BriaCell Therapeutics Corp. (NASDAQ:BCTX) announced Tuesday that the first patient in its Bria-OTS trial achieved an 11-month sustained complete resolution of a lung metastasis, providing a significant early validation for the company’s personalized "off-the-shelf" immunotherapy platform.
The patient, a 78-year-old woman with advanced hormone receptor-positive, HER2-negative metastatic breast cancer, had failed multiple prior lines of treatment before enrolling in the Phase 1/2a study.
Following just four doses of Bria-OTS as a monotherapy, imaging confirmed a 100% resolution of the lung lesion.
The clinical response, first observed at the two-month mark, has remained durable through nearly a year of follow-up, during which the patient received 17 cycles of treatment without experiencing any dose-limiting toxicities.
The Bria-OTS platform is designed to offer the benefits of personalized immunotherapy—traditionally a slow and expensive process—using pre-manufactured cell lines that are matched to a patient’s specific HLA (human leukocyte antigen) type via a simple saliva test.
This "off-the-shelf" approach aims to deliver targeted treatment in less than a week, a critical timeline for patients with aggressive, late-stage disease.
With the Phase 1 dose-escalation portion of the study now complete, BriaCell has moved into Phase 2a, where it is evaluating Bria-OTS in combination with an immune checkpoint inhibitor.
The company is also running a pivotal Phase 3 trial for its lead candidate, Bria-IMT, with an interim analysis expected in the first half of 2026.