Berkeley, CA and Vancouver, BC – November 29, 2016 – BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV: BCT) (OTCQB: BCTXF), a clinical-stage immuno-oncology company dedicated to the development of immuno-oncology treatments, is pleased to announce that it has filed a patent application with the U.S. Patent and Trademark Office (USPTO) as basis for potential future commercialization of tests for identifying patients with a high likelihood of responding favorably to the Company’s lead product candidate, BriaVax™, and/or other whole-cell cancer vaccines.
The patent application, entitled “Companion Diagnostics for Whole-Cell Cancer Vaccine”, is based on molecular analyses of both BriaVax™, and blood samples collected from patients treated with BriaVax™ in previous Phase I clinical studies. As reported earlier, BriaCell has identified a “gene signature” in BriaVax™ that seems consistent with its strong anti-tumor activity observed at multiple sites including in the breast, lungs, and brain of one of the patients who had failed prior conventional cancer treatments. As a critical element in the Company’s companion diagnostic program, the patent application outlines biomarkers and methods for developing a test (BriaDx™) for identifying patients likely to respond to BriaVax™ with tumor regression.
“Even though immunotherapy offers exciting and promising options for cancer patients, success is variable”, commented Dr. Lacher, BriaCell’s Head of R&D. “By building the foundation of a companion diagnostic for BriaVax™, our latest patent application addresses this unmet need. Our upcoming breast cancer Phase I/IIa clinical trial — for which enrollment is anticipated to begin in the first quarter of 2017 — is expected to yield data consistent with the scope of the patent application and the companion diagnostic”, he continued. “The FDA has recently encouraged companies to find ways to identify patients most likely to respond to their drugs, especially targeted cancer therapies,” commented William V. Williams, M.D., President and CEO of BriaCell. “A companion diagnostic will greatly facilitate further development of BriaVax™, which is a novel targeted immunotherapy.”
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 http://briacell.com/novel-technology/clinical-trials/, and on BriaCell per se, http://briacell.com/.
For further information contact:
BriaCell Therapeutics Corp.
820 Heinz Avenue
Berkeley, CA 94710
Ms. Farrah Dean
Manager, Corporate Development
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Except for the statements of historical fact, this news release contains “forward-looking information” within the meaning of the applicable Canadian securities legislation which involves known and unknown risks relevant to the Company in particular and to the biotechnology and pharmaceutical industries in general, uncertainties and other factors that may cause actual events to differ materially from current expectation. These risks are more fully described in the Company’s public filings available at www.sedar.com.
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