On August 5, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported that the U.S. Food and Drug Administration (FDA) has completed its review of the Investigational New Drug (IND) application for Bria-PROS+ and issued a Study May Proceed letter, clearing the way for clinical evaluation of Bria-PROS+, its next generation, personalized, off-the-shelf, cell-based immunotherapy for prostate cancer.
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"We are pleased to announce FDA clearance of the IND for Bria-PROS+, our next-generation personalized immunotherapy for prostate cancer," stated Dr. William V. Williams, BriaCell’s President & CEO. "Bria-PROS+ is designed to activate multiple components of the immune system, which we believe has the potential to support meaningful therapeutic benefit with a favorable safety profile. We look forward to advancing Bria-PROS+ into the clinic as we work to develop new treatment options for patients with advanced prostate cancer."
In August 2025, BriaCell was awarded a $2 million non-dilutive grant from the US National Cancer Institute to support the manufacturing and planned clinical evaluation of Bria-PROS+.
As reported in BriaCell’s preclinical poster presentation, at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, Bria-PROS+ demonstrated activation of both adaptive and innate immune responses including activation of naïve (resting) T-cells, dendritic cells and natural killer (NK) cells. BriaCell believes this multipronged immune activation may enhance clinical efficacy and help prevent immune escape in patients with prostate cancer.
BriaCell’s Bria-PROS+ builds on the Company’s oncology platform with its Bria-IMT program, currently in its Phase 3 pivotal trial for metastatic breast cancer, its Bria-OTS breast cancer clinical program, in which the first patient dosed experienced sustained complete resolution of a lung metastasis, and its Bria-BRES+ program, which recently received FDA clearance to initiate clinical evaluation of its enhanced, personalized, off-the-shelf cellular immunotherapy for breast cancer. Bria-PROS+, Bria-OTS and Bria-BRES+ programs are personalized immunotherapies, based on HLA matching between patients and the respective immunotherapy cell lines.
(Press release, BriaCell Therapeutics, AUG 5, 2026, View Source [SID1234669756])