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Oncolytics Biotech Inc (2)
Symbol ONC
Shares Issued 73,398,847
Close 2023-11-08 C$ 2.15
Market Cap C$ 157,807,521
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Oncolytics plans to start phase 3 PDAC study mid-2024

2023-11-09 10:03 ET - News Release

Dr. Matt Coffey reports

ONCOLYTICS PROVIDES UPDATE ON PANCREATIC CANCER PROGRAM FOR PELAREOREP

Oncolytics Biotech Inc. has provided an update on the planned program for pelareorep in pancreatic ductal adenocarcinoma (PDAC).

Oncolytics's collaborator, The Pancreatic Cancer Action Network (PanCAN), a pancreatic cancer patient advocacy organization, advised the company that it is implementing a strategic re-evaluation of the Precision PromiseSM program and will not be adding any new investigational therapies to the platform until the re-evaluation is complete. Oncolytics and PanCAN had previously planned to initiate a phase 3 trial using the Precision PromiseSM platform in H1 2024. Oncolytics now plans to conduct an adaptive phase 3 program of pelareorep, gemcitabine, nab-paclitaxel and atezolizumab, similar to the Precision Promise study, and manage it directly within its clinical group and a contract research organization (CRO), with the goal of enrolling the first patient in mid-2024.

Additionally, Oncolytics and PanCAN confirmed that PanCAN will continue with its plans to grant $5-million (U.S.) to Oncolytics as part of the Therapeutic Accelerator Award for the new phase 2 Goblet study arm evaluating the combination of pelareorep and modified Folfirinox (mFolfirinox) in pancreatic cancer patients.

Dr. Matt Coffey, president and chief executive officer of Oncolytics, said: "Oncolytics remains steadfast in its commitment to initiate the phase 3 program for pelareorep, starting in PDAC, in 2024. Having a compelling phase 2 data set in hand, and strong connections with the pancreatic cancer community, Oncolytics is well positioned to effectively conduct the phase 3 pancreatic cancer program. Trial preparations are actively under way, and we expect to initiate the enrolment of the first patient in mid-2024. The company plans to provide a further update on the design of the phase 3 trial in H1 2024."

Dr. Coffey continued: "The opportunity to work with the strong scientific, regulatory and clinical leadership teams at PanCAN continues to be valuable for Oncolytics. We are grateful for our ongoing collaboration through the $5-million (U.S.) Therapeutic Accelerator Award grant program in support of the new arm of the Goblet study of pelareorep and mFOLFIRINOX, slated to begin in H1 2024."

"While we are undertaking a strategic re-evaluation of the program and are not adding any new therapies until the evaluation is complete, we remain committed to Oncolytics's efforts to accelerate therapies for pancreatic cancer patients through the $5-million (U.S.) Therapeutic Accelerator Award grant," said Julie Fleshman, president and chief executive officer of PanCAN.

Dr. Coffey concluded by saying: "Looking ahead, we believe our updated plan to conduct the pelareorep phase 3 pancreatic cancer program will enable us to be much closer to the conduct of the trial and the data. We believe this will be strategically valuable as we advance our partnering discussions and explore regulatory strategies to accelerate the development of pelareorep in order to bring this potentially important immunotherapeutic agent to people with cancer."

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in phase 2 studies in breast and pancreatic cancers. 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 and hematological malignancies as it advances toward registrational studies in metastatic breast cancer and pancreatic cancer.

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