Briacell Therap (BCTX) has upcoming FDA regulatory milestones for Bria-IMT. The table below outlines estimated target dates and event types for these pending regulatory actions.
This section highlights FDA-related milestones and regulatory updates for drugs developed by Briacell Therap (BCTX).
Over the past two years, Briacell Therap has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Bria-IMT, Bria-BRES+, Bria-IMT+CPI, Bria-OTS, and Bria-PROS+. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Bria-IMT FDA Regulatory Timeline and Events
Bria-IMT is a drug developed by Briacell Therap for the following indication: Metastatic breast cancer (breast cancer that has spread beyond the breast).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Bria-IMT
- Announced Date:
- May 12, 2026
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp. announces that its pivotal Phase 3 Bria-ABC study has screened over 315 and enrolled over 230 patients. BriaCell anticipates reporting topline data in 2026.
AI Summary
BriaCell Therapeutics Corp. said its pivotal Phase 3 Bria-ABC study has now screened more than 315 patients and enrolled more than 230 patients. The company is testing Bria-IMT in patients with metastatic breast cancer, and overall survival is the main goal of the study.
An interim analysis is planned after 144 patient events, meaning deaths, have been recorded. BriaCell said the study is moving forward as planned and expects to report topline results in 2026. If the results are positive, they could help support full approval of Bria-IMT for this cancer type.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- April 20, 2026
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp announces that it is presenting positive data in three clinical posters at the 2026 American Association for Cancer Research (AACR) Annual Meeting, taking place April 17–22 at the San Diego Convention Center in San Diego, California.
AI Summary
BriaCell Therapeutics Corp. announced it will present positive data in three clinical posters at the 2026 American Association for Cancer Research (AACR) Annual Meeting, April 17–22 at the San Diego Convention Center. The company said the results are encouraging for its cancer immunotherapy programs and will be shared with researchers and clinicians attending the meeting.
One poster, titled "Mitosis in Circulating Tumor Cells Correlates with Highly Aggressive Disease in Metastatic Breast Cancer," is scheduled for the Clinical Research session on April 19, 2026, from 2:00–5:00 PM PST in Poster Section 42 (Poster Board 5, Poster Number 1065). After the meeting, BriaCell will make copies of all three posters available at https://briacell.com/scientific-publications/.
BriaCell is a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care. More information is available at https://briacell.com/.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- March 18, 2026
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp. announces that it will present four posters at the 2026 American Association for Cancer Research (AACR) Annual Meeting, taking place April 17–22 at the San Diego Convention Center in San Diego, California.
AI Summary
BriaCell Therapeutics Corp. announced it will present four posters at the 2026 American Association for Cancer Research (AACR) Annual Meeting, April 17–22 at the San Diego Convention Center. The posters will share positive clinical and preclinical data that the company says support the efficacy and favorable safety profile of its novel immunotherapy. “We are expanding the body of evidence supporting the efficacy and favorable safety profile of our novel immunotherapy, with the goal of improving care for patients with cancer who remain in urgent need of new treatment options,” said William V. Williams, MD, BriaCell’s President & CEO.
One highlighted poster, “Mitosis in Circulating Tumor Cells Correlates with Highly Aggressive Disease in Metastatic Breast Cancer,” is scheduled for April 19, 2026, 2:00–5:00 PM in Poster Section 42 (Poster Board 5, Poster 1065). Following the meeting, copies of all posters will be posted at https://briacell.com/scientific-publications/.
BriaCell is a clinical-stage biotechnology company developing novel immunotherapies to improve cancer care. More information is available at https://briacell.com/.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- February 17, 2026
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp. announces that the independent Data Safety Monitoring Board (DSMB) has issued its fifth consecutive positive recommendation following review of safety data from BriaCell's pivotal Phase 3 Bria-ABC study of Bria-IMT plus immune checkpoint inhibitor (CPI) in patients with metastatic breast cancer (NCT06072612).
AI Summary
BriaCell Therapeutics announced that an independent Data Safety Monitoring Board (DSMB) has issued its fifth consecutive positive recommendation after reviewing safety data from the company’s pivotal Phase 3 Bria-ABC study of Bria-IMT plus an immune checkpoint inhibitor (CPI) in patients with metastatic breast cancer (NCT06072612). The DSMB raised no safety concerns and recommended the trial continue without modifications.
The DSMB meets quarterly under the study protocol, and this fifth positive review supports the favorable safety profile seen so far with the Bria-IMT regimen. BriaCell said it is encouraged by the ongoing safety confirmation, remains focused on advancing the program for patients with limited treatment options, and will provide additional clinical updates as the study progresses.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- December 18, 2025
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp. is pleased to announce its Phase 3 Bria-IMT™ clinical trial in metastatic breast cancer has been prominently and independently featured in the Nature Medicine Year In Review's publication, "Eleven clinical trials that will shape medicine in 2026"
AI Summary
BriaCell Therapeutics announced that its Phase 3 Bria-IMT clinical trial in metastatic breast cancer was independently highlighted in Nature Medicine’s “Eleven clinical trials that will shape medicine in 2026.” The feature quoted Dr. Sara A. Hurvitz, who called the BRIA-ABC study an exciting and inclusive trial that enrolls people across all breast cancer subtypes, including those with brain metastases and extensive prior treatments. She also noted the trial’s use of a real-world comparator arm, which can make results more meaningful for everyday care.
The pivotal study tests Bria-IMT plus an immune checkpoint inhibitor versus physician’s choice in advanced metastatic breast cancer. BriaCell has screened more than 230 patients and enrolled over 160 so far. An interim analysis will occur after 144 patient events to assess overall survival, the primary endpoint, and the company anticipates reporting top-line data as early as the first half of 2026. ClinicalTrials.gov identifier: NCT06072612.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- December 10, 2025
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, presents positive Phase 2 survival, and Phase 3 biomarker data across three clinical posters at the 2025 San Antonio Breast Cancer Symposium (SABCS®) taking place December 9-12, 2025 at Henry B. Gonzalez Convention Center, 900 E. Market Street, San Antonio, Texas.
AI Summary
BriaCell Therapeutics presented positive Phase 2 survival and Phase 3 biomarker data across three posters at the 2025 San Antonio Breast Cancer Symposium (SABCS). The company highlighted that biomarkers may help identify patients who benefit from its Bria-IMT regimen, which is being tested alone and with an immune checkpoint inhibitor in metastatic breast cancer.
