BriaCell Receives Positive Recommendation from Data Safety Monitoring Board (DSMB) for Phase 3 Study in Metastatic Breast Cancer

BriaCell (Nasdaq:BCTX) reported that an independent Data Safety Monitoring Board issued a sixth consecutive positive recommendation for its pivotal Phase 3 Bria-ABC study of Bria-IMT plus checkpoint inhibitor in metastatic breast cancer.

Rhea-AI Summary

BriaCell (Nasdaq:BCTX) reported that an independent Data Safety Monitoring Board issued a sixth consecutive positive recommendation for its pivotal Phase 3 Bria-ABC study of Bria-IMT plus checkpoint inhibitor in metastatic breast cancer.

The DSMB found no safety concerns and advised continuing the Fast Track-designated trial without modifications.

Positive

• Sixth consecutive positive DSMB recommendation for Phase 3 Bria-ABC study
• DSMB identified no safety concerns and advised continuation without modifications
• Quarterly DSMB oversight supports ongoing safety monitoring of Bria-IMT plus CPI
• Phase 3 metastatic breast cancer study conducted under FDA Fast Track designation

Negative

• None.

Argus May 26 session

-2.01% close to close Open Argus

Details

News Market Reaction – BCTX

In the May 26 session, BCTX declined 2.01%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement reports a sixth consecutive positive DSMB recommendation with no safety concerns f...

Analysis

This announcement reports a sixth consecutive positive DSMB recommendation with no safety concerns for BriaCell’s pivotal Phase 3 Bria‑ABC study under FDA Fast Track. It reinforces the tolerability of Bria‑IMT plus checkpoint inhibitor in metastatic breast cancer. In context of recent ASCO data and expanding trial sites, key watchpoints remain future efficacy readouts, enrollment progression, and how ongoing development is balanced against the company’s funding needs.

Key Figures

DSMB recommendations: 6 consecutive positive Trial phase: Phase 3 DSMB meeting frequency: Quarterly

DSMB recommendations

6 consecutive positive

Safety reviews for pivotal Phase 3 Bria-ABC study

Trial phase

Phase 3

Bria-IMT plus immune checkpoint inhibitor in metastatic breast cancer

DSMB meeting frequency

Quarterly

Per Phase 3 Bria-ABC study protocol

Previous Clinical trial Reports

5 past events · Latest: May 22

Same Type 5 events

1. May 22

   ASCO 2026 data

   24h Move

   -6.2%

   Positive Phase 2 survival and biomarker data for Bria‑IMT in metastatic breast cancer.

2. May 13

   Site expansion

   24h Move

   +2.5%

   Added Penn Medicine’s Abramson Cancer Center as a Phase 3 Bria‑ABC study site.

3. May 12

   Enrollment update

   24h Move

   -1.9%

   Reported Phase 3 Bria‑ABC enrollment surpassing 230 patients with 315+ screened.

4. May 07

   Site expansion

   24h Move

   -1.2%

   Added NYU Langone’s Perlmutter Cancer Center as a clinical site for the Phase 3 study.

5. Apr 27

   ASCO presentations

   24h Move

   +3.9%

   Announced six metastatic breast cancer clinical data presentations for ASCO 2026.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

data safety monitoring board, immunotherapy, immune checkpoint inhibitor, fast track designation

4 terms

data safety monitoring board medical

"the independent Data Safety Monitoring Board (DSMB) has issued its sixth..."

A data safety monitoring board is a group of experts who regularly review information from a research or testing process to ensure it is safe and ethical. Think of them as watchdogs that watch over ongoing projects to protect participants and ensure everything is proceeding correctly. Their oversight helps maintain trust and safety, which is important for investors who want to see responsible management and reliable results.

immunotherapy medical

"a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care"

Treatment that uses or enhances the body’s immune system to detect and fight disease, most often cancers or chronic infections; think of it as training or arming the body’s own soldiers to find and destroy targets. It matters to investors because successful immunotherapies can lead to high-value drug approvals, recurring revenue from long-term treatments, and changes in competitive dynamics, while failures or safety issues in clinical trials can materially affect company valuations.

immune checkpoint inhibitor medical

"pivotal Phase 3 Bria-ABC study of Bria-IMT plus immune checkpoint inhibitor (CPI)"

An immune checkpoint inhibitor is a type of medicine that helps the body's immune system recognize and attack cancer cells more effectively. It works by blocking certain signals that cancer uses to hide from immune defenses, allowing the immune system to target tumors. This breakthrough has led to new cancer treatments, making immune checkpoint inhibitors an important area of growth and innovation in the healthcare industry.

fast track designation regulatory

"Phase 3 study is being conducted under Fast Track designation, reflecting the significant..."

