Oncolytics Secures FDA Path for Pancreatic Cancer Immunotherapy

VANCOUVER, British Columbia – December 12, 2025 – In a significant development for one of oncology’s most formidable challenges, Oncolytics Biotech Inc. has secured alignment from the U.S. Food and Drug Administration (FDA) on the design of a pivotal Phase 3 trial for its lead candidate, pelareorep. The decision establishes a clear regulatory pathway for what is positioned to be the only immunotherapy registration study currently planned for first-line metastatic pancreatic cancer, a disease with historically poor outcomes and limited treatment advances.

This regulatory milestone follows a productive Type C meeting with the agency and places Oncolytics at the forefront of a new therapeutic wave targeting difficult-to-treat gastrointestinal (GI) cancers. As the broader immuno-oncology market is projected to swell to over US$400 billion by 2034, companies that can unlock durable responses in resistant tumors are drawing intense interest from both the medical and investment communities.

A Defined Regulatory and Clinical Strategy

The FDA's alignment provides critical validation for Oncolytics' clinical strategy. The forthcoming Phase 3 study will evaluate pelareorep in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC), a setting with a dire unmet medical need. The trial's sophisticated three-arm design is structured for a definitive outcome. It will compare the current standard-of-care chemotherapy (gemcitabine plus nab-paclitaxel) against two experimental arms: the same chemotherapy combined with pelareorep, and a triple combination of chemotherapy, pelareorep, and a checkpoint inhibitor.

With overall survival (OS) as the primary endpoint, the study is designed so that either of the pelareorep-containing arms can independently demonstrate success and support a registration filing. This built-in flexibility increases the probability of a positive outcome and de-risks the trial's path to completion.

"We now have regulatory clarity to allow us to start a pivotal study and ultimately the chance to bring the first approved immunotherapy treatment option to the pancreatic cancer treatment landscape," said Jared Kelly, CEO of Oncolytics Biotech, in a recent statement. "The data speaks for itself, but we want to sincerely thank the FDA for its great work in helping us clear this initial regulatory hurdle."

Further bolstering the program, pelareorep has already been granted both Fast Track and Orphan Drug designations by the FDA for pancreatic cancer. These designations are reserved for drugs addressing serious conditions with high unmet needs, providing benefits such as more frequent FDA meetings, eligibility for accelerated approval and priority review, and a period of market exclusivity upon approval.

The Science of Turning 'Cold' Tumors 'Hot'

Pancreatic cancer has long been notoriously resistant to immunotherapy. Its tumors are typically characterized as immunologically "cold," meaning they are adept at evading the body's immune system and lack the T-cell infiltration necessary for checkpoint inhibitors to be effective. Pelareorep, an intravenously delivered immuno-oncolytic virus, is engineered to overcome this fundamental challenge.

The drug's mechanism is twofold. First, as an oncolytic virus, it preferentially infects and destroys cancer cells, particularly those with an activated Ras pathway—a mutation common in pancreatic cancer. This direct lysis of tumor cells releases new viral particles to target adjacent cancer cells. More importantly, this process triggers a powerful inflammatory response within the tumor microenvironment. It effectively serves as an in-situ cancer vaccine, generating a cascade of immune-signaling molecules that recruit and activate the body's innate and adaptive immune systems. This process turns "cold" tumors "hot," making them visible and vulnerable to immune attack and, crucially, creating a synergistic effect with other immunotherapies like checkpoint inhibitors.

The scientific premise is backed by compelling clinical data. Pooled results from two prior studies in first-line metastatic pancreatic cancer showed that pelareorep more than doubled the two-year survival rate compared to historical benchmarks (21.9% vs. 9.2%). More recently, in a cohort of the GOBLET trial, the combination of pelareorep with chemotherapy and a checkpoint inhibitor yielded an impressive 62% objective response rate, a stark improvement over the ~23% rate typically seen with standard chemotherapy alone.

"The FDA's feedback confirms that our design is appropriate to support registration if successful," noted Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. The company's platform potential extends beyond the pancreas, with recent data in second-line anal cancer showing response rates more than double the current standard of care, further validating its utility across GI malignancies.

Navigating the Competitive Immuno-Oncology Landscape

Oncolytics' progress comes amid a flurry of activity in the GI oncology space. Agenus recently secured reimbursed compassionate access in France for its combination therapy in refractory colorectal cancer, while Cardiff Oncology reported encouraging Phase 2 data for its candidate, onvansertib, in first-line RAS-mutated metastatic colorectal cancer. Meanwhile, industry giants like Exelixis and Gilead Sciences are advancing their own oncology pipelines, with Exelixis reporting strong revenues from its cabozantinib franchise and Gilead highlighting growth in its oncology portfolio led by Trodelvy.

While these developments underscore the fierce competition and immense opportunity within the broader immuno-oncology field, Oncolytics has carved out a distinct and valuable niche. By focusing on the high-need, immunotherapy-resistant indication of first-line pancreatic cancer, it has positioned itself to launch what it believes will be the only registration trial of its kind. This strategic focus mitigates direct competition and maximizes the potential impact of a successful trial.

The company's leadership team, including CEO Jared Kelly and Chief Business Officer Andrew Aromando, brings a track record of significant value creation, having played key roles in Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson. This experience in navigating assets through development to major strategic transactions provides a layer of confidence as Oncolytics moves toward its most critical clinical milestone. With the recent formation of a Gastrointestinal Scientific Advisory Board to guide pelareorep's expansion into other indications, the company is signaling a long-term vision. As it finalizes the protocol and begins site selection for the pivotal trial, Oncolytics stands at a crucial inflection point, transitioning from a company of clinical promise to one on a clear path toward regulatory and commercial reality.