Drugs / SV-BR-1-GM
SV-BR-1-GM
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07199413 | Jun 2026 → Apr 2029 | malignant leptomeningeal tumor, metastatic malignant neoplasm in the brain | Medical College of Wisconsin | Withdrawn | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT04418219 | Dec 2020 → Jan 2023 | female breast carcinoma, invasive breast carcinoma | Thomas Jefferson University | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT03328026 | Mar 2018 → Mar 2026 | breast cancer | BriaCell Therapeutics Corporation | Completed | No outcome recorded |
| Phase 1/2 | NCT03066947 | May 2017 → Nov 2018 | breast cancer | BriaCell Therapeutics Corporation | Completed | No outcome recorded |
| Phase 1/2 | NCT00095862 | Nov 2004 → ? | breast cancer | Wiseman Research Initiatives LLC | Terminated | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06072612 | Dec 2023 → Dec 2027 expected | breast cancer | BriaCell Therapeutics Corporation | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 45
| Date | Issuer | Release |
|---|---|---|
| 2026-06-01 | BriaCell Therapeutics Corporation | Results BriaCell Presents Positive Clinical Data at ASCO 2026 briacell.com ↗
Final Bria-IMT™ Phase 2 data show 55% >1 year and 27% >2-year survival in heavily pre-treated metastatic breast cancer (MBC) patients |
| 2026-05-22 | BriaCell Therapeutics Corporation | Results BriaCell Presentations Highlight Positive Clinical Data for Bria-IMT(TM) at ASCO 2026 briacell.com ↗ |
| 2026-04-20 | BriaCell Therapeutics Corporation | Results BriaCell Presents Positive Phase 3 Quality of Life and Phase 2 Biomarker Data at the 2026 AACR Meeting briacell.com ↗
Phase 3 clinical data in heavily pretreated metastatic breast cancer patients with prior failed ADC, CPI, and CDK4/6 inhibitor treatments shows quality of life (QOL) largely preserved |
| 2026-03-18 | BriaCell Therapeutics Corporation | Results BriaCell to Present Positive Clinical Data for Bria-IMT(TM) and Preclinical Data for Next Generation Bria-OTS+(TM) Personalized Immunotherapy at the 2026 AACR Conference briacell.com ↗
Heavily pretreated metastatic breast cancer patients in the pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor maintained overall health status and key functional measures with a favorable safety profile. |
| 2026-01-28 | BriaCell Therapeutics Corporation | Results BriaCell Patients’ Images Show Regression and Resolution of Metastasized Tumors and Immune Activation briacell.com ↗
BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ, BCTXL) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, releases new images highlighting resolution of metastatic breast cancer lesions in patients with orbital (eye), temporal lobe (brain), liver, and spinal involvement. |
| 2026-01-27 | BriaCell Therapeutics Corporation | Results BriaCell Highlights Extended >18-47 Months Survival in Phase 2 Metastatic Breast Cancer Patients briacell.com ↗
9 of 25 BriaCell patients treated since 2022 remain alive >18-47 months post enrollment, markedly exceeding benchmarks reported for standard of care therapies in similar patient populations |
| 2025-12-10 | BriaCell Therapeutics Corporation | Results BriaCell Presents Outstanding Phase 2 Survival & Promising Phase 3 Clinical Data at SABCS® 2025 briacell.com ↗
Bria-IMT immunotherapy produced Th1 biased cytokine and chemokine changes consistent with immune activation suggesting their use as potential biomarkers to predict clinical responses of cancer patients to Bria-IMT regimen. |
| 2025-12-02 | BriaCell Therapeutics Corporation | Results BriaCell to Present Phase 2 Survival & Phase 3 Clinical Data at SABCS® 2025 briacell.com ↗
Th1-biased cytokine signatures as biomarkers of clinical benefit following SV-BR-1-GM cancer vaccination in breast cancer. |
