BriaCell Therapeutics Receives Sixth Positive Recommendation from DSMB
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 4 days ago
0mins
BriaCell Therapeutics announces that the independent Data Safety Monitoring Board, DSMB, has issued its sixth consecutive positive recommendation following review of safety data from BriaCell's Phase 3 Bria-ABC study of Bria-IMT plus immune checkpoint inhibitor 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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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 Immunotherapy Study Receives Positive DSMB Recommendation
- Clinical Trial Progress: BriaCell Therapeutics' Bria-ABC study in metastatic breast cancer has received its sixth consecutive positive recommendation from the independent Data Safety Monitoring Board, indicating no safety concerns and allowing the trial to proceed without modifications.
- FDA Fast Track Designation: Conducted under FDA Fast Track designation, the study underscores the significant unmet medical need in metastatic breast cancer, highlighting the strategic importance of the company's development of novel immunotherapies.
- CEO's Positive Remarks: CEO Dr. William V. Williams described this milestone as 'another step forward,' emphasizing BriaCell's commitment to addressing urgent patient needs and advancing its immunotherapy approach.
- Stock Performance Volatility: BCTX shares have traded between $2.98 and $36.90 over the past year, closing at $3.49, down 6.18% from the previous trading day, reflecting market caution regarding the company's future prospects.
See More
BriaCell's Phase 3 Study Receives Sixth Positive DSMB Recommendation
- Safety Assessment Results: The independent Data Safety Monitoring Board (DSMB) has issued its sixth consecutive positive recommendation for the continuation of BriaCell's Phase 3 Bria-ABC study, indicating favorable safety and tolerability of the immunotherapy, which enhances investor confidence in the company's future prospects.
- FDA Fast Track Designation: The study is being conducted under the FDA's Fast Track designation, reflecting a significant unmet medical need in metastatic breast cancer, positioning BriaCell's innovative therapies to potentially fill this market gap and enhance the company's competitiveness in the biotechnology sector.
- Clinical Trial Progress: The positive DSMB recommendation suggests that the combination of Bria-IMT and immune checkpoint inhibitors shows good safety in clinical trials, potentially offering new hope for patients in urgent need of treatment, thereby increasing BriaCell's market recognition.
- Strategic Company Implications: BriaCell's CEO, William V. Williams, noted that this milestone not only recognizes the company's research capabilities but also lays the groundwork for future financing and collaboration opportunities, further driving innovation in cancer treatment.
See More
BriaCell Reports Positive Clinical Data at ASCO 2026
- Survival Rate Data: The latest clinical trial indicates a median overall survival of 16.6 months for Bria-IMT, demonstrating its effectiveness in heavily pre-treated metastatic breast cancer patients, which signifies a crucial clinical advancement in extending patient survival.
- Quality of Life Improvement: The ongoing Phase 3 study shows that patients maintain stable quality of life (QOL) with no significant toxicity, suggesting that the combination of Bria-IMT and immune checkpoint inhibitors can effectively enhance overall health status and has potential for self-administration.
- Biomarker Analysis: The study reveals that 65% of patients experienced stability or a drop in Cancer-Associated Macrophage-Like cells (CAMLs), which significantly correlates with better progression-free survival (PFS), underscoring the importance of biomarkers in predicting treatment efficacy.
- Clinical Data Presentation: BriaCell will showcase six clinical data presentations at the 2026 ASCO Annual Meeting, emphasizing its commitment to innovative cancer treatment options, aiming to provide new hope for patients in need of better therapies.
See More
BriaCell Expands Focus on Women's Health with New Ovarian Cancer Therapy
- New Therapy Development: BriaCell is developing Bria-OVA+, a personalized immunotherapy for ovarian cancer designed to enhance anti-tumor activity through additional immune-stimulating components, reflecting the company's strategic expansion into women's health.
- Market Demand: According to the National Cancer Institute, an estimated 21,010 women in the U.S. will be diagnosed with ovarian cancer by 2026, with approximately 12,450 expected to die from the disease, highlighting the urgent need for new therapies, especially for patients unresponsive to existing treatments.
- Preclinical Data Support: BriaCell recently presented preclinical data for Bria-BRES+ at the AACR conference, demonstrating its ability to activate both adaptive and innate immunity, supporting the potential of the Bria-OTS+ platform and providing a scientific basis for the development of Bria-OVA+.
