PHILADELPHIA and VANCOUVER, British Columbia — August 5, 2026 — Leads & Copy — BriaCell Therapeutics Corp. announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for Bria-PROS+, paving the way for a Phase 1/2a clinical study of the novel immunotherapy in patients with prostate cancer. Bria-PROS+ is BriaCell’s next-generation personalized immunotherapy designed to incorporate additional immune-activating components to potentially enhance clinical efficacy.
The IND clearance allows BriaCell to proceed with clinical evaluation of Bria-PROS+, which is described as a personalized, off-the-shelf, cell-based immunotherapy for prostate cancer.
Dr. William V. Williams, BriaCell’s President & CEO, stated, “We are pleased to announce FDA clearance of the IND for Bria-PROS+, our next-generation personalized immunotherapy for prostate cancer. 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 received a $2 million non-dilutive grant from the US National Cancer Institute. This funding is intended to support the manufacturing and planned clinical evaluation of Bria-PROS+.
Preclinical data presented by BriaCell at the American Association of Cancer Research (AACR) Annual Meeting indicated that Bria-PROS+ demonstrated activation of both adaptive and innate immune responses. Specifically, it showed activation of naïve T-cells, dendritic cells, and natural killer (NK) cells. BriaCell suggests this multifaceted immune activation may improve clinical efficacy and help prevent immune escape in prostate cancer patients.
Bria-PROS+ is part of BriaCell’s broader oncology platform, which includes other programs such as Bria-IMT™, currently in its Phase 3 pivotal trial for metastatic breast cancer; Bria-OTS™, a breast cancer clinical program where a patient experienced complete resolution of a lung metastasis; and Bria-BRES+™, which recently received FDA clearance for its enhanced, personalized, off-the-shelf cellular immunotherapy for breast cancer.
The Bria-PROS+, Bria-OTS, and Bria-BRES+ programs are all based on personalized immunotherapies that utilize HLA matching between patients and the respective immunotherapy cell lines.
BriaCell Therapeutics Corp. is a biotechnology company focused on immuno-oncology, developing targeted therapies for cancer management. More information is available at https://briacell.com/.
Source: BriaCell Therapeutics Corp.
