not too shabby news BriaCell to Partner With Top U.S. Medical Institution Washington University to Produce Its BriaVax(TM) Cancer Vaccine
VANCOUVER, BC--(Marketwired - May 27, 2015) - BriaCell Therapeutics Corp (TSX VENTURE: BCT), an immuno-oncology focused biotechnology company with a proprietary vaccine technology (BriaVax™), 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 BriaVax™ for BriaCell's anticipated clinical trial. Washington University will manufacture 300 vials of BriaVax™ 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 BriaVax™, 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 BriaVax™ 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 BriaVax™ 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.