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-OTS, and Bria-PROS+. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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:
- 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
- Estimated Event Date Range:
- May 30, 2025 - May 30, 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
- Estimated Event Date Range:
- October 1, 2025 - December 31, 2025
- Target Action Date:
- 2025-LATE
- 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
- 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 22, 2025
- Estimated Event Date Range:
- January 1, 2026 - June 30, 2026
- Target Action Date:
- 2026-H1
- 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 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-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:
- 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 Timeline and 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