In a pooled interim analysis of 116 Phase 3 patients (median six prior therapies), the Bria-IMT regimen showed a favorable safety profile with no treatment-related discontinuations. Early progression-free survival (PFS) signals were highest in HR+/HER2- (median 3.7 months) and HER2-low (3.9 months) subtypes. Neutrophil-to-lymphocyte ratio (NLR 0.7–2.3) correlated with longer PFS (4.4 vs. 2.6 months).
Phase 2 data (54 patients) showed significantly longer overall survival for patients with a positive delayed-type hypersensitivity (DTH+) response (11.3 vs. 4.7 months). Th1-biased cytokine and chemokine signatures (e.g., IL-2, IL-15, TNF-α, CXCL10) also associated with clinical benefit, supporting biomarker-driven patient selection.Read Announcement
- Drug:
- Bria-IMT
- Announced Date:
- December 9, 2025
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp. is pleased to announce its Phase 3 clinical study has screened over 230 and enrolled over 160 patients. BriaCell anticipates reporting topline data as early as 1H2026.
AI Summary
BriaCell Therapeutics Corp. reports its pivotal Phase 3 study in metastatic breast cancer has screened more than 230 patients and enrolled over 160, surpassing expectations and reflecting strong interest from clinical sites, patients, and investigators. The trial is testing Bria-IMT combined with an immune checkpoint inhibitor versus physician’s choice in advanced metastatic breast cancer. The company anticipates reporting topline data as early as the first half of 2026.
Interim analysis will begin once 144 patient events (deaths) have occurred and will assess overall survival as the primary endpoint, comparing the Bria-IMT combination to physician’s choice. BriaCell says positive results from this pivotal study could support full approval and marketing authorization of Bria-IMT for metastatic breast cancer. The company emphasizes it will collect, analyze, and share Phase 3 data as milestones are met to inform patients, clinicians, and regulators. Timelines depend on event accrual and study progress.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- December 2, 2025
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp will be presenting positive Phase 2 survival, and Phase 3 biomarker data across three clinical posters at the 2025 San Antonio Breast Cancer Symposium (SABCS®) taking place December 9-12, 2025 at Henry B. Gonzalez Convention Center, 900 E. Market Street, San Antonio, Texas.
AI Summary
BriaCell Therapeutics will present three clinical posters at the 2025 San Antonio Breast Cancer Symposium (SABCS), held December 9–12, 2025 at the Henry B. Gonzalez Convention Center in San Antonio, Texas. The company will highlight positive Phase 2 overall survival results and key Phase 3 biomarker findings. The pivotal Phase 3 Bria-ABC study is ongoing, with an interim analysis expected in the first half of 2026. The posters are scheduled for presentation on December 10, 2025.
Poster highlights include a pooled interim analysis of 116 patients with MHC subtyping showing an excellent safety profile, improved progression-free survival in HR+/HER2- and HER2-low subtypes, and neutrophil-to-lymphocyte ratio (NLR) as a possible biomarker. Phase 2 data from 54 metastatic breast cancer patients show continued overall survival benefit and suggest delayed-type hypersensitivity (DTH) as a predictive marker. A third poster analyzing 30 patients found Th1-biased cytokine and chemokine signatures that may predict response to the Bria-IMT regimen.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- November 18, 2025
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp is pleased to announce that the Company will be presenting three clinical and one preclinical posters at the 2025 San Antonio Breast Cancer Symposium (SABCS®) taking place from December 9-12, 2025 at Henry B. Gonzalez Convention Center, 900 E. Market Street, San Antonio, Texas.
AI Summary
BriaCell Therapeutics Corp. will present three clinical and one preclinical posters at the 2025 San Antonio Breast Cancer Symposium (SABCS®), held December 9–12, 2025 at the Henry B. Gonzalez Convention Center in San Antonio, Texas. BriaCell is a clinical‑stage biotech developing novel immunotherapies for cancer.
Among the presentations are two late‑breaking clinical posters: Abstract 3688, “Impact of Prior Therapy, Genotype Matching, and Biomarkers in the Bria‑ABC Phase 3 Trial,” and Abstract 3713, “Survival Results of Phase II Bria‑IMT Allogenic Whole Cell‑Based Cancer Vaccine” — both scheduled Wednesday, December 10, 12:30–2:00 PM. An additional poster (Abstract 1614) covers Th1‑biased cytokine signatures as biomarkers of clinical benefit following SV‑BR‑1‑GM vaccination and is scheduled December 10, 5:00–6:30 PM. The set includes updated key biomarker data from the pivotal Phase 3 study and updated survival data from the Phase 2 Bria‑IMT plus CPI study.
Copies of the posters will be posted after the meeting at https://briacell.com/scientific-publications/. The company says these data will be shared with breast cancer specialists to help advance treatment options.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- October 22, 2025
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp. announces that the independent Data Safety Monitoring Board (DSMB) has issued its fourth consecutive positive recommendation following review of safety data from BriaCell's pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor (CPI) in patients with metastatic breast cancer (NCT06072612).
AI Summary
BriaCell Therapeutics announced that an independent Data Safety Monitoring Board (DSMB) has issued its fourth consecutive positive recommendation for its pivotal Phase 3 study (NCT06072612) combining Bria-IMT™ with an immune checkpoint inhibitor in patients with metastatic breast cancer. After its quarterly safety review, the DSMB identified no concerns and advised continuing the trial without modifications. This consistent endorsement underscores the regimen’s favorable safety and tolerability profile observed to date under Fast Track designation.
Bria-IMT is an investigational cell-based immunotherapy designed to boost the body’s anti-tumor immune response alongside checkpoint inhibitors. Conducted to address significant unmet medical needs in advanced breast cancer, the study’s momentum continues thanks to repeated positive DSMB feedback. President & CEO Dr. William V. Williams said these findings strengthen confidence in Bria-IMT’s potential to become a transformative treatment option for patients facing urgent care gaps.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- October 21, 2025
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp. is pleased to announce the addition of several key large cancer centers to its ongoing pivotal Phase 3 clinical study (ClinicalTrials.gov as NCT06072612), notably Dartmouth Cancer Center, Cedars-Sinai Medical Center, and Winship Cancer Institute of Emory University. BriaCell anticipates reporting top line data as early as H1-2026.
AI Summary
BriaCell Therapeutics Corp. has expanded its pivotal Phase 3 trial in metastatic breast cancer by adding three leading cancer centers—Dartmouth Cancer Center, Cedars-Sinai Medical Center, and Winship Cancer Institute of Emory University. These additions join 79 clinical sites across 23 U.S. states, creating a broad national network that already includes facilities like Mayo Clinic and Yale’s Smilow Cancer Hospital. The network’s growth underscores strong support for BriaCell’s novel immunotherapy approach.
