Translational Data from Anal Cancer Patients Show Pelareorep Drives HPV-Specific Immune Responses, Supporting its Potential Across HPV-Driven Cancers

Oncolytics aims to translate the evidence into collaborations to accelerate pelareorep development across HPV-associated cancers.

Rhea-AI Summary

Oncolytics Biotech (ONCY) reported anal cancer study data showing HPV-specific immune responses with pelareorep combined with a checkpoint inhibitor. The ongoing Phase 1/2 study involves patients with second-line or later unresectable squamous cell anal cancer. The combination more than doubled objective response rate and increased median duration of response by 50% compared with the current approved therapy in that population.

After one treatment cycle, seven of eight evaluable patients had greater than two-fold increases in immune-activation biomarkers. After three cycles, all four evaluable patients showed expansion of tumor-infiltrating lymphocyte clones—groups of related immune cells—in blood, associated with tumor shrinkage, including two complete and two partial responses.

7 points · 0 major

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Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointObjective response rate more than doubled versus current approved therapy in second-line or later anal cancer.
• Moderate pointMedian duration of response increased 50% versus current approved therapy in that patient population.
• Minor pointSeven of eight evaluable patients had greater than two-fold immune-activation biomarker increases after one treatment cycle.
• Minor pointAll four evaluable patients showed immune-cell clone expansion after three cycles, with two complete and two partial responses.
• Minor pointFour responding patients with tumor-infiltrating lymphocyte expansion also showed expansion of at least one HPV-16-specific T cell clone.

2 minor points

• Minor pointSix of 14 patients evaluated for HPV-16-specific responses showed clonal expansion; four of those six had tumor shrinkage.
• Minor point. Forward-looking: it has not happened yet and may not happen.Oncolytics prioritizes collaborations to accelerate development across HPV-associated cancers.

Negative

• None.

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Details

Market move: ONCY +10.74% vs previous close. Anal cancer clinical data

$0.39 – $0.43 Day Range

$56.63M Mkt Cap at Last Price

On Nov 4, the day this news came out, the latest delayed price for ONCY is 10.74% above the previous close. Our momentum scanner has recorded 12 alerts for this stock so far that day. The latest delayed price is $0.43. Relative volume is above average at 1.6x what this stock usually trades by this time of day.

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Key Figures

Objective response rate: More than doubled Median duration of response: Increased by 50% Immune-activation biomarkers: Greater than two-fold increases in 7 of 8 patients +4 more

Objective response rate

More than doubled

Pelareorep plus a checkpoint inhibitor versus current approved therapy in second-line or later SCAC

Median duration of response

Increased by 50%

Pelareorep plus a checkpoint inhibitor versus current approved therapy in second-line or later SCAC

Immune-activation biomarkers

Greater than two-fold increases in 7 of 8 patients

CXCL10, IFN-γ, and soluble PD-L1 after one cycle

TIL clone expansion

4 of 4 evaluable patients

After three cycles of treatment

Tumor responses

2 complete responses and 2 partial responses

Patients with TIL clone expansion after three cycles

HPV-16-specific clonal expansion

6 of 14 patients; 4 experienced tumor shrinkage

Patients evaluated for HPV-16-specific immune responses

Potential market

$3 to 5 billion

Company internal estimate for HPV-associated cancers

Historical Context

1 past event · Latest: Oct 27

1 event

1. Oct 27

   anal cancer clinical data

   24h Move

   -2.3%

   Earlier Cohort 4 report disclosed durable responses with pelareorep plus atezolizumab in the same anal-cancer population.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

tumor-infiltrating lymphocyte, checkpoint inhibitor, objective response rate, simon 2-stage

4 terms

tumor-infiltrating lymphocyte medical

"tumor-infiltrating lymphocyte (“TIL”) clones"

Immune cells, mainly T cells, that have moved from the bloodstream into a tumor and are present among the cancer cells and supporting tissue; they are identified by examining tumor tissue with microscopy or molecular tests. Tumor-infiltrating lymphocytes (TILs) can include different types of lymphocytes (for example, CD8+ cytotoxic T cells and CD4+ helper T cells) and indicate an immune system interaction with the tumor, but their presence or number does not by itself prove those cells are effectively killing cancer cells. TILs are also the source material for certain cancer immunotherapies, where these cells are isolated, sometimes expanded outside the body, and returned to the patient.

checkpoint inhibitor medical

"combined with a checkpoint inhibitor generated promising efficacy signals"

A checkpoint inhibitor is a type of medicine that helps the immune system spot and attack cancer by blocking proteins that act like brakes on immune cells. For investors, these drugs matter because clinical trial results, regulatory approvals, safety profiles and market demand can quickly change a developer’s revenue and valuation; think of them as releasing the brakes on the immune system—potentially high reward but with safety and trial-risk consequences.

objective response rate medical

"more than doubling the objective response rate"

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.

simon 2-stage technical

"The Phase 1/2, Simon 2-stage study is assessing the safety and efficacy"

A Simon two-stage design is a statistical plan used in early-phase clinical trials (commonly single-arm phase II) that lets researchers stop the study early if the treatment shows insufficient activity. The protocol specifies two sample sizes and two decision thresholds: after enrolling the first-stage group, the trial is halted for futility if the number of responders is at or below a pre-set cutoff; if it passes that cutoff the trial continues to the second stage and a final cutoff across both stages determines whether the treatment is considered promising. The design controls the probabilities of false-positive and false-negative conclusions by fixing acceptable type I and type II error rates and yields smaller average sample sizes when ineffective treatments are stopped early.

