BriaCell Therapeutics Corp. (BCTX), Tuesday announced that enrollment is rapidly accelerating in its ongoing pivotal Phase 3 clinical trial evaluating Bria-IMT in combination with an immune checkpoint inhibitor for patients with advanced metastatic breast cancer or MBC.
The company reported that more than 100 patients have consented, and over 75 patients have been enrolled in the study to date.
The trial is currently active at 54 clinical sites across 15 U.S. states, including prominent institutions such as Northwestern University, Texas Oncology, and Sylvester Comprehensive Cancer Center.
BriaCell expects to complete enrollment by late 2025 or early 2026, with top-line results potentially available in the first half of 2026.
"We are pleased at the expanding patient enrollment in our Phase 3 study and expect this trend to continue," said Dr. William V. Williams, CEO of BriaCell Therapeutics.
He further added that, "We believe our novel therapeutic approach has the potential to transform cancer care for metastatic breast cancer patients."
The pivotal trial, compares the Bria-IMT and checkpoint inhibitor combination to physician's choice treatment, with overall survival or OS as the primary endpoint.
Interim analysis will be conducted after 144 events (deaths) have occurred. Positive results could support FDA approval and marketing authorization for Bria-IMT in the MBC setting.
"Enrollment pace and investigator enthusiasm are higher than anything I've seen," added Dr. Giuseppe Del Priore, BriaCell's Chief Medical Officer.
BriaCell noted that the Bria-IMT regimen has already demonstrated encouraging Phase 2 survival data in a similar patient population and has been granted FDA Fast Track designation for advanced breast cancer.
The company emphasized that accelerating enrollment, strong clinical engagement, and positive early data reinforce its mission to deliver a novel immunotherapy option to patients with limited treatment alternatives in advanced-stage breast cancer.
Currently, BCTX is trading at $4.69 up by 12.05 percent on the Nasdaq.
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