The ongoing study (ClinicalTrials.gov NCT06072612) evaluates Bria-IMT plus an immune checkpoint inhibitor versus physician’s choice of treatment. BriaCell plans an interim analysis after 144 patient events and expects to report topline data as early as the first half of 2026. Positive results could pave the way for full approval and broader patient access to this therapy.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- October 20, 2025
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp. announces encouraging clinical biomarker data in its ongoing pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer.
AI Summary
BriaCell Therapeutics Corp. reported encouraging clinical biomarker data from its ongoing pivotal Phase 3 trial of Bria-IMT combined with an immune checkpoint inhibitor in patients with metastatic breast cancer. The blinded, pooled analysis includes 113 patients who had an average of six prior treatments. These results were shared in a poster at the European Society for Medical Oncology (ESMO) Congress 2025.
The study confirmed that the neutrophil-to-lymphocyte ratio (NLR) remains a potential predictor of benefit. Patients with an NLR between 0.7 and 2.3 showed a median progression-free survival (PFS) of 4.5 months versus 2.5 months in those with lower or higher values (hazard ratio 0.5, p=0.005).
Bria-IMT has been well tolerated, with no treatment-related discontinuations. The most common side effects were fatigue, anemia and nausea. An interim analysis of overall survival will occur after 144 patient events, which could support full approval of the Bria-IMT combination regimen.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- October 13, 2025
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp will be presenting positive clinical biomarker data of its ongoing pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer at its poster presentation at the European Society for Medical Oncology (ESMO) Congress 2025 Annual Meeting taking place October 17 – 21 in Berlin, Germany.
AI Summary
BriaCell Therapeutics will present positive clinical biomarker data from its ongoing pivotal Phase 3 study of Bria-IMT combined with an immune checkpoint inhibitor at the European Society for Medical Oncology (ESMO) Congress 2025. The poster session takes place October 20, 2025, from 12:00 to 1:00 pm CET in Hall 25 at Messe Berlin.
In 68 evaluable patients with a median of six prior treatments, those who developed a delayed-type hypersensitivity (DTH) immune response showed significantly longer progression-free survival (p=0.0002). This finding aligns with similar trends seen in an earlier Phase 2 study.
Bria-IMT was well tolerated, with no treatment-related discontinuations. The most common side effects were fatigue, anemia, and nausea.
The trial is still enrolling patients, and a final overall survival analysis will occur after 144 events. Positive results could support future approval and marketing of Bria-IMT in metastatic breast cancer.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- July 31, 2025
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp. announces the addition of UCLA Health Jonsson Comprehensive Cancer Center, a leading cancer center in California, to its ongoing pivotal Phase 3 clinical study (Bria-ABC, NCT06072612) evaluating Bria-IMT™ in combination with a checkpoint inhibitor versus physician's choice in patients with advanced metastatic breast cancer (MBC).
AI Summary
BriaCell Therapeutics Corp. announced the addition of UCLA Health Jonsson Comprehensive Cancer Center, a leading cancer center in California, to its ongoing pivotal Phase 3 clinical study (Bria-ABC, NCT06072612). This trial is testing Bria-IMT combined with a checkpoint inhibitor against physician’s choice in patients with advanced metastatic breast cancer.
Kelly E. McCann, MD, PhD, Lead Investigator at UCLA Health Jonsson Comprehensive Cancer Center, said the Phase 2 data for the Bria-IMT combination were encouraging. She said joining the Phase 3 study offers an opportunity for meaningful progress in survival outcomes and they expect to enroll patients quickly through their large multi-center site.
The study’s primary endpoint is overall survival. An analysis will occur after 144 patient deaths. The design builds on positive survival data from the Phase 2 study presented at ASCO 2025. BriaCell expects to share top-line Phase 3 data in 2026.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- July 25, 2025
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp. announces two clinical data poster presentations at the European Society for Medical Oncology (ESMO) Congress 2025 Annual Meeting taking place October 17 – 21 in Berlin, Germany.
AI Summary
BriaCell Therapeutics Corp. will present two clinical data posters at the European Society for Medical Oncology (ESMO) Congress 2025 Annual Meeting, held October 17–21 in Berlin, Germany.
The first poster, “Phase III Pivotal Trial of Bria-IMT + CPI vs Physician’s Choice in Advanced Metastatic Breast Cancer (BRIA-ABC),” compares Bria-IMT cell therapy plus a checkpoint inhibitor against standard treatments. The second, “Feasibility and Biomarker Validation of an International Randomized Phase 3 Trial of Bria-IMT Cell Therapy in Late Stage MBC (BRIA-ABC),” explores key biological markers and trial design in late-stage metastatic breast cancer.
Abstracts will be available on the ESMO website at 00:05 CEST on October 13, 2025 (6:05 p.m. ET on October 12). Following the presentations, BriaCell will post copies at https://briacell.com/scientific-publications/.
BriaCell is a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care. More information is available at https://briacell.com/.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- July 15, 2025
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp is pleased to announce the addition of a key clinical site, Mayo Clinic, to its ongoing pivotal Phase 3 clinical study (ClinicalTrials.gov as NCT06072612) in metastatic breast cancer.
AI Summary
BriaCell Therapeutics Corp. has expanded its pivotal Phase 3 clinical study in metastatic breast cancer by adding Mayo Clinic as a key clinical site. This inclusion brings the study’s roster to 69 active sites across 15 states. The trial is evaluating the company’s leading immunotherapy candidate, Bria-IMT™, in combination with an immune checkpoint inhibitor, compared to the physician’s choice of treatments.
Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer, expressed enthusiasm about teaming up with Mayo Clinic, a renowned center that previously participated in the company’s Phase 2 study. He emphasized that the partnership with such a respected institution could play an important role in advancing cancer care. This strategic move is seen as a significant step toward potentially transforming treatment options for patients battling advanced metastatic breast cancer.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- July 11, 2025
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp announced updated Phase 2 survival data for its lead immunotherapy candidate, Bria-IMT, in combination with an immune check point inhibitor (CPI).
AI Summary
BriaCell Therapeutics Corp. recently announced promising updated Phase 2 survival data for its lead immunotherapy candidate, Bria-IMT, when used in combination with an immune checkpoint inhibitor. The study showed that in patients with triple-negative breast cancer, the median overall survival reached 13.9 months, outperforming the 11.8 months reported with the approved antibody-drug conjugate Trodelvy and significantly exceeding the 6.9 months achieved with single-agent chemotherapy.
