BriaCell Therapeutics Corp., a biotechnology company that focuses on immune-oncology and its unique vaccine technology called BriaVax, recently announced it has successfully finished all of the tests the Food and Drug Administration (FDA) requires.
BriaCell announced March 10 that it submitted a final Phase I/II Protocol. This application included an outline for the company’s upcoming clinical trial. As a response, the FDA sent the company a standard request for more information about the stability, identity, potency and purity of the company’s BriaVax Vaccine. Then, BriaCell asked to run a range of tests to provide answers, and the FDA agreed that the results of those tests would provide sufficient information.
BriaCell’s team ran 13 laboratory tests on the vaccine. Some of these tests required the researchers to spend weeks monitoring various cells. When the tests finished with successful results, the company’s regulatory affairs team sent the compilation to the FDA.
"The team worked diligently to ensure that we had a strategy in place showing that our vaccine remains in top shape, and the tests were conducted to the highest possible standards of quality,” Charles Wiseman said. “We are delighted that our BriaVax has displayed all the results we had hoped for. I firmly believe that there is significant room to create tremendous value if we keep hitting our milestones as we have the past six months, as we continue to shift from a Phase I company into a more advanced biotech."
BriaCell is waiting for an official reply to the tests, which the company expects by mid-June.