BriaCell (NASDAQ: BCTX, BCTXW) (TSX-V:BCT) is an immuno-oncology focused biotechnology company developing targeted and safe approaches for the management of cancer.
BriaCell is conducting a Phase I/IIa clinical trial of Bria-IMT™, BriaCell’s lead candidate, in a combination with the immunotherapy development candidates INCMGA00012, an anti-PD-1 antibody, and epacadostat, an orally bioavailable small-molecule inhibitor of indoleamine 2,3-dioxygenase 1 (both provided by Incyte)*. The combination study is listed in ClinicalTrials.gov as NCT03328026.
BriaCell currently has a non-exclusive clinical trial collaboration with Incyte Corporation to evaluate the effects of combinations of novel clinical candidates. Under the agreement, Incyte and BriaCell will be evaluating novel combinations of compounds from Incyte’s development portfolio with BriaCell’s drug candidates in advanced breast cancer patients.
BriaCell is also developing Bria-OTS™*, an off-the-shelf personalized immunotherapy, for advanced breast cancer. Bria-OTS™ immunotherapy treatments are personalized to match the patient without the need for personalized manufacturing. Bria-OTS™, which is expected to cover over 99 percent of the patient population, is designed to produce a potent and selective immune response against the cancer of each patient while eliminating the time, expense and complex manufacturing logistics associated with other personalized immunotherapies.
In November 2020, BriaCell announced a Cooperative Research and Development Agreement with the National Cancer Institute (NCI, Center for Cancer Research), part of the National Institutes of Health, to investigate novel off-the-shelf personalized therapeutics for cancer.
Clinical and pathological data presented from the clinical trials of Bria-IMT™ alone and in combination with immune checkpoint inhibitors in advanced breast cancer indicates high responding subset with protracted progression-free survival:
- Data suggests a link with cancer grade, disease control, and progression-free-survival in patients treated with Bria-IMT™.
- Highest rate of disease control and longest progression free survival were observed in patients with Grade I/II tumors.
- Median overall survival of 12.5 months in patients with Grade I/II tumors versus 7.2-9.8 months in a recent study of third line breast cancer.
The findings indicate disease control in advanced breast cancer patients, including stable disease (SD), partial responses (PR) or complete responses (CR). Disease control was especially noted in patients with Grade I/II (i.e. well or moderately differentiated) tumors or those that matched Bria-IMT™ at 2 or more HLA alleles. Patients with low or undetectable levels of circulating cancer cells were more likely to benefit from therapy.