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Add on Google Not now

• Independent DSMB has identified no safety concerns, to date, and recommends continuation of BriaCell’s pivotal Phase 3 study of Bria-IMT™ plus immune check point inhibitor
• Sixth consecutive positive DSMB recommendation to proceed highlights the favorable safety and tolerability of BriaCell’s novel immunotherapy approach 
• Phase 3 study is being conducted under FDA Fast Track Designation, reflecting the significant unmet need in metastatic breast cancer
  

PHILADELPHIA and VANCOUVER, British Columbia, May 26, 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, announces that the independent Data Safety Monitoring Board (DSMB) has issued its sixth consecutive positive recommendation following review of safety data from BriaCell’s pivotal Phase 3 Bria-ABC study of Bria-IMT plus immune checkpoint inhibitor (CPI) in patients with metastatic breast cancer (NCT06072612).

Following its review, the DSMB raised no safety concerns and recommended that the study continue without modifications. DSMB meetings occur quarterly in accordance with the study protocol. BriaCell’s ongoing pivotal Phase 3 study is being conducted under Fast Track designation granted by the US Food and Drug Administration (FDA), reflecting the significant unmet medical need in metastatic breast cancer.

“We are highly encouraged by the sixth consecutive positive recommendation of the DSMB for continuation of BriaCell’s pivotal Phase 3 Bria-ABC study,” said Dr. William V. Williams, President and Chief Executive Officer of BriaCell. “This important milestone represents another step forward in advancing BriaCell’s novel immunotherapy approaches for patients with urgent unmet medical needs.”

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 Bria-IMT’s safety and tolerability profile, as related to the positive DSMB recommendations; the continued conduct and advancement of BriaCell’s pivotal Phase 3 Bria‑ABC study under FDA Fast Track designation; and Bria-IMT’s potential as a transformative immunotherapy 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, 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

What did BriaCell (BCTX) announce about its Phase 3 metastatic breast cancer trial?

BriaCell announced a sixth consecutive positive DSMB recommendation for its Phase 3 Bria-ABC trial in metastatic breast cancer. According to BriaCell, the DSMB identified no safety concerns and advised the Bria-IMT plus checkpoint inhibitor study continue without modifications.

What does the positive DSMB recommendation mean for BriaCell's BCTX Phase 3 Bria-ABC study?

The positive DSMB recommendation means the Phase 3 Bria-ABC study can continue as planned. According to BriaCell, the independent board found no safety concerns and recommended ongoing conduct of the Bria-IMT plus checkpoint inhibitor trial without protocol changes.

How many positive DSMB reviews has BriaCell (BCTX) received for Bria-IMT in metastatic breast cancer?

BriaCell has received six consecutive positive DSMB recommendations for Bria-IMT in metastatic breast cancer. According to BriaCell, each quarterly review of the pivotal Phase 3 Bria-ABC study has found no safety concerns and supported continued trial conduct.

Is BriaCell's (BCTX) Phase 3 Bria-ABC trial under FDA Fast Track designation?

Yes, the Phase 3 Bria-ABC metastatic breast cancer trial is under FDA Fast Track designation. According to BriaCell, this designation reflects the significant unmet medical need for patients and supports development of Bria-IMT plus immune checkpoint inhibitor therapy.

What treatment combination is being tested in BriaCell's BCTX Phase 3 Bria-ABC trial?

The Phase 3 Bria-ABC trial is testing Bria-IMT plus an immune checkpoint inhibitor in metastatic breast cancer. According to BriaCell, this novel immunotherapy combination is being evaluated with quarterly DSMB oversight under an FDA Fast Track-designated pivotal study.

How often does the DSMB review safety data in BriaCell's (BCTX) Phase 3 metastatic breast cancer study?

The DSMB reviews safety data for BriaCell's Phase 3 study on a quarterly basis. According to BriaCell, these regular meetings have so far produced six consecutive positive recommendations, with no safety concerns and advice to continue the trial unchanged.