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    DRUG:

    Bria-IMT (SV-BR-1-GM)

    i
    Other names: SV-BR-1-GM, SV BR 1 GM cancer vaccine, allogeneic GM CSF secreting cancer vaccine
    Company:
    BriaCell
    Drug class:
    Immunostimulant, G-CSF stimulant
    Related drugs:
    2ms
    Allogeneic, Antigen-Presenting, GM-CSF-secreting, SV-BR-1-GM Whole Cell-Therapeutic Vaccine and Immunotherapy: A Phase I Pilot Safety and Feasibility Study for Solid Tumor Patients With CNS Metastases (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, Medical College of Wisconsin
    New P1 trial
    |
    Keytruda (pembrolizumab) • cyclophosphamide • Bria-IMT (SV-BR-1-GM) • ViraferonPeg (peginterferon-α-2b)
    9ms
    BRIA-ABC: Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer. (clinicaltrials.gov)
    P3, N=404, Recruiting, BriaCell Therapeutics Corporation | Trial completion date: Dec 2025 --> Jun 2026 | Trial primary completion date: Jun 2025 --> Jan 2026
    Trial completion date • Trial primary completion date
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    carboplatin • capecitabine • cyclophosphamide • Halaven (eribulin mesylate) • Zynyz (retifanlimab-dlwr) • Bria-IMT (SV-BR-1-GM)
    10ms
    BRI-ROL-001: Combination Study of SV-BR-1-GM With Retifanlimab (clinicaltrials.gov)
    P1/2, N=36, Enrolling by invitation, BriaCell Therapeutics Corporation | Trial completion date: Jun 2024 --> Nov 2028 | Trial primary completion date: Jun 2024 --> Nov 2025
    Trial completion date • Trial primary completion date
    |
    ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor)
    |
    HER-2 positive • HER-2 negative • PGR positive
    |
    cyclophosphamide • Zynyz (retifanlimab-dlwr) • Bria-IMT (SV-BR-1-GM)
    1year
    PD-L1 Upregulation in Circulating Tumor Associated Cells Predicts for clinical outcomes in a phase I/II clinical trial using SV-BR-1-GM vaccine with the check point inhibitor retifanlimab in Metastatic Breast Cancer Patients, an Interim Analysis (SABCS 2024)
    SV-BR-1-GM treatment includes low pre-dose cyclophosphamide, intradermal inoculation of ~20 million irradiated SV-BR-1-GM cells, post-dose local interferon-α with cycles and an anti-PD-1 inhibitor (retifanlimib), with cycles every 3 weeks. In an interim analysis of heavily treated mBC patient population, we observed that treatment with the SV-BR-1-GM regimen was associated with decreases in the presence of CTCs and CAMLs in 38% of patients, which significantly correlated with better PFS and trended for better OS within 2 years. Further, SV-BR-1-GM therapy appeared to upregulate PD-L1 in n=13 patients which appeared to have better responses to combination treatment with the anti-PD-1 check point inhibitor retifanlimab.
    Clinical data • P1/2 data • Clinical • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 expression
    |
    FoundationOne® Liquid CDx
    |
    cyclophosphamide • Zynyz (retifanlimab-dlwr) • Bria-IMT (SV-BR-1-GM)
    over1year
    Results of a phase I/IIa trial of SV-BR-1-GM inoculation with low-dose cyclophosphamide and interferon alpha (Bria-IMT) in metastatic breast cancer. (PubMed, Hum Vaccin Immunother)
    Eight of 10 patients significantly upregulated programmed cell death ligand 1 (PD-L1) on CTCs/CAMLs with treatment (p = .0012). These observations support the safety of the Bria-IMT regimen, demonstrate clinical regressions, imply a role for HLA matching, and identify a possible value for monitoring CAMLs in peripheral blood.