- Strategic Collaboration: BriaCell has licensed ovarian cancer cell lines from the American Type Culture Collection (ATCC) and has commenced development activities to support the production of Bria-OVA+ for potential clinical use, further solidifying its position in the cancer immunotherapy space.
See More
BriaCell Launches Next-Gen Immunotherapy for Prostate Cancer
- Clinical Supply Completion: BriaCell has completed the manufacturing of clinical supplies for Bria-PROS+ and plans to initiate a Phase 1/2a clinical study in prostate cancer in the coming months, marking a significant advancement in cancer treatment.
- Funding Support: In August 2025, BriaCell was awarded a $2 million non-dilutive grant to support the manufacturing and clinical evaluation of Bria-PROS+, enhancing its R&D capabilities and market competitiveness.
- Immune Activation Effects: Bria-PROS+ demonstrated activation of both adaptive and innate immunity in a recent AACR preclinical presentation, including activation of naïve T-cells, dendritic cells, and natural killer cells, indicating its potential as an immunotherapy for prostate cancer.
- Platform Advantage: Bria-PROS+ is based on the Bria-OTS+ platform, which has shown significant efficacy in breast cancer treatment, further solidifying BriaCell's leading position in the field of immuno-oncology.
See More
BriaCell's Phase 3 Clinical Trial Shows Significant Progress
- Patient Recruitment Status: BriaCell's Phase 3 Bria-ABC study has screened over 315 patients and enrolled more than 230, demonstrating strong clinical site and patient interest, which is expected to drive future commercialization efforts.
- Clinical Trial Recognition: The study has gained sustained attention from leading cancer centers due to its mention in a Nature Medicine article, further enhancing patient engagement and indicating its potential impact in cancer treatment.
- Survival Rate Analysis: The primary endpoint of the study is overall survival, with an interim analysis expected after 144 patient events occur; positive results could support full approval of Bria-IMT for patients with metastatic breast cancer.
- FDA Fast Track Designation: The Bria-IMT combination regimen has received FDA Fast Track designation, highlighting its potential significance in cancer treatment, with BriaCell planning to report interim analysis results in 2026 to advance its innovative immunotherapy to market.
See More
BriaCell's Immunotherapy Study Receives Positive DSMB Recommendation
- Clinical Trial Progress: BriaCell Therapeutics' Bria-ABC study in metastatic breast cancer has received its sixth consecutive positive recommendation from the independent Data Safety Monitoring Board, indicating no safety concerns and allowing the trial to proceed without modifications.
- FDA Fast Track Designation: Conducted under FDA Fast Track designation, the study underscores the significant unmet medical need in metastatic breast cancer, highlighting the strategic importance of the company's development of novel immunotherapies.
- CEO's Positive Remarks: CEO Dr. William V. Williams described this milestone as 'another step forward,' emphasizing BriaCell's commitment to addressing urgent patient needs and advancing its immunotherapy approach.
- Stock Performance Volatility: BCTX shares have traded between $2.98 and $36.90 over the past year, closing at $3.49, down 6.18% from the previous trading day, reflecting market caution regarding the company's future prospects.
See More
BriaCell's Phase 3 Study Receives Sixth Positive DSMB Recommendation
- Safety Assessment Results: The independent Data Safety Monitoring Board (DSMB) has issued its sixth consecutive positive recommendation for the continuation of BriaCell's Phase 3 Bria-ABC study, indicating favorable safety and tolerability of the immunotherapy, which enhances investor confidence in the company's future prospects.
- FDA Fast Track Designation: The study is being conducted under the FDA's Fast Track designation, reflecting a significant unmet medical need in metastatic breast cancer, positioning BriaCell's innovative therapies to potentially fill this market gap and enhance the company's competitiveness in the biotechnology sector.
- Clinical Trial Progress: The positive DSMB recommendation suggests that the combination of Bria-IMT and immune checkpoint inhibitors shows good safety in clinical trials, potentially offering new hope for patients in urgent need of treatment, thereby increasing BriaCell's market recognition.
