Oncolytics Biotech® to Present New Mechanistic and Translational Data Supporting Pelareorep as an Immune-Priming Backbone at AACR 2026
Rhea-AI Summary
Oncolytics (NASDAQ: ONCY) announced two AACR 2026 presentations reporting translational and mechanistic data for pelareorep as a systemic immune-priming backbone.
Key findings: a 62% objective response rate in first-line metastatic pancreatic ductal adenocarcinoma with pelareorep plus atezolizumab and chemotherapy, a median PFS of 7.5 vs. 5.6 months in patients with immune activation signatures, evidence of tertiary lymphoid structure formation in early breast cancer biopsies, and stimulation of RAS-specific T-cell clones in GI cancers.
Positive
- Objective response rate 62% in first-line metastatic pancreatic ductal adenocarcinoma
- Median progression-free survival 7.5 vs. 5.6 months for patients with immune activation signatures
- Evidence of tertiary lymphoid structure formation and coordinated immune activation
Negative
- Data derive from early-phase trials (Phase 1/2 GOBLET) and exploratory analyses
- Small sample size in breast biopsy cohort (Cohort 2, n=8) limits generalizability
Key Figures
Market Reality Check
Peers on Argus
ONCY was down 3.06% while momentum-screened peers like HURA (+3.19%), ACTU (+3.16%), and NKTX (+5.36%) were moving higher, pointing to stock-specific trading rather than a broad sector move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 02 | Trial launch | Positive | -9.7% | Randomized Phase 2 REO 033 trial launched in 2L RAS-mutant MSS colorectal cancer. |
| Feb 24 | Strategy update | Positive | +6.6% | Company prioritized registrational programs in anal and colorectal cancer post-GOBLET. |
| Feb 04 | Regulatory designation | Positive | +2.5% | FDA granted Fast Track for pelareorep combo in 2L KRAS-mutant MSS colorectal cancer. |
| Jan 14 | Executive appointments | Positive | +5.0% | New EVP of Strategy/Operations and Head of Biostatistics to support late-stage work. |
| Jan 12 | Clinical data update | Positive | +2.5% | Updated GOBLET Cohort 4 anal cancer data showed durable responses and long DOR. |
Recent positive clinical and strategic updates have more often aligned with modest positive price reactions, but the colorectal trial launch saw a notable negative divergence.
Over recent months, Oncolytics has steadily advanced pelareorep with multiple catalysts. On Jan 12, updated GOBLET anal cancer data showed durable responses. This was followed by key hires on Jan 14 to support late-stage development, and an FDA Fast Track designation in colorectal cancer on Feb 4. A strategic shift to registration-focused programs was announced on Feb 24, then the REO 033 colorectal study launch on Mar 2. Today’s AACR mechanistic data further reinforce the immune-priming backbone narrative built by these prior updates.
Market Pulse Summary
This announcement highlights new AACR 2026 mechanistic and translational data showing pelareorep driving coordinated immune activation, TLS formation, and a 62% objective response rate in first-line mPDAC, with median PFS of 7.5 months in biomarker-selected patients. It builds on prior Fast Track designation and registration-focused plans in gastrointestinal cancers. Key watch points include larger confirmatory datasets, validation of the 14‑protein signature, and how these immune-priming findings translate into registrational trial design and regulatory discussions.
Key Terms
immune-priming medical
checkpoint inhibitors medical
objective response rate medical
progression-free survival medical
metastatic pancreatic ductal adenocarcinoma medical
AI-generated analysis. Not financial advice.
Pelareorep treatment drives coordinated immune activation and tertiary lymphoid structure formation
Translational data suggest potential to boost response to immunotherapy and targeted therapy in RAS-driven tumors
Pelareorep’s ability to engage the innate and adaptive immune system results in doubling or nearly tripling response rates in breast and gastrointestinal cancers
SAN DIEGO, March 19, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced two abstracts across distinct tumor types were accepted for presentation at the American Association for Cancer Research (“AACR”) Annual Meeting 2026, at the San Diego Convention Center from April 17-22, 2026. Pelareorep is an investigational, systemically delivered immunotherapy that has been shown to activate innate immune-sensing pathways via double‑stranded RNA signaling, driving interferon production, dendritic cell activation, and cytotoxic T‑cell priming.
“These new translational findings strengthen our understanding of pelareorep as a systemic immune‑priming agent that reshapes the tumor microenvironment,” said Jared Kelly, Chief Executive Officer of Oncolytics. “The coordinated immune activation and tertiary lymphoid structure formation we are observing support pelareorep as a foundational backbone for combination therapy across multiple tumor types, including RAS-driven cancers. RAS mutations are especially prevalent in deadly cancers, including roughly
Biomarker data from cohort 1 of the Phase 1/2 GOBLET trial in advanced pancreatic cancer suggest pelareorep plus atezolizumab and gemcitabine/nab-paclitaxel can shift tumors toward a more immune-active state. Patients with an immune activation signature after four weeks were more likely to achieve durable clinical benefit, supporting a potential biomarker. Pancreatic cancer continues to pose a significant unmet clinical need, with approximately 510,000 new cases reported globally each year.1
Additionally, new first-of-its-kind data from AWARE-1 show pelareorep can drive coordinated anti-tumor immune responses, including tertiary lymphoid structure (“TLS”) formation, helping make immunologically cold tumors more susceptible to immunotherapy. This could include patients who have failed checkpoint inhibitors, representing a significant portion of the patient population and a meaningful unmet need in oncology.