| 2025-10-22 | BriaCell Therapeutics Corporation | Results BriaCell Receives Positive Recommendation from Data Safety Monitoring Board (DSMB) for Phase 3 Study in Metastatic Breast Cancer briacell.com ↗
Following its review, the DSMB raised no safety concerns and recommended that the study continue without modifications. |
| 2025-10-20 | BriaCell Therapeutics Corporation | Results BriaCell Presents Phase 3 Clinical Biomarker Data at ESMO 2025 briacell.com ↗
BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, 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. |
| 2025-10-13 | BriaCell Therapeutics Corporation | Results BriaCell to Present Positive Clinical Biomarker Data of Phase 3 Study at ESMO 2025 briacell.com ↗
Positive delayed-type hypersensitivity (DTH) – a potential biomarker predictive of improved clinical outcomes – significantly associated with longer progression-free survival (PFS) in a blinded analysis of all current Phase 3 patients |
| 2025-07-11 | BriaCell Therapeutics Corporation | Results BriaCell’s Bria-IMT(TM) Demonstrates Survival Advantage over Trodelvy® and Control Group in Metastatic Breast Cancer briacell.com ↗
BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, today announced updated Phase 2 survival data for its lead immunotherapy candidate, Bria-IMT, in combination with an immune check point inhibitor (CPI). |
| 2025-07-10 | BriaCell Therapeutics Corporation | Results BriaCell Reports Complete and Sustained Resolution of Brain Metastasis and Sustained Regression of Orbital Metastasis in “Eye-Bulging” Breast Cancer Patient briacell.com ↗
BriaCell is pleased to report the sustained complete resolution of temporal lobe brain metastasis and continued orbital (behind the eye) tumor reduction after > 18 months of treatment in the Phase 2 study. |
| 2025-06-02 | BriaCell Therapeutics Corporation | Results BriaCell Reports Robust Overall Survival and Clinical Benefit Data at ASCO 2025 briacell.com ↗
Median Overall Survival of 17.3 months in Phase 2 study patients treated with Phase 3 formulation (since 2022) is superior to outcomes reported for comparable patients in the literature |
| 2025-05-23 | BriaCell Therapeutics Corporation | Results BriaCell Abstracts Showcase Positive Survival and Clinical Benefit Data at ASCO 2025 briacell.com ↗
Phase 2 survival and clinical benefit data meet or exceed outcomes of FDA-approved therapies in comparable metastatic breast cancer patients, with no treatment-related discontinuations |
| 2025-04-30 | BriaCell Therapeutics Corporation | Results BriaCell Reports “Late-Breaker” Phase 3 Data at AACR 2025: Positive Tolerability Profile and Potential Response Biomarkers Identified briacell.com ↗
Biomarkers could be utilized to predict and provide better patient outcomes, including response rates and survival benefits with BriaCell’s novel Bria-IMT regimen. |
| 2025-03-20 | BriaCell Therapeutics Corporation | Results Second Data Safety Monitoring Board Issues Positive Recommendation to Continue BriaCell’s Phase 3 Study in Metastatic Breast Cancer briacell.com ↗
The Data Safety Monitoring Board (DSMB) identified no safety concerns, and recommended continuation of BriaCell’s pivotal Phase 3 study of Bria-IMT™ plus immune check point inhibitor in metastatic breast cancer |
| 2024-12-13 | BriaCell Therapeutics Corporation | Results BriaCell 2024 SABCS® Poster Highlights Ability of Bria-IMT(TM) Regimen to Increase Cancer-Fighting Immune Cells in Metastatic Breast Cancer briacell.com ↗
BriaCell employed this advanced imaging technology as a precision diagnostic tool to monitor patients’ immune system responses in its phase 2 study, establishing the ability of the Bria-IMT™ regimen to induce tumor infiltration with CD8+ “killer” T cells. |