- Strategic Company Implications: BriaCell's CEO, William V. Williams, noted that this milestone not only recognizes the company's research capabilities but also lays the groundwork for future financing and collaboration opportunities, further driving innovation in cancer treatment.
See More
BriaCell Reports Positive Clinical Data at ASCO 2026
- Survival Rate Data: The latest clinical trial indicates a median overall survival of 16.6 months for Bria-IMT, demonstrating its effectiveness in heavily pre-treated metastatic breast cancer patients, which signifies a crucial clinical advancement in extending patient survival.
- Quality of Life Improvement: The ongoing Phase 3 study shows that patients maintain stable quality of life (QOL) with no significant toxicity, suggesting that the combination of Bria-IMT and immune checkpoint inhibitors can effectively enhance overall health status and has potential for self-administration.
- Biomarker Analysis: The study reveals that 65% of patients experienced stability or a drop in Cancer-Associated Macrophage-Like cells (CAMLs), which significantly correlates with better progression-free survival (PFS), underscoring the importance of biomarkers in predicting treatment efficacy.
- Clinical Data Presentation: BriaCell will showcase six clinical data presentations at the 2026 ASCO Annual Meeting, emphasizing its commitment to innovative cancer treatment options, aiming to provide new hope for patients in need of better therapies.
See More
BriaCell Expands Focus on Women's Health with New Ovarian Cancer Therapy
- New Therapy Development: BriaCell is developing Bria-OVA+, a personalized immunotherapy for ovarian cancer designed to enhance anti-tumor activity through additional immune-stimulating components, reflecting the company's strategic expansion into women's health.
- Market Demand: According to the National Cancer Institute, an estimated 21,010 women in the U.S. will be diagnosed with ovarian cancer by 2026, with approximately 12,450 expected to die from the disease, highlighting the urgent need for new therapies, especially for patients unresponsive to existing treatments.
- Preclinical Data Support: BriaCell recently presented preclinical data for Bria-BRES+ at the AACR conference, demonstrating its ability to activate both adaptive and innate immunity, supporting the potential of the Bria-OTS+ platform and providing a scientific basis for the development of Bria-OVA+.
- Strategic Collaboration: BriaCell has licensed ovarian cancer cell lines from the American Type Culture Collection (ATCC) and has commenced development activities to support the production of Bria-OVA+ for potential clinical use, further solidifying its position in the cancer immunotherapy space.
See More
BriaCell Launches Next-Gen Immunotherapy for Prostate Cancer
- Clinical Supply Completion: BriaCell has completed the manufacturing of clinical supplies for Bria-PROS+ and plans to initiate a Phase 1/2a clinical study in prostate cancer in the coming months, marking a significant advancement in cancer treatment.
- Funding Support: In August 2025, BriaCell was awarded a $2 million non-dilutive grant to support the manufacturing and clinical evaluation of Bria-PROS+, enhancing its R&D capabilities and market competitiveness.
- Immune Activation Effects: Bria-PROS+ demonstrated activation of both adaptive and innate immunity in a recent AACR preclinical presentation, including activation of naïve T-cells, dendritic cells, and natural killer cells, indicating its potential as an immunotherapy for prostate cancer.
- Platform Advantage: Bria-PROS+ is based on the Bria-OTS+ platform, which has shown significant efficacy in breast cancer treatment, further solidifying BriaCell's leading position in the field of immuno-oncology.
See More
BriaCell's Phase 3 Clinical Trial Shows Significant Progress
- Patient Recruitment Status: BriaCell's Phase 3 Bria-ABC study has screened over 315 patients and enrolled more than 230, demonstrating strong clinical site and patient interest, which is expected to drive future commercialization efforts.
- Clinical Trial Recognition: The study has gained sustained attention from leading cancer centers due to its mention in a Nature Medicine article, further enhancing patient engagement and indicating its potential impact in cancer treatment.
- Survival Rate Analysis: The primary endpoint of the study is overall survival, with an interim analysis expected after 144 patient events occur; positive results could support full approval of Bria-IMT for patients with metastatic breast cancer.
- FDA Fast Track Designation: The Bria-IMT combination regimen has received FDA Fast Track designation, highlighting its potential significance in cancer treatment, with BriaCell planning to report interim analysis results in 2026 to advance its innovative immunotherapy to market.
See More
