BriaCell Treatment Shows Significant Improvement in Metastatic Breast Cancer
BriaCell Therapeutics releases new images highlighting resolution of metastatic breast cancer lesions in patients with orbital, temporal lobe, liver, and spinal involvement. Survival details on these and other select patients in its Phase 2 study, along with comparable populations, were previously reported. "The CD8 ImmunoPET images are remarkable, verifying the ability of the BriaCell treatment to activate CD8+ cytotoxic T cells and induce their infiltration into the cancerous tumors. This is key to the mechanism of action of the BriaCell approach and likely play a role in enhancing the long-term survival of patients even after they come off study," stated Dr. William Williams, CEO. A 66-year-old woman with ER+/PR+/HER2+ metastatic breast cancer, heavily pretreated with 8 prior lines of therapy, including an antibody-drug conjugate, remains alive 27 months post-enrollment. At baseline, she presented with metastatic involvement of the right orbit, right temporal lobe of the brain and multiple skeletal sites. Following treatment, she achieved complete resolution of the temporal lobe metastasis, substantial improvement in the orbital lesion and stable disease in the bone. She remained on study for 26 months after initiating treatment and receiving 35 cycles of therapy. Images though 20 months for this patient have been previously described. Shown here are updated images through 2 years with measurements superimposed. Bria-IMT treatment resulted in complete resolution of the right temporal lobe lesion and continued regression of the right orbital tumor. A 44-year-old woman with ER+/PR+/HER2- metastatic breast cancer, previously treated with 5 prior lines of therapy. At baseline, she presented with metastases to the spine. She completed 6 cycles of therapy achieving stable disease as her best response and remains in survival follow-up 27 months after study entry. Pre-treatment imaging of cervical lymph nodes with moderate uptake indicating presence of some CD8+ cytotoxic T cells. Post treatment enhancement of cervical lymph nodes indicating immune system activation and increased presence of CD8+ cytotoxic T cells. A 64-year-old woman with ER+/PR-/HER2- metastatic breast cancer, heavily pre-treated with 8 prior lines of therapy, including the antibody-drug conjugate Trodelvy, remains alive 25 months post-enrollment. At baseline, presented with hepatic metastasis. Before BriaCell Treatment: A liver metastasis is "cold," indicating minimal to no CD8+ cytotoxic T cells in the tumor while enlarged lymph nodes show moderate uptake. After BriaCell Treatment: Swelling around the metastasis demonstrates the liver metastasis has become "hot", indicating marked CD8+ cytotoxic T cell infiltration while further lymph node enlargement is consistent with increased activity indicating increased CD8+ T cells.
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BriaCell Treatment Shows Significant Efficacy in Cancer Patients
- Significant Clinical Efficacy: The Bria-IMT treatment achieved complete resolution of right temporal lobe metastasis in a 66-year-old female patient, who survived 27 months post-enrollment, demonstrating the therapy's potential in heavily pre-treated patients.
- Evidence of Immune Activation: CD8 ImmunoPET imaging revealed a significant increase in CD8+ T cells in the cervical lymph nodes post-Bria-IMT treatment, indicating immune system activation that may contribute to long-term survival.
- Study Scale and Results: Among 54 heavily pre-treated metastatic breast cancer patients, 37 received the Bria-IMT regimen, with no reported treatment discontinuations related to Bria-IMT to date, indicating good safety and tolerability of the therapy.
- Future Research Prospects: The ongoing Phase 3 clinical trial (NCT06072612) by BriaCell will further validate the efficacy of Bria-IMT, potentially bringing new hope to cancer treatment.

BriaCell's New Therapy Significantly Extends Survival in Breast Cancer Patients
- Impressive Survival Data: As of the latest assessment, nine patients treated with Bria-IMT since 2022 have survived over 18 months, significantly exceeding benchmarks for standard therapies, indicating the potential efficacy of this treatment.
- Strong Treatment Continuity: No Bria-IMT-related discontinuations have been reported to date, suggesting good tolerability of the regimen among patients, which may provide new treatment options for heavily pre-treated individuals.
- Clinical Trial Progress: The Bria-IMT regimen continues under Fast Track Designation from the US FDA, expected to offer more effective treatment options for late-stage breast cancer patients, addressing the urgent market need for new therapies.
- Future Research Directions: BriaCell's ongoing pivotal Phase 3 study will focus on overall survival as its primary endpoint, aiming to further validate the efficacy of Bria-IMT and promote its broader acceptance in clinical applications.









