Berkeley, CA and Vancouver, BC – July 5, 2017 – BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV: BCT) (OTCQB: BCTXF), an immuno-oncology focused biotechnology company, announced today that it has successfully manufactured a new batch of its BriaVax™ vaccine, and that this new batch has passed all release testing in compliance with recent guidelines from the Center for Biologics Evaluation and Research (CBER) division of the FDA. The new BriaVax™ batch is similar to the previous one which was manufactured at the UC Davis GMP facility. This provides a sufficient quantity to support reporting on the safety and efficacy of BriaVax™. After dosing the first cohort of 10 patients, an interim safety assessment will be conducted to report on safety and efficacy of BriaVax™. BriaVax™ is a genetically engineered whole-cell vaccine derived from a human breast tumor cell line.
“We are pleased that our newly manufactured batch of the vaccine has passed the stringent CBER testing requirements, and will be available for clinical use”, stated Dr. Bill Williams, President & CEO of BriaCell. “This will provide us with an adequate supply of BriaVax™ to dose several patients and facilitate rapid recruitment of our first cohort. We are grateful to our manufacturing partner at the UC Davis GMP facility, one of our vaccine manufacturing sites, for providing us with additional supply of the clinical grade vaccine in a timely manner. We are pleased with the level of interest from the patients from our current clinical site at Annadel Medical Group and St. Joseph Health-Sonoma County in California. Additionally, we are in discussion with new clinical sites to further facilitate patient recruitment, and are on track to obtain interim data on the first 10 patients in the first quarter of 2018.”
BriaCell is an immuno-oncology focused biotechnology company developing a more targeted, less toxic approach to cancer management. BriaCell’s mission is to serve late-stage cancer patients with no available treatment options.
BriaVax™, the Company’s lead product candidate, is a genetically engineered whole-cell vaccine derived from a human breast tumor cell line. It is believed to activate the immune system to recognize and eliminate cancerous cells by inducing tumor-directed T cell and potentially antibody responses. The Company has already demonstrated encouraging clinical results, and is intent on building upon these results to further advance BriaVax™ through additional FDA-approved clinical trials in order to help cancer patients with limited therapeutic options. The results of two previous Phase I clinical trials (one with the precursor cell line not genetically engineered to produce GM-CSF and one with BriaVax™) have been encouraging in patients with advanced solid tumors. Most notably, one patient with metastatic breast cancer responded to BriaVax™ with substantial reduction in tumor burden including lung and brain metastases.
The Phase I/IIa clinical trial is an open-label study enrolling up to 25-40 late-stage breast cancer patients with recurrent and/or metastatic disease. Patients will be administered BriaVax™ every two weeks for the first month of treatment, then monthly up to one year. The primary objective of the clinical trial is to evaluate the safety of BriaVax™ in study subjects, and the principal secondary objective is an evaluation of the tumor size reduction. Tumor response will be monitored every three months during the study. The trial will also evaluate progression-free survival (PFS) and overall survival (OS).
For additional details regarding the clinical trial, please visit: https://www.clinicaltrials.gov/ct2/show/NCT03066947.
For additional information on BriaCell, please visit our website: https://briacell.com/
Cautionary Note Regarding Forward-Looking Information
Except for the statements of historical fact, this news release contains “forward-looking information” within the meaning of the applicable Canadian securities legislation which involves known and unknown risks relevant to the Company in particular and to the biotechnology and pharmaceutical industries in general, uncertainties and other factors that may cause actual events to differ materially from current expectation. These risks are more fully described in the Company’s public filings available at www.sedar.com. Other forward-looking information in this news release includes but is not limited to the intended use of proceeds of the Offering and other terms of the Offering, the expected timing of completion of the Offering, the Company’s ability to satisfy the conditions to completion of the Offering and the need for additional financing.
Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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BriaCell Therapeutics Corp.:
Manager, Corporate Development