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Noticias de ONCY
Eventos de ONCY
Oncolytics Biotech Releases New Data on Pelareorep Showing Significant Efficacy in Anal Squamous Cell Carcinoma Patients
Oncolytics Biotech announced new translational data from an ongoing study showing pelareorep's ability to increase human papillomavirus-16-specific T cell clones and tumor-infiltrating lymphocyte clones in second-line or later squamous cell anal cancer patients at the Society for Immunotherapy of Cancer 2026 Annual Meeting. Pelareorep combined with a checkpoint inhibitor generated promising efficacy signals in second-line or later SCAC, including more than doubling the objective response rate and increasing median duration of response by 50% compared to the current approved therapy in that patient population. Multiple analyses help explain how pelareorep generates innate and adaptive immune responses and synergizes with other therapies. Highlights from the SITC abstract include: In seven of eight evaluable patients, greater than two-fold increases in levels of the immune-activation biomarkers CXCL10, IFN-gamma, and soluble PD-L1 were observed after one cycle of therapy. After three cycles of treatment, all four evaluable patients saw expansion of TIL clones in peripheral blood, which was associated with reductions in tumor size, including two complete responses and two partial responses. The four responding patients with TIL expansion also demonstrated significant expansion of at least one HPV-16-specific T cell clone. Among 14 patients evaluated for HPV-16-specific immune responses, six showed HPV-16 clonal expansion, and four of those patients experienced tumor shrinkage. The Phase 1/2, Simon 2-stage study is assessing the safety and efficacy of pelareorep in combination with a checkpoint inhibitor in second-line or later unresectable SCAC patients. "These data reinforce pelareorep's potential in multiple HPV-driven cancers as those tumor types generally exhibit low response rates to checkpoint inhibitors," said Thomas Heineman, CMO. "Pelareorep's ability to increase tumor-infiltrating lymphocyte populations and expand HPV-specific T cells form the basis for its synergy with checkpoint inhibitors and reinforces the potential of this combination to combat tumor growth in HPV-associated cancers. More broadly, these data support our belief in pelareorep as a backbone immunotherapy capable of activating anti-tumor immunity and improving responses to multiple therapies across a wide range of tumor types."
Oncolytics Biotech Updates GOBLET Study Data
Oncolytics Biotech announced updated data from Cohort 4 of its Phase 1/2 GOBLET study evaluating pelareorep in combination with atezolizumab in patients with second-line or later squamous cell anal cancer. Although median overall survival has not yet been reached, the median duration of response is approximately 15 months, which compares favorably with historical results of 9.5 months for U.S. Food and Drug Administration-approved retifanlimab monotherapy in a similar patient population. Notably, all patients who responded to treatment survived beyond 12 months, including multiple patients surviving over 24 months. These results provide encouraging evidence that pelareorep enhanced the clinical benefit of checkpoint inhibition in advanced SCAC, a disease in which more than 90% of cases are associated with human papillomavirus. Following recent FDA interactions and receipt of Fast Track Designation, Oncolytics plans to explore additional clinical studies with a potential checkpoint inhibitor partner to support registrational development in SCAC. The Company believes that durable clinical responses may support an accelerated approval pathway, while overall survival could provide evidence of clinical benefit supporting full approval, subject to FDA agreement. The Company also sees potential to expand into HPV-associated head and neck squamous cell carcinoma. HPV accounts for approximately 70% of oropharyngeal cancers in the United States, representing a substantial patient population where checkpoint inhibitors are already established therapies. Pelareorep has previously demonstrated signals of antitumor activity in head and neck cancer studies, although it has not yet been evaluated in combination with a checkpoint inhibitor in this disease. Oncolytics may explore initiating such a combination study in the near term as part of its broader HPV-driven cancer strategy.
