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Cancer research

Oncolytics Biotech Initiates Regulatory Discussions for Potential Pivotal Study in First-Line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

Strategic Insights

— 1 min read

Oncolytics Biotech Inc. has initiated regulatory discussions with the U.S. Food and Drug Administration (FDA) for a potential registration-enabled pivotal study in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). The Company expects to commence study start-up activities before the end of 2025, assuming discussions with the FDA go as expected. This milestone reflects Oncolytics' conviction in pelareorep's differentiated mechanism of action and its encouraging survival signal in one of the most lethal and underserved solid tumors.

Key Takeaways:

  • Oncolytics has initiated regulatory discussions with the FDA for a potential registration-enabled pivotal study in first-line mPDAC.
  • The Company expects to commence study start-up activities before the end of 2025, assuming discussions with the FDA go as expected.
  • The FDA interaction will focus on finalizing a clinical trial design that leverages pelareorep's demonstrated synergy with chemotherapy with or without checkpoint inhibition, and overall survival as the primary endpoint.
  • Oncolytics will consider proposing an adaptive study in collaboration with a third party.
  • The Company believes its recent Key Opinion Leader event reinforced the clinical promise of pelareorep in mPDAC and other gastrointestinal (GI) cancers.
  • Oncolytics has Fast Track and Orphan Drug designations in mPDAC and translational data supporting pelareorep's immunologic activity.
  • The upcoming regulatory discussions and planned trial initiation represent major catalysts for strategic collaboration and long-term value creation.
  • Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and early-phase studies in pancreatic and colorectal cancer.
  • Pelareorep induces anti-cancer immune responses by converting immunologically "cold" tumors "hot" through the activation of innate and adaptive immune responses.

Statistics:

  • 2025: Expected year for study start-up activities to commence, assuming discussions with the FDA go as expected.
  • 20-25%: Percentage of patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) who survive beyond 2 years (in comparison to 5-7% with current standard-of-care chemotherapy).
  • $100 million: Estimated spending required to advance pelareorep from $1 million to $100 million per month by the end of 2027.

Sources:

  • Oncolytics Biotech Inc. Press Release, July 29, 2025.
  • Securities and Exchange Commission (SEC) Form 8-K, July 29, 2025.
  • Oncolytics Biotech Inc. Corporate Presentation, June 2025.

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