Soon to Be Phase 1/2 Trial: Bria-PROS+ Receives FDA Clearance to Begin Clinical Study in Prostate Cancer

Bria-PROS+ has received clearance from the U.S. Food and Drug Administration to enter clinical testing as an investigational personalized, off-the-shelf cellular immunotherapy for prostate cancer. The FDA completed its review of the Investigational New Drug application allowing a Phase 1/2a clinical study to move forward.

The study is expected to evaluate the safety, tolerability, and preliminary therapeutic activity of Bria-PROS+ in patients with advanced prostate cancer.

Bria-PROS+ is designed to stimulate multiple components of the immune system through a combination of adaptive and innate immune activation. Preclinical findings presented at the American Association for Cancer Research Annual Meeting indicated that the therapy activated naïve T cells, dendritic cells, and natural killer cells.

This multipronged immune activity is intended to improve the immune system’s ability to recognize and attack prostate cancer cells while potentially reducing the risk of immune escape.

The treatment uses a personalized matching strategy based on human leukocyte antigen, or HLA, characteristics. Bria-PROS+ cell lines are selected according to compatibility with individual patients, with the aim of improving immune recognition and interaction between the therapeutic cells and the patient’s immune system.

The Phase 1/2a study will initially focus on safety, tolerability, dosing, and biological activity, while also evaluating preliminary signs of antitumor effects. Important future data points will include first-patient dosing, adverse-event findings, immune-monitoring results, prostate-specific antigen responses, radiographic tumor responses, and measures of disease control.

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