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BriaCell Opens First Canadian Site - Sunnybrook - for Pivotal Phase 3 Trial in Metastatic Breast Cancer

MWN-AI** Summary

BriaCell Therapeutics Corp. has announced the opening of its first Canadian clinical site at Sunnybrook’s Odette Cancer Centre in Toronto, Ontario, for its pivotal Phase 3 clinical trial investigating Bria-IMT in combination with an immune checkpoint inhibitor for metastatic breast cancer. This study is notable, having been highlighted in *Nature Medicine* as one of the eleven clinical trials expected to significantly influence medicine by 2026. The trial, identified as ClinicalTrials.gov NCT06072612, aims to assess the overall survival of patients receiving the Bria-IMT regimen compared to physician’s choice treatment.

Dr. Katarzyna Jerzak from Sunnybrook emphasized the profound need for effective treatment options in metastatic breast cancer, expressing enthusiasm for the potential of BriaCell's new immunotherapy approach. BriaCell's study now comprises over 80 active sites across the U.S., including prominent institutions like Mayo Clinic and Penn Medicine’s Abramson Cancer Center.

Dr. William V. Williams, BriaCell’s CEO, described this milestone as crucial for expanding treatment options to Canadian patients while accelerating the development of Bria-IMT. The primary endpoint of the trial is overall survival, with an interim analysis set after the occurrence of 144 patient deaths, providing insights into the efficacy of the treatment.

Moreover, the combination therapy has already received FDA Fast Track designation, highlighting its potential. BriaCell recently reported encouraging Phase 2 survival data at ASCO 2026 for a similar patient population, strengthening the case for Bria-IMT’s efficacy in treating advanced metastatic breast cancer. For further information on the trial, interested parties can refer to ClinicalTrials.gov.

MWN-AI** Analysis

BriaCell Therapeutics Corp. (Nasdaq: BCTX, TSX: BCT) has taken a significant step forward by opening its first Canadian site at the Sunnybrook Odette Cancer Centre for its pivotal Phase 3 trial targeting metastatic breast cancer. This initiative not only expands the patient base but also solidifies BriaCell’s position within the competitive oncology landscape.

The Odette Cancer Centre is renowned for its cutting-edge cancer research and treatment, further adding credibility to BriaCell's clinical efforts. The trial focuses on the efficacy of Bria-IMT in combination with immune checkpoint inhibitors, an innovative approach that could potentially address the gap in treatment options for patients with advanced metastatic breast cancer. Given the poor prognosis and limited effective therapies currently available, this study is highly anticipated.

BriaCell's recognition in Nature Medicine as a trial that may shape future medical practices underscores the importance of this research. The FDA's Fast Track designation for Bria-IMT enhances its potential marketability, which could significantly affect investor sentiment favorably. The company has shown promise in interim analysis and reported positive Phase 2 survival data, which may drive further interest from both clinical experts and institutional investors.

From an investment standpoint, BriaCell appears to be on a trajectory with potential high returns; however, it is essential for investors to consider the inherent risks associated with clinical trials, including the uncertain regulatory environment and competition from other therapies. Keeping an eye on enrollment rates and upcoming interim analysis results can provide a clearer picture of the trial's impact on the company's valuation.

In conclusion, BriaCell is poised for potentially transformative advancements in treatment for metastatic breast cancer, with significant implications for its market position and stock performance in the coming years. Close monitoring of trial outcomes and market responses will be crucial for stakeholders.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: GlobeNewswire
  • Sunnybrook’s Odette Cancer Centre, a world-class cancer center in Toronto, Ontario, Canada, joins BriaCell’s pivotal Phase 3 clinical trial in metastatic breast cancer
  • BriaCell Phase 3 trial featured in Nature Medicine as one of “Eleven clinical trials that will shape medicine in 2026”

PHILADELPHIA and VANCOUVER, British Columbia, July 16, 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 the Odette Cancer Centre at Sunnybrook Health Sciences Centre, a leading cancer center in Toronto, Ontario, Canada, 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).

