Breakthrough in breast cancer treatment? BriaCell Therapeutics shares soar 150%!

BriaCell Therapeutics Corp., a clinical-stage biotechnology company, saw its shares surge by more than 150% to $1.55 following the release of positive overall survival data from its Phase 2 clinical study involving Bria-IMT in combination with an immune checkpoint inhibitor. The treatment is aimed at patients with late-stage metastatic breast cancer. However, despite this recent rally, the company’s shares are still down by 76% over the past year.

Positive Trial Results for Bria-IMT in Metastatic Breast Cancer

The Philadelphia-based biotechnology firm announced that the median overall survival for its most recent group of patients—treated since 2022—was 15.6 months. This represents a significant improvement when compared to similar patients reported in the literature, whose median overall survival ranges from 6.7 to 9.3 months. These patients are being treated with the same Bria-IMT formulation currently employed in BriaCell’s ongoing Phase 3 pivotal study of metastatic breast cancer. The recent data also reflects results from patients enrolled post-COVID, after full study activities resumed.

The updated survival data is a marked improvement over BriaCell’s previously reported median overall survival of 13.4 months in December 2023. The Phase 2 study involved 54 heavily pre-treated metastatic breast cancer patients, all treated with the Bria-IMT regimen alongside an immune checkpoint inhibitor. Of these, 37 patients received the Phase 3 formulation, and 25 of these were treated after COVID-19 disruptions, demonstrating the continued promise of the treatment regimen.

Expert Insights and Future Expectations

Commenting on the promising results, Sara A. Hurvitz, MD, Professor of Medicine at Fred Hutch Cancer Center and University of Washington, and a member of BriaCell’s medical advisory board, noted, “Overall survival in patients with heavily pre-treated metastatic breast cancer is very poor. The BriaCell early data is quite encouraging from both efficacy and tolerability standpoints.”

BriaCell’s President and CEO, Dr. William V. Williams, also expressed optimism, stating, “The nearly two-fold overall survival benefit we are seeing with the Bria-IMT regimen, together with the similar previously reported approximate doubling of progression-free survival compared with literature controls, strongly support our belief that Bria-IMT could have a meaningful impact in the lives of heavily pre-treated metastatic breast cancer patients.”

The company continues to push forward with its ongoing Phase 3 pivotal study, listed on ClinicalTrials.gov as NCT06072612, aiming to establish Bria-IMT as a new standard of care for metastatic breast cancer patients.

Unprecedented Survival Numbers for Challenging Patient Cases

BriaCell’s Chief Medical Officer, Giuseppe Del Priore, MD, MPH, emphasized the significance of the findings, stating, “The Bria-IMT regimen is the only investigational drug we have seen to show these impressive survival numbers in heavily pre-treated metastatic breast cancer patients who have failed numerous prior treatments, including immune checkpoint inhibitors and antibody-drug conjugates.”

As BriaCell continues to build upon these encouraging clinical results, the company is optimistic about the potential of the Bria-IMT regimen to transform cancer care for patients who have exhausted other treatment options. The positive Phase 2 data and the ongoing development efforts in Phase 3 offer hope for a breakthrough in the treatment landscape of metastatic breast cancer.