BriaCell Enrollment Pace Accelerating in Phase 3 Clinical Study in Advanced Metastatic Breast Cancer (Bria-ABC)
Rhea-AI Summary
BriaCell Therapeutics (Nasdaq: BCTX) reports accelerating enrollment in its pivotal Phase 3 clinical study for advanced metastatic breast cancer treatment. The study has enrolled over 75 patients across 54 clinical sites in 15 states, evaluating Bria-IMT plus immune checkpoint inhibitor versus physician's choice.
The company expects to complete patient enrollment by late 2025 or early 2026, with potential top-line data release in H1-2026. The study's primary endpoint compares overall survival between treatment groups, with interim analysis planned after 144 patient events. The Bria-IMT combination regimen has received FDA Fast Track designation, and positive Phase 3 results could lead to full approval and marketing authorization for metastatic breast cancer treatment.
Positive
- Strong enrollment pace with over 75 patients enrolled in Phase 3 trial
- FDA Fast Track designation obtained for Bria-IMT combination
- Wide clinical site coverage across 54 locations in 15 states
- Previous Phase 2 showed positive survival data in similar patient population
Negative
- Final trial results not expected until H1-2026
- Requires 144 patient deaths for interim analysis
News Market Reaction 1 Alert
On the day this news was published, BCTX gained 27.68%, reflecting a significant positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
- Over 75 patients enrolled in BriaCell’s pivotal Phase 3 study of Bria-IMT™ plus immune check point inhibitor in metastatic breast cancer (MBC)
- 54 clinical sites across 15 states currently enrolling patients including Sylvester Comprehensive Cancer Center, Cancer Care Northwest, Hematology Oncology Associates of Fredericksburg, Northwestern University, Manhattan Hematology/Oncology Associates, New York Cancer and Bood Specialists, and Texas Oncology-Baylor Charles A. Sammons Cancer Center
PHILADELPHIA and VANCOUVER, British Columbia, April 22, 2025 (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, is pleased to announce that its ongoing pivotal Phase 3 clinical study (listed on ClinicalTrials.gov as NCT06072612) has consented over 100 and has enrolled over 75 patients. BriaCell anticipates completing patient enrollment in late 2025 or early 2026, and may report top line data as early as H1-2026.
BriaCell’s pivotal Phase 3 clinical study is evaluating BriaCell’s lead clinical candidate, Bria-IMT, plus immune check point inhibitor versus physician’s choice in advanced metastatic breast cancer (Bria-ABC).
“We are pleased at the expanding patient enrollment in our Phase 3 study, and expect this to continue to grow,” stated Dr. William V. Williams, BriaCell’s President & CEO. “We believe our novel therapeutic approach has the potential to transform cancer care for metastatic breast cancer patients, and are determined to bring our novel immunotherapy to market to help these patients.”
“Enrollment pace and clinical investigator interest in our Bria-ABC study is above any I have seen,” noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. “We would like to thank our dedicated clinical investigators and patients for participating in this important study. Through their efforts, we will advance our novel cancer immunotherapy to other MBC patients whose medical needs remain unmet.”
About BriaCell’s Pivotal Phase 3 Clinical Study of Bria-IMT Combination Regimen in MBC patients
Fifty-four clinical sites in the US are actively 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 patient 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. BriaCell recently announced positive Phase 2 survival data in a similar MBC patient population treated with the same Bria-IMT combination regimen. 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 those about the Company’s anticipated expansion of patient enrollment, timeline for completing patient enrollment and timeline for reporting top line data in its ongoing pivotal Phase 3 clinical study; the Company’s beliefs regarding its ability to bring their novel immunotherapy to the market; the Company’s beliefs regarding the Bria-IMT combination regimen’s potential to transform cancer care for metastatic breast cancer patients; the Company offering its novel cancer immunotherapy to other metastatic breast cancer patients; the Company’s plans and timelines regarding its analysis of interim data on the Bria-IMT combination regimen, and how such data will be analyzed; and the Company’s beliefs regarding Bria-IMT receiving full approval and marketing authorization for metastatic breast cancer patients, 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, such as those 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.
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
Investor Relations Contact:
investors@briacell.com
FAQ
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