Pelareorep has also been shown to stimulate RAS-specific T-cell clones in gastrointestinal cancers, which may enhance its ability to target RAS-mutated tumor cells. The Company will present more data on this topic at an upcoming scientific meeting.
Together, the data support pelareorep as a novel immune‑priming strategy capable of enhancing the activity of multiple therapeutic classes, including checkpoint inhibitors, targeted therapies, chemotherapy, and emerging immuno‑oncology modalities.
Abstract: Pelareorep combined with atezolizumab and chemotherapy shows immune conversion activity in advanced pancreatic cancer: Biomarker results of cohort 1 of the GOBLET trial
New biomarker data from cohort 1 of the Phase 1/2 GOBLET study demonstrated that pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel led to meaningful immune activation in patients with metastatic pancreatic ductal adenocarcinoma (“mPDAC”).
An exploratory analysis integrating routine serum markers, a 172-protein circulating panel, selected T-cell receptor sequencing, and clinical outcomes found early on-treatment changes showed increases in adaptive immune and cytotoxicity-associated proteins, including interferon signaling and CD8+/NK-related markers, alongside decreases in tumor/stroma-associated proteins. A 14-protein signature linked to oncolytic activity stratified patients at Week 4 into ‘hot’ vs. ‘cold’ immune phenotypes relative to baseline. Patients demonstrating immune activation signatures experienced longer median progression-free survival (7.5 months) compared with patients who did not exhibit similar immune responses (5.6 months).
As previously reported, the combination of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel demonstrated a
Abstract: Imaging mass cytometry of pelareorep treated early breast cancer samples reveals developing tertiary lymphoid structures
AWARE-1 is a window-of-opportunity study evaluating the effects of pelareorep in early-stage breast cancer. In biopsies from Cohort 2 (n=8), cellular neighborhood analysis identified immune-cell clusters, including cytotoxic T cells, dendritic cells, T helper cells, activated T helper cells, B cells, differentiated B cells, and M2 macrophages. Interactions between these cells developed into TLS in select patients. TLS function as localized immune hubs that facilitate antigen presentation, T‑cell activation, and sustained anti‑tumor immune responses. Published studies link TLS formation with improved responses to immunotherapy.
These findings support pelareorep’s potential to expand cytotoxic T cells, activate dendritic cells, and promote TLS formation, helping to convert immunologically ‘cold’ tumors into immune-responsive ‘hot’ tumors.
About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:
- Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;
- Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;
- Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients
- Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and
- Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.
About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.
About AWARE-1
AWARE-1 was an open-label window-of-opportunity study in early-stage breast cancer. The study combined pelareorep, without or with atezolizumab, and standard of care therapy according to breast cancer subtype. Tumor tissue was collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day their tumor is surgically resected. Key objectives of the study were to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to collect biomarker data. The primary endpoint of the translational study was overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes that is associated with favorable clinical outcomes). Secondary endpoints for the study included safety and tumor and blood-based biomarkers. The combination of pelareorep, letrozole, and atezolizumab resulted in
Reference
- Leiphrakpam PD, Chowdhury S, Zhang M, et al. Trends in the Global Incidence of Pancreatic Cancer and a Brief Review of its Histologic and Molecular Subtypes. J Gastrointest Cancer. 2025 Feb 24;56(1):71.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses.
The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal and pancreatic cancer. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics.
Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
Forward-looking statements
This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; the Company’s goals, strategies, and objectives; expectations around the timing of the AACR Annual Meeting 2026; expectations as to the content and potential opportunities associated with the findings from the various studies expected to be presented via abstracts in the future; expectations around the design, milestones, anticipated timelines and expected outcomes for current and future studies; anticipated timelines and objectives for future meetings with regulatory bodies, including the FDA; and its belief in the clinical promise of pelareorep in anal, colorectal, pancreatic and other gastrointestinal cancers as well as breast cancer. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.
Company Contact
Jon Patton
Director of IR & Communication
jpatton@oncolytics.ca
FAQ
What did Oncolytics (ONCY) report about pelareorep response rates in pancreatic cancer?
How did pelareorep affect progression-free survival in the GOBLET trial (ONCY)?
What evidence did ONCY present for pelareorep creating tertiary lymphoid structures in breast cancer?
Can pelareorep improve response to immunotherapy for RAS-driven tumors (ONCY)?
What is the clinical stage and scope of the pelareorep data presented by Oncolytics (ONCY)?
What are the limitations investors should note about ONCY’s pelareorep data?
