Oncolytics Biotech Inc（ONCY）资讯与事件ONCYOncolytics Biotech Inc

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.