08:25:51 EDT Tue 01 Jul 2025
Enter Symbol
or Name
USA
CA



Login ID:
Password:
Save
Oncolytics Biotech Inc (2)
Symbol ONC
Shares Issued 85,501,442
Close 2025-02-19 C$ 1.03
Market Cap C$ 88,066,485
Recent Sedar Documents

Oncolytics gets green light to continue study enrolment

2025-02-19 17:59 ET - News Release

Mr. Wayne Pisano reports

ONCOLYTICS BIOTECH ADVANCES KEY PANCREATIC AND ANAL CANCER TRIALS, STRENGTHENING PIPELINE IN 2025

Oncolytics Biotech Inc. continues to make good progress in 2025 with key regulatory and clinical advancements, reinforcing pelareorep's potential in hard-to-treat cancers. Oncolytics is pleased to highlight two significant developments for its immunotherapy, pelareorep: the safety and regulatory clearance to advance enrolment in its pancreatic cancer study and the recent presentation of new efficacy and safety data at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in late January.

"We're hitting critical milestones that validate our progress and set the stage for what we believe will be an exciting year," said Wayne Pisano, interim chief executive officer and chair of Oncolytics' board of directors. "With positive feedback from regulators in place, we're advancing our pancreatic cancer study toward full enrolment, and our ASCO GI presentations highlighted pelareorep's strong safety and efficacy results in two hard-to-treat cancers. We remain focused on bringing new treatment options to patients while creating value for shareholders as we move forward in 2025."

German regulatory agency gives green light for pancreatic cancer study to continue as planned:

  • Approval to fully enroll the cohort secured: Germany's Paul-Ehrlich-Institute (PEI) has given Oncolytics the go-ahead to continue enrolling patients in its pancreatic cancer trial (Goblet cohort 5) after a positive safety review.
  • What this means: Pelareorep, in combination with modified Folfirinox with and without atezolizumab, is now progressing toward full enrolment, with 30 patients set to participate in Stage 1 across the two treatment arms.
  • Next steps: Oncolytics will continue to collect safety data, and an initial efficacy readout is expected later this year.

ASCO GI 2025 data confirm Pelareorep's potential in pancreatic and anal cancers

At ASCO GI 2025, Oncolytics presented new clinical results demonstrating pelareorep's potential in two challenging cancer types:

  • Anal cancer: Patients receiving pelareorep plus atezolizumab continue to show stronger responses than expected based on published studies with checkpoint inhibitors alone.
  • Pancreatic cancer: Pelareorep previously demonstrated a strong efficacy signal when administered with gemcitabine, nab-paclitaxel and atezolizumab. The most recent data support a favourable safety profile when combining pelareorep with a different chemotherapy regimen (modified Folfirinox) with and without the checkpoint inhibitor atezolizumab, potentially expanding its treatment applications.

Why this matters: These findings further derisk pelareorep's development and could pave the way for larger registration-enabling clinical trials in these indications.

Looking ahead -- more catalysts in 2025

Oncolytics is entering a pivotal year with multiple coming milestones, including:

  • Additional data readouts from continuing trials in gastrointestinal cancers, including translational results that further characterize pelareorep's mechanism of action;
  • interactions with regulatory agencies that could accelerate future trials and move pelareorep closer to potential registration-enabling studies in breast cancer and gastrointestinal cancers.

"We're seeing clinical validation across multiple studies," added Mr. Pisano. "With encouraging regulatory interactions in hand and data readouts ahead, 2025 is shaping up to be an exciting year for Oncolytics and our investors. As we have shown in Goblet, Bracelet-1 and numerous previous studies, pelareorep has a favourable safety profile and efficacy signals across multiple indications with a high unmet need. We are excited about the potential for moving to a registration-enabling study in breast cancer and advancing our clinical program in gastrointestinal cancers."

About Goblet

The Goblet (gastrointestinal tumours 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 tumours. The study is being conducted at 17 centres in Germany and is being managed by AIO-Studien-gGmbH. The co-primary end points of the study are objective response rate (ORR) and/or disease control rate and safety. Key secondary and exploratory end points include additional efficacy assessments and evaluation of potential biomarkers. Favourable safety and positive clinical efficacy signals have been seen in the pancreatic and anal cancer cohorts.

About Goblet cohort 5

The modified Folfirinox (mFolfirinox) cohort of the phase 1/2 Goblet study is designed to evaluate newly diagnosed metastatic pancreatic ductal adenocarcinoma patients treated with pelareorep plus mFolfirinox with or without atezolizumab. A three-patient safety run-in was incorporated to evaluate the safety and tolerability of each treatment arm: pelareorep plus mFolfirinox plus atezolizumab and pelareorep plus mFolfirinox. A total of 15 evaluable patients will be randomized to each arm in stage 1 of this Simon two-stage study. The co-primary end points are objective response rate and safety. If stage 1 success criteria are met, one or both treatment arms may be expanded to stage 2, in which 17 additional evaluable patients per arm will be enrolled. Blood and tumour samples will also be collected for translational evaluations.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized phase 2 studies in metastatic breast cancer and phase 1 and phase 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumour phenotype -- turning cold tumours hot -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it prepares for registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received fast-track designation from the FDA (U.S. Food and Drug Administration).

We seek Safe Harbor.

© 2025 Canjex Publishing Ltd. All rights reserved.