BriaCell Receives Positive Recommendation from Independent Data Monitoring Board
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 day ago
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Should l Buy BCTX?
BriaCell Therapeutics announces that the independent Data Safety Monitoring Board, DSMB, has issued its fifth consecutive positive recommendation following review of safety data from BriaCell's Phase 3 Bria-ABC study of Bria-IMT plus immune checkpoint inhibitor, CPI, in patients with metastatic breast cancer. Following its review, the DSMB raised no safety concerns and recommended that the study continue without modifications. DSMB meetings occur quarterly in accordance with the study protocol. BriaCell's ongoing pivotal Phase 3 study is being conducted under Fast Track designation granted by the US Food and Drug Administration, reflecting the significant unmet medical need in metastatic breast cancer.
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Analyst Views on BCTX
About BCTX
BriaCell Therapeutics Corp. is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. Bria-IMT, its Phase 3 lead candidate, is a patented, off-the-shelf, cell-based, targeted immunotherapy that activates the patient’s immune system to specifically kill cancer cells without harming other cells. The Company is advancing its Bria-IMT targeted immunotherapy in combination with an immune check point inhibitor (Retifanlimab) in a pivotal Phase 3 study in metastatic breast cancer. It is also developing personalized off-the-shelf immunotherapies, Bria-OTS and Bria-OTS+, which provides a platform technology to develop personalized off-the-shelf immunotherapies for numerous types of cancer, and a soluble CD80 protein therapeutic which act both as a stimulator of the immune system, as well as an immune checkpoint inhibitor. Its pipeline also includes Bria-IMT + CPI, Bria-BRES/BRES+, Bria-PROS+, Bria-LUNG+ and Bria-MEL+.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
BriaCell's Phase 3 Study Receives Fifth Positive DSMB Recommendation
- 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.
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- 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.
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- 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.
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- 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.
See More
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- 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.
See More
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- 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.
See More
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