Advancing a Transformative Double-Stranded RNA Immunotherapy Platform for Gastrointestinal Tumors

We are developing pelareorep, a first-in-class double-stranded RNA (dsRNA) immunotherapeutic agent with Fast Track Designation for colorectal and pancreatic cancer, as a platform immunotherapy for the treatment of gastrointestinal (GI) tumors. We believe GI cancers are the largest unmet medical need in oncology and that pelareorep can extend survival while maintaining a favorable safety profile that has been demonstrated in over 1,300 patients.

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Pelareorep

An investigational first-in-class double-stranded RNA immunotherapeutic agent.
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Pipeline

The unique mechanism of action behind pelareorep positions it as a platform immunotherapy for a variety of GI tumor indications.

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Prevalence of mPDAC

mPDAC impacts 500,000 patients globally1, representing a $3 billion total addressable market with a 15% compound annual growth rate (CAGR) projected through 20322. Despite its devastating impact, mPDAC remains one of the most challenging malignancies to treat.

Current Treatments for mPDAC

The current treatment landscape for mPDAC is dominated by chemotherapy, with no approved immunotherapy options available. mPDAC carries a dismal 3% five-year survival rate3, highlighting the critical unmet need for novel therapeutic approaches. While chemotherapy regimens can provide some benefit, they often come with significant side effects and limited durability of response.

Pelareorep in mPDAC

Pelareorep has demonstrated a consistent survival benefit for people with first-line mPDAC in multiple clinical trials. Most recently, in Cohort 1 of GOBLET (13 patients), a Phase 1/2 trial evaluating pelareorep in multiple gastrointestinal cancers, treatment with pelareorep in combination with gemcitabine, nab-paclitaxel, and atezolizumab in first-line mPDAC led to a 45% 1-year survival and a 62% objective response rate, which is more than double the response rate seen in historical control trials4-6.

mPRAC Program Status

Pelareorep has been granted Fast Track Designation from the FDA for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma.

Prevalence of mCRC

Colorectal cancer affects 1.9 million patients worldwide7 and represents a $12.5 billion total addressable market with a 4.7% CAGR projected through 20338. As one of the fastest-growing cancers in people under 50 years old, colorectal cancer presents an escalating global health challenge.

mCRC Symptoms and Patient Population

Colorectal cancer patients experience a range of symptoms depending on tumor location and stage. The mCRC patient population faces particularly poor outcomes, with only a 13% five-year survival rate9. Within this population, patients with KRAS-mutant tumors represent a subset with especially high unmet medical need, as these tumors are often resistant to available targeted therapies.

Current Treatments for mCRC

While several treatment options exist for mCRC, including chemotherapy, targeted therapies, and immunotherapy for specific subsets of patients (such as those with microsatellite instability-high tumors), most colorectal cancer patients, particularly those with KRAS-mutant disease, have limited effective options. Current treatments often fall short of providing durable responses, and many patients eventually experience disease progression.

Pelareorep in mCRC
In REO 022, a clinical trial evaluating pelareorep in combination with FOLFIRI and bevacizumab in people with platinum refractory second-line KRAS-mutant mCRC, treatment with the pelareorep combo led to results that more than doubled historical third-party benchmarks10-11. Progression-free survival was observed to be 16.6 months in the pelareorep combo versus 5.7 months for the standard second-line treatment regimen11. Overall survival was 27 months in the pelareorep combo versus 11.2 months for the standard second-line treatment regimen11.

REO 022 also evaluated pelareorep in combination with standard-of-care therapy. Notably, 33% of KRAS-mutant microsatellite-stable (MSS) patients achieved an objective response, compared to the well-established historical objective response rate of approximately 6–11% for Avastin® (bevacizumab) plus FOLFIRI in second-line mCRC11,12.