In addition, for hormone receptor–positive metastatic breast cancer patients, the median overall survival was 17.3 months compared to 14.4 months with Trodelvy and 11.2 months with other chemotherapy treatments. Importantly, the regimen was well tolerated, with no treatment-related discontinuations reported. These encouraging findings come from a study involving heavily pretreated patients and support further evaluation in BriaCell’s ongoing pivotal Phase 3 trial focused on overall survival.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- July 10, 2025
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp announced updated results from its ongoing Phase 2 study of Bria-IMT™ in combination with check point inhibitor in patients with advanced metastatic breast cancer (MBC).
AI Summary
BriaCell Therapeutics Corp announced updated, encouraging results from its ongoing Phase 2 study of Bria-IMT™ in combination with a checkpoint inhibitor for advanced metastatic breast cancer patients. In this study, a patient who had failed eight previous treatment regimens, including antibody-drug conjugate therapy, experienced a complete resolution of a temporal lobe brain metastasis. The patient’s orbital tumor has also continued to shrink and shows sustained improvement over more than 18 months of treatment.
Serial imaging at 8, 11, and 20 months confirmed no detectable brain tumor recurrence, while tumor marker levels remained significantly reduced. These findings indicate that the Bria-IMT regimen may offer long-lasting immunotherapeutic benefits for late-stage breast cancer patients with brain metastases who have exhausted other options, underscoring the potential of this novel approach to improve patient outcomes.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- June 24, 2025
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp is pleased to report that the independent Data Safety Monitoring Board (DSMB) has completed its third scheduled safety data review of BriaCell's pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor (CPI) in metastatic breast cancer (NCT06072612).
AI Summary
BriaCell Therapeutics announced that the independent Data Safety Monitoring Board (DSMB) has completed its third scheduled safety review of the pivotal Phase 3 study evaluating Bria-IMT combined with an immune checkpoint inhibitor in metastatic breast cancer patients. The DSMB found no safety concerns and recommended that the study continue without any modifications. This third consecutive positive review supports the strong safety and tolerability profile of the treatment regimen.
The study is being conducted under the FDA Fast Track designation, which is granted in situations where there is a significant unmet medical need. This designation highlights the potential impact of Bria-IMT plus the immune checkpoint inhibitor as a promising immunotherapy approach for metastatic breast cancer. BriaCell remains optimistic about these encouraging results as the trial progresses.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- May 23, 2025
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp. announces the presentation of positive survival and clinical benefit data in three clinical poster presentations and one publish-only abstract at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30 – June 3 at McCormick Place, Chicago, IL.
AI Summary
BriaCell Therapeutics Corp. announced that it will present promising survival and clinical benefit data from its Phase 2 Bria-IMT study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL, from May 30 to June 3. The company will share these findings through three clinical poster presentations and one publish-only abstract. These presentations focus on data showing that Bria-IMT achieves survival outcomes and clinical benefits that meet or exceed those from FDA-approved therapies, even among patients who were heavily pre-treated. BriaCell’s leadership highlighted that the regimen was well-tolerated, with positive results supporting its potential use for patients battling metastatic breast cancer. This presentation at ASCO 2025 will provide additional insights into Bria-IMT’s efficacy and safety profile, reinforcing its promise as a novel immunotherapy option in the field of cancer treatment.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- April 30, 2025
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp is presenting clinical data from the pivotal Phase 3 study of its lead product candidate, Bria-IMT™, in metastatic breast cancer (BRIA-ABC; NCT06072612) supporting the use of specific biomarkers to predict patients' clinical response to Bria-IMT treatments.
AI Summary
BriaCell Therapeutics Corp. announced new clinical data from its pivotal Phase 3 study evaluating Bria-IMT™ for metastatic breast cancer (BRIA-ABC; NCT06072612). The data highlights the potential use of specific biomarkers to predict patient response to the Bria-IMT treatment. Researchers found that a positive delayed-type hypersensitivity (DTH) reaction and a favorable neutrophil-to-lymphocyte ratio (NLR) were linked to longer progression-free survival. In contrast, the presence of circulating tumor cells (CTCs) after treatment was associated with poorer outcomes, marking it as a negative prognostic indicator.
This promising biomarker research indicates that doctors may soon be able to identify patients who will benefit the most from Bria-IMT, potentially resulting in improved treatment responses and survival rates. The study’s findings support the continued evaluation of these biomarkers in the search for more personalized cancer therapies.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- April 28, 2025
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp. is presenting positive data from its Phase 2 study of lead product candidate, Bria-IMT™, in metastatic breast cancer, and from its preclinical Bria-OTS+ platform at the 2025 American Association for Cancer Research (AACR) Annual Meeting taking place from April 25th – 30th at McCormick Place Convention Center, Chicago, IL.
AI Summary
At the 2025 AACR Annual Meeting in Chicago (April 25–30) at McCormick Place Convention Center, BriaCell Therapeutics Corp. presented encouraging data on its cancer immunotherapy programs. The company reported positive results from its Phase 2 study of the lead candidate, Bria-IMT™, in patients with metastatic breast cancer. These findings included improved overall survival and clinical benefits, even among heavily pretreated patients with multiple prior therapies.
In addition, preclinical data from the Bria-OTS+ platform, designed to activate both innate and adaptive immunity, demonstrated strong potential for enhanced anti-cancer effects. This data supports BriaCell’s novel approach in addressing unmet needs in cancer care and signals promise for future treatment strategies. Overall, the results highlight a significant step forward in developing effective cancer immunotherapies.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- April 23, 2025
- Target Action Date:
- May 30, 2025
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp. is pleased to announce three clinical data poster presentations and one publish-only abstract at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30 – June 3 at McCormick Place, Chicago, IL.
AI Summary
BriaCell Therapeutics Corp. announced that it will present three clinical data posters and one publish-only abstract at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled for May 30 – June 3 at McCormick Place in Chicago, IL. The company’s presentations will focus on metastatic breast cancer treatments and include updates from its Phase III trial of Bria-IMT combined with checkpoint inhibitors, as well as Phase I/II survival results compared to benchmark trials.
In addition, BriaCell will share insights from an ongoing trial of its Bria-OTS cellular immunotherapy in metastatic recurrent breast cancer and present research on the impact of HLA matching on clinical outcomes in a Phase 2 trial of Bria-IMT plus anti-PD1 therapy. The abstracts will be available starting May 22, 2025, with presentations posted on the company’s scientific publications website following the meeting.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- April 22, 2025
- Target Action Date:
- LATE 2025
- Estimated Target Date Range:
- October 1, 2025 - December 31, 2025
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell anticipates completing patient enrollment in late 2025 or early 2026
AI Summary
BriaCell Therapeutics has made progress in its pivotal Phase 3 clinical study, which is testing Bria-IMT in combination with an immune checkpoint inhibitor for advanced metastatic breast cancer. Over 75 patients have been enrolled so far at 54 clinical sites across the United States, with additional sites in various stages of start-up. The study aims to evaluate the Bria-IMT combination regimen compared to treatment choices made by physicians.
