SAN DIEGO, May 22, 2026
Oncolytics Biotech® announced new translational data from its GOBLET and AWARE-1 studies showing that pelareorep generated strong innate and adaptive anti-tumor immune responses across gastrointestinal and breast cancer models, further supporting the investigational immunotherapy’s potential in difficult-to-treat cancers. The findings, which will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrated expansion of KRAS-specific tumor-reactive T cells, activation of antiviral immune signaling pathways, and increased tumor-infiltrating lymphocyte activity associated with tumor regression in pancreatic cancer. The company believes the new data strengthen pelareorep’s position as a promising immunotherapy capable of converting immunologically “cold” tumors into more responsive “hot” tumors.
Pelareorep Expands KRAS-Specific Tumor-Fighting Immune Cells
According to Oncolytics, translational analyses from the Phase 1/2 GOBLET trial in advanced pancreatic cancer demonstrated that pelareorep activates a multi-step immune response involving both antiviral and tumor-specific immune mechanisms. Researchers observed significant expansion of antiviral T cells following treatment, along with clonal expansion of pre-existing tumor-reactive T cells in patient blood samples after one cycle of therapy.
Importantly, the expansion of tumor-infiltrating lymphocyte (TIL) clones correlated with reductions in tumor volume in pancreatic cancer patients. Advanced T-cell receptor sequencing confirmed the expansion of mutant KRAS-specific T-cell clones, providing evidence that pelareorep may enhance immune recognition and targeting of KRAS-driven tumors. KRAS-mutant cancers remain among the most resistant tumor types to current immunotherapy strategies, making the findings particularly significant for future gastrointestinal cancer treatment approaches.
The company stated that pelareorep works by stimulating antiviral immune pathways through double-stranded RNA signaling, triggering inflammatory cytokine production and immune activation inside tumors. Researchers believe this mechanism helps amplify existing anti-tumor immune responses rather than introducing entirely new antigens, potentially improving immune-mediated tumor control.
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Breast Cancer Data Show Tertiary Lymphoid Structure Formation
Additional translational data from the AWARE-1 breast cancer study demonstrated significant increases in antiviral and immune gene expression following pelareorep treatment. Serial tumor biopsies showed activation of Toll-like receptor 3 (TLR3) signaling pathways alongside increased expression of CXCL13, a chemokine associated with formation of tertiary lymphoid structures (TLS) within tumors.
Oncolytics reported that imaging mass cytometry further confirmed evidence of tertiary lymphoid structure development in treated breast cancer tissue. Across both GOBLET and AWARE-1 studies, investigators observed expansion of tumor-infiltrating lymphocytes in both tumor tissue and blood samples, supporting pelareorep’s ability to enhance immune cell recruitment and anti-tumor immune surveillance.
The company believes these findings provide important mechanistic insight into how pelareorep may synergize with checkpoint inhibitors and chemotherapy combinations across multiple solid tumor settings.
ASCO 2026 Data Support Broader GI Cancer Development Strategy
The featured ASCO presentation titled “Influence of pelareorep on mutant KRAS-specific blood TIL clonal expansion” will be presented on May 30, 2026. Oncolytics said the translational data help bridge mechanistic immune activation findings with observed clinical efficacy, strengthening confidence in the company’s ongoing gastrointestinal cancer development strategy.
The ongoing GOBLET study is evaluating pelareorep in combination with Tecentriq® (atezolizumab), chemotherapy, and other standard therapies across multiple gastrointestinal tumor indications, including metastatic pancreatic cancer, colorectal cancer, and anal cancer. Pelareorep has already received FDA Fast Track designation for pancreatic and colorectal cancer development programs.
Oncolytics continues advancing pelareorep as a systemically delivered immunotherapeutic designed to stimulate anti-cancer immune responses by activating both innate and adaptive immunity. The company believes the growing body of translational evidence may support future combination immunotherapy strategies for highly resistant KRAS-driven tumors and other difficult-to-treat cancers.
Source: Oncolytics Biotech press release
