Pelareorep

Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Feb. 24, 2026 /PRNewswire/ -- USA News Group News Commentary, The global oncology market is on track to nearly triple in value over the next decade, growing from $279.98 billion in 2026 to an estimated $748.17 billion by 2035[1]. Cancer drug revenues alone are projected to reach $335.2 billion by 2033, driven by a surge in targeted therapies and immunotherapy adoption[2]. Five companies advancing novel approaches in the oncology sector include Oncolytics Biotech (NASDAQ: ONCY), Exelixis (NASDAQ: EXEL), Eli Lilly (NYSE: LLY), Merck (NYSE: MRK), and Gilead Sciences (NASDAQ: GILD). The immunotherapy drugs market is experiencing significant growth as rising cancer prevalence accelerates demand for targeted treatments and combination therapies[3]. The immuno-oncology segment specifically is forecast to expand from $65.22 billion in 2025 to $170.19 billion by 2032, representing a compound annual growth rate of 14.9%[4]. Oncolytics Biotech Inc. (NASDAQ: ONCY) recently announced its decision to focus on registrational programs in anal and colorectal cancer, concluding enrollment in the GOBLET gastrointestinal study after generating sufficient clinical and translational data to chart a clear path toward FDA approval. The promising efficacy signal in GOBLET Cohort 4 has defined a clear registrational path for pelareorep in second-line and later squamous cell anal cancer, a setting where available therapies offer only limited benefit to patients. Oncolytics expects to meet with the FDA in mid-April to align on study design, and believes a clinical trial of well under 100 subjects will be sufficient to secure approval in this rare cancer indication. With sufficient cash on hand to execute near-term milestones, the company expects to avoid immediate material dilution, redirecting capital from the GOBLET cohorts toward its highest-conviction registration programs. "GOBLET has done its job successfully. We now know where pelareorep can make the greatest impact for patients and where we can pursue approval most efficiently," said Jared Kelly, CEO of Oncolytics Biotech. "Our disciplined strategy is to run registrational or registration-enabling studies with ruthless efficiency that can create maximum shareholder value without unnecessary dilution." The registration push builds on pelareorep's recent Fast Track Designation from the FDA for second-line KRAS-mutant microsatellite-stable (MSS) metastatic colorectal cancer. Clinical data showed pelareorep combined with standard chemotherapy and Avastin® achieved a 33% response rate versus roughly 10% with chemotherapy and Avastin®, while median overall survival reached 27 months versus 11.2 months with standard treatment. KRAS-mutant MSS colorectal cancer represents one of the hardest-to-treat populations, with limited options after first-line treatment fails. The global market for second-line treatment in this patient group runs between $3 billion and $5 billion annually. The company plans to launch a controlled study with the first clinical site activating in March and interim data expected by year-end 2026. Pelareorep is also delivering strong results in anal cancer, where third-line patients achieved a 29% response rate with the median duration of response lasting around 17 months in a setting with no FDA-approved treatments. In second-line or later patients, the 30% response rate more than doubled the benchmark for the FDA-approved immunotherapy. The company continues strengthening its leadership, having recently appointed John McAdory as EVP of Strategy and Operations and Yujun Wu as Head of Biostatistics. Kelly and Chief Business Officer Andrew Aromando both joined from Ambrx Biopharma, which sold to Johnson & Johnson for $2 billion in 2024. CONTINUED… Read this and more news for Oncolytics Biotech at: In other industry developments: Exelixis (NASDAQ: EXEL) reported strong results for fiscal year 2025, with U.S. net product revenues from its cabozantinib franchise reaching $2.1 billion. The FDA accepted the company's New Drug Application for zanzalintinib in combination with atezolizumab for previously treated metastatic colorectal cancer. "The team is highly motivated to build a second Exelixis oncology franchise with zanzalintinib and is working diligently to advance a first potential indication in metastatic colorectal cancer, following the recent acceptance of our New Drug Application by U.S. regulatory authorities," said Michael M. Morrissey, Ph.D., President and CEO of Exelixis. The company has a target FDA action date of December 2026 for zanzalintinib, which could establish a second major oncology franchise. Eli Lilly (NYSE: LLY) announced positive results from its Phase 3 LIBRETTO-432 trial, showing that Retevmo delivered a highly statistically significant improvement in event-free survival as adjuvant therapy in early-stage RET fusion-positive non-small cell lung cancer. The trial is the first randomized Phase 3 study to evaluate a selective RET kinase inhibitor in this population. "We have consistently observed that cancer medicines can deliver their greatest impact when administered early in the course of a patient's treatment journey," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. The company plans to present detailed results at an upcoming medical congress and discuss findings with global health authorities. Merck (NYSE: MRK) received FDA approval for KEYTRUDA and its subcutaneous formulation KEYTRUDA QLEX plus paclitaxel for adults with PD-L1-positive platinum-resistant ovarian cancer. KEYTRUDA is the first PD-1 inhibitor approved for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. "For many patients with ovarian cancer, the disease can become platinum-resistant, at which point recurrence is not just a setback, it's when options can become limited, and the reality patients face can change very quickly," said Dr. Bradley Monk, gynecologic oncologist at Florida Cancer Specialists and Research Institute. The KEYNOTE-B96 trial demonstrated a 28% reduction in the risk of disease progression or death and a 24% reduction in the risk of death compared to placebo. Gilead Sciences (NASDAQ: GILD) received an updated label for its Kite subsidiary's Yescarta CAR T-cell therapy, with the FDA removing previous limitations of use in relapsed or refractory primary central nervous system lymphoma. Yescarta is now the only CAR T-cell therapy approved for large B-cell lymphoma with this designation. "This update to the axi-cel prescribing information provides clinicians with important evidence for patients who have historically had very limited treatment options," said Lakshmi Nayak, MD, Director of the Center for CNS Lymphoma at Dana-Farber Cancer Institute. Article Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. 