Full Press Release Details
• 35 sites active and enrolling in pivotal Phase 3 study of Bria-IMT™ combination with immune check point inhibitor in metastatic breast cancer (MBC)
• Primary endpoint is overall survival (OS) with Bria-IMT™ regimen plus Check Point Inhibitor (CPI) vs treatment of physician’s choice
• Interim data analysis planned at 144 events (deaths) could provide full approval and marketing authorization
• Pivotal Phase 3 study patient enrollment completion is expected in mid-2025
• No serious adverse events related to Bria-IMT™ have been reported to date
PHILADELPHIA, PA and VANCOUVER, British Columbia, October 15, 2024— BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, today provides a clinical engagement update of its pivotal Phase 3 study of Bria-IMT™ in combination with immune check point inhibitor in metastatic breast cancer (MBC). The study will enroll up to 354 patients randomized 1:1 to the BriaCell combination regimen or physician’s choice and will include a small number (n=50) of patients randomized to Bria-IMT™ monotherapy.
“We are very pleased to report that patient enrollment is on track for expected completion by mid-2025. We anticipate the interim data analysis of the ongoing pivotal Phase 3 study will confirm the effectiveness of the Bria-IMT™ combination regimen in patients with metastatic breast cancer who failed approved therapies,” stated Dr. William V. Williams, BriaCell’s President and CEO.
“Despite multiple approved drugs, breast cancer remains the second-leading cause of cancer death in American women,” stated Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. “We are determined to make our novel immunotherapy available to breast cancer patients whose medical needs remain unmet.”
35 clinical sites (18 main and 17 satellite) are active and enrolling patients in BriaCell’s pivotal Phase 3 study in metastatic breast cancer. Additional sites are in various stages of start-up.
Interim data will be analyzed once 144 events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT™ combination regimen versus those treated with physician’s choice as the primary endpoint. Positive results of the pivotal Phase 3 study could result in full approval and marketing authorization for Bria-IMT™ in MBC patients. Secondary analyses include comparison of the Bria-IMT™ combination regimen vs Bria-IMT™ monotherapy. BriaCell recently announced impressive Phase 2 survival data in a similar MBC patient population . The Bria-IMT™ combination regimen has received FDA Fast Track designation .
For additional information on BriaCell’s pivotal Phase 3 study of Bria-IMT™ and an immune check point inhibitor in metastatic breast cancer, please visit ClinicalTrials.gov NCT06072612 .
About BriaCell Therapeutics Corp.
BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.com/ .
Safe Harbor
This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including statements about: the Company’s beliefs about expected timing and completion of patient enrollment in BriaCell’s pivotal Phase 3 clinical study in metastatic breast cancer and the Company’s future reporting of specific patient enrolment numbers; the Company’s proposed analysis of interim data, and the Company’s belief that such interim data will confirm the effectiveness of the Bria-IMT™ combination regimen in certain patients; the Company’s beliefs regarding the availability of the Bria-IMT™ immunotherapy to patients whose medical needs remain unmet; and the Company’s belief that the results of the Phase 3 study could result in full approval and marketing authorization for Bria-IMT™, are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risks and Uncertainties” in the Company’s most recent Management’s Discussion and Analysis, under the heading “Risk Factors” in the Company’s most recent Annual Information Form, and under “Risks and Uncertainties” in the Company’s other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company’s profiles on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov . Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law.
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