| 2024-12-11 | BriaCell Therapeutics Corporation | Results BriaCell Presents Unprecedented Overall Survival Data in Metastatic Breast Cancer in Spotlight Poster at 2024 SABCS® briacell.com ↗
Significantly lowered levels of circulating tumor cells (CTCs) and cancer associated macrophage-like cells (CAMLs) in 40% of heavily pre-treated MBC patients |
| 2024-12-02 | BriaCell Therapeutics Corporation | Results BriaCell Receives Green-Light from Data Safety Monitoring Board for its Phase 3 Study in Metastatic Breast Cancer briacell.com ↗
The DSMB issued a statement recommending continuation of the study in metastatic breast cancer patients. |
| 2024-11-26 | BriaCell Therapeutics Corporation | Results BriaCell 2024 SABCS® Spotlight Poster to Showcase Positive Overall Survival Data Across All Patient Subtypes in Metastatic Breast Cancer briacell.com ↗
Patients receiving the pivotal Phase 3 Bria-IMT™ combination regimen (n=37) showed significantly higher median overall survival (OS) (13.4), an objective response rate (ORR) of 9.5% and a clinical benefit rate (CBR) of 55%. |
| 2024-10-22 | BriaCell Therapeutics Corporation | Results BriaCell Reports Outperforming Metastatic Breast Cancer Patients and Standard-Beating Survival Data briacell.com ↗
BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, announces new positive survival data, outperforming patients, and survival rates in its Phase 2 metastatic breast cancer (MBC) study. |
| 2024-10-01 | BriaCell Therapeutics Corporation | Results BriaCell Reports 100% Resolution of Brain Metastasis in Breast Cancer Patient with “Eye-Bulging” Tumor briacell.com ↗
The patient demonstrated an initial partial response at 2 months in the brain lesion with no detectable disease following 8 and 11 months of treatment. |
| 2024-09-18 | BriaCell Therapeutics Corporation | Regulatory BriaCell Announces FDA-Authorized Expanded Access Policy for Metastatic Breast Cancer Patients briacell.com ↗
FDA has authorized the Expanded Access Policy (EAP) to help metastatic breast cancer patients in need for novel treatments |
| 2024-09-11 | BriaCell Therapeutics Corporation | Results BriaCell Reports Positive Overall Survival (OS) in Metastatic Breast Cancer briacell.com ↗
Median overall survival of 15.6 months is reported in BriaCell’s most recent patients (treated since 2022) vs. 6.7-9.3 months for similar patients reported in the literature (see table below). |
| 2024-07-18 | BriaCell Therapeutics Corporation | Results BriaCell Quadruples Progression Free Survival (PFS) in Patient with “Eye-Bulging” Metastatic Breast Cancer briacell.com ↗
BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, is pleased to report significantly higher PFS for its top responder patient in the Phase 2 study of BriaCell’s Bria-IMT™ regimen in combination with an immune checkpoint inhibitor in metastatic breast cancer. |
| 2024-06-03 | BriaCell Therapeutics Corporation | Results BriaCell Presents Clinical Efficacy Data at ASCO 2024 briacell.com ↗
In evaluable patients, the ORR was 12% and CBR was 53% which is remarkable versus similar data suggesting clinical benefit. |
| 2024-05-24 | BriaCell Therapeutics Corporation | Results BriaCell Doubles Progression-Free-Survival (PFS) and Reports Clinical Benefit Data at ASCO 2024 briacell.com ↗ |
| 2024-04-09 | BriaCell Therapeutics Corporation | Results BriaCell Showcases Data Demonstrating Unmatched Progression-Free Survival (PFS) and Clinical Efficacy in Antibody-Drug Conjugate (ADC) Resistant and Central Nervous System (CNS) Metastatic Breast Cancer at the 2024 AACR briacell.com ↗
In summary, the data to date shows that Bria-IMT™ provides prolonged progression-free survival and clinical benefits in heavily pre-treated, ADC resistant breast cancer patients compared with those in other similar studies. |
