BriaCell’s phase 3 breast cancer study continues after safety review

PHILADELPHIA/VANCOUVER - BriaCell Therapeutics Corp. (NASDAQ:BCTX, TSX:BCT), a clinical-stage biotech with a market capitalization of $2.5 million, announced Tuesday that its pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor for metastatic breast cancer will continue without modifications following a third consecutive positive safety review. According to InvestingPro data, while the company maintains stable trial progress, it faces the challenge of quick cash burn rate typical of early-stage biotechs.

The independent Data Safety Monitoring Board (DSMB) completed its scheduled review of the trial’s safety data and identified no safety concerns, according to a company press release statement. The DSMB conducts quarterly reviews as required by the study protocol.

The Phase 3 clinical trial is being conducted under Fast Track designation granted by the U.S. Food and Drug Administration (FDA), a status given to treatments addressing serious conditions with significant unmet medical needs.

"The third consecutive DSMB review is a meaningful milestone in our Phase 3 trial, which continues to highlight the excellent safety and tolerability profile of BriaCell’s regimen," said Dr. William V. Williams, BriaCell’s President and CEO, in the statement.

The study (NCT06072612) is evaluating the company’s Bria-IMT immunotherapy in combination with an immune checkpoint inhibitor for patients with metastatic breast cancer.

BriaCell Therapeutics is a clinical-stage biotechnology company focused on developing novel immunotherapies for cancer treatment. The company’s shares are listed on both Nasdaq and the Toronto Stock Exchange.

In other recent news, BriaCell Therapeutics Corp. has made significant advancements in its cancer treatment studies. The company reported promising results from its Phase 1/2 monotherapy study of Bria-OTS, where a patient with metastatic breast cancer experienced a complete resolution of lung metastasis. This development prompted BriaCell to initiate a combination phase with a checkpoint inhibitor (CPI) to potentially enhance anti-tumor effects. Additionally, BriaCell announced new survival data from its Phase 2 study of Bria-IMT in combination with CPIs for metastatic breast cancer, showing improved median overall survival compared to the current standard of care, TRODELVY®. The study revealed that 25 out of 37 hormone receptor-positive patients had a median overall survival of 17.3 months, surpassing the 14.4 months with TRODELVY®. BriaCell’s ongoing Phase 3 study aims to further evaluate these findings. The company is also testing an optimized version of its immunotherapy platform, Bria-OTS+, across various cancer types. These developments underscore BriaCell’s efforts to provide new therapeutic options for hard-to-treat cancers.

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