A key milestone for the company is that it anticipates completing patient enrollment in late 2025 or early 2026. This timeline underscores BriaCell’s commitment to advancing clinical data quickly and potentially reporting topline results as early as the first half of 2026. The progress of this study is seen as an essential step toward providing a novel therapeutic option for patients with metastatic breast cancer.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- April 22, 2025
- Target Action Date:
- H1 2026
- Estimated Target Date Range:
- January 1, 2026 - June 30, 2026
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell anticipates top line data as early as H1-2026.
AI Summary
BriaCell Therapeutics is advancing its pivotal Phase 3 study for its new cancer treatment, Bria-IMT™, used in combination with an immune checkpoint inhibitor. The trial, which aims to offer a novel option for patients with metastatic breast cancer, is currently conducted at 54 sites in the United States. Over 100 patients have consented, with more than 75 already enrolled, reflecting strong interest from clinical investigators and patients alike.
The company expects to complete patient enrollment by late 2025 or early 2026. Importantly, BriaCell anticipates that top line data from the study will be available as early as the first half of 2026. These upcoming results could play a critical role in providing a new therapeutic approach for patients with advanced metastatic breast cancer and addressing an area with significant unmet medical needs.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- April 22, 2025
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp is pleased to announce that its ongoing pivotal Phase 3 clinical study (listed on ClinicalTrials.gov as NCT06072612) has consented over 100 and has enrolled over 75 patients.
AI Summary
BriaCell Therapeutics Corp has announced progress in its pivotal Phase 3 clinical study (ClinicalTrials.gov identifier NCT06072612) for metastatic breast cancer. The study is evaluating Bria-IMT in combination with an immune checkpoint inhibitor, comparing this regimen to the physician’s standard treatment.
So far, over 100 patients have consented to participate, and more than 75 have been enrolled at 54 clinical sites across the United States. This strong enrollment highlights growing interest and support from clinical investigators and patients, which may help address the high unmet needs in metastatic breast cancer care.
The company expects to complete patient enrollment by late 2025 or early 2026, with top line data anticipated as early as the first half of 2026.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- April 16, 2025
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp announces new positive survival data in its Phase 2 study of Bria-IMT plus check point inhibitors (CPI), outperforming ADC drugs in hormone receptor positive (HR+) metastatic breast cancer (MBC) patients.
AI Summary
BriaCell Therapeutics Corp. has shared positive results from its Phase 2 study in metastatic breast cancer. In the study, 25 hormone receptor positive (HR+) patients treated with the Bria-IMT regimen plus checkpoint inhibitors achieved a median overall survival of 17.3 months. This survival rate notably exceeds the 14.4 months typically seen with the ADC drug TRODELVY® in similar heavily pre-treated patients. The data suggest that the Bria-IMT combination may offer a more effective treatment option for HR+ metastatic breast cancer patients, who often have limited therapeutic choices. Additionally, similar favorable outcomes were observed in triple negative breast cancer patients, with survival rates close to those seen with TRODELVY® and significantly higher than with standard chemotherapy. The study also reported that the regimen was well-tolerated, with no Bria-IMT related discontinuations to date.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- March 20, 2025
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp announces that the external Data Safety Monitoring Board (DSMB), an independent group of experts who review and monitor the safety data of the BriaCell clinical study to determine if the study should continue, be modified, or be halted, has completed its second safety data review of BriaCell's pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor (CPI) in metastatic breast cancer (NCT06072612) and recommended continuation of the ongoing study without any modifications.
AI Summary
BriaCell Therapeutics Corp announced that its external Data Safety Monitoring Board (DSMB) has completed the second safety review of its pivotal Phase 3 study. This study tests the combination of Bria-IMT with an immune checkpoint inhibitor in metastatic breast cancer (NCT06072612). The DSMB, an independent panel of experts, found no safety concerns during this review and recommended that the trial continue without any modifications.
The positive evaluation reinforces confidence in the study's safety and the potential effectiveness of the treatment combination. The ongoing trial is being conducted under the FDA’s Fast Track Designation, highlighting its importance in addressing an urgent medical need. BriaCell’s management expressed optimism about the results and anticipation of further updates as the trial progresses, marking another step forward in developing new therapies for metastatic breast cancer.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- December 11, 2024
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp. is pleased to showcase its impressive survival and clinical benefit data in MBC patients, including those with CNS metastases, treated with the Bria-IMT™ plus CPI regimen. The data is featured in BriaCell's "Spotlight" poster presentation session, at the 2024 San Antonio Breast Cancer Symposium® (SABCS®) held at Henry B. Gonzalez Convention Center, San Antonio, TX.
AI Summary
BriaCell Therapeutics Corp. has revealed impressive survival and clinical benefit data in metastatic breast cancer (MBC) patients, including those with central nervous system (CNS) metastases, treated with its Bria-IMT™ plus CPI regimen. This data, showcased during the "Spotlight" poster session at the 2024 San Antonio Breast Cancer Symposium® held at the Henry B. Gonzalez Convention Center, highlights significant progress in a patient population with few treatment options.
Results show a median overall survival of 13.4 months in Phase 2 patients using the Phase 3 formulation, with patients treated since 2022 reaching 15.6 months, and CNS metastasis patients achieving a median OS of 13.7 months. The data underscores the regimen’s promising tolerability and robust clinical benefits, even among heavily pre-treated patients, and suggests that emerging biomarkers may help identify individuals most likely to benefit from this innovative immunotherapy approach.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- December 2, 2024
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp announces that the Data Safety Monitoring Board (DSMB), an independent group of experts who review and monitor safety data of a clinical study to determine if a study should continue, be modified, or be halted early, has completed its first review of safety events in patients enrolled in BriaCell's pivotal randomized Phase 3 study of Bria-IMT™ plus an immune checkpoint inhibitor (CPI) combination regimen (NCT06072612).
AI Summary
BriaCell Therapeutics announced that the independent Data Safety Monitoring Board (DSMB) completed its first review of safety events in patients enrolled in its pivotal randomized Phase 3 study. This trial is testing a combination regimen of Bria-IMT™ and an immune checkpoint inhibitor for treating metastatic breast cancer.
