^
Contact us  to learn more about
our Premium Content:  News alerts, weekly reports and conference planners
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:
3ms
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)
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 | 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)
1year
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)
1year
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)
1year
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)
over1year
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)
over1year
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
almost2years
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)
2years
Combination Study of SV-BR-1-GM With Retifanlimab (clinicaltrials.gov)
P1/2, N=36, Recruiting, BriaCell Therapeutics Corporation | N=60 --> 36
Enrollment change • 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
Regression of Breast Cancer Metastases Following Treatment with Irradiated SV-BR-1-GM, a GM-CSF Overexpressing Breast Cancer Cell Line: Intellectual Property and Immune Markers of Response. (PubMed, Recent Pat Anticancer Drug Discov)
A whole-cell immunotherapy regimen with SV-BR-1-GM cells induced regression of metastatic breast cancer. We develop intellectual property based on SV-BR-1-GM's predicted mechanism of action to develop additional whole-cell immunotherapies for cancer patients.
Clinical • Preclinical • IO biomarker
|
HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • CSF2 (Colony stimulating factor 2)
|
cyclophosphamide • Bria-IMT (SV-BR-1-GM)
over2years
Toward a personalized off-the-shelf cellular immunotherapy for cancer (AACR 2022)
SV-BR-1-GM has been in clinical trials in a regimen including low-dose pre-dose cyclophosphamide to reduce immune suppression, and post-dose local interferon alpha to boost the immune response. Hum Immunol. 2013;74(10):1313-1320.
PD(L)-1 Biomarker • IO biomarker
|
HLA-A (Major Histocompatibility Complex, Class I, A) • CSF2 (Colony stimulating factor 2)
|
CSF2 expression
|
cyclophosphamide • Bria-IMT (SV-BR-1-GM)
over3years
Breast Cancer Vaccine in Combination With Pembrolizumab for Treatment of Persistent, Recurrent, or Metastatic Breast Cancer (clinicaltrials.gov)
P1/2, N=0, Withdrawn, Thomas Jefferson University | N=42 --> 0 | Not yet recruiting --> Withdrawn
Clinical • Enrollment change • Trial withdrawal • Combination therapy • IO biomarker
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • PD-L2 (Programmed Cell Death 1 Ligand 2) • PRAME (Preferentially Expressed Antigen In Melanoma)
|
PD-L1 expression • HER-2 positive • ER positive • HER-2 negative • ER positive + PGR positive • PGR positive • PGR negative
|
Keytruda (pembrolizumab) • Bria-IMT (SV-BR-1-GM) • cyclophosphamide intravenous
over3years
Combination Study of SV-BR-1-GM in Combination With INCMGA00012 and Epacadostat (clinicaltrials.gov)
P1/2, N=60, Recruiting, BriaCell Therapeutics Corporation | Trial completion date: Dec 2020 --> Dec 2022 | Trial primary completion date: Dec 2020 --> Dec 2022
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 positive • HER-2 negative • PGR positive • PGR negative
|
Zynyz (retifanlimab-dlwr) • epacadostat (INCB024360) • Bria-IMT (SV-BR-1-GM) • Intron A (interferon α-2b) • cyclophosphamide intravenous
almost4years
Breast Cancer Vaccine in Combination With Pembrolizumab for Treatment of Persistent, Recurrent, or Metastatic Breast Cancer (clinicaltrials.gov)
P1/2, N=42, Not yet recruiting, Thomas Jefferson University | Initiation date: Jul 2020 --> Dec 2020
Clinical • Trial initiation date • Combination therapy • PD(L)-1 Biomarker • IO biomarker
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • PD-L2 (Programmed Cell Death 1 Ligand 2) • PRAME (Preferentially Expressed Antigen In Melanoma)
|
PD-L1 expression • HER-2 positive • ER positive • HER-2 negative • ER positive + PGR positive • PGR positive • PGR negative
|
Keytruda (pembrolizumab) • Bria-IMT (SV-BR-1-GM) • cyclophosphamide intravenous
4years
[VIRTUAL] Results of a Phase I/IIa Trial of Combination Whole-Cell Targeted Immunotherapy Vaccine and Checkpoint Inhibitor in Treatment of Metastatic/Recurrent Breast Cancer (SSO 2020)
Combination therapy with SV-BR-1-GM and pembrolizumab is safe and consistently produces anti-cancer immunity as measured by DTH reactions. Further study is needed to determine the efficacy of combination therapy in the treatment of aggressive BC.
P1/2 data • Checkpoint inhibition
|
HER-2 (Human epidermal growth factor receptor 2) • CSF2 (Colony stimulating factor 2)
|
Keytruda (pembrolizumab) • Bria-IMT (SV-BR-1-GM) • cyclophosphamide intravenous
over4years
[VIRTUAL] Clinical and pharmacodynamic responses to a modified whole tumor cell immunotherapy in patients with advanced breast cancer from two phase I-IIa trials (AACR-II 2020)
The combination study is evaluating the SV-BR-1-GM regimen with checkpoint inhibitors (PD-1 inhibitors pembrolizumab or INCMGA00012) with cycles every 3 weeks (11 patients have been dosed to date)...Pharmacodynamic analysis of humoral and cell-mediated immune responses showed notable upregulation, the strongest responses being seen in those with measurable clinical regression. Patients with Grade I or II tumors appeared more likely to respond.
Clinical • P1/2 data • PK/PD data
|
HER-2 (Human epidermal growth factor receptor 2) • IL2 (Interleukin 2) • CSF2 (Colony stimulating factor 2) • PRAME (Preferentially Expressed Antigen In Melanoma) • CD40LG (CD40 ligand) • IL1R1 (Interleukin 1 receptor, type I)
|
CSF2 elevation
|
Keytruda (pembrolizumab) • Zynyz (retifanlimab-dlwr) • Bria-IMT (SV-BR-1-GM) • cyclophosphamide intravenous
over4years
[VIRTUAL] Breast cancer grade and clinical benefit in patients with advanced breast cancer treated with an engineered whole tumor cell-targeted immunotherapy alone or in combination with checkpoint inhibition. (ASCO 2020)
The SV-BR-1-GM regimen with or without pembrolizumab appears safe and able to induce clinical benefit even in very heavily pre-treated patients with low or intermediate grade advanced breast cancer. Research Funding: BriaCell Therapeutics Corporation
Clinical • Combination therapy • Checkpoint inhibition
|
CSF2 (Colony stimulating factor 2)
|
Keytruda (pembrolizumab) • Bria-IMT (SV-BR-1-GM) • cyclophosphamide intravenous
5years
Efficacy and safety of a modified whole tumor cell targeted immunotherapy in patients with advanced breast cancer alone and in combination with immune checkpoint inhibitors (SABCS 2019)
Therefore, a combination study with pembrolizumab was initiated...This study is ongoing and is being modified to evaluate combination therapy with the PD-1 inhibitor INCMGA00012 and the IDO inhibitor epacadostat... SV-BR-1-GM appears to be safe and well-tolerated. Contrary to conventional wisdom, SV-BR-1-GM can produce regression of metastatic breast cancer correlating with an immunologic response and HLA matching. Combination therapy with checkpoint inhibitors is ongoing.
Clinical • Combination therapy • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • IL6 (Interleukin 6) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • CSF2 (Colony stimulating factor 2)
|
Keytruda (pembrolizumab) • Zynyz (retifanlimab-dlwr) • epacadostat (INCB024360) • Bria-IMT (SV-BR-1-GM) • cyclophosphamide intravenous