In the United States, BriaCell’s Phase 3 study now has over 80 active clinical sites across 15 states, including Penn Medicine's Abramson Cancer Center, Mayo Clinic, Smilow Cancer Hospital at Yale New Haven, DHR Health Oncology Institute, Hematology Oncology Associates of Fredericksburg, Los Angeles Cancer Network, Manhattan Hematology/Oncology Associates, New York Cancer & Blood Specialists, Northwestern University, Sylvester Comprehensive Cancer Center (University of Miami), Texas Oncology-Baylor Charles A. Sammons Cancer Center, and the University of Arizona.

“There are a limited number of effective treatment options for patients with metastatic breast cancer and, unfortunately for most patients, standard treatments eventually stop working,” commented Katarzyna Jerzak, MD, MSc, FRCPC, Medical Oncologist and Clinician Investigator at Sunnybrook’s Odette Cancer Centre, and Associate Professor in the Department of Medicine, University of Toronto. “We are excited to evaluate BriaCell’s innovative immunotherapy approach and to offer these patients the opportunity to access a potentially effective new treatment.”

“Opening our first Canadian clinical site for BriaCell’s pivotal Phase 3 study is an important milestone,” stated Dr. William V. Williams, BriaCell’s President & Chief Executive Officer. “Sunnybrook is a world-class cancer center, and its participation expands access to our Bria-IMT regimen to patients in Canada, as we work to accelerate development of this our novel immunotherapy for patients with metastatic breast cancer.”

BriaCell’s pivotal Phase 3 clinical study is evaluating BriaCell’s lead clinical candidate, Bria-IMT™, in combination with an immune checkpoint inhibitor (CPI), compared with physician’s treatment of physician’s choice in patients with advanced metastatic breast cancer (the Bria-ABC study). The study’s primary endpoint is overall survival (OS). An interim analysis is planned after 144 patient deaths have occurred, comparing mortality 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 reported 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 and an immune checkpoint 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 regarding the participation of Sunnybrook’s Odette Cancer Centre in BriaCell’s ongoing pivotal Phase 3 study, the continued enrollment, advancement and outcomes of the Phase 3 study, the continued development and potential commercialization of Bria-IMT, and the potential benefits of Bria-IMT for patients with metastatic breast cancer, 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


FAQ**

How does the inclusion of Sunnybrook’s Odette Cancer Centre in BriaCell Therapeutics Corp.'s Phase 3 trial for metastatic breast cancer impact the overall strategy of the trial, specifically regarding patient access to Bria-IMT?
The inclusion of Sunnybrook’s Odette Cancer Centre in BriaCell Therapeutics Corp.'s Phase 3 trial enhances the overall strategy by expanding patient access to Bria-IMT, facilitating a more diverse participant pool and potentially accelerating recruitment and data collection for the trial.
What are the implications of BriaCell Therapeutics Corp. Warrants BCTXL on the funding and future developments of the Phase 3 trial now that it has expanded to a prominent Canadian cancer center?
The implications of BriaCell Therapeutics Corp. Warrants BCTXL on funding and future developments of the Phase 3 trial, now expanded to a prominent Canadian cancer center, suggest potential increased investor confidence and enhanced capital for further advancements and research validation.
Can you elaborate on the specific criteria for patient enrollment in the BriaCell Therapeutics Corp. Phase 3 study, particularly in relation to those treated at the Odette Cancer Centre?
The specific criteria for patient enrollment in BriaCell Therapeutics Corp.'s Phase 3 study at the Odette Cancer Centre include advanced breast cancer patients who have experienced disease progression after standard therapies and have measurable disease as defined by RECIST criteria.
Given the recent positive Phase 2 survival data, what expectations does BriaCell Therapeutics Corp. have for patient outcomes as the trial at Sunnybrook's Odette Cancer Centre progresses, especially concerning the BriaCell Therapeutics Corp. Warrants BCTXL?
BriaCell Therapeutics Corp. expects improved patient outcomes in the ongoing trial at Sunnybrook's Odette Cancer Centre based on recent positive Phase 2 survival data, which may enhance investor confidence in the value of BriaCell Therapeutics Corp. Warrants BCTXL.

**MWN-AI FAQ is based on asking OpenAI questions about BriaCell Therapeutics Corp. Warrants (NASDAQ: BCTXL).

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