USA News Group News Commentary
Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER, BC, Feb. 19, 2025 /PRNewswire/ — USA News Group News Commentary – Amid the excitement surrounding Project Stargate—the $500 billion investment aimed at revolutionizing AI-driven data centers—concerns over the rising global cancer rates, particularly among younger populations, remain pressing. Lifestyle factors are increasingly under scrutiny, with the World Health Organization (WHO) now advocating for cancer warning labels on alcohol products. Despite these alarming trends, several biotech companies have already made notable strides in 2025, with recent advancements coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), GRAIL, Inc. (NASDAQ: GRAL), Quest Diagnostics Incorporated (NYSE: DGX), Renovaro Inc. (NASDAQ: RENB), and Predictive Oncology Inc. (NASDAQ: POAI).
The article continued: The Center for Innovation and Translation of Point of Care Technologies for Equitable Cancer Care (CITEC) has launched a global initiative focused on accelerating next-generation cancer detection technologies. With demand for advanced oncology solutions increasing, industry projections suggest significant market expansion, as DelveInsight Business Research forecasts a 9.12% compound annual growth rate (CAGR)—pushing the global cancer therapy market to an estimated $285.96 billion by 2030.
Oncolytics Biotech® Strengthens Its Pipeline in 2025 with Key Pancreatic and Anal Cancer Advances in Addition to Metastatic Breast Cancer
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage company focused on immunotherapy for cancer, continues to make good progress in 2025 with key regulatory and clinical advancements, reinforcing pelareorep’s potential in hard-to-treat cancers. Oncolytics was pleased to highlight two significant developments for its immunotherapy, pelareorep: the safety and regulatory clearance to advance enrollment in its pancreatic cancer study and the recent presentation of new efficacy and safety data at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in late January.
“We’re hitting critical milestones that validate our progress and set the stage for what we believe will be an exciting year,” said Wayne Pisano, Interim CEO and Chair of Oncolytics’ Board of Directors. “With positive feedback from regulators in place, we’re advancing our pancreatic cancer study toward full enrollment, and our ASCO GI presentations highlighted pelareorep’s strong safety and efficacy results in two hard-to-treat cancers. We remain focused on bringing new treatment options to patients while creating value for shareholders as we move forward in 2025.”
Germany’s Paul-Ehrlich-Institute (PEI) has granted Oncolytics Biotech approval to proceed with full enrollment in its pancreatic cancer trial (GOBLET Cohort 5) following a successful safety review. This milestone allows the study to advance as planned, with 30 patients set to participate in Stage 1 across two treatment arms evaluating pelareorep in combination with modified FOLFIRINOX, with or without atezolizumab. With the safety run-in complete, Oncolytics will continue gathering safety data, with an initial efficacy readout expected later this year. This progress reinforces pelareorep’s potential in one of the most aggressive and challenging-to-treat cancers, bringing the company one step closer to expanding its clinical impact in gastrointestinal oncology.
At ASCO GI 2025, Oncolytics Biotech presented new clinical data reinforcing pelareorep’s potential in two difficult-to-treat cancers: anal and pancreatic cancer. In anal cancer, patients receiving pelareorep + atezolizumab continue to show stronger-than-expected responses, outperforming results seen in published studies using checkpoint inhibitors alone. In pancreatic cancer, pelareorep has previously demonstrated a strong efficacy signal in combination with gemcitabine, nab-paclitaxel, and atezolizumab. The latest findings confirm a favorable safety profile when using pelareorep with a different chemotherapy regimen (modified FOLFIRINOX), with and without atezolizumab, potentially broadening its clinical applications. These results further de-risk pelareorep’s development and could support the advancement into larger, registration-enabling trials, bringing the therapy closer to addressing major unmet needs in gastrointestinal oncology.
As Oncolytics moves into a pivotal year, multiple high-impact milestones are set to shape the company’s progress. Upcoming data readouts from ongoing gastrointestinal cancer trials will provide further insights, including translational results that help characterize pelareorep’s mechanism of action. Additionally, regulatory interactions throughout the year could play a crucial role in accelerating future trials, bringing pelareorep closer to potential registration-enabling studies in both breast and gastrointestinal cancers. These milestones position Oncolytics for continued momentum as it advances its clinical pipeline toward broader patient impact.
