Oncolytics Biotech develops pelareorep, an investigational systemically delivered immunotherapy for cancer that has been shown to activate innate immune-sensing pathways. Company news centers on pelareorep clinical and translational data, FDA interactions, and study activity across gastrointestinal and other solid tumor indications, including metastatic colorectal cancer, squamous cell anal carcinoma, pancreatic cancer, and breast cancer.
Recurring updates also cover the company's registration-focused development priorities, Fast Track Designation for pelareorep-based treatment in second-line KRAS-mutant microsatellite-stable metastatic colorectal cancer, scientific meeting presentations, financing arrangements, and its completed change of jurisdiction to Nevada while ONCY common stock continues to trade on Nasdaq.
Oncolytics Biotech (ONCY) reported updated Phase 1/2 GOBLET anal cancer data showing approximately 15-month median response duration with pelareorep plus atezolizumab. Cohort 4 evaluated patients with second-line or later squamous cell anal cancer. The historical median response duration for approved retifanlimab monotherapy in a similar population was 9.5 months. Median overall survival has not been reached; all responding patients survived beyond 12 months, including multiple patients surviving over 24 months.
Following FDA Fast Track Designation and regulatory interactions, Oncolytics plans to explore additional studies with a potential checkpoint inhibitor partner. The company sees a possible accelerated approval pathway based on durable responses, subject to FDA agreement. It may also explore a head and neck cancer combination study. The efficacy estimates came from internal calculations identified as being for a draft.
Oncolytics Biotech (ONCY) is presenting its ongoing randomized Phase 2 REO 033 colorectal cancer study at the ESMO Congress 2026. The study compares investigational pelareorep plus FOLFIRI chemotherapy and bevacizumab against FOLFIRI and bevacizumab alone in second-line RAS-mutant, microsatellite-stable metastatic colorectal cancer. It plans to randomize 30 patients per arm after progression on first-line oxaliplatin-based therapy.
The primary endpoint is objective response rate, the proportion of patients whose tumors shrink. Earlier REO 022 results in KRAS-mutant disease showed median progression-free survival of 17 months versus 6 months for historical standard-of-care outcomes, not a randomized comparison. Oncolytics says FDA interactions provide an opportunity for a pivotal Part B expansion that could support accelerated approval based on response rate and full approval based on progression-free survival.
Oncolytics Biotech (ONCY) updated its GOBLET Phase 1/2 study and expects the final PanCAN grant payment in Q4 2026. Enrollment is complete, and every cohort that enrolled the required number of patients met its pre-specified efficacy success criteria.
The company expects final Cohort 4 results in Q4 2026 and initial Cohort 5 results in the first half of 2027, although continued treatment and follow-up could extend the latter timeline. Cohort 4 tests pelareorep with atezolizumab in second-line and later squamous cell anal cancer; Cohort 5 tests pelareorep with chemotherapy, with and without atezolizumab, in first-line metastatic pancreatic cancer.
Oncolytics is winding down the broader study infrastructure while remaining patients continue treatment and follow-up. It plans to use the data to guide its strategy for combining pelareorep with a checkpoint inhibitor, a type of immunotherapy, in gastrointestinal and additional tumors.
Oncolytics Biotech (ONCY) has secured patents in several countries covering pelareorep as a cancer immunotherapy and outlined further portfolio expansion. The company expects corresponding U.S. issuance in the near term. Existing manufacturing patent protection runs through 2044, while Oncolytics expects new method-of-use patents, once issued, to protect covered therapeutic applications into the late 2040s.
Three patent application families are pending, including applications covering therapeutic uses and combinations. Oncolytics expects to request U.S. Track One prioritized examination for one application this quarter. With an academic partner, it is developing modified pelareorep and expects a patent covering the modified substance, potentially providing up to 20 years of protection from the applicable filing date. Protection depends on granted claims and patent rules; any enhanced efficacy requires further studies.
Oncolytics Biotech (ONCY) reported published preclinical liver cancer findings showing that pelareorep increased markers of immune activity in tumors.
The paper was published in the Proceedings of the National Academy of Sciences on September 28, 2026. In hepatocellular carcinoma, pelareorep increased PD-L1 expression, ICOSL levels on tumor cells and CD8+ T-cell density. The findings suggest tumors may become more susceptible to immune-based therapies, including checkpoint inhibitors. The results are preclinical, and Oncolytics said it does not intend to pursue liver cancer as an indication at this time.