The DSMB, which carefully monitors clinical study safety data, reported no safety concerns and recommended that the study continue without any protocol modifications. This positive review is an important milestone, supporting BriaCell’s efforts to develop safe and effective immunotherapies. The Phase 3 study is also being conducted under the FDA’s Fast Track Designation, emphasizing its potential to transform cancer care for patients with this challenging condition.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- November 26, 2024
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp will be highlighting its positive overall survival and clinical benefit data in metastatic breast cancer (MBC) patients including those with CNS metastasis (not shown on the abstracts) who were treated with the Bria-IMT™ plus immune checkpoint inhibitor (CPI) combination in its "Spotlight" poster presentation session, at the 2024 San Antonio Breast Cancer Symposium® (SABCS®) held at Henry B. Gonzalez Convention Center, San Antonio, TX.
AI Summary
BriaCell Therapeutics will feature a Spotlight poster presentation at the 2024 San Antonio Breast Cancer Symposium®, highlighting promising overall survival and clinical benefit data from its Phase 2 study. The data focus on metastatic breast cancer patients, including those with central nervous system (CNS) metastases, treated with the Bria-IMT™ vaccine in combination with an immune checkpoint inhibitor. The study reported a median overall survival of 13.4 months, which exceeds historical benchmarks, suggesting significant improvements in patient outcomes. The findings span across all metastatic breast cancer subtypes and hint at the potential for biomarkers to help predict which patients may benefit most from the therapy. The positive clinical signals reinforce BriaCell’s commitment to advancing novel immunotherapies and set the stage for further validation in their upcoming pivotal Phase 3 trial.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- October 1, 2024
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp is pleased to report dramatic anti-tumor response including complete resolution of temporal lobe breast cancer metastasis in a patient treated in the Phase 2 study of BriaCell's Bria-IMT™ plus an immune checkpoint inhibitor regimen.
AI Summary
BriaCell Therapeutics Corp reported a dramatic anti-tumor response in a patient with metastatic breast cancer during its Phase 2 study. The patient, who had been heavily pre-treated and had failed eight previous regimens, showed complete resolution of a right temporal lobe metastasis. This significant healing was observed through serial imaging at 8 and 11 months of treatment with the Bria-IMT™ regimen combined with an immune checkpoint inhibitor.
In addition to the complete disappearance of the temporal lobe tumor, the patient’s "eye-bulging" orbital tumor also was markedly reduced, and her tumor markers in blood tests declined significantly. These positive outcomes highlight the potential of the Bria-IMT™ combination therapy as a new treatment option for metastatic breast cancer patients with brain metastases.
Read Announcement - Drug:
- Bria-IMT
- Announced Date:
- September 18, 2024
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp. announce U.S. FDA (FDA) authorization of an Expanded Access Policy (EAP) for metastatic breast cancer (MBC) patients.
AI Summary
BriaCell Therapeutics has received U.S. FDA authorization for its Expanded Access Policy (EAP), which aims to help patients with metastatic breast cancer who have exhausted other treatment options. Through this program, patients who are not enrolled in the pivotal Phase 3 trial can access the company’s novel Bria-IMT™ regimen. The FDA approved the EAP as part of the conditions for granting Fast Track designation, showing its confidence in the safety and potential effectiveness of the treatment. Company leaders believe that this approval expands treatment options and offers new hope for patients battling a disease that remains a leading cause of cancer death among American women. The broader availability of Bria-IMT™ via EAP may provide timely relief to those with few alternatives, marking an important step toward innovative care in metastatic breast cancer.
Read Announcement- Drug:
- Bria-IMT
- Announced Date:
- September 11, 2024
- Indication:
- Metastatic breast cancer (breast cancer that has spread beyond the breast)
Announcement
BriaCell Therapeutics Corp. announce positive overall survival data of its Phase 2 clinical study of Bria-IMT™ in combination with an immune check point inhibitor (CPI) in late stage metastatic breast cancer.
AI Summary
BriaCell Therapeutics recently announced promising overall survival results from its Phase 2 study, where patients with late-stage metastatic breast cancer treated with Bria-IMT™ in combination with an immune checkpoint inhibitor had a median overall survival of 15.6 months. This outcome compares very favorably to the 6.7 to 9.3 months reported in similar patient groups in other studies.
The marked improvement in survival suggests that the combination of Bria-IMT™ and immune checkpoint inhibitors could offer significant benefits to heavily pre-treated metastatic breast cancer patients. The encouraging data indicate potential additive or synergistic effects between the treatments. Notably, the patients in this Phase 2 study received the same formulation of Bria-IMT™ that is currently being tested in an ongoing Phase 3 study. These findings support further clinical development with the hope of establishing this regimen as a new standard of care for metastatic breast cancer treatment.
Read Announcement
Bria-BRES+ FDA Regulatory Events
Bria-BRES+ is a drug developed by Briacell Therap for the following indication: in Breast Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Bria-BRES+
- Announced Date:
- May 6, 2026
- Indication:
- in Breast Cancer
Announcement
BriaCell Therapeutics Corp. is pleased to report it has received FDA clearance to initiate clinical evaluation of Bria-BRES+, its next generation, personalized, off-the-shelf, cell-based immunotherapy for metastatic breast cancer.
AI Summary
BriaCell Therapeutics Corp. announced it has received FDA clearance to begin clinical evaluation of Bria-BRES+, a next‑generation, personalized, off‑the‑shelf, cell‑based immunotherapy designed for metastatic breast cancer. Bria‑BRES+ is described as a targeted cell therapy that aims to engage a patient’s immune system against tumors. The clearance allows BriaCell to start formal clinical testing to evaluate the product’s safety and how well it works in people with advanced breast cancer.
This step moves BriaCell from preclinical development toward human trials and could speed development of a new treatment option for patients with metastatic disease. BriaCell is an immuno‑oncology biotech company focused on developing targeted approaches for cancer management. The clinical evaluation will generate data needed to assess the therapy’s potential and guide further development decisions.
Read Announcement
Bria-IMT+CPI FDA Regulatory Events
Bria-IMT+CPI is a drug developed by Briacell Therap for the following indication: breast cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Bria-IMT+CPI
- Announced Date:
- April 27, 2026
- Indication:
- breast cancer
Announcement
BriaCell Therapeutics Corp is pleased to announce three clinical data poster presentations and three publication-only abstracts at the 2026 ASCO Annual Meeting, taking place May 29-June 2, 2026 at McCormick Place, Chicago, Illinois.
