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Oncolytics Biotech® Makes Major Progress in 2025 Cancer Treatments

Oncolytics Biotech® Inc., a prominent clinical-stage biotechnology company focused on developing innovative immunotherapy solutions, is achieving significant milestones in 2025. Recent advancements in its clinical pipeline highlight the company's commitment to addressing hard-to-treat cancers, specifically pancreatic and anal cancers, as well as metastatic breast cancer.

Progress in 2025

February 18, 2025, marked a pivotal moment for Oncolytics, particularly following positive feedback from regulatory bodies regarding its immunotherapeutic agent, pelareorep. The Paul-Ehrlich-Institute in Germany has granted approval for Oncolytics to fully enroll patients in its pancreatic cancer clinical trial (GOBLET Cohort 5), following a favorable safety assessment. This study, which tests pelareorep in combination with modified FOLFIRINOX and atezolizumab, is expected to significantly advance clinical options for patients suffering from pancreatic ductal adenocarcinoma.

Interim CEO Wayne Pisano expressed optimism, stating, "We are witnessing critical milestones that validate our progress, leading us to believe this year will be particularly exciting for our investors." The safety reviews by German regulators pave the way for 30 patients to participate in the trial, setting the stage for collecting valuable safety and efficacy data.

Key Clinical Outcomes

At the recently held American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, Oncolytics presented promising new clinical data underscoring pelareorep's efficacy in challenging cancer types. Patients with anal cancer receiving the pelareorep and atezolizumab combination have shown more significant responses than anticipated, based on previous studies utilizing checkpoint inhibitors alone.

Similarly, for pancreatic cancer, pelareorep exhibited strong efficacy signals when paired with gemcitabine, nab-paclitaxel, and atezolizumab. The recent findings support a positive safety profile when pelareorep is combined with modified FOLFIRINOX, either with or without atezolizumab, potentially broadening treatment opportunities for patients.

These developments are crucial as they further mitigate risks associated with pelareorep's ongoing development and open the pathway for large-scale registration-enabling clinical trials across these indications.

Looking Ahead: Promising Future Prospects

With 2025 already shaping up to be a transformative year, Oncolytics has multiple critical milestones lined up. These include:

• - Additional data readouts from ongoing clinical trials in gastrointestinal cancers, emphasizing translational studies that explore pelareorep's mechanism of action.
• - Interactions with regulatory agencies that may expedite future trial designs and move pelareorep closer to potential commercialization.

With mounting clinical validation across studies, Pisano remarked, "Encouraging interactions with regulators and upcoming data readouts mark 2025 as an exciting year for Oncolytics and our stakeholders." The company's ambitious plans include advancing towards registration-enabling trials for breast and gastrointestinal cancers, both areas with substantial unmet medical needs.

About GOBLET Study

The GOBLET study (Gastrointestinal tumors exploring the treatment combinations with the oncolytic reovirus pelareorep and anti-PD-L1) is a phase 1/2 study focusing on advanced metastatic gastrointestinal tumors. Conducted at 17 centers in Germany, the study analyzes essential endpoints, including objective response rates and safety metrics.

In conclusion, Oncolytics Biotech® Inc. stands on the threshold of significant clinical advancements, with pelareorep promising to provide new hope for patients battling aggressive malignancies. As the company navigates through 2025, both patients and investors await the unfolding of pivotal data that could transform cancer treatment options globally.