CALGARY, Alberta, November 4, 2025 — Oncolytics Biotech® Inc. (NASDAQ: ONCY; TSX: ONC) announced the formation of a Gastrointestinal (GI) Tumor Scientific Advisory Board (SAB) to advance the development of pelareorep, its investigational oncolytic immunotherapy. This new advisory body unites leading oncologists and immunotherapy researchers to guide clinical strategy and accelerate translational progress for pelareorep as a platform immunotherapy across multiple gastrointestinal tumor types.
Science Significance
At the core of this announcement lies pelareorep, an intravenously delivered oncolytic virus engineered to infect and destroy tumor cells while activating systemic anti-tumor immunity. Its dual mechanism—direct tumor lysis and immune priming—makes it a promising platform therapy capable of synergizing with immune checkpoint inhibitors and chemotherapy. The establishment of a specialized GI Scientific Advisory Board allows Oncolytics to refine clinical hypotheses, explore tumor microenvironment dynamics, and identify biomarker-driven indications. This scientific collaboration could unlock new mechanistic insights into how viral immunotherapies reshape immune surveillance in colorectal, gastric, and pancreatic cancers.
Regulatory Significance
By assembling a board of experts from leading academic cancer centers, Oncolytics Biotech is strengthening its regulatory readiness for upcoming Phase 2 and Phase 3 studies of pelareorep. Guidance from the GI SAB will help ensure that trial endpoints, patient selection criteria, and safety parameters meet the evolving expectations of global regulatory bodies such as the FDA, EMA, and Health Canada. Moreover, integrating scientific advisory oversight demonstrates proactive adherence to Good Clinical Practice (GCP) standards and enhances the credibility of regulatory submissions that support pelareorep’s potential approval as an innovative biological therapy.
Business Significance
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The new GI advisory board reflects Oncolytics Biotech’s strategy to position pelareorep as a platform asset capable of generating multiple oncology partnerships and indications. By targeting a spectrum of gastrointestinal malignancies, the company broadens its market potential and strengthens investor confidence in its clinical pipeline. The initiative also supports future collaborations with pharmaceutical companies developing immuno-oncology agents, potentially opening doors to co-development agreements and licensing opportunities. As Oncolytics continues to expand its clinical footprint, this move consolidates its business foundation in the high-value immuno-oncology space.
Patients’ Significance
For patients facing GI cancers—which remain among the most difficult to treat—pelareorep offers hope for immune-based therapy options that go beyond traditional chemotherapy. Early clinical data suggest durable responses and manageable safety profiles, particularly in combination with checkpoint inhibitors. The GI SAB’s expertise in clinical design aims to accelerate access to next-generation viral immunotherapies that harness the body’s immune system against tumors. This represents a step toward personalized, less toxic, and more effective cancer care for patients who urgently need better options.
Policy Significance
The establishment of the GI Tumor SAB aligns with global oncology policy goals encouraging collaborative research between biotech innovators and academic experts. It supports the broader healthcare agenda of promoting immuno-oncology innovation and developing cost-effective biologics that can improve cancer survival outcomes. Furthermore, this initiative resonates with regulatory modernization efforts that prioritize scientific rigor, ethical governance, and translational efficiency in cancer trials. The SAB model serves as a blueprint for future biotech-academic partnerships that enhance both clinical quality and public health impact.
The launch of the Gastrointestinal Tumor Scientific Advisory Board underscores Oncolytics Biotech’s scientific depth and strategic vision in advancing pelareorep as a transformative immunotherapy platform. By bridging world-class expertise in oncology, regulatory science, and patient advocacy, the company reinforces its leadership in biologic-based cancer innovation. As pelareorep progresses through its clinical journey, this new board will play a central role in shaping its path toward global approval and real-world patient benefit.
Source: Oncolytics Biotech® Inc. press release