| 2024-02-07 | BriaCell Therapeutics Corporation | Results BriaCell Announces Strong Clinical Data in Breast Cancer Patients; Reports Another Notable Responder Case briacell.com ↗
Disease control rate of 61% observed in evaluable Phase 2 patients treated with the same formulation in BriaCell’s pivotal Phase 3 study |
| 2024-01-04 | BriaCell Therapeutics Corporation | Results BriaCell Images Confirm Robust Anti-Tumor Activity in Patient with “Eye-Bulging” Metastatic Breast Cancer briacell.com ↗
We observed significant tumor reduction along with significant eye pain reduction after only 3 cycles of treatment with the Bria-IMT™ combination regimen. |
| 2023-12-28 | BriaCell Therapeutics Corporation | Results BriaCell Reports 71% Central Nervous System Response Rate in Advanced Breast Cancer Patients briacell.com ↗
BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, is pleased to report marked 71% intracranial objective response rate (iORR) in advanced breast cancer patients suffering from central nervous system (CNS) metastases and treated with BriaCell’s Bria-IMT™ regimen. |
| 2023-12-06 | BriaCell Therapeutics Corporation | Results BriaCell Highlights Outstanding Topline Survival and Clinical Benefit Data in Advanced Metastatic Breast Cancer at the 2023 SABCS briacell.com ↗
Interim analysis using Kaplan-Meier curve method, measuring the probability of patients’ survival in time, showed median overall survival (OS) of 13.4 months for 54 patients. |
| 2023-12-06 | BriaCell Therapeutics Corporation | Results BriaCell 2023 SABCS Posters Confirm Activation of Cancer-Fighting Immune Cells and Identify Potential Predictors of Clinical Benefit briacell.com ↗
Using protein array technology, we were able to identify antibody responses that differed between clinical responders (defined as patients who achieved complete response, partial response or stable disease) and non-responders. |
| 2023-11-30 | BriaCell Therapeutics Corporation | Results BriaCell Records New Responder with Remarkable Improvement of “Eye-Bulging” Metastatic Tumor briacell.com ↗
The patient had cancer behind the eye, causing proptosis (eye-bulging) and significant pain that were both resolved with BriaCell’s treatment. |
| 2023-09-08 | BriaCell Therapeutics Corporation | Results BriaCell Reports Benchmark-Beating Patient Survival and Clinical Benefit in Advanced Metastatic Breast Cancer briacell.com ↗
21 out of 29 patients that have received treatment since 2022 remain alive suggesting tolerability and survival efficacy. |
| 2023-06-27 | BriaCell Therapeutics Corporation | Regulatory FDA Approves BriaCell’s Pivotal Registrational Study Design in Advanced Metastatic Breast Cancer briacell.com ↗
FDA has approved the study design, the primary and secondary endpoints, and patient population in BriaCell’s upcoming pivotal registration clinical study. |
| 2023-04-17 | BriaCell Therapeutics Corporation | Results BriaCell Presents Positive Data Demonstrating Survival and Clinical Benefits in Advanced Metastatic Breast Cancer at the 2023 AACR briacell.com ↗
15 of 18 patients remain alive of those recruited since the study reopened in 2021. |
| 2023-02-23 | BriaCell Therapeutics Corporation | Results BriaCell Reports Positive Survival Data in Advanced Metastatic Breast Cancer briacell.com ↗
9 of 11 (82%) patients remain alive from 2021/2022 dosing, suggesting strong survival benefits. |
| 2022-12-08 | BriaCell Therapeutics Corporation | Results BriaCell Announces Positive Clinical and Quality of Life Data in Advanced Metastatic Breast Cancer at 2022 San Antonio Breast Cancer Symposium® briacell.com ↗
