On May 27, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ; TSX: BCT), a clinical-stage biotechnology company advancing personalized immunotherapies for cancer, reported that Bria-OTS has cleared its safety evaluation in the Phase 1/2 monotherapy study and has now transitioned to dosing patients in combination with a checkpoint inhibitor (CPI) (Press release, BriaCell Therapeutics, MAY 27, 2025, View Source [SID1234653599]). The first patient has been dosed in the checkpoint inhibitor combination cohort of the ongoing Phase 1/2 study of Bria-OTS (NCT06471673) in metastatic breast cancer.
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Bria-OTS, a personalized next-generation version of Bria-IMT—currently in a pivotal Phase 3 trial—is designed to enhance immune responses against tumors. The CPI combination cohort follows the successful completion of a three-patient monotherapy safety run-in. Notably, the first monotherapy patient remains on study with complete resolution of lung metastasis .
"The encouraging responses seen will give us reason to believe that combining Bria-OTS with a checkpoint inhibitor could yield even greater anti-tumor activity," said Neal S. Chawla, MD, Director at the Sarcoma Oncology Center, Santa Monica, Ca., and Principal Investigator for the Bria-OTS study. "This approach may offer a new option for patients who have not responded to existing to antibody-drug-conjugates (ADCs) or checkpoint inhibitors. We are excited to further explore the therapeutic potential of the Bria-OTS platform."
"Initiating the CPI combination cohort marks a significant milestone for BriaCell," added Dr. William V. Williams, BriaCell’s President and CEO. "We believe Bria-OTS has the potential to address major gaps in current cancer care, and this step brings us closer to offering a much-needed personalized immunotherapy for difficult-to-treat cancers."
The ongoing study will assess Bria-OTS in combination with a CPI in up to 12 patients with metastatic breast cancer, with safety and objective response rate (ORR) as primary endpoints. BriaCell also plans to evaluate Bria-OTS+, a further optimized version of the platform, across multiple cancer types including breast and prostate cancers.