In addition to the clinical activity, a separate translational analysis of paired tumor biopsies revealed that treatment with pelareorep led to a notable increase in KRAS-mutant–specific T-cell populations, indicating that pelareorep may directly enhance anti-tumor immune recognition in this genetically defined subgroup. These findings provide strong biological support for pursuing pelareorep as a precision immunotherapy capable of addressing a patient population that rarely benefits from checkpoint inhibitors or other immunotherapies.

More recently, in Cohort 3 of GOBLET, pelareorep combined with atezolizumab and TAS-102 met its predefined efficacy endpoint. The regimen achieved durable disease control and survival rates greater than historical benchmarks for 3L mCRC treated with TAS-102.

mCRC Program Status
The clinical and mechanistic data support advancing pelareorep into a controlled study in second-line KRAS-mutant MSS mCRC, which the company expects to initiate following consultation with key opinion leaders and regulatory authorities. The planned study is intended to confirm pelareorep’s potential to significantly outperform the current standard-of-care in a controlled setting and establish a new treatment paradigm for KRAS-mutant colorectal cancer.

Prevalence of SCAC

Anal cancer impacts ~54,000 patients globally13 and represents a $1.01 billion total addressable market with an 8.7% CAGR projected through 203214. While relatively rare compared to other gastrointestinal malignancies, anal cancer presents unique treatment challenges and a significant burden for affected patients.

Current Treatments for SCAC

The treatment landscape for anal cancer features an evolving standard of care with very few therapeutic options available to patients. mSCAC carries a 36% five-year survival rate15, and patients who progress after standard treatments face limited alternatives. Current therapies often involve combinations of chemotherapy and radiation, which have been associated with significant toxicity and quality-of-life impacts. The scarcity of effective treatment options, particularly in the metastatic setting, underscores the critical need for novel therapeutic approaches.

Pelareorep in SCAC

Pelareorep provides a promising new immunotherapy option in SCAC.

In Cohort 4 of GOBLET, four of 14 evaluable patients with 3L SCAC who received pelareorep and atezolizumab achieved objective responses, resulting in an objective response rate of approximately 29%. These responses included two complete responses and two partial responses. The median duration of response was approximately 17 months (67 weeks), indicating both depth and durability of clinical benefit in a heavily pretreated population.

In addition, 20 patients with 2L SCAC who received pelareorep in combination with atezolizumab achieved an objective response rate of 30%. This represents a nearly 2.5x improvement over the 13.8% objective response rate reported for the only FDA-approved immunotherapy for 2L SCAC. In addition, the median duration of response was 15.5 months for people treated with the pelareorep combo compared to 9.5 months for the current standard of care.

SCAC Program Status

If the objective response rate and duration of response observed in GOBLET Cohort 4 are reproduced in a planned registration study, Oncolytics believes the resulting dataset would be sufficient to support accelerated approval in this indication, consistent with regulatory precedent in rare cancers with no available therapies. After initial encouraging feedback from KOLS and the FDA, Oncolytics is planning to have a Type C meeting with the FDA in Q1 2026 to discuss and receive guidance on this development plan.

News

April 1, 2026
Oncolytics Biotech® Completes Domicile Change to the United States
March 19, 2026
Oncolytics Biotech® to Present New Mechanistic and Translational Data Supporting Pelareorep as an Immune-Priming Backbone at AACR 2026
March 2, 2026
Oncolytics Biotech® Launches Randomized Colorectal Cancer Study
View all news
    1. World Cancer Research Fund, Pancreatic Cancer Statistics, 2025
    2. Fortune Business Insights, Pancreatic Cancer Treatment Market Size, Share & Industry Analysis, By Type (Exocrine and Endocrine), By Treatment Type (Chemotherapy, Radiation Therapy, and Others), By End-user (Hospitals, Clinics, and Others), and Regional Forecast, 2024-2032, 2025
    3. American Cancer Society, Survival Rates for Pancreatic Cancer, 2025
    4. Von Hoff D et al. N Engl J Med 2013; 369:1691-1703 DOI: 10.1056/NEJMoa1304369
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