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PHILADELPHIA/VANCOUVER - BriaCell Therapeutics Corp. (Nasdaq:BCTX; TSX:BCT), a $2.5 million market cap biotechnology company, announced Wednesday the addition of Los Angeles Cancer Network and Smilow Cancer Hospital at Yale New Haven to its pivotal Phase 3 clinical study for metastatic breast cancer treatment, adding 30 satellite locations to the trial. According to InvestingPro data, the company faces significant cash burn challenges typical of clinical-stage biotech firms.
The study, which is evaluating BriaCell’s lead candidate Bria-IMT plus an immune checkpoint inhibitor against physician’s choice in advanced metastatic breast cancer, now has 58 active clinical sites across 15 states.
According to the company’s statement, patient enrollment is expected to be completed in late 2025 or early 2026, with potential top-line data available as early as the first half of 2026.
"Clinical investigator interest in our Phase 3 study has exceeded our expectations which has significantly expanded patient access to our treatment," said Giuseppe Del Priore, BriaCell’s Chief Medical Officer.
The trial will analyze interim data once 144 patient deaths occur, comparing overall survival between the treatment groups. The company noted that positive results could lead to full approval and marketing authorization for Bria-IMT in metastatic breast cancer patients.
BriaCell recently presented positive Phase 2 survival data at ASCO 2025 for the same treatment regimen in a similar patient population. The Bria-IMT combination has received FDA Fast Track designation.
The information in this article is based on a press release statement from BriaCell Therapeutics. For deeper insights into BriaCell’s financial health and growth prospects, including 8 additional exclusive ProTips, visit InvestingPro.
In other recent news, BriaCell Therapeutics Corp. has announced that its Phase 3 study of Bria-IMT combined with an immune checkpoint inhibitor for metastatic breast cancer will proceed without changes after a positive safety review. This follows the independent Data Safety Monitoring Board’s assessment, which found no safety issues, allowing the trial to continue under the Fast Track designation by the U.S. FDA. In another development, BriaCell has advanced its Bria-OTS immunotherapy to a combination phase with checkpoint inhibitors after a successful safety evaluation in a Phase 1/2 study. Notably, a patient in this study experienced complete resolution of lung metastasis, showing promising early results for the therapy. Furthermore, BriaCell has reported new survival data from its Phase 2 study, indicating that Bria-IMT in combination with checkpoint inhibitors may offer improved survival rates compared to the standard treatment, TRODELVY®, for patients with hormone receptor-positive and triple-negative breast cancer. The ongoing Phase 3 study aims to further evaluate these findings. BriaCell continues to explore the potential of its therapies to address unmet medical needs in breast cancer treatment.
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