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Pelareorep-driven changes in the tumor microenvironment are associated with tumor responses and shrinkage

Immune activation levels more than doubled in nearly all patients after one cycle of treatment

Substantial increases in HPV-16-specific T cells and tumor-infiltrating lymphocytes observed when pelareorep is combined with a checkpoint inhibitor

SAN DIEGO, Nov. 04, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech^® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced new translational data from an ongoing study showing pelareorep’s ability to increase human papillomavirus (“HPV”)-16-specific T cell clones and tumor-infiltrating lymphocyte (“TIL”) clones in second-line or later squamous cell anal cancer (“SCAC”) patients at the Society for Immunotherapy of Cancer (“SITC”) 2026 Annual Meeting.

Pelareorep combined with a checkpoint inhibitor generated promising efficacy signals in second-line or later SCAC, including more than doubling the objective response rate and increasing median duration of response by 50% compared to the current approved therapy in that patient population. Multiple analyses help explain how pelareorep generates innate and adaptive immune responses and synergizes with other therapies. Highlights from the SITC abstract include:

• In seven of eight evaluable patients, greater than two-fold increases in levels of the immune-activation biomarkers CXCL10, IFN-γ, and soluble PD-L1 were observed after one cycle of therapy.
• After three cycles of treatment, all four evaluable patients saw expansion of TIL clones in peripheral blood, which was associated with reductions in tumor size, including two complete responses and two partial responses.
• The four responding patients with TIL expansion also demonstrated significant expansion of at least one HPV-16-specific T cell clone.
• Among 14 patients evaluated for HPV-16-specific immune responses, six showed HPV-16 clonal expansion, and four of those patients experienced tumor shrinkage.
• The Phase 1/2, Simon 2-stage study is assessing the safety and efficacy of pelareorep in combination with a checkpoint inhibitor in second-line or later unresectable SCAC patients.
  

“These data reinforce pelareorep’s potential in multiple HPV-driven cancers as those tumor types generally exhibit low response rates to checkpoint inhibitors,” said Thomas Heineman, MD, PhD, Chief Medical Officer of Oncolytics. “Pelareorep’s ability to increase tumor-infiltrating lymphocyte populations and expand HPV-specific T cells form the basis for its synergy with checkpoint inhibitors and reinforces the potential of this combination to combat tumor growth in HPV-associated cancers. More broadly, these data support our belief in pelareorep as a backbone immunotherapy capable of activating anti-tumor immunity and improving responses to multiple therapies across a wide range of tumor types.”

“We see HPV-associated cancers as a compelling business development opportunity for pelareorep, spanning anal, HPV-positive oropharyngeal, cervical, and other malignancies and representing a potential $3 to 5 billion market based on our internal estimates,” said Jared Kelly, Chief Executive Officer of Oncolytics. “The combination of HPV-specific T cell expansion in our anal cancer study and prior clinical efficacy signals in head and neck cancer gives prospective partners a differentiated scientific and clinical rationale to explore pelareorep alongside checkpoint inhibitors. With systemic delivery, substantial clinical experience, and the potential to pursue multiple indications, we believe pelareorep offers a scalable opportunity to extend immunotherapy franchises into underserved patient populations. Our priority is to translate this evidence into strategic collaborations that can accelerate development and realize the broader commercial opportunity.”

About Pelareorep
Pelareorep is an intravenously delivered, systemically active, investigational immunotherapy with a dual mechanism of action that selectively replicates in tumor cells while activating both innate and adaptive anti-tumor immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes. It has been administered to over 1,200 patients, and clinical studies have demonstrated pelareorep’s potential to enhance the activity of checkpoint inhibitors and other anti-cancer therapies across multiple solid tumor types.

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 inactive tumors to active 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 U.S. Food and Drug Administration for colorectal, anal, 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 LinkedIn and on X @oncolytics.

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 the Company’s beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; the potential implications of the translational data from the anal cancer study; the Company’s goals, strategies, and objectives; expectations around the design, milestones, anticipated timelines and expected outcomes for current and future studies; its belief in the clinical promise of pelareorep in anal, colorectal, pancreatic and other gastrointestinal cancers; the Company’s goals and expectations for its potential registrational development path for pelareorep in multiple gastrointestinal cancers; and plans for future disclosure of clinical trial results. 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.com

FAQ

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What response results did Oncolytics report for pelareorep in anal cancer?

Pelareorep combined with a checkpoint inhibitor more than doubled objective response rate and increased median duration of response by 50% compared with the current approved therapy in second-line or later squamous cell anal cancer.

What HPV-specific immune responses did Oncolytics observe with pelareorep?

Among 14 patients evaluated for HPV-16-specific immune responses, six showed HPV-16 clonal expansion, and four of those patients experienced tumor shrinkage. The four responding patients with expansion of tumor-infiltrating lymphocytes also showed expansion of at least one HPV-16-specific T cell clone.

Which immune-activation biomarkers increased in Oncolytics' pelareorep anal cancer study?

The biomarkers were CXCL10, IFN-γ and soluble PD-L1. Greater than two-fold increases in their levels were observed in seven of eight evaluable patients after one cycle of therapy.