Berkeley, CA and Vancouver, BC – November 10, 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 that can enhance the lives of cancer patients, today provided a comprehensive clinical development update for BriaVaxTM, its proprietary vaccine for advanced breast cancer.
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 inducing tumor-directed T cell and potentially antibody responses. BriaVaxTM is entering an open-label Phase I/IIa clinical trial designed to evaluate its safety and activity in patients with metastatic breast cancer. The clinical trial will be conducted under the leadership of Dr. Jarrod P. Holmes, a prominent breast cancer vaccine expert, at St. Joseph Health-Sonoma County.
Clinical Development Update
The Company has decided to only use BriaVax™ newly generated by the UC Davis Good Manufacturing Practice (GMP) facility in its upcoming Phase I/IIa clinical trial and not material generated more than a decade ago, as previously planned. In compliance with the most recent guidelines of the Center for Biologics Evaluation and Research (CBER) division of the FDA, BriaCell is currently conducting extensive testing on newly generated lots — to ensure patient safety. The Company expects the testing results for the material intended to dose the first patient in late December 2016, and for the clinical trial to initiate mid to late Q1 2017.
“We are very excited with the prospects of BriaVax™ as a potential second line treatment for advanced breast cancer,” said Dr. Williams, BriaCell’s President & CEO. “We look forward to working closely with the experts at the manufacturing site, UC Davis GMP certified facility, Cancer Insight, our Clinical Research Organization, and Dr. Holmes, the study’s principal investigator to initiate the Ph I/IIa clinical trial in the coming months. BriaVax™ has been undergoing extensive testing in collaboration with the UC Davis GMP production facility with excellent results to date”.
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, 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 FDA 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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Cautionary Note Regarding Forward-Looking Information
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.
Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.