BriaCell Enters into Definitive Agreement to Begins GMP Manufacturing of BriaVax™

BriaCell Therapeutics Corp (TSXV:BCT) announced that it has entered into a definitive agreement to begin current Good Manufacturing Processes (mGMP) of BriaVax.™ The company also announced that it received a positive response from the FDA.

As quoted in the press release:

BriaVax™ is the Company’s proprietary cancer immunotherapy being tested in the upcoming Phase I/II clinical trial that will enroll up to 24 patients with advanced stages of cancer. The Company executed the agreement on June 11 as a result of positive feedback from the United States Food and Drug Administration (FDA) to the Company’s response letter dated May 19, 2015. It is anticipated that manufacture of fully qualified, clinical-grade BriaVax™ should be completed during Q3 of this year.

Under the terms of the Agreement for Services with the University of California, Davis Health System, the University’s Institute for Regenerative Cures will provide a number of services to BriaCell, most notably the cGMP manufacture, quality control and release testing of sufficient amounts of BriaVax™ to support the upcoming clinical trial. In order to avoid scheduling delays, the Company has identified UC Davis as its primary manufacturing site for the current study; the Siteman Comprehensive Cancer Center of Washington University, St. Louis will serve as a backup site, if necessary.

Joseph Wagner, PhD, president and CEO of BriaCell, commented:

With the entry into a Definitive Agreement to manufacture BriaVax™, BriaCell continues to progress toward initiating our important clinical Phase I/II clinical study. Initiation of GMP manufacturing was dependent on important feedback from the FDA on a number of issues, most importantly the results of stability testing of our BriaVax Master Cell Bank. We now have the clarity we need from the FDA to confidently initiate the final manufacture of clinical-grade material. FDA has requested to review final lot release testing of GMP material prior to initiating the clinical study, which is consistent with my past experience working on cell therapy clinical trials. I look forward to working with our manufacturing site to ensure timely completion of this process and fully anticipate initiating our clinical trial of BriaVax in the early-Q4 timeframe.

Click here to read the full BriaCell Therapeutics Corp (TSXV:BCT) press release.