VANCOUVER, BC—(Marketwired – May 27, 2015) – BriaCell Therapeutics Corp (TSX VENTURE: BCT), an immuno–oncology focused biotechnology company with a proprietary vaccine technology (BriaVaxâ„¢), is pleased to announce that it has just signed an LOI outlining a Manufacturing Partnership with Washington University in St. Louis and its Siteman Comprehensive Cancer Center (“Washington University” or “Siteman Comprehensive Cancer Center”).
The proposed Manufacturing Partnership outlines terms through which Washington University's Siteman Comprehensive Cancer Center will produce BriaVaxâ„¢ for BriaCell's anticipated clinical trial. Washington University will manufacture 300 vials of BriaVaxâ„¢ utilizing its Current Good Manufacturing Practice; otherwise known as a cGMP Facility.
cGMP is the highest standard of manufacturing prescribed by the FDA, and as a general rule, Phase–II clinical trials onward require cGMP manufacturing. Therefore, the Company is very excited to implement cGMP in its planned Phase–I/II, given that it leaves open the potential to roll into a full–fledged Phase–II. If the Company can demonstrate positive results in its planned Phase–I/II utilizing a cGMP manufactured BriaVaxâ„¢, the Company believes that it would be a serious candidate for rolling this Phase–I/II into a robust Phase–II.
This milestone marks the culmination of BriaCell's discussions and negotiations with a number of prospective manufacturing institutions over the past 6 months. cGMP facilities are often pursued by larger biotechs who can sign long term deals worth millions of dollars. Thus, in order for smaller biotechs to gain access, many are forced to incur delays while spending hundreds of thousands of their precious R&D dollars. In contrast to this, Washington University's team of top–tier staff is prepared to launch the BriaVaxâ„¢ manufacturing process immediately upon signing of a Definitive Agreement, meaning that BriaCell will be very well positioned to meet its target dates for upcoming milestones.
It is anticipated that this Definitive Agreement will be finalized within the coming weeks, at which point the Company will be able to issue a more comprehensive press release announcing the finalized terms, as well as initiate the actual BriaVaxâ„¢ manufacturing process itself.
Dr. Charles Wiseman commented, “This is a major near–term milestone for BriaCell, in my mind second only to the FDA approving our planned trial, something we eagerly await. We are partnering with a renowned institution on favorable business terms. We must thank Washington University, as they have allowed BriaCell to obtain a top–notch cGMP facility, while leaving us with a strong balance sheet. I have a deep personal respect for Washington University, having myself completed a residency there many years ago. It is without a doubt one of the finest medical institutions in the country, and we are excited about this partnership. More importantly perhaps, we would like to hope Washington University is as excited as we are.”
BACKGROUND ON WASHINGTON UNIVERSITY
Washington University in St. Louis was ranked the #1 Medical School in the United States with regards to Primary Care. U.S. News released this ranking in their 2015 report. U.S. News also ranked United States medical schools with regards to Research. In this report, Washington University ranked #6 in the United States, behind only Harvard, Stanford, Johns Hopkins, UCSF, and UPenn.
Washington University has a rich history, and its alumni include an array of Nobel Laureates in Medicine. Many top scientists and oncologists began their careers at Washington University, including BriaCell's own Founder Dr. Charles Wiseman.
Washington University's Siteman Comprehensive Cancer Center is an international leader in cancer treatment, research, prevention, education and community outreach. It is the only cancer center in the state to hold the prestigious Comprehensive Cancer Center designation from the National Cancer Institute and membership in the National Comprehensive Cancer Network
Washington University's Siteman Comprehensive Cancer Center was awarded “comprehensive” status because of its strong basic and clinical research programs; programs in cancer prevention, control and population–based research; and a body of interactive research bridging these areas. Siteman also was recognized for outreach and education efforts aimed at residents of the St. Louis region and health–care professionals.
BACKGROUND ON FDA cGMP GUIDELINES
As per the FDA Website: “FDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (cGMP) regulations. The cGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.
“The approval process for new drug and generic drug marketing applications includes a review of the manufacturer's compliance with the cGMP. FDA inspectors determine whether the firm has the necessary facilities, equipment, and skills to manufacture the new drug for which it has applied for approval.
“Decisions regarding compliance with cGMP regulations are based upon inspection of the facilities, sample analyses, and compliance history of the firm. This information is summarized in reports which represent several years of history of the firms.” For further information, please visit the U.S. FDA's website at www.FDA.gov.
ABOUT BRIACELL
BriaCell is an immuno–oncology biotechnology company. 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. Immunotherapies are believed to be a more targeted, less toxic approach to managing cancer. This approach is also 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 BriaVaxâ„¢ 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 all other available therapies including various kinds of chemotherapy. In some cases, the lifespan was five times longer expected. The results were targeted, with little to no side effects, and were achieved rapidly, with regression occurring within 6 weeks.
In one patient, cancer regressed in all sites to which the cancer had spread, including lesions in the breast, lung, and even brain. This result was the most unique finding, given that the brain is largely considered an untouchable site in terms of cancer regression. Again, results were seen rapidly and with little to no adverse side effects.
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 submitted 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: www.briacell.com or its introductory video at 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.
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