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.
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 Director of IR & Communication jpatton@oncolytics.ca | Investor Relations for Oncolytics LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com |
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