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PHILADELPHIA/VANCOUVER - BriaCell Therapeutics Corp. (Nasdaq:BCTX, TSX: BCT), a $2.5 million market cap biotechnology company, announced Tuesday that 52% of patients in its most recent 25-patient cohort have survived beyond the one-year mark in its Phase 2 clinical study of Bria-IMT for metastatic breast cancer. According to InvestingPro data, analysts anticipate sales growth for the company in the current year, though the company currently operates with negative cash flows.
According to the company’s press release, this survival rate exceeds what would be expected with current standard of care therapies in similar patient populations. Eleven patients remain alive as of recent contact, with two patients reaching 38.3 and 30.3 months of survival respectively.
The company noted that many participants had advanced metastatic breast cancer and had already failed multiple prior treatments, including checkpoint inhibitors and antibody-drug conjugates such as TRODELVY and ENHERTU. The median number of prior treatments among the 54 total patients enrolled was six.
"BriaCell’s Phase 2 data indicate a robust survival signal and a well-tolerated profile," said Adam M. Brufsky, Professor of Medicine at the University of Pittsburgh School of Medicine, as quoted in the company statement.
The company reported no treatment discontinuations attributed to Bria-IMT. The Phase 2 study enrolled a total of 54 patients, with 37 receiving the formulation currently being used in BriaCell’s ongoing pivotal Phase 3 study. InvestingPro analysis shows the company is quickly burning through cash, with a negative free cash flow of $3.36 million in the last twelve months - a crucial metric for investors monitoring the company’s runway through clinical trials.
BriaCell’s Phase 3 clinical trial in metastatic breast cancer is currently listed on ClinicalTrials.gov as NCT06072612. The company stated that final median overall survival calculations for the Phase 2 study are pending as many patients remain alive.
The biotechnology company is developing novel immunotherapies for cancer treatment, with Bria-IMT being evaluated in combination with checkpoint inhibitors for metastatic breast cancer patients. For deeper insights into BriaCell’s financial health and growth prospects, InvestingPro subscribers have access to over 30 additional financial metrics and expert analysis.
In other recent news, BriaCell Therapeutics Corp. has announced significant developments in its ongoing clinical trials for metastatic breast cancer treatments. The company has expanded its Phase 3 clinical study of Bria-IMT by adding the Los Angeles Cancer Network and Smilow Cancer Hospital at Yale New Haven, bringing the total to 58 active sites across 15 states. Patient enrollment is anticipated to complete by late 2025 or early 2026, with top-line data expected in the first half of 2026. BriaCell also reported that its Phase 3 study will proceed without modifications after a third consecutive positive safety review by an independent Data Safety Monitoring Board. Additionally, BriaCell has advanced its Bria-OTS immunotherapy into a combination study with a checkpoint inhibitor, following promising safety evaluations in a Phase 1/2 monotherapy study. The company noted a complete resolution of lung metastasis in a patient treated with Bria-OTS, marking a noteworthy achievement in their Phase 1/2a clinical trial. Furthermore, BriaCell shared survival data from its Phase 2 study, showing that patients treated with Bria-IMT plus a checkpoint inhibitor had a median overall survival of 17.3 months, surpassing the 14.4 months observed with the current standard treatment, TRODELVY®. These developments underscore BriaCell’s ongoing efforts to address unmet medical needs in metastatic breast cancer treatment.
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