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BriaCell Therapeutics Corp. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for Bria-BRES+. This clearance allows the company to initiate a Phase 1/2a clinical study targeting metastatic breast cancer with its next-generation personalized immunotherapy. The treatment is designed to enhance clinical efficacy through additional immune-activating components integrated into its cell-based platform. This regulatory milestone is a significant step forward for the micro-cap biotech firm in its clinical development pipeline. The study will focus on evaluating the safety and preliminary efficacy of the immunotherapy in patients with advanced stages of the disease. Investors view this as a positive development, marking the transition of Bria-BRES+ into formal clinical evaluation.
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