BriaCell’s Pivotal Phase 3 Metastatic Breast Cancer Study Expands to Leading Cancer Center
Adding MSK as a Phase 3 site broadens Bria-IMT access and reinforces regulatory and clinical momentum in metastatic breast cancer.
Rhea-AI Summary
BriaCell Therapeutics (BCTX) has added Memorial Sloan Kettering Cancer Center as a site in its ongoing pivotal Phase 3 Bria-IMT™ plus immune checkpoint inhibitor trial for metastatic breast cancer (NCT06072612).
The study now includes more than 80 active clinical sites across 15 U.S. states, including major centers such as Penn Medicine’s Abramson Cancer Center, Mayo Clinic, Northwestern University and Yale’s Smilow Cancer Hospital. The randomized Bria-ABC study compares the Bria-IMT combination with physician’s choice of treatment, with overall survival as the primary endpoint and an interim analysis planned after 144 deaths. The trial recently received a positive recommendation from an independent DSMB to continue, follows positive Phase 2 survival data presented at ASCO 2026, holds FDA Fast Track designation, and was highlighted in Nature Medicine as one of “Eleven clinical trials that will shape medicine in 2026.” MSK has institutional financial interests related to BriaCell.
Positive
- Phase 3 Bria-IMT trial expanded to 80+ active sites across 15 states
- Study has FDA Fast Track designation for the Bria-IMT combination regimen
- Independent DSMB gave a positive recommendation to continue the Phase 3 study
- Phase 2 data in a similar population showed positive survival results at ASCO 2026
- Trial featured in Nature Medicine’s list of “Eleven clinical trials that will shape medicine in 2026”
Negative
- None.
Key Figures
- Active clinical sites
- More than 80 active clinical sites
- Pivotal Phase 3 metastatic breast cancer study
- States with active sites
- 15 states
- Pivotal Phase 3 metastatic breast cancer study
- Interim analysis threshold
- 144 deaths
- Planned interim overall-survival analysis
Previous Clinical trial Reports
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Sunnybrook joined the Bria-ABC Phase 3 study as its first Canadian clinical site
-
Penn Medicine’s Abramson Cancer Center joined the pivotal Bria-ABC Phase 3 study
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Key Terms
immune checkpoint inhibitor medical
overall survival medical
data safety monitoring board regulatory
fast track designation regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Now Enrolling Patients at Memorial Sloan Kettering Cancer Center (MSK)
- BriaCell Phase 3 trial featured in Nature Medicine as “Eleven clinical trials that will shape medicine in 2026”
PHILADELPHIA and VANCOUVER, British Columbia, Sept. 08, 2026 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, today announced that Memorial Sloan Kettering Cancer Center (MSK) has joined BriaCell’s ongoing pivotal Phase 3 study of Bria-IMT™ plus an immune checkpoint inhibitor in metastatic breast cancer (ClinicalTrials.gov identifier: NCT06072612).
BriaCell’s Phase 3 study now has more than 80 active clinical sites across 15 states, including Penn Medicine’s Abramson Cancer Center, Mayo Clinic, DHR Health Oncology Institute, Hematology Oncology Associates of Fredericksburg, Los Angeles Cancer Network, Manhattan Hematology/Oncology Associates, New York Cancer & Blood Specialists, Northwestern University, Smilow Cancer Hospital at Yale New Haven, Sylvester Comprehensive Cancer Center, Texas Oncology-Baylor Charles A. Sammons Cancer Center, and University of Arizona.
“We are pleased to welcome MSK as a clinical site in BriaCell’s Phase 3 study,” stated Dr. William V. Williams, BriaCell’s President & CEO. “MSK is one of the world’s leading cancer centers, and its participation expands patient access to the Bria-IMT regimen as we continue advancing a potential new therapeutic approach for heavily pretreated patients.”
“We are pleased that MSK is now enrolling patients in BriaCell’s pivotal Phase 3 study evaluating Bria-IMT for advanced breast cancer in patients with limited therapeutic options. We look forward to collaborating with BriaCell,” commented Phaedon Zavras, MD, the MSK Breast Medical Oncologist and Assistant Attending Physician who is serving as principal investigator for the MSK study site.
BriaCell’s pivotal Phase 3 clinical study is evaluating BriaCell’s lead clinical candidate, Bria-IMT in combination with an immune check point inhibitor (CPI), compared with physician’s choice of treatment in advanced metastatic breast cancer (the Bria-ABC study).
The study’s primary endpoint is overall survival (OS). An interim analysis is planned after 144 deaths have occurred, comparing OS in patients treated with the Bria-IMT combination regimen versus those treated with physician’s choice. BriaCell recently received a positive recommendation from the independent Data Safety Monitoring Board (DSMB) to continue the Phase 3 Study in metastatic breast cancer. At ASCO 2026, BriaCell also announced positive Phase 2 survival data in a similar metastatic breast cancer 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 please visit ClinicalTrials.gov NCT06072612.
Memorial Sloan Kettering Cancer Center (MSK) has institutional financial interests related to BriaCell.
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 regarding BriaCell’s ongoing Phase 3 study of Bria-IMT in metastatic breast cancer, the enrollment of MSK and expansion of clinical trial sites, the potential therapeutic benefits of the Bria-IMT regimen, and the recognition of the Phase 3 study by Nature Medicine as one of the clinical trials expected to shape medicine in 2026,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.
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
