BriaCell Therapeutics Reports Sustained 100% Resolution of Lung Metastasis in Phase 1/2a Bria-OTS Study
DENVER, Colo., Apr 24, 2025 (247marketnews.com)- BriaCell Therapeutics (NASDAQ:BCTX) reported the sustained complete resolution of lung metastasis in a hormone receptor-positive (HR+) metastatic breast cancer patient, four months after initiating treatment in its Phase 1/2a Bria-OTS study. Initially reported in February 2025, the 100% tumor resolution in the patient’s lung, coupled with stable disease elsewhere, underscores the potential of Bria-OTS, a personalized, off-the-shelf immunotherapy.
Remarkable Clinical Outcome
The patient, a 78-year-old woman with HR+/HER2- metastatic breast cancer, had progressed through multiple prior therapies before enrolling in the study on November 21, 2024. At baseline, she exhibited extensive metastases across bone, lymph nodes, and lung. Treated with the lowest dose of Bria-OTS via intradermal injections every two weeks for six weeks (four doses), followed by dosing every three weeks, her lung metastasis was undetectable after two months and confirmed fully resolved at four months. The treatment was well-tolerated, with the patient remaining on study and maintaining stable disease in other metastatic sites.
Dr. Neal S. Chawla, Principal Investigator at Sarcoma Oncology Center, Santa Monica, CA, stated, “Despite recent advancements with Antibody-drug-conjugates (ADCs) and immune check point inhibitors (CPIs), many patients, including those with HR+ disease, like BriaCell’s first OTS patient, have very few options. We are thrilled with our initial data with single agent Bria-OTS showing rapid and strong anti-tumor activity in an HR+ patient and look forward to continuing this novel approach in patients with MBC, and other cancers.”
Dr. William V. Williams, BriaCell’s President and CEO, added, “This unprecedented anti-cancer response in the first patient dosed with Bria-OTS is an important milestone for us and provides early validation of BriaCell’s personalized immunotherapy approach.”
Scientific and Clinical Significance
Bria-OTS, an advancement of BriaCell’s lead candidate Bria-IMT (currently in a pivotal Phase 3 study), is under evaluation in a Phase 1/2a dose escalation study (ClinicalTrials.gov: NCT06471673) for metastatic breast cancer. The study assesses Bria-OTS as a monotherapy, with plans to combine it with an immune checkpoint inhibitor. This early success validates BriaCell’s personalized immunotherapy approach, designed to target specific cancer profiles with off-the-shelf convenience.
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