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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- Transaction Overview: BriaPro has entered into a purchase agreement with BriaCell to acquire worldwide rights to develop and commercialize sCD80, with the transaction expected to close around March 12, 2026, marking a significant advancement in cancer treatment.
- Funding Support: BriaCell will provide up to $3 million to BriaPro for research and development, aimed at accelerating the development of sCD80, which is expected to significantly enhance BriaPro's R&D capabilities and market competitiveness.
- Equity Changes: As part of the transaction, BriaPro will issue 23,972,589 common shares to BriaCell, increasing BriaCell's ownership in BriaPro to approximately 78% post-transaction, thereby strengthening its control over the subsidiary.
- Immunotherapy Potential: sCD80 has shown good tolerability and anti-tumor activity in animal models, and BriaCell plans to explore its use in combination with other immunotherapies, potentially providing new treatment options for cancer patients and holding significant market potential.

Agreement Overview: A new agreement has been reached for the purchase of exclusive soluble CD80 licenses.
Parties Involved: The agreement involves BRIACELL and a partner entity, indicating a strategic collaboration in the biotech sector.
- Safety Confirmation: The independent Data Safety Monitoring Board (DSMB) has issued its fifth consecutive positive recommendation for BriaCell's Phase 3 Bria-ABC study, indicating no safety concerns with the Bria-IMT regimen combined with immune checkpoint inhibitors, thereby bolstering investor confidence in the therapy.
- FDA Fast Track Designation: The study is being conducted under the FDA's Fast Track designation, highlighting the significant unmet medical need in metastatic breast cancer, which suggests that BriaCell is positioned to capitalize on substantial market opportunities in this area.
- Clinical Progress Outlook: BriaCell's CEO, William V. Williams, emphasized that the ongoing support from the DSMB will facilitate the advancement of the Bria-IMT regimen, aiming to provide new hope for patients with limited treatment options, showcasing the company's commitment to innovative therapies.
- Regular Review Mechanism: The DSMB meets quarterly to ensure the safety and efficacy of the study, and the continuous positive feedback not only enhances the credibility of the research but also adds significant weight to BriaCell's reputation in the biotechnology sector.
- 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.

- 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.
- Retail Sales Surge: U.S. retail sales increased by 0.6% month-over-month in November, marking the largest surge since July, indicating a potential rebound in consumer spending that could positively impact economic recovery.
- Tech Stock Decline: Information technology stocks fell by 1.3% on Wednesday, reflecting market concerns over the tech sector, which may affect investor confidence and lead to capital outflows.
- High-Risk Stock Surge: High Roller Technologies, Inc. (NYSE:ROLR) shares skyrocketed 289% to $13.64 after announcing a binding Letter of Intent with Crypto.com to launch an event-based prediction markets product in the U.S., demonstrating strong market demand for innovative offerings.
- IPO Impact: Briacell Therapeutics Corp. (NASDAQ:BCTX) priced its $30 million public offering at $5.59 per unit, leading to a 53% drop in its stock price to $5.09, reflecting market sensitivity to financing activities.




