Oncolytics Biotech® Advances Toward Registration-Enabling Trial for Pelareorep in Breast Cancer with Submission of Type C Meeting Request to FDA
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Insights
From the perspective of oncology research, the announcement by Oncolytics Biotech regarding their upcoming meeting with the FDA signifies a pivotal moment in the clinical development of pelareorep for the treatment of HR+/HER2- metastatic breast cancer. The data suggesting a tripled confirmed response rate and a 50% improvement in median progression-free survival is particularly noteworthy, as it indicates a potential advancement in therapeutic options for patients who have limited responses to current treatments. The hazard ratio of 0.29 is also a critical metric, suggesting a substantial reduction in the risk of disease progression or death when compared to the control group.
Furthermore, the intention to explore biomarkers like tumor-infiltrating lymphocytes and T cell receptor sequencing could lead to more personalized and effective treatment strategies. This focus on biomarker-driven research is aligned with current trends in oncology, where the goal is to tailor treatments based on individual patient profiles, potentially improving outcomes and reducing unnecessary exposure to ineffective therapies.
The strategic implications for Oncolytics Biotech and its stakeholders are significant. The anticipation of overall survival data from the BRACELET-1 study and the ongoing discussions with the FDA could potentially lead to a surge in investor confidence if the results are positive. This is especially true in the context of metastatic breast cancer, a market with a high unmet medical need and a patient population seeking more effective treatment options.
Moreover, the mention of advancing strategic partnering discussions indicates that Oncolytics is looking to leverage its clinical data to potentially secure partnerships or licensing agreements, which could provide additional financial resources and expertise to support commercialization efforts. The outcome of these discussions could have substantial financial implications for the company and its partners, influencing stock market performance and investor interest.
Regarding regulatory affairs, the Type C meeting request to the FDA represents an essential step in clarifying the pathway for pelareorep's approval. The design and objectives of the registrational trial will be under scrutiny, as they must meet the FDA's rigorous standards for safety and efficacy. The company's proactive approach in seeking alignment with the FDA before initiating the trial is a prudent strategy that may mitigate regulatory risks and streamline the approval process.
Additionally, the focus on potential biomarkers for patient selection could also have regulatory implications. If these biomarkers are validated, they may facilitate a more efficient regulatory review by providing clear evidence of the drug's effectiveness in a specific patient subgroup. This could lead to a more targeted label and potentially expedite the drug's time to market.
Requested for Q2 2024, the Type C meeting is to focus on planned registration-enabling trial in HR+/HER2- metastatic breast cancer
Overall survival results from the randomized HR+/HER2- metastatic breast cancer BRACELET-1 trial expected in H2 2024
"A key focus for Oncolytics in 2024 is defining the regulatory path for pelareorep in breast cancer treatment. We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer. Our position is strengthened by encouraging data from two randomized studies (BRACELET-1 and IND-213) and the AWARE-1 study, paving the way for the next phase of pelareorep's development and its registration. Ongoing discussions with our clinical collaborators and partners have helped us to prepare a robust, compelling briefing document," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "We eagerly anticipate our discussion with the FDA to align on the design and objectives of the registrational trial for pelareorep in metastatic breast cancer, a critical step towards bringing this innovative treatment to patients. Having a well-defined plan for the registrational track study will also help advance our strategic partnering discussions. We hope to meet with the agency in Q2 2024 and look forward to a productive dialogue. With anticipated overall survival data from the BRACELET-1 study and productive discussions with the FDA, 2024 is poised to be a transformative year for Oncolytics and our stakeholders."
Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics, added, "The data from the randomized BRACELET-1 trial showcased compelling results for the pelareorep/paclitaxel combination therapy in HR+/HER2- metastatic breast cancer patients, with a nearly tripled confirmed response rate, a
Dr. Heineman continued, "Our proposed study plans to evaluate pelareorep in patients with HR+/HER2- mBC who are eligible for chemotherapy after progressing on prior hormonal therapy, including a CDK 4/6 inhibitor. We also intend to evaluate potential biomarkers, including the expansion of tumor-infiltrating lymphocytes, using T cell receptor sequencing. We look forward to the opportunity to discuss our plans with the agency and align on the best approach to advance the development of pelareorep as a potential treatment option to improve outcomes for breast cancer 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 Phase 2 studies in breast and pancreatic cancers. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "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 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 plans for a meeting with the FDA in relation to the Company's planned registration-enabling trial for pelareorep in patients with HR+/HER-2 mBC and the anticipated timing thereof; our focus in 2024; our belief that 2024 is poised to be a transformative year for Oncolytics and its stakeholders; the design and areas of evaluation for our proposed study of pelareorep in patients with HR+/HER-2 mBC; 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. We may incur expenses or delays relating to such events outside of our control, including public health crises such as pandemics and epidemics, 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
Company Contact Jon Patton Director of IR & Communication | Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 |
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FAQ
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