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BriaCell to Partner with Washington University Medical Center to Produce its BriaVax™ Cancer Vaccine
BriaCell Therapeutics Corp. (TSXV:BCT) announced that its has signed an LOI outlining a manufacturing partnership with Washington University and its Siteman Comprehensive Cancer Center to produce its BriaVax™ cancer vaccine.
BriaCell Therapeutics Corp. (TSXV:BCT) announced that its has signed an LOI outlining a manufacturing partnership with Washington University and its Siteman Comprehensive Cancer Center to produce its BriaVax™ cancer vaccine.
As quoted in the press release:
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.
Click here to read the full BriaCell Therapeutics Corp. (TSXV:BCT) press release.
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