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

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.

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.

P3, N=404, Recruiting, BriaCell Therapeutics Corporation | Initiation date: Oct 2023 --> Feb 2024

P3, N=404, Recruiting, BriaCell Therapeutics Corporation | Not yet recruiting --> Recruiting

P3, N=404, Not yet recruiting, BriaCell Therapeutics Corporation

P1/2, N=36, Enrolling by invitation, BriaCell Therapeutics Corporation | Recruiting --> Enrolling by invitation

P1/2, N=36, Recruiting, BriaCell Therapeutics Corporation | Trial completion date: Jun 2023 --> Jun 2024 | Trial primary completion date: Jun 2023 --> Jun 2024

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

P1/2, N=36, Recruiting, BriaCell Therapeutics Corporation | Trial completion date: Dec 2022 --> Jun 2023 | Trial primary completion date: Dec 2022 --> Jun 2023

P1/2, N=36, Recruiting, BriaCell Therapeutics Corporation | N=60 --> 36

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.

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.

P1/2, N=0, Withdrawn, Thomas Jefferson University | N=42 --> 0 | Not yet recruiting --> Withdrawn

P1/2, N=60, Recruiting, BriaCell Therapeutics Corporation | Trial completion date: Dec 2020 --> Dec 2022 | Trial primary completion date: Dec 2020 --> Dec 2022

P1/2, N=42, Not yet recruiting, Thomas Jefferson University | Initiation date: Jul 2020 --> Dec 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.

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.

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

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.