- The randomized pivotal Phase 3 study is expected to enroll a total of 354 patients in either Bria-IMT™ combination or physician’s choice therapy (1:1)
- Positive results of the pivotal Phase 3 study could result in full approval and marketing authorization for Bria-IMT™
- The study’s primary endpoint is overall survival in patients treated with the Bria-IMT™ combination regimen versus those treated with physician’s choice
- The study initiation follows FDA Fast Track designation and earlier supportive Phase 2 safety and efficacy data in the same patient population
PHILADELPHIA and VANCOUVER, British Columbia, Oct. 03, 2023 (GLOBE NEWSWIRE) -- 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 announces that its registration-enabling pivotal Phase 3 study of its lead clinical candidate, Bria-IMT™, in combination with an immune check point inhibitor, is fully approved by the Institutional Review Board (IRB) and will soon enroll patients with advanced metastatic breast cancer.
“Timely initiation of our pivotal study is a key milestone for us further confirming our expedited timeline for FDA approval of our immunotherapy,” stated Dr. William V. Williams, BriaCell’s President and CEO. “Based on our recently announced benchmark beating survival data, we strongly believe that our novel immunotherapy may transform the way we treat advanced metastatic breast cancer patients, and we look forward to sharing additional development milestones in the coming months.”
The study will evaluate the efficacy and safety of the Bria-IMT™ combination regimen in patients who have failed at least two approved therapies for the disease.
Bria-IMT™ is currently under Fast Track Designation by the U.S. FDA intended to accelerate the review process of novel treatments that address unmet medical needs. Positive completion of the pivotal study, following review by FDA, could lead to full approval of the Bria-IMT™ immune checkpoint inhibitor combination in advanced metastatic breast cancer.
FDA has agreed that improvement in overall survival in the Bria-IMT™ combination arm as compared to the physician’s choice of treatment arm will be the primary endpoint of the study. The study will enroll 177 patients in the Bria-IMT™ combination therapy arm and 177 patients in the treatment of physician’s choice arm. To gather additional information on the Bria-IMT™ regimen alone, 50 patients will be enrolled in this regimen and will be eligible for combination therapy following their initial post treatment evaluation. We expect frequent and responsive FDA communication under our Fast Track status during our pivotal Phase 3 study.
The successful completion of the pivotal study would allow BriaCell to subsequently submit a Biologics License Application and accelerate the path to commercialization.
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, including statements relating to enrollment of patients in the study of the Bria-IMT™ combination regimen in advanced metastatic breast cancer, the potential of the study of the Bria-IMT™ combination regimen in advanced metastatic breast cancer to result in full approval and marketing authorization for Bria-IMT™, the survival benefit and tolerability of the Bria-IMT™ regimen in advanced metastatic breast cancer patients and the additive and/or synergistic effects of immune check point inhibitors with Bria-IMT™, the potential for its novel immunotherapy to transform the way that advanced metastatic breast cancer patients are treated, the duration of the study, the possibility and timing of a Biologics License Application to accelerate the path to commercialization.
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 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.sedar.com 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.
Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release.
Contact Information
Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
info@briacell.com
Media Relations:
Jules Abraham
Director of Public Relations
CORE IR
917-885-7378
julesa@coreir.com
Investor Relations Contact:
CORE IR
investors@briacell.com