    P1/2 data • Journal • Metastases
    |
    CSF2 (Colony stimulating factor 2)
    |
    cyclophosphamide • Bria-IMT (SV-BR-1-GM)
    almost2years
    BRIA-ABC: Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer. (clinicaltrials.gov)
    P3, N=404, Recruiting, BriaCell Therapeutics Corporation | Initiation date: Oct 2023 --> Feb 2024
    Trial initiation date • Metastases
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    carboplatin • capecitabine • cyclophosphamide • Halaven (eribulin mesylate) • Zynyz (retifanlimab-dlwr) • Bria-IMT (SV-BR-1-GM)
    2years
    BRIA-ABC: Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer. (clinicaltrials.gov)
    P3, N=404, Recruiting, BriaCell Therapeutics Corporation | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    carboplatin • capecitabine • cyclophosphamide • Halaven (eribulin mesylate) • Zynyz (retifanlimab-dlwr) • Bria-IMT (SV-BR-1-GM)
    2years
    BRIA-ABC: Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer. (clinicaltrials.gov)
    P3, N=404, Not yet recruiting, BriaCell Therapeutics Corporation
    New P3 trial • Metastases
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    carboplatin • capecitabine • cyclophosphamide • Halaven (eribulin mesylate) • Zynyz (retifanlimab-dlwr) • Bria-IMT (SV-BR-1-GM)
    2years
    Combination Study of SV-BR-1-GM With Retifanlimab (clinicaltrials.gov)
    P1/2, N=36, Enrolling by invitation, BriaCell Therapeutics Corporation | Recruiting --> Enrolling by invitation
    Enrollment status • Combination therapy • Metastases
    |
    ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor)
    |
    HER-2 positive • HER-2 negative • PGR positive • PGR negative
    |
    cyclophosphamide • Zynyz (retifanlimab-dlwr) • Bria-IMT (SV-BR-1-GM)
    over2years
    Combination Study of SV-BR-1-GM With Retifanlimab (clinicaltrials.gov)
    P1/2, N=36, Recruiting, BriaCell Therapeutics Corporation | Trial completion date: Jun 2023 --> Jun 2024 | Trial primary completion date: Jun 2023 --> Jun 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor) • HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1)
    |
    HER-2 positive • HER-2 negative • PGR positive • HLA-A*24:02 • PGR negative
    |
    cyclophosphamide • Zynyz (retifanlimab-dlwr) • Bria-IMT (SV-BR-1-GM)
    over2years
    Engineering semi-allogeneic whole cancer vaccines with enhanced immunogenicity for the treatment of advanced solid tumors (AACR 2023)
    We sought to harness gene-modified tumor cells as a vaccine platform and developed cancer vaccines composed of breast cancer cells expressing GM-CSF (SV-BR-1-GM). Different types of cancer vaccines have been developed with moderate success, often hampered by lack of strong immunogenicity and complex manufacturing. BriaCell’s Bria OTS provides a solution by increasing vaccine immunogenicity and decreasing manufacturing costs while personalizing the therapy based on matching the patient’s HLA type.1.Lacher MD et al, Front Immunol. 2018 May 15;9:776
    Metastases
    |
    CD4 (CD4 Molecule) • CSF2 (Colony stimulating factor 2) • IFNA1 (Interferon Alpha 1) • IL7 (Interleukin 7) • CD80 (CD80 Molecule) • CD86 (CD86 Molecule)
    |
    CSF2 expression
    |
    Bria-IMT (SV-BR-1-GM) • Bria-OTS
    almost3years
    Combination Study of SV-BR-1-GM With Retifanlimab (clinicaltrials.gov)
    P1/2, N=36, Recruiting, BriaCell Therapeutics Corporation | Trial completion date: Dec 2022 --> Jun 2023 | Trial primary completion date: Dec 2022 --> Jun 2023
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor) • HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1)
    |
    HER-2 positive • HER-2 negative • PGR positive • HLA-A*24:02 • PGR negative
    |
    cyclophosphamide • Zynyz (retifanlimab-dlwr) • Bria-IMT (SV-BR-1-GM)