AI Summary
BriaCell Therapeutics announced three clinical poster presentations and three publication-only abstracts at the 2026 ASCO Annual Meeting, May 29–June 2, 2026, at McCormick Place in Chicago. The posters present final randomized Phase 2 survival and quality-of-life results for Bria-IMT plus checkpoint inhibitors, and ongoing Phase 3 biomarker analyses that may predict response. Poster sessions: survival (Poster Board 222) and quality of life/tolerability (Poster Board 221) will be displayed June 1, 1:30–4:30 PM CDT; blood-based biomarker monitoring (Poster Board 442) will be shown May 30, 1:30–4:30 PM CDT.
The three publication-only abstracts cover a second-generation cell therapy (BC1), a liquid-biopsy method to stratify progression risk, and monitoring PD-L1 in circulating cancer-associated cells to predict outcomes with immune checkpoint inhibitors. ASCO will publish abstracts on May 21, 2026; BriaCell will post the posters afterward on its website.
Read Announcement- Drug:
- Bria-IMT+CPI
- Announced Date:
- November 25, 2025
- Indication:
- breast cancer
Announcement
BriaCell Therapeutics Corp. will present positive biomarker and survival data across three clinical posters at the 2025 San Antonio Breast Cancer Symposium (SABCS®) taking place December 9-12, 2025 at Henry B. Gonzalez Convention Center, 900 E. Market Street, San Antonio, Texas.
AI Summary
BriaCell Therapeutics will present positive biomarker and survival data across three clinical posters at the 2025 San Antonio Breast Cancer Symposium (SABCS), held December 9–12 in San Antonio. The presentations highlight positive Phase 2 safety and efficacy signals and confirm differentiated biomarker findings seen in both the Phase 2 study and the ongoing pivotal Phase 3 program.
All three posters are scheduled for Wednesday, December 10. They include: “Impact of Prior Therapy, Genotype Matching, and Biomarkers in the Bria‑ABC Phase 3 Trial” (late‑breaking), “Survival Results of Phase II Bria‑IMT Allogenic Whole Cell‑Based Cancer Vaccine” (late‑breaking), and “Th1‑biased cytokine signatures as biomarkers of clinical benefit following SV‑BR‑1‑GM cancer vaccination in breast cancer.” The posters report biomarker patterns and survival outcomes that support the therapy’s mechanism of action and clinical benefit signals.
The pivotal Phase 3 study of Bria‑IMT+CPI is ongoing, with an interim analysis expected in the first half of 2026. Abstracts and posters will be made available on BriaCell’s website.Read Announcement
Bria-OTS FDA Regulatory Timeline and Events
Bria-OTS is a drug developed by Briacell Therap for the following indication: In metastatic breast cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Bria-OTS
- Announced Date:
- April 21, 2026
- Indication:
- In metastatic breast cancer
Announcement
BriaCell Therapeutics Corp is presenting positive data from its preclinical Bria-OTS+ platform at the 2026 American Association for Cancer Research (AACR) Annual Meeting taking place April 17–22 at the San Diego Convention Center in San Diego, California..
AI Summary
BriaCell Therapeutics Corp is presenting positive preclinical data for its Bria-OTS+ platform at the 2026 American Association for Cancer Research (AACR) Annual Meeting, April 17–22 at the San Diego Convention Center. The company says the data show strong immune activation in lab models and will be displayed in a poster available via their scientific publications page: https://briacell.com/scientific-publications/.
In vitro studies show Bria-OTS+ triggers early, potent and durable activation of both innate and adaptive immune responses in cancer cell line models. Immune cells activated by Bria-OTS+ demonstrated “serial killing” ability, repeatedly clearing tumor cells across multiple challenge rounds. These results support the platform’s potential to sustain anti-tumor activity.
BriaCell plans to advance Bria-OTS+ toward clinical testing, aiming to enter trials for metastatic breast and prostate cancer later this year, with lung cancer and melanoma indications planned for 2027. BriaCell is a clinical-stage biotech developing novel immunotherapies (https://briacell.com/).
Read Announcement- Drug:
- Bria-OTS
- Announced Date:
- November 7, 2025
- Indication:
- In metastatic breast cancer
Announcement
BriaCell Therapeutics Corp. is pleased to announce that the Company is presenting evidence of strong immune system engagement and anti-cancer activity of its next generation Bria-OTS+ platform in preclinical models at a poster presentation at the Society for Immunotherapy of Cancer (SITC) 40th Anniversary Annual Meeting, to be held November 7-9, 2025, in National Harbor, MD.
AI Summary
BriaCell Therapeutics Corp. announced that it will present preclinical data on its next-generation Bria-OTS+ immunotherapy platform at the Society for Immunotherapy of Cancer’s 40th Annual Meeting in National Harbor, MD, on November 7–9, 2025. The data shows rapid, potent and durable anti-cancer activity by activating both innate and adaptive immune responses in breast and prostate tumor models.
In these studies, Bria-BRES+™ (targeting breast cancer) and Bria-PROS+™ (prostate cancer) induced increased tumor cell cytotoxicity. The platform trained key immune cells to recognize and kill cancer cells, leading to sustained immune responses. BriaCell’s Chief Scientific Officer, Dr. Miguel A. Lopez-Lago, emphasized the comprehensive and long-lasting immune activation observed.
The broad activity across multiple solid tumor types reinforces the potential of Bria-OTS+. BriaCell plans to initiate Phase 1/2a trials for Bria-BRES+ and Bria-PROS+, aiming to translate these encouraging preclinical results into clinical benefit for patients.
Read Announcement- Drug:
- Bria-OTS
- Announced Date:
- November 4, 2025
- Indication:
- In metastatic breast cancer
Announcement
BriaCell Therapeutics Corp announce that the Company will be showing evidence of strong immune system engagement inducing potent anti-cancer cell activity of its next generation Bria-OTS+ platform in preclinical models at a poster presentation at the Society for Immunotherapy of Cancer (SITC) 40th Anniversary Annual Meeting, to be held November 7-9, 2025, in National Harbor, MD.
AI Summary
BriaCell Therapeutics Corp. will present new data on its next-generation Bria-OTS+ cancer immunotherapy at the Society for Immunotherapy of Cancer (SITC) 40th Anniversary Annual Meeting, November 7–9, 2025, in National Harbor, MD. At a November 7 poster session, the company will show strong immune system engagement and potent anti-cancer activity in preclinical models, highlighting how Bria-OTS+ reawakens both innate and adaptive immunity to target tumors.
The platform’s lead candidates—Bria-BRES+ for breast cancer and Bria-PROS+ for prostate cancer—have completed good manufacturing practice (GMP) production ahead of planned Phase 1/2a trials. A $2 million National Cancer Institute Small Business Innovative Research award will support GMP manufacturing and clinical evaluation of Bria-PROS+.
