Mon Sep 14, 2015 9:30am EDT
BriaCell Launches Development of Companion Diagnostic Product, BriaDx(TM)
Also Provides General Corporate Update Including Consolidation of Its Corporate Headquarters and Research Laboratories in San Francisco Bay Area; Attends NYC Biotechnology Conference and Posts Updated Investor Presentation
VANCOUVER, BC–(Marketwired – September 14, 2015) – BriaCell Therapeutics Corp (OTCQB: ANCCF) (TSX VENTURE: BCT) (“BriaCell”, the “Company”, or “BCT”) is pleased to announce the initiation of its key research and development program pertaining to BriaCell’s novel companion diagnostic product, which is to be called “BriaDx™”.
President & CEO Dr. Joseph Wagner commented, “Since joining BriaCell in June, I have been very excited about the prospect of developing BriaDx™, a proprietary companion diagnostic product, to be co-developed with our BriaVax™ therapeutic cancer vaccine. Companion Diagnostics is a rapidly growing field, one that I have particular expertise in through my prior experiences. Our thesis is that a companion diagnostic such as BriaDx™ could maximize health outcomes and health economics by predicting which patients will most benefit from BriaVax™ treatment. Furthermore, we believe the strategy of co-developing BriaDx™ in parallel with BriaVax™ will maximize our likelihood of clinical trial success.”
BriaCell’s R&D program is currently focused on analyzing samples obtained from patients previously treated with BriaVax™ along with co-analysis of previously manufactured vaccine lots and will run in parallel with the Company’s planned clinical trial. Testing is now underway, and includes a variety of cutting-edge testing methods including gene expression analysis, blood and tumor sampling, and proteomics. Upon initiation of the Company’s planned Phase I/IIa trial, samples obtained from newly-enrolled patients will be subjected to similar analyses with the goal of devising a predictive test that determines BriaVax™ responsiveness based on the expression of specific biomarkers in patients.
This announcement marks the culmination of a very active summer for BriaCell, wherein the Company has aggressively advanced its core operations. The Company has been successful in executing and implementing a strategy to most effectively integrate Drs. Wagner and Lacher, including consolidating major portions of corporate operations to the San Francisco Bay Area, while maintaining a clinical presence at the Beverly Hills Cancer Center in order to continue leveraging the experience and networks of the Chief Medical Officer and Founder, Dr. Charles Wiseman.
BriaCell’s San Francisco Bay Area presence at a newly-leased facility in the East Bay Innovation Corridor in Berkeley, California, home to numerous biotechnology companies, allows the Company access to the vast university and biotech presence in the Bay Area and opens the door to potential partnering with any number of top tier institutions and companies. The result is an efficient and economical structure with BriaCell’s Corporate HQ and Research Laboratory in San Francisco, combined with an economical presence at the Beverly Hills Cancer Center wherein Dr. Wiseman will continue to run the Clinical Operations.
Founder & Chief Medical Officer, Dr. Charles Wiseman commented, “This structure allows us to utilize the respective expertise of each of our key scientists. With Dr. Wagner running corporate and overseeing the R&D operation of the Company in the heart of biotech central, San Francisco Bay Area, I can focus my attention towards my knitting: the clinical development of BriaVax™.”
INVESTOR RELATIONS UPDATE
BriaCell also reports that the Company attended the BioCentury biotechnology conference, which was held in New York City last week. Surrounding this conference, BriaCell President & CEO Dr. Wagner is making corporate presentations to a variety of institutional investors and analysts. An updated version of the corporate presentation will be posted on the BriaCell corporate website in concert with these meetings.
“I’m thrilled to make the announcement of launching our development of BriaDX™, which marks the culmination of a very active summer ticking off important operational goals in order to strategically prepare for the clinical trial and research program, and I can say that we are more prepared than ever to most rapidly advance both fronts. Therefore, I believe we are now well positioned to allocate more of our resources towards investor relations, and my New York meetings are the beginning of this”, commented Dr. Joseph Wagner.
BriaCell is an immuno-oncology biotechnology company, developing a more targeted and less toxic approach to managing cancer. Immunotherapies have come to the forefront of the fight against cancer, because they harness the body’s own immune system in recognizing and selectively destroying the cancer cells, sparing normal ones. Immunotherapy approach is more likely to prevent recurrence and is not expected to produce the serious side effects seen with chemotherapy.
The Company has demonstrated unique and unprecedented results, and is intent on building upon these results to further advance BriaVax™ through the FDA Clinical Trials in order to help cancer patients with no other options. The results of two FDA Phase I clinical trials have been encouraging in terms of both safety and efficacy in patients with advanced, stage-IV breast cancer. Most uniquely, BriaCell has achieved these results in patients who had prior failed the available therapies including various kinds of chemotherapy. In some cases, the lifespan was three to five times longer than expected. The results were targeted, with little to no side effects, and were achieved rapidly, with regression occurring within 6 weeks.
BriaCell is also developing a companion diagnostic technology, called BriaDx™. BriaCell believes that an effective companion diagnostic technology could maximize health outcomes and health economics by predicting which patients would most benefit from BriaVax™ treatment.
The Company is planning to advance its cancer immunotherapy technology in an FDA Phase I/II clinical trial with up to 24 breast cancer patients with advanced stages of solid tumors. The FDA-approved protocol has provision to allow testing the vaccine in selected patients with other cancers as well, including prostate, ovarian, pancreas, lung and bladder cancers among others. Although the focus of the Company is currently breast cancer, it recognizes that upon further proof of concept, its technology may be applicable to such other cancers as well. For further information, please refer to Company’s website at www.briacell.com or its YouTube channel www.youtube.com/watch?v=el-yFF1uHoQ
The TSX Venture Exchange Inc. has in no way passed upon the merits of the Company has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. This news release contains forward-looking information, which involves known and unknown risks, uncertainties and other factors that may cause actual events to differ materially from current expectation. Important factors — including the availability of funds, the results of financing efforts, the results of exploration activities — that could cause actual results to differ materially from the Company’s expectations are disclosed in the Company’s documents filed from time to time on SEDAR (see 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. This press release does not constitute an offer to sell or a solicitation of an offer to sell any of the securities described herein in the United States or elsewhere. These securities have not been, and will not be, registered in the United States Securities Act of 1933, as amended, or any state securities laws, and may not be offered or sold in the United States or to U.S. persons unless registered or exempt therefrom.
For further information contact:
BriaCell Therapeutics Corp.
820 Heinz Avenue
Berkeley, CA 94710
Joseph Wagner, Ph.D.
President and CEO