Oncolytics Biotech® Reports Successful FDA Type C Meeting on Metastatic Breast Cancer Program

Oncolytics Biotech Inc. announced significant progress in its efforts to advance pelareorep, an immunotherapeutic agent for the treatment of HR+/HER2- metastatic breast cancer (mBC). This advancement follows productive feedback from their Type C meeting with the U.S. Food and Drug Administration (FDA). The FDA has expressed support for the planned registration-enabling trial, endorsing progression-free survival as the primary endpoint and overall survival as a critical secondary endpoint. The proposed study aims to enroll patients who have not responded to hormonal therapy and have undergone no more than one line of antibody-drug conjugate (ADC) therapy.

Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics, emphasized the importance of aligning with the FDA on the trial's design and objectives. Heineman highlighted that this step is crucial for bringing pelareorep to patients in need. The company's approach is built on substantial data from the BRACELET-1 and IND-213 randomized studies, which demonstrated meaningful benefits for patients receiving pelareorep and paclitaxel compared to those receiving paclitaxel alone. Additionally, the AWARE-1 study provided translational data underscoring pelareorep's immune-mediated mechanism of action in breast cancer patients. Heineman expressed confidence in the company's position to make pelareorep accessible to patients who require better treatment options.

Wayne Pisano, Interim CEO and Chair of the Board, also expressed gratitude for the FDA's constructive dialogue, noting the regulatory milestone was a significant step forward for pelareorep’s registration in HR+/HER2- mBC. Pisano revealed that initiating a registration-enabling trial is now a major corporate objective. Moreover, the company is on track to report overall survival data from the BRACELET-1 study in the second half of the year. Pisano believes that these upcoming data will further strengthen the evidence for pelareorep's therapeutic potential, reinforcing the company's commitment to improving the standard of care and addressing the high unmet medical needs of breast cancer patients.

Oncolytics Biotech Inc. is a clinical-stage biotechnology company that is developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has shown promising results in two randomized Phase 2 studies for metastatic breast cancer and in Phase 1 and 2 studies for pancreatic cancer. The drug acts by inducing anti-cancer immune responses and promoting an inflamed tumor phenotype—essentially converting "cold" tumors into "hot" ones. This immune activation allows anti-tumor immune cells, induced by pelareorep, to attack the cancer more effectively.

Pelareorep has demonstrated synergies with several approved oncology treatments. Currently, Oncolytics is conducting and planning combination clinical trials with pelareorep for both solid and hematological malignancies. The company is advancing towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA.

This announcement marks a pivotal moment for Oncolytics Biotech Inc. as it continues to make strides towards providing innovative treatment options for cancer patients. The support from the FDA and the promising data from prior studies provide a solid foundation for pelareorep's future development and potential approval. Oncolytics remains committed to its mission of improving the standard of care for patients with metastatic breast cancer, offering hope for better outcomes and addressing unmet medical needs.