BriaCell Reports Positive Pre-IND Meeting with FDA for Bria-PROS+™ for Prostate Cancer

BriaCell Therapeutics Corp., a biotechnology firm engaged in developing innovative immunotherapies for cancer treatment, has announced positive feedback from the U.S. Food and Drug Administration (FDA) following a Pre-Investigational New Drug Application (Pre-IND) meeting. This progress marks a significant step toward filing an Investigational New Drug application (IND) and initiating a Phase 1/2 clinical study for Bria-PROS+™, an advanced prostate cancer treatment.

Dr. William V. Williams, President and CEO of BriaCell, expressed appreciation for the FDA's keen interest in Bria-PROS+™. He emphasized the urgency of addressing prostate cancer, which remains the second leading cause of cancer-related deaths among American men, despite the availability of various approved treatments. The FDA's constructive feedback is viewed as a pivotal moment in the development of Bria-PROS+™, bolstering the company’s mission to provide new hope to patients and their families.

Significantly, the FDA has waived the requirement for animal toxicology and animal pharmacokinetic (PK) studies, simplifying the pathway to open the IND for Bria-PROS+™. This exemption reduces the complexity of the development process, enabling BriaCell to focus on the necessary manufacturing and testing requirements before commencing the Phase 1/2 study.

The discussions during the Pre-IND meeting also covered BriaCell's broader development strategy, including its proprietary Bria-OTS+™ platform. This platform supports the development of other personalized immunotherapies, such as Bria-BRES+™ for breast cancer, Bria-LUNG+™ for lung cancer, and Bria-MEL+™ for melanoma. These developments align with BriaCell's aim to revolutionize cancer care through personalized treatment approaches.

Currently, BriaCell is conducting a Phase 1/2a study of its personalized immunotherapy Bria-BRES™ for metastatic breast cancer. The ongoing study aims to validate the efficacy and safety of this treatment in patients who have exhausted other therapeutic options.

BriaCell Therapeutics Corp. remains committed to transforming cancer treatment through innovative immunotherapies. The company continues to advance its pipeline of personalized treatments, aiming to address various forms of cancer and improve patient outcomes.

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