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BriaCell Therapeutics Corp
Symbol BCT
Shares Issued 84,736,315
Close 2015-05-26 C$ 0.31
Market Cap C$ 26,268,258
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BriaCell agrees to Wash. U. producing BriaVax

2015-05-27 09:20 ET - News Release

Dr. Charles Wiseman reports

BRIACELL TO PARTNER WITH TOP U.S. MEDICAL INSTITUTION WASHINGTON UNIVERSITY TO PRODUCE ITS BRIAVAX(TM) CANCER VACCINE

BriaCell Therapeutics Corp. has signed an LOI outlining a manufacturing partnership with Washington University in St. Louis and its 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 six months. cGMP facilities are often pursued by larger biotechs which 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 favourable 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."

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