Oncolytics Biotech (ONCY) has activated nearly all planned Part A sites in its randomized REO 033 colorectal cancer study.
Multiple patients are enrolled. Part A is expected to randomize approximately 60 patients with second-line RAS-mutant, microsatellite-stable metastatic colorectal cancer to pelareorep plus FOLFIRI and bevacizumab or the same regimen without pelareorep. Its primary measure is objective response rate, the share of patients whose tumors shrink. Other measures include survival, safety and biomarkers. Oncolytics expects an interim Part A update by year-end 2026, depending on evaluable enrollment by the end of October.
In the earlier, small, non-randomized REO 022 study, response rate was 33% versus a historical benchmark of ~6–11%; cross-study comparisons have limitations. Oncolytics said it aligned with the FDA on the concept for a potential Part B expansion that could support an accelerated approval submission based on response rate and potential full approval based on progression-free survival.
Oncolytics Biotech (ONCY) reported positive preclinical data combining its investigational immunotherapy pelareorep with a pan‑RAS inhibitor in a RAS‑driven colorectal cancer model.
During an initial intensive phase with pelareorep dosed every other day, pelareorep alone, the RAS inhibitor alone, and the combination all reduced tumor growth versus control, with the greatest reductions in the RAS inhibitor and combination groups. Pelareorep activity was maintained in the presence of RAS inhibition, with no evidence of antagonism. When pelareorep dosing was later reduced to weekly, its incremental activity became less apparent. The company said these findings, which align with prior independent work suggesting RAS inhibitors do not block pelareorep’s tumor‑selective infection mechanism, support further studies to optimize dosing and assess whether sustained pelareorep activity can deepen and prolong responses to RAS‑targeted therapy and delay resistance.
Oncolytics Biotech (Nasdaq: ONCY) reported receiving written feedback from the U.S. FDA on the design of a potential pivotal Part B expansion of REO 033, its randomized study of pelareorep in second-line RAS-mutant, MSS metastatic colorectal cancer. According to the company, the FDA’s responses provide alignment around using objective response rate and duration of response to support a potential accelerated approval, with progression-free survival intended to support full approval. The ongoing Part A (n=60) is designed to generate clinical data to inform the decision to launch Part B. Oncolytics plans to begin Part B start-up activities once positive interim Part A data are available and will pursue an End-of-Phase meeting with the FDA to finalize key elements of the registration program. Pelareorep combination therapy in this setting has FDA Fast Track designation and prior studies (including REO 022) showed encouraging efficacy signals.
Oncolytics Biotech (Nasdaq: ONCY) received U.S. FDA Fast Track designation for pelareorep in combination with a checkpoint inhibitor to treat patients with inoperable, locally recurrent or metastatic squamous cell carcinoma of the anal canal who have progressed on or were intolerant to one or more prior systemic therapies.
The designation, which can enable more frequent FDA interactions, rolling BLA review and potential Priority Review, supports advancement toward a pivotal study. It is Oncolytics’ third Fast Track in gastrointestinal cancers, following KRAS‑mutated metastatic colorectal cancer and pancreatic cancer, in an estimated U.S. market approaching $1 billion annually with no FDA‑approved options after current first‑line standard of care.
Fast Track was supported by GOBLET study data in advanced anal cancer showing an objective response rate of ~30%, longer median duration of response (15.5 vs. 9.5 months) and higher 12‑month overall survival (82% vs. 45.7%) versus historical benchmarks.
Oncolytics Biotech (Nasdaq: ONCY) reported clinical and regulatory progress for REO 033, its randomized study of pelareorep plus FOLFIRI and bevacizumab in second-line RAS-mutant MSS metastatic colorectal cancer. REO 033 builds on REO 022, where pelareorep more than doubled historical benchmarks across several efficacy measures and subsequently received FDA Fast Track designation for this indication.
According to the company, Part A of REO 033 (n=60) is advancing, with about half of planned sites to be activated by end of July and remaining sites expected by end of August 2026; more than 20 patients have been pre-identified. Oncolytics plans a Type D FDA meeting in the first half of August 2026 to discuss adding a registration-directed Part B that would increase enrollment and add blinded independent central review, aiming to support both potential accelerated and traditional approval within the same study. The company expects initial tumor response data from Part A by year-end 2026 and, subject to FDA feedback, plans to begin enrollment in Part B in the first quarter of 2027.