitor combination SAN DIEGO&#8211;(BUSINESS WIRE)&#8211; Oncolytics Biotech\u00ae Inc. (Nasdaq: ONCY) (\u201cOncolytics\u201d or the \u201cCompany\u201d), a clinical-stage immunotherapy company developing pelareorep, today announced alignment with the U.S. Food and Drug Administration (\u201cFDA\u201d) regarding the design of its pivotal study of pelareorep in combination with standard-of-care therapy for the first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). The Company and the FDA completed a recent Type C meeting and have agreed on the key elements of the &hellip; Continue reading &quot;Oncolytics Biotech\u00ae Aligns with FDA on Pivotal Study Design for Pelareorep in First-Line Pancreatic Cancer&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/oncolytics-biotech-aligns-with-fda-on-pivotal-study-design-for-pelareorep-in-first-line-pancreatic-cancer\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-11-19T14:30:41+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20251119471276r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/oncolytics-biotech-aligns-with-fda-on-pivotal-study-design-for-pelareorep-in-first-line-pancreatic-cancer\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/oncolytics-biotech-aligns-with-fda-on-pivotal-study-design-for-pelareorep-in-first-line-pancreatic-cancer\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Oncolytics Biotech\u00ae Aligns with FDA on Pivotal Study Design for Pelareorep in First-Line Pancreatic Cancer\",\"datePublished\":\"2025-11-19T14:30:41+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/oncolytics-biotech-aligns-with-fda-on-pivotal-study-design-for-pelareorep-in-first-line-pancreatic-cancer\\\/\"},\"wordCount\":980,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/oncolytics-biotech-aligns-with-fda-on-pivotal-study-design-for-pelareorep-in-first-line-pancreatic-cancer\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&amp;sty=20251119471276r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/oncolytics-biotech-aligns-with-fda-on-pivotal-study-design-for-pelareorep-in-first-line-pancreatic-cancer\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/oncolytics-biotech-aligns-with-fda-on-pivotal-study-design-for-pelareorep-in-first-line-pancreatic-cancer\\\/\",\"name\":\"Oncolytics Biotech\u00ae Aligns with FDA on Pivotal Study Design for Pelareorep in First-Line Pancreatic Cancer - 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(Nasdaq: ONCY) (\u201cOncolytics\u201d or the \u201cCompany\u201d), a clinical-stage immunotherapy company developing pelareorep, today announced alignment with the U.S. Food and Drug Administration (\u201cFDA\u201d) regarding the design of its pivotal study of pelareorep in combination with standard-of-care therapy for the first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). The Company and the FDA completed a recent Type C meeting and have agreed on the key elements of the &hellip; Continue reading \"Oncolytics Biotech\u00ae Aligns with FDA on Pivotal Study Design for Pelareorep in First-Line Pancreatic Cancer\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/oncolytics-biotech-aligns-with-fda-on-pivotal-study-design-for-pelareorep-in-first-line-pancreatic-cancer\/","og_site_name":"Market Newsdesk","article_published_time":"2025-11-19T14:30:41+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20251119471276r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/oncolytics-biotech-aligns-with-fda-on-pivotal-study-design-for-pelareorep-in-first-line-pancreatic-cancer\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/oncolytics-biotech-aligns-with-fda-on-pivotal-study-design-for-pelareorep-in-first-line-pancreatic-cancer\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Oncolytics Biotech\u00ae Aligns with FDA on Pivotal Study Design for Pelareorep in First-Line Pancreatic Cancer","datePublished":"2025-11-19T14:30:41+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/oncolytics-biotech-aligns-with-fda-on-pivotal-study-design-for-pelareorep-in-first-line-pancreatic-cancer\/"},"wordCount":980,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/oncolytics-biotech-aligns-with-fda-on-pivotal-study-design-for-pelareorep-in-first-line-pancreatic-cancer\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20251119471276r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/oncolytics-biotech-aligns-with-fda-on-pivotal-study-design-for-pelareorep-in-first-line-pancreatic-cancer\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/oncolytics-biotech-aligns-with-fda-on-pivotal-study-design-for-pelareorep-in-first-line-pancreatic-cancer\/","name":"Oncolytics Biotech\u00ae Aligns with FDA on Pivotal Study Design for Pelareorep in First-Line Pancreatic Cancer - 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