As previously disclosed , clinical benefits were observed across multiple subtypes of advanced metastatic breast cancer patients, especially in patients with hormone receptor positive (“HR+”) cancer, a very large segment of the patient population. |
| 2022-11-10 | BriaCell Therapeutics Corporation | Results BriaCell Reports Positive Breast Cancer Efficacy Data with Bria-IMT(TM) Immunotherapy Treatment at SITC Annual Meeting briacell.com ↗
Disease control, tumor shrinkage, and potential survival benefit were observed amongst 12 patients in the Phase I/IIa clinical study of Bria-IMT™ in combination with Incyte’s retifanlimab. |
| 2022-10-21 | BriaCell Therapeutics Corporation | Results BriaCell Announces Successful Completion of Phase I Portion of Clinical Study in Advanced Breast Cancer; Randomized Phase II Efficacy Evaluation Progressing briacell.com ↗
The combination treatment showed a favorable safety profile in 12 patients. |
| 2022-06-24 | BriaCell Therapeutics Corporation | Results BriaCell Anti-Cancer Technology Published in Leading Cancer Drug Discovery Journal briacell.com ↗
As previously reported, clinical data in 4 advanced breast cancer patients who had failed multiple prior treatments showed that the Bria-IMT™ (also known as SV-BR-1-GM) immunotherapy regimen was safe and well tolerated and produced immune responses in all 4 patients. |
| 2022-04-13 | BriaCell Therapeutics Corporation | Regulatory BriaCell Receives FDA Fast Track Approval for Targeted Breast Cancer Immunotherapy briacell.com ↗
U.S. Food and Drug Administration (FDA) has granted Fast Track status to BriaCell’s lead candidate, Bria-IMT™, for the treatment of metastatic breast cancer. |
| 2021-12-09 | BriaCell Therapeutics Corporation | Results BriaCell Summarizes Clinical Data Poster Presented at the 2021 San Antonio Breast Cancer Symposium® briacell.com ↗
The treatment was generally safe and well tolerated in both the monotherapy and the combination studies. |
All press releases naming this drug 54 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SVBR- 1-GM | “SVBR- 1-GM Cell Line Genetically Engineered To Produce Granulocyte- Macrophage Colony Stimulating Factor” NCT00095862 ↗6“clinical formulations of SV-BR-1-GM, a GM-CSF-secreting breast tumor cell line” PMID 29867922 ↗ May 2018 |
| Known as | Breast Cancer Vaccine SV-BR-1-GM | “Breast Cancer Vaccine SV-BR-1-GM, Bria-IMT, GM-CSF Gene-transfected Breast Cancer Vaccine SV-BR-1-GM, SV-BR-1 Breast Cancer Cell Line Vaccine, SV-BR-1-GM, SV-BR-1-GM Vaccine” NCT04418219 ↗ |
| Known as | Bria-IMT | “Breast Cancer Vaccine SV-BR-1-GM, Bria-IMT, GM-CSF Gene-transfected Breast Cancer Vaccine SV-BR-1-GM, SV-BR-1 Breast Cancer Cell Line Vaccine, SV-BR-1-GM, SV-BR-1-GM Vaccine” NCT04418219 ↗ |
| Known as | GM-CSF Gene-transfected Breast Cancer Vaccine SV-BR-1-GM | “Breast Cancer Vaccine SV-BR-1-GM, Bria-IMT, GM-CSF Gene-transfected Breast Cancer Vaccine SV-BR-1-GM, SV-BR-1 Breast Cancer Cell Line Vaccine, SV-BR-1-GM, SV-BR-1-GM Vaccine” NCT04418219 ↗ |
| Known as | SV-BR-1 Breast Cancer Cell Line Vaccine | “Breast Cancer Vaccine SV-BR-1-GM, Bria-IMT, GM-CSF Gene-transfected Breast Cancer Vaccine SV-BR-1-GM, SV-BR-1 Breast Cancer Cell Line Vaccine, SV-BR-1-GM, SV-BR-1-GM Vaccine” NCT04418219 ↗ |
| Known as | SV-BR-1-GM Vaccine | “Breast Cancer Vaccine SV-BR-1-GM, Bria-IMT, GM-CSF Gene-transfected Breast Cancer Vaccine SV-BR-1-GM, SV-BR-1 Breast Cancer Cell Line Vaccine, SV-BR-1-GM, SV-BR-1-GM Vaccine” NCT04418219 ↗ |
| Modality | Vaccine | “tumor vaccine comprising HER2/neu-positive allogeneic (non-self) breast cancer cells transfected with the sargramostim (GM-CSF) gene” NCT00095862 ↗ |
| Route | Other | “tumor vaccine comprising HER2/neu-positive allogeneic (non-self) breast cancer cells transfected with the sargramostim (GM-CSF) gene intradermally (ID) on day 1” NCT00095862 ↗ |