BriaCell's Bria-OTS treatment shows sustained complete resolution of lung metastasis in breast cancer patient.

BriaCell Therapeutics announced sustained complete resolution of lung metastasis in a patient with hormone receptor-positive, HER2-negative, metastatic breast cancer treated with Bria-OTS, their personalized off-the-shelf immunotherapy. The patient achieved 100% resolution of a lung metastasis after four doses of Bria-OTS monotherapy. The complete response was first observed at six months and the patient remains on study with stable disease elsewhere, with no treatment-limited toxicities observed.

BriaCell Therapeutics (NASDAQ: BCTX) has announced a significant milestone in its ongoing clinical trials for Bria-OTS, a personalized off-the-shelf immunotherapy. The company reported sustained complete resolution of lung metastasis in a 78-year-old patient with hormone receptor-positive, HER2-negative metastatic breast cancer. This patient, who had experienced multiple prior treatment failures, achieved 100% resolution of lung metastasis after just four doses of Bria-OTS monotherapy. The complete response was first observed at two months and confirmed at four and six months, with the patient remaining on the study with stable disease elsewhere and no treatment-limiting toxicities observed.

The patient received 12 cycles of Bria-OTS monotherapy, demonstrating strong single-agent activity in a challenging patient population. This result is particularly noteworthy as it was achieved at the lowest dose level of the Phase 1/2a study, suggesting potential for even greater efficacy at higher doses. The lack of treatment-limiting toxicities is also significant, as tolerability is a crucial factor in elderly patients with multiple treatment failures.

From a clinical perspective, several elements make this result particularly noteworthy. First, this response was achieved with monotherapy rather than a combination approach, which is uncommon in advanced metastatic disease. Second, the patient population – elderly with multiple treatment failures – represents a challenging cohort with typically poor prognosis. Third, the response occurred at the lowest dose level of the Phase 1/2a study, suggesting potential for even greater efficacy at higher doses.

BriaCell’s President and CEO, Dr. William V. Williams, stated, “We are highly encouraged by this remarkable and durable clinical response, especially at the lowest dose level. This data underscores the therapeutic potential of our Bria-OTS platform, and we look forward to further evaluating it in combination with a checkpoint inhibitor to improve outcomes in patients with advanced breast cancer.”

The company’s plans to evaluate Bria-OTS in combination with checkpoint inhibitors represent a logical next step, as such combinations often show synergistic effects in immunotherapy approaches. While this represents data from just a single patient and broader efficacy patterns remain to be established, complete responses with durability beyond six months in heavily pretreated metastatic breast cancer patients are relatively rare.

References:
[1] https://www.stocktitan.net/news/BCTX/bria-cell-patient-achieves-sustained-complete-resolution-of-lung-kpx0tzqaqc78.html
[2] https://finance.yahoo.com/news/briacell-phase-2-survival-achievement-113000536.html