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Company to wind down the GOBLET gastrointestinal study to focus on registration path in the U.S. With sufficient cash on hand to execute near-term milestones, the Company expects to avoid immediate material dilution SAN DIEGO, Feb. 24, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech ® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced that it has concluded enrollment in the GOBLET study, having generated the necessary clinical and translational data to inform its next phase of development. With sufficient cash on hand to execute near-term milestones, the Company will now focus its efforts and resources on registrational and registration-enabling studies in squamous cell anal cancer (“SCAC”) and metastatic colorectal cancer (“CRC”). “GOBLET has done its job successfully. We now know where pelareorep can make the greatest impact for patients and where we can pursue approval most efficiently,” said Jared Kelly, Chief Executive Officer of Oncolytics. “Our disciplined strategy is to run registrational or registration-enabling studies with ruthless efficiency that can create maximum shareholder value without unnecessary dilution.” The promising efficacy signal observed in GOBLET Cohort 4 has defined a clear registrational path for pelareorep-based therapy in second-line and later SCAC, a setting in which available therapies offer only limited benefit. The Company is planning to move quickly to pursue regulatory approval through a U.S.-based study to ensure the enrollment of patients representative of the current standard of care. Oncolytics expects to meet with the U.S. Food and Drug Administration (“FDA”) in mid-April. The objective of this meeting is to align on the design of a single-arm SCAC registrational study. Based on the observed efficacy signal in GOBLET Cohort 4, the Company believes a clinical trial of well under 100 subjects will be sufficient to secure FDA approval in this rare cancer indication. Given its strategic focus on SCAC and CRC, and the desire to deploy capital efficiently, Oncolytics has elected to stop further enrollment in the GOBLET Cohort 5 metastatic pancreatic ductal adenocarcinoma (“PDAC”) cohorts at approximately 20 patients per arm. The Company believes the available data are sufficient to inform its future PDAC strategy while limiting additional spend on this indication at this time. Current enrollment in GOBLET Cohort 5 allows responses to therapy, including overall survival, to be analyzed. The Company will continue to follow Cohort 5 patients currently on study, monitor their responses, and plan to report results once the data reach maturity. “The GOBLET study has provided invaluable insights into the efficacy and safety of pelareorep in gastrointestinal cancers,” said Thomas Heineman, MD, Chief Medical Officer of Oncolytics. “These data have provided crucial support for our platform approach in GI cancers. They have, in fact, allowed us to identify a clear and efficient path forward as we move into registration-focused development of pelareorep in GI cancers.” About GOBLET The GOBLET ( G astrointestinal tum O rs exploring the treatment com B inations with the oncolytic reovirus pe L ar E orep and an T i-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups: Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1 st line advanced/metastatic pancreatic cancer patients; Pelareorep in combination with atezolizumab in 1 st line MSI (microsatellite instability)-high metastatic colorectal cancer patients; Pelareorep in combination with atezolizumab and TAS-102 in 3 rd line metastatic colorectal cancer patients Pelareorep in combination with atezolizumab in 2 nd line advanced and unresectable anal cancer patients; and Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients. About AIO AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally. About Oncolytics Biotech Inc. Oncolytics 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 “cold” tumors “hot” through the activation of innate and adaptive immune responses. The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal and pancreatic cancer. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: or follow the Company on social media on LinkedIn and on X @ oncolytics . Forward-looking statements 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 “forward-looking statements”). 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; the anticipated design, size, protocols strategy, priorities, timelines, milestones, and outcomes of current and future studies; the Company’s expectations regarding its cash position, liquidity, and funding requirements; the Company’s goals, strategies, and objectives; anticipated timelines and objectives for future meetings with regulatory bodies, including the FDA; and its belief in the clinical promise of pelareorep in anal, colorectal 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’ 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. Company Contact Jon Patton Director of IR & Communication jpatton@oncolytics.ca Investor Relations for Oncolytics Mike Moyer LifeSci Advisors +1-617-308-4306 mmoyer@lifesciadvisors.com Media Contact for Oncolytics Owen Blaschak LifeSci Communications oblaschak@lifescicomms.com