Bria-OTS+ is an off-the-shelf approach that combines immune-activating cytokines and co-stimulatory signals to deliver a cost-effective, powerful therapy designed to spare healthy tissue while attacking cancer cells.
Read Announcement- Drug:
- Bria-OTS
- Announced Date:
- October 21, 2025
- Indication:
- In metastatic breast cancer
Announcement
BriaCell Therapeutics Corp is pleased to announce a collaboration with Memorial Sloan Kettering Cancer Center's (MSK's) Therapeutics Accelerator Cohort program to accelerate the clinical development of Bria-OTS+, BriaCell's next generation personalized off-the-shelf immunotherapy, for multiple cancer indications including metastatic breast cancer, prostate cancer, and other cancers.
AI Summary
BriaCell Therapeutics Corp. has teamed up with Memorial Sloan Kettering Cancer Center’s Therapeutics Accelerator Cohort program to speed up the clinical development of its Bria-OTS+ immunotherapy platform. Bria-OTS+ is an off-the-shelf, personalized treatment designed for various cancers, including metastatic breast cancer and prostate cancer.
The partnership covers manufacturing, preparation of an Investigational New Drug (IND) application, and support for a Phase 1 clinical trial of Bria-BRES+—the breast cancer candidate within the Bria-OTS+ family. By working with MSK, BriaCell gains access to world-class cell therapy manufacturing, clinical protocol design, and regulatory expertise to move the therapy into patients more quickly.
Company leaders say this collaboration will help meet urgent needs for metastatic breast cancer patients and could transform cancer care. MSK experts stress that programs like this accelerate promising discoveries into real treatment options and improve outcomes for people facing hard-to-treat cancers.
Read Announcement- Drug:
- Bria-OTS
- Announced Date:
- October 3, 2025
- Indication:
- In metastatic breast cancer
Announcement
BriaCell Therapeutics Corp. is pleased to announce that the Company will be presenting preclinical Bria-OTS+ data at a poster presentation at the Society for Immunotherapy of Cancer (SITC) 40th Anniversary Annual Meeting, held November 7-9, 2025, in National Harbor, MD.
AI Summary
BriaCell Therapeutics Corp. announced it will present new preclinical data on its Bria-OTS+ cancer vaccine candidate at the Society for Immunotherapy of Cancer’s 40th Anniversary Annual Meeting. The meeting takes place November 7–9, 2025, at the Gaylord National Resort in National Harbor, Maryland.
The poster, titled “Redefining Cancer Vaccines: Bria-OTS+ Integrates Trained Innate Immunity and Adaptive Memory to Overcome Immune Resistance,” is abstract number 353. It will be displayed in the Prince George ABC Exhibit Halls on Friday, November 7. After the session, the full poster will be available at https://briacell.com/scientific-publications/.
BriaCell is a clinical-stage biotechnology company focused on developing novel immunotherapies to transform cancer care. By combining trained innate immunity with adaptive memory, Bria-OTS+ aims to overcome immune resistance in solid tumors. For more on its research and pipeline, visit https://briacell.com/.
Read Announcement- Drug:
- Bria-OTS
- Announced Date:
- July 9, 2025
- Indication:
- In metastatic breast cancer
Announcement
BriaCell Therapeutics Corp announced the sustained complete resolution of lung metastasis in a patient with hormone receptor-positive (HR+), HER2-negative, metastatic breast cancer (MBC) treated with Bria-OTS, the Company's personalized off the shelf immunotherapy.
AI Summary
BriaCell Therapeutics Corp announced a promising clinical milestone in its Phase 1/2a study for metastatic breast cancer. The company reported that its personalized off-the-shelf immunotherapy, Bria-OTS, achieved a sustained complete resolution of lung metastasis in a 78-year-old patient with hormone receptor-positive (HR+), HER2-negative advanced breast cancer. After four doses of Bria-OTS, the patient’s right lung tumor was 100% resolved, with the response first noted at two months and confirmed at four and six months. Importantly, no treatment-limited toxicities were observed, and the patient continues to maintain stable disease in other areas. This significant outcome highlights the potential of Bria-OTS to overcome challenges in patients with multiple prior treatment failures and supports further exploration, including combination approaches with checkpoint inhibitors, to improve outcomes for advanced breast cancer patients.
Read Announcement- Drug:
- Bria-OTS
- Announced Date:
- May 27, 2025
- Indication:
- In metastatic breast cancer
Announcement
BriaCell Therapeutics Corp. announced that Bria-OTS has cleared its safety evaluation in the Phase 1/2 monotherapy study and has now transitioned to dosing patients in combination with a checkpoint inhibitor (CPI).
AI Summary
BriaCell Therapeutics announced that its personalized immunotherapy, Bria-OTS, has successfully passed the safety evaluation in its Phase 1/2 monotherapy study. This achievement has allowed the study to transition to a new phase where patients with metastatic breast cancer will receive Bria-OTS in combination with a checkpoint inhibitor (CPI). The addition of the CPI aims to boost the body’s immune response against tumors and may provide a more effective treatment option.
The study will now include up to 12 patients to closely monitor both safety and potential improvements in response rates. Early signs are encouraging, as the first patient in the monotherapy phase showed a complete resolution of lung metastasis. BriaCell believes that this combination approach could be a promising new option for patients who have not responded to existing treatments.
Read Announcement
Bria-PROS+ FDA Regulatory Events
Bria-PROS+ is a drug developed by Briacell Therap for the following indication: For Prostate Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Bria-PROS+
- Announced Date:
- September 10, 2024
- Indication:
- For Prostate Cancer
Announcement
BriaCell Therapeutics Corp is pleased to announce that it has received positive feedback from its Pre-IND meeting with the U.S. Food and Drug Administration (FDA), which is a step forward to opening an IND to conduct a Phase 1/2 study of its personalized off-the-shelf immunotherapy, Bria-PROS+™, in advanced prostate cancer.
AI Summary
BriaCell Therapeutics Corp. announced that it received positive feedback from the FDA during a Pre-IND meeting focused on its personalized off-the-shelf immunotherapy, Bria-PROS+™ for advanced prostate cancer. The FDA experts expressed strong interest in this novel approach and provided clear guidance that moves BriaCell closer to opening an IND to conduct a Phase 1/2 study. Notably, the FDA waived the usual animal toxicology and pharmacokinetic studies, simplifying the development pathway and speeding up the process for clinical trials.
By streamlining these requirements, the company is better positioned to begin the necessary standard manufacturing and testing needed before the trials start. This progress marks an important step towards offering a new treatment option for patients suffering from advanced prostate cancer, a disease that remains a major cause of cancer-related deaths in American men.
Read Announcement
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