Oncolytics Biotech Presents REO 033 Study Progress at ESMO 2026
Oncolytics Biotech is presenting a trial-in-progress abstract and e-poster discussing the REO 033 study at the European Society for Medical Oncology Congress 2026. REO 033 is a randomized study evaluating pelareorep in combination with folinic acid, fluorouracil, and irinotecan and bevacizumab versus standard-of-care FOLFIRI and bevacizumab as second-line treatment for RAS-mutant, microsatellite-stable metastatic colorectal cancer patients. The study is designed to validate the encouraging efficacy signals observed in REO 022 while generating the controlled clinical data necessary to support future regulatory interactions and potential registration. Highlights from the REO 033 trial-in-progress abstract include: The randomized, controlled, open-label study will evaluate patients with RAS-mutated, MSS mCRC who have progressed on first-line oxaliplatin-based therapy. Thirty patients per arm will be randomized to receive either: pelareorep + FOLFIRI + bevacizumab, or FOLFIRI + bevacizumab. The primary endpoint is objective response rate. Secondary endpoints include other efficacy assessments, such as overall survival, progression-free survival, disease control rate, duration of response, and safety and tolerability. Blood and tumor samples are being collected for biomarker evaluations. Recent U.S. Food and Drug Administration interactions have provided the opportunity to initiate a pivotal expansion of the REO 033 study that would build upon the trial currently enrolling and could support an accelerated approval submission based on ORR and a full approval based on PFS. A previous study, REO 022, evaluated second-line KRAS-mutant, MSS mCRC patients with treatment histories similar to those of patients enrolled in the current study. In that study, the ORR, median PFS, median OS, and median DOR were more than doubled in patients treated with pelareorep + FOLFIRI/bevacizumab compared to historical outcomes for patients treated with FOLFIRI and bevacizumab alone.
Oncolytics Biotech Publishes Liver Cancer Immunotherapy Study Data
Oncolytics Biotech announced data published in the Proceedings of the National Academy of Sciences show pelareorep's ability to change an immunologically inactive liver cancer tumor microenvironment into one that is immunologically active and potentially susceptible to immune-based therapy. The academic paper titled "MicroRNA-driven regulation of immunosuppressive microenvironment in hepatocellular carcinoma" was published in Proceedings of the National Academy of Sciences on September 28. Pelareorep is an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes. "This publication provides additional evidence that pelareorep alters the tumor microenvironment in traditionally challenging indications," said Thomas Heineman, CMO. "The ability to enable chemotherapy, checkpoint inhibitors, RAS inhibitors, and other treatments to be viable in cancers that have previously been untreatable is helping to drive our business development conversations. While liver cancer is not an indication we intend to pursue at this time, the data align with our narrative that pelareorep works in challenging tumor types and can be considered a backbone immunotherapy that can improve the activity of many cancer treatments, while maintaining a favorable safety profile." Hepatocellular carcinoma tends to have low levels of CD8+ T cell infiltration and Inducible T cell Costimulatory Ligand in addition to high levels of Transforming Growth Factor Beta / Suppressor of Cytokine Signaling 1 / Yes-associated protein 1, which are signs of a significantly immunosuppressive tumor microenvironment. Preclinical data presented in this publication show that infection with pelareorep reversed several of these effects, including dramatic increases in PD-L1 expression, ICOSL levels on tumor cells, and CD8+ T cell density. These changes imply the tumor microenvironment shifted from immunologically inactive or "cold" to "hot" or immunologically active, enabling immune-mediated lysis of tumor cells. This cascade of immune responses creates an environment in which checkpoint inhibitors and other therapies can be effective. Pelareorep has previously shown the ability to initiate coordinated changes in the tumor microenvironment, including the formation of tertiary lymphoid structures, that are associated with improved responses to immunotherapy. In this paper, there is a noted increase in CD8+ T cells, PD-1/PD-L1 upregulation, and Inducible T cell Co-stimulator-ICOSL signaling. These are all necessary conditions for immunotherapies like checkpoint inhibitors to work in liver cancer, which is an especially challenging tumor type.
Oncolytics Biotech Advances REO 033 Clinical Study
Oncolytics Biotech announced continued clinical and operational progress in REO 033, its randomized study evaluating pelareorep in second-line RAS-mutant, microsatellite-stable metastatic colorectal cancer. Nearly all planned clinical sites for Part A of REO 033 have now been activated, and multiple patients are currently enrolled. With the site activation process largely complete, the Company is focused on accelerating enrollment and generating randomized clinical data evaluating the contribution of pelareorep to the current standard-of-care regimen. REO 033 is a randomized controlled study evaluating pelareorep in combination with folinic acid, fluorouracil and irinotecan and bevacizumab versus FOLFIRI and bevacizumab in patients with second-line RAS-mutant MSS mCRC. Part A is expected to enroll approximately 60 patients randomized between the two treatment arms, with objective response rate as the primary endpoint, and progression-free survival, overall survival, safety, and biomarker analyses among the additional endpoints.
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