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

MWN-AI** Summary

BriaCell Therapeutics Corp. has announced a significant milestone in its Phase 3 study for Bria-IMT™, an innovative treatment for metastatic breast cancer. The independent Data Safety Monitoring Board (DSMB) has issued a fifth consecutive positive recommendation following a detailed review of safety data, confirming that there are no safety concerns and advising that the study continue as planned. This pivotal Phase 3 study, known as Bria-ABC, includes the combination of Bria-IMT and an immune checkpoint inhibitor and is currently conducted under the FDA’s Fast Track designation, underscoring the substantial unmet medical need in treating metastatic breast cancer.

Dr. William V. Williams, the President and CEO of BriaCell, expressed optimism regarding the safety profile of Bria-IMT and emphasized the company's dedication to advancing this promising therapy for patients who have limited treatment options. The ongoing DSMB reviews occur quarterly in accordance with the study protocol, which further highlights the proactive measures taken to monitor the safety of participants.

BriaCell is committed to continuing its innovative approach to cancer care through novel immunotherapies and plans to provide further clinical updates as the study progresses. The focus on the unmet needs in breast cancer treatment reflects the urgency and importance of the research being conducted. As BriaCell moves forward through its pivotal Phase 3 study, investors and stakeholders will be keenly watching for updates that may shape the future landscape of metastatic breast cancer therapies.

For further details about BriaCell and its activities, interested parties can visit the company’s official website.

MWN-AI** Analysis

BriaCell Therapeutics Corp. recently received its fifth consecutive positive recommendation from an independent Data Safety Monitoring Board (DSMB) regarding its Phase 3 study of Bria-IMT combined with immune checkpoint inhibitors for metastatic breast cancer. This is a significant milestone for BriaCell, indicating that no safety concerns have been identified, thereby bolstering confidence in the drug’s safety profile. The ongoing Phase 3 study has also been granted FDA Fast Track designation, underscoring the pressing medical need for effective therapies in this patient population.

As BriaCell advances in this pivotal study, investors should view these series of favorable recommendations as an encouraging signal for the company's growth potential. The consistently positive feedback from the DSMB not only reflects a robust safety profile but also reinforces BriaCell’s position in a competitive and high-demand sector. The unmet need in metastatic breast cancer, coupled with the clinical progress BriaCell is making, increases the likelihood of eventual regulatory approval—a crucial turning point that could lead to substantial revenue streams.

However, investors should remain cautious and consider potential risks. As noted in the press release, the forward-looking statements issued by BriaCell are subject to inherent uncertainties and may not always materialize as anticipated. Market fluctuations and regulatory hurdles could impact the advancement of Bria-IMT's development.

In conclusion, while the positive DSMB recommendation is a solid indicator of BriaCell's trajectory, a comprehensive assessment of market conditions and ongoing monitoring of clinical trials will be imperative for investors. Those considering investment in BriaCell should balance the optimistic outlook with an awareness of the associated risks.

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

Source: GlobeNewswire
  • Independent DSMB has identified no safety concerns, and recommends continuation of BriaCell’s pivotal Phase 3 study of Bria-IMT™ plus immune check point inhibitor
  • Fifth consecutive positive DSMB recommendation supports the favorable safety profile observed to date
  • 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, Feb. 17, 2026 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ, BCTXL) (TSX: BCT) (“BriaCell” or the “Company”), clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, announces that the independent Data Safety Monitoring Board (DSMB) has issued its fifth 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.

“This marks the fifth consecutive DSMB review supporting the continued conduct of BriaCell’s pivotal Phase 3 Bria-ABC study,” said Dr. William V. Williams, President and Chief Executive Officer of BriaCell. “We are encouraged by the DSMB’s ongoing confirmation of the safety profile of the Bria-IMT regimen and remain focused on advancing this program for patients with limited treatment options. We look forward to providing additional clinical updates as the study progresses.”

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; 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
[email protected] 

Investor Relations Contact:
[email protected]


FAQ**

How might the positive recommendations from the DSMB affect investor confidence in BriaCell Therapeutics Corp. Warrants BCTXL, particularly given the ongoing Phase 3 study of Bria-IMT in metastatic breast cancer?

Positive recommendations from the DSMB could significantly boost investor confidence in BriaCell Therapeutics Corp. Warrants BCTXL, as they indicate progress and safety in the ongoing Phase 3 study of Bria-IMT in metastatic breast cancer, potentially enhancing future market value.

What implications do the findings of the DSMB have for the future market potential of BriaCell Therapeutics Corp. Warrants BCTXL, especially if the Phase 3 study meets its endpoints?

If the DSMB findings support the safety and efficacy of BriaCell Therapeutics Corp. in its Phase 3 study, it could significantly boost investor confidence, leading to increased market potential and demand for Warrants BCTXL, potentially driving their value higher.

Given the favorable safety profile observed by the DSMB, how do you anticipate that will influence the valuation of BriaCell Therapeutics Corp. Warrants BCTXL in the competitive landscape of cancer therapeutics?

The favorable safety profile from the DSMB is likely to enhance BriaCell Therapeutics Corp.'s valuation of Warrants BCTXL by increasing investor confidence and interest, positioning the company more favorably against competitors in the cancer therapeutics market.

In light of the FDA Fast Track designation, what strategic advantages might BriaCell Therapeutics Corp. Warrants BCTXL experience compared to similar companies and their clinical trials in oncology?

BriaCell Therapeutics Corp. Warrants BCTXL could gain expedited development and approval timelines, enhanced communication with the FDA, and potential priority review benefits, positioning it competitively over similar companies conducting oncology clinical trials.

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

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