FDA Clears Bria-PROS+ Immunotherapy Trial in Prostate Cancer

The FDA has cleared an investigational new drug (IND) application for Bria-PROS+, a personalized, off-the-shelf, whole-cell immunotherapy for prostate cancer, according to a news release from BriaCell Therapeutics.¹

The clearance, issued as a “study may proceed” letter, allows the company to initiate a phase 1/2a clinical study of Bria-PROS+ in patients with advanced prostate cancer. Bria-PROS+ is designed as a next-generation iteration of the company’s personalized immunotherapy platform, incorporating additional immune-activating components intended to enhance clinical efficacy beyond earlier constructs.

“We are pleased to announce FDA clearance of the IND for Bria-PROS+, our next-generation personalized immunotherapy for prostate cancer,” William V. Williams, MD, BriaCell’s president and CEO, said in the news release. “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.”

Preclinical Background

Bria-PROS+, like BriaCell’s other personalized immunotherapy candidates, is based on human leukocyte antigen matching between patients and the company’s immunotherapy cell lines. In preclinical findings presented in a poster at the American Association for Cancer Research (AACR) Annual Meeting, Bria-PROS+ demonstrated activation of both adaptive and innate immune responses, including activation of naive T cells, dendritic cells, and natural killer cells.² According to the company, the immune activation of multiple cell types may boost clinical efficacy and help prevent immune escape in this disease setting. Bria-PROS+ demonstrated durable cytokine responses and cytotoxic activity without signs of functional exhaustion across multiple tumor targets.

The company received a $2 million non-dilutive grant from the National Cancer Institute in August 2025 to support the development of Bria-PROS+.¹

Broader Development Context

Bria-PROS+ builds on BriaCell’s broader oncology platform, which includes Bria-IMT, currently in a phase 3 pivotal trial for metastatic breast cancer, and Bria-OTS, a breast cancer clinical program in which the company has reported that the first patient dosed experienced sustained complete resolution of a lung metastasis. The company’s Bria-BRES+ program, an enhanced, personalized, off-the-shelf cellular immunotherapy for breast cancer, also recently received FDA clearance to begin clinical evaluation, according to the news release.

REFERENCES

1. BriaCell Receives FDA Clearance to Initiate Bria-PROS+ Clinical Study in Prostate Cancer. News release. BriaCell Therapeutics Corp. GLOBE NEWSWIRE. August 5, 2026. Accessed August 5, 2026. https://tinyurl.com/ja4waf62

2. BriaCell Presents Robust Anti-Cancer Activity of Bria-OTS+(TM) in Preclinical Cancer Models. News release. BriaCell Therapeutics Corp. April 21, 2026. Accessed August 6, 2026. https://tinyurl.com/2hsh35t4