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RECEIVES FDA CLEARANCE TO INITIATE PHASE I/IIA CLINICAL TRIAL OF BRIAVAX IN PATIENTS WITH ADVANCED BREAST CANCER

 

The U.S. Food and Drug Administration (FDA) has provided clearance to initiate an open-label phase I/IIa clinical trial of Briacell Therapeutics Corp.'s ( BCT.V ) BriaVax in patients with advanced breast cancer. BriaVax, the company's lead product candidate, is a genetically engineered whole-cell vaccine derived from a human breast tumour cell line.

"We are excited to further advance clinical development of our novel targeted immunotherapy, BriaVax{A ™}, which has previously demonstrated impressive safety and efficacy results in prior clinical evaluation," stated Dr. Bill Williams, President and CEO of BriaCell Therapeutics. "The upcoming Phase I/IIa clinical trial is designed to determine the optimal dosing regimen for patients, further assess the vaccine's safety profile, and provide additional efficacy findings including survival rate. The clinical trial will also provide important data to help establish our companion diagnostic, BriaDx{A ™}, to determine those patients most likely to respond to BriaVax{A ™} treatment."

"We urgently need a new approach to rescue patients with advanced breast cancer as the currently available medications fail in all but a few percent," commented Dr. Charles Wiseman, inventor of BriaVax{A ™}. "Our previously published results in a small number of patients showed that BriaVax{A ™} could induce rapid and widespread tumor regression and the patients had better than expected survival. This study will build on those results."

About the Phase I/IIa Clinical Trial Protocol

The Phase I/IIa clinical trial is an open-label study enrolling up to 24 late-stage breast cancer patients with recurrent and/or metastatic disease. Patients will be administered BriaVax{A ™} 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{A ™} 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.

ABOUT BRIACELL

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.

Immunotherapy has come to the forefront of the fight against cancer, harnessing the body's own immune system in recognizing and selectively destroying the cancer cells while sparing normal ones. Immunotherapy, in addition to generally being more targeted and less toxic than commonly used types of chemotherapy, is also thought to be a strong type of approach aimed at preventing cancer recurrence.

BriaVax{A ™}, 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{A ™} 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{A ™}) have been encouraging in patients with advanced solid tumors. Most notably, one patient with metastatic breast cancer responded to BriaVax{A ™} with substantial reduction in tumor burden including lung and brain metastases.