Oncolytics Biotech® Announces Productive FDA Type C Meeting on its Metastatic Breast Cancer Program
Oncolytics Biotech announced productive feedback from the U.S. FDA on its Type C meeting, supporting the planned potential registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC). The FDA endorsed progression-free survival as the primary endpoint and overall survival as a key secondary endpoint. The study will include patients who have failed hormonal therapy and have received no more than one line of ADC therapy. This step builds on promising data from previous studies (BRACELET-1, IND-213, and AWARE-1) showcasing pelareorep's efficacy and immunotherapeutic action. Oncolytics is on track to report overall survival data from the BRACELET-1 trial in H2 2024, advancing their mission to offer better treatment options for breast cancer patients.
- FDA support for the registration-enabling trial of pelareorep in HR+/HER2- mBC.
- Clear path forward in trial design and objectives.
- Building on positive data from BRACELET-1, IND-213, and AWARE-1 studies.
- On track to report overall survival results from BRACELET-1 trial in H2 2024.
- None.
Insights
The FDA's feedback and support for Oncolytics Biotech's planned registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC) is encouraging from a medical standpoint. Pelareorep, a virus-based treatment, works by stimulating the immune system to target and destroy cancer cells, offering a novel approach compared to traditional therapies. The use of progression-free survival as the primary endpoint and overall survival as a key secondary endpoint aligns with standard clinical trial practices, ensuring that the trial's outcomes will be clinically meaningful.
Furthermore, the patient enrollment criteria—focusing on those who have failed hormonal therapy and received limited prior treatment—suggests a targeted approach to identify patients who could benefit most from this therapy. This is crucial, as HR+/HER2- mBC patients often face limited treatment options after exhausting hormone therapies. The success of previous studies, BRACELET-1 and IND-213, provides a strong foundation for this trial, indicating potential efficacy and safety profiles.
As a retail investor, understanding the medical landscape and the unmet needs in HR+/HER2- mBC can provide context to why this advancement is significant. If successful, pelareorep could become a valuable addition to the oncology treatment arsenal, improving patient outcomes and potentially leading to a substantial market opportunity.
From a financial perspective, the FDA's alignment on the trial design for Oncolytics Biotech's pelareorep is a positive development, as it reduces regulatory uncertainty and paves the way for potential market approval. The emphasis on progression-free survival as the primary endpoint and overall survival as a secondary endpoint is standard in oncology trials, providing clarity on the study's objectives and potential outcomes.
The fact that Oncolytics is on track to report overall survival results from the BRACELET-1 trial in the second half of 2024 is noteworthy. Positive results could significantly bolster investor confidence and drive the company's stock price higher, considering the high unmet medical need in HR+/HER2- mBC. Additionally, the clear path towards a registration-enabling trial suggests that Oncolytics is making strategic progress towards commercializing pelareorep.
Retail investors should note the potential for value creation if the trial progresses as planned. However, it's also important to remain aware of the inherent risks associated with clinical-stage biotech companies, including trial failures and regulatory setbacks. Diversifying investments and staying informed about ongoing developments will be key to managing these risks.
Clear path forward on key elements of the planned potential registration-enabling trial in HR+/HER2- metastatic breast cancer
On track to report overall survival results from the randomized HR+/HER2- metastatic breast cancer BRACELET-1 trial in H2 2024
"Aligning with the FDA on key design elements and objectives of our planned registrational trial for pelareorep marks a critical step towards bringing this innovative treatment to patients," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Our de-risked program builds on compelling data and key learnings from two randomized studies, BRACELET-1 and IND-213, which demonstrated clinically meaningful benefit in patients receiving pelareorep and paclitaxel compared to paclitaxel alone. Additionally, translational data from the AWARE-1 study highlights pelareorep's immune-mediated mechanism of action in breast cancer patients. We are now well-positioned to deliver on our mission of making pelareorep available to breast cancer patients in need of better treatment options."
Wayne Pisano, Interim CEO and Chair of the Board of Oncolytics, commented, "We are appreciative of the thoughtful dialog with the FDA and are pleased to have reached an important regulatory milestone that provides a clear path forward for pelareorep's advancement towards registration in HR+/HER2- mBC. Looking ahead, initiating a registration-enabling trial has become a major corporate objective, and in parallel, we remain on track to report survival data from the BRACELET-1 study in HR+/HER2- mBC in the second half of the year. We believe these data will further bolster our compelling data package and underscores the therapeutic potential of pelareorep. We remain committed to improving the standard of care and addressing the high unmet medical needs of these patients."
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 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot." This allows the anti-tumor immune cells, induced by pelareorep, to attack the cancer.
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 towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our belief that we are now well-positioned to deliver on our mission of making pelareorep available to breast cancer patients in need of better treatment options; our belief that the outcome of the meeting with the FDA is an important regulatory milestone that provides a clear path forward for pelareorep's advancement towards registration in HR+/HER2- mBC; our corporate objective of initiating a registration-enabling trial; our belief that we remain on track to report survival data from the BRACELET-1 study in HR+/HER2- mBC in the second half of the year; our belief in the therapeutic potential of pelareorep; our commitment to improving the standard of care and addressing the high unmet medical needs of these patients; our plans to advance towards registrational studies in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and
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Company Contact
Jon Patton
Director of IR & Communication
jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
tim@lifesciadvisors.com
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SOURCE Oncolytics Biotech® Inc.
FAQ
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