BriaCell Moves Forward to Initiate Phase I/IIa Clinical Study for BriaVax(TM) in Advanced Breast Cancer

BriaCell Therapeutics (TSX VENTURE: BCT) (OTCQB: BCTXF), a clinical-stage company dedicated to the development of immuno-oncology treatments, today announced that the Company has submitted a Chemistry, Manufacturing, and Controls (CMC) amendment which includes the details of extensive testing performed on BriaVax™, the Company’s proprietary vaccine for advanced breast cancer. Upon authorization by the FDA, the company plans to proceed with the initiation of the Phase I/IIa Clinical Study for BriaVax™ in advanced breast cancer as previously announced.
BriaVax™ is a genetically engineered whole-cell vaccine derived from a human breast tumor cell line. It is believed to activate the immune system to recognize and eliminate cancerous cells by potentially inducing tumor directed T cell and antibody responses. BriaCell is on track to launch its open-label Phase I/IIa clinical trial to evaluate the safety and activity of BriaVax™ in patients with metastatic breast cancer in the first quarter of 2017.
The CMC amendment contained the detailed analysis of extensive testing on a new batch of BriaVax™ (to be used for the upcoming clinical study) and BriaTest™ (the parental cell line, SV-BR-1, used to evaluate hypersensitivity to BriaVax™). This included testing for over 20 infectious agents (including for bacteria and viruses such as HIV, hepatitis B virus, and other viruses known to cause life-threatening effects), production of immuno-stimulatory granulocyte-macrophage colony-stimulating factor or GM-CSF (potency), and identity as well as purity of the cell line based on cellular markers. The new batch of BriaVax™ passed all of the stringent tests for sterility, potency and identity. Once cleared by the FDA, BriaCell is well-prepared to initiate the Phase I/IIa clinical study of BriaVax™ in advanced breast cancer patients at full speed.
“I wanted to thank Dr. Markus Lacher, BriaCell’s head of R&D, and our colleagues at the UC Davis GMP Facility and Biologics Consulting Group for a tremendous job putting this submission together,” commented Dr. Williams, BriaCell’s President & CEO. “The FDA green light will clear the path for the clinical development of BriaVax™ for advanced breast cancer and its companion diagnostic platform, BriaDx™, which is designed to provide a method of selecting patients most likely to respond to BriaVax™. We look forward to working with the FDA in this key milestone, and we are well prepared to work with the experts at Cancer Insight, LLC., BriaCell’s contract research organization (CRO) partner, and St. Joseph Health Center, the clinical site for the clinical study, to initiate the Phase I/IIa clinical trial to bring hope to the patients with advanced breast cancer.”
About BriaCell
BriaCell is an immuno-oncology biotechnology company developing a more targeted and potentially less toxic approach to cancer management compared to traditional chemotherapy strategies. BriaCell’s mission is to serve late-stage cancer patients with limited treatment options.
Immunotherapy has come to the forefront of the fight against cancer, harnessing the body’s own immune system to recognize and selectively destroy cancer cells while sparing normal cells. Immunotherapy, in addition to generally being more targeted than commonly used types of chemotherapy, is also thought to be a highly potent approach aimed at preventing cancer recurrence.
BriaVax™, the Company’s lead product candidate, is a genetically engineered whole-cell vaccine derived from a human breast tumor cell line. It is believed to activate the immune system to recognize and eliminate cancerous cells by inducing tumor-directed T cell and potentially antibody responses. The Company has already demonstrated encouraging clinical results, and is intent on building upon these results to further advance BriaVax™ through additional FDA-approved clinical trials in order to help cancer patients with limited therapeutic options. The results of two previous Phase I clinical trials (one with the precursor cell line not genetically engineered to produce GM-CSF and one with BriaVax™) have been encouraging in patients with advanced solid tumors. Most notably, one patient with metastatic breast cancer responded to BriaVax™ with substantial reduction in tumor burden including lung and brain metastases.
For more information on the previous clinical trials, please visit https://briacell.com/noveltechnology/clinical-trials/, and on BriaCell per se, https://briacell.com.
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