“We’re seeing clinical validation across multiple studies,” added Pisano. “With encouraging regulatory interactions in hand and data readouts ahead, 2025 is shaping up to be an exciting year for Oncolytics and our investors. As we have shown in GOBLET, BRACELET-1, and numerous previous studies, pelareorep has a favorable safety profile and efficacy signals across multiple indications with a high unmet need. We are excited about the potential for moving to a registration-enabling study in breast cancer and advancing our clinical program in gastrointestinal cancers.”
CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
In other recent industry developments and happenings in the market include:
GRAIL, Inc. (NASDAQ: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, and Quest Diagnostics Incorporated (NYSE: DGX), a leading provider of diagnostic information services, recently announced the initial phase of a program to improve provider access to GRAIL’s Galleri® multi-cancer early detection (MCED) test.
Providers can now order the Galleri test directly from GRAIL through the Quest Diagnostics connectivity system. The Quest Diagnostics connectivity system enables providers in the United States to order and receive reports of laboratory tests electronically through Quest’s Quanum laboratory portal and more than 900 electronic health record (EHR) systems. More than 500,000 providers used the Quest connectivity system last year.
“Quest Diagnostics and GRAIL share a commitment to improving access to cancer screening and have worked productively together to enable patient access to GRAIL’s Galleri test via Quest’s phlebotomy network since 2021,” said Mark Gardner, Senior Vice President, Molecular Genomics and Oncology for Quest Diagnostics. “Integrating GRAIL’s Galleri test into the Quest connectivity system is the next step in this collaboration. We expect it to increase patient access by giving Quest’s provider clients the ability to seamlessly order the test through Quest, same as they do for other blood work. This collaboration brings to life the tremendous value of Quest’s ability to scale diagnostic innovation to make it accessible for all.”
Renovaro Inc. (NASDAQ: RENB), a pioneer in cancer diagnostics and therapeutics powered by artificial intelligence, recently announced it entered into a binding LOI to acquire Predictive Oncology Inc. (NASDAQ: POAI) in an all-stock transaction.
By leveraging Predictive Oncology’s extensive biobank of 150,000 tumor samples, Renovaro gains a critical resource to accelerate biomarker discovery, optimize clinical trials, and enhance decision-support tools across multiple cancer types. The combined organization will operate a state-of-the-art, CLIA, NYSDOH, and CA-certified laboratory staffed by an experienced team, streamlining diagnostic test development and validation while expanding market reach in Europe. Additionally, Renovaro introduces a novel in vivo chemosensitivity and resistance assay, improving cancer treatment predictions for European patients and enabling multi-omic collaborations for drug discovery.
“We recognize that by integrating Predictive Oncology’s AI-driven drug discovery platform and vast biobank of more than 150,000 patient tumor samples, 200,000 pathology slides and decades of longitudinal drug response data with Renovaro’s multi-disciplinary artificial intelligence, multi-omics and multi-modal data expertise, we are opening to door to diagnostic, therapeutic and drug discovery possibilities that we otherwise would never have considered,” said Raymond Vennare, CEO of Predictive Oncology.
In the long term, this partnership lays the foundation for a global point-of-care cancer solution, integrating Predictive Oncology’s AI-driven small molecule solid tumor expertise with Renovaro’s AI-powered liquid biopsy and cancer vaccine programs. This first-in-class, full-stack clinical service has the potential to advance cancer therapy at every stage—from early detection and diagnostics to personalized treatment and biomarker discovery—ultimately improving patient outcomes and reducing costs.
“Renovaro is on a quest to offer cancer patients early diagnostic options, treatment protocols, and recurrence monitoring,” said David Weinstein, CEO of Renovaro. “Predictive Oncology will enhance our capabilities by assisting oncologists with patient specific diagnostic and therapeutic clinical support data. Predictive Oncology’s proprietary AI/ML platform has been proven to predict tumor-drug response with 92% accuracy which, I believe, will allow us to launch as a decision support platform for medical oncologists in 2025. As importantly, there are strong synergies with Predictive’s small molecule solid tumor drug-tumor response modeling capabilities and Renovaro’s liquid biopsy approach to early cancer detection and monitoring.”
Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
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