Berkeley, CA -- (SBWire) -- 11/08/2017 --BriaCell Therapeutics Corp. ("BriaCell" or the "Company"), an immuno-oncology focused biotechnology company with a proprietary vaccine technology, today released a clinical update on its ongoing Phase I/IIa study of its lead vaccine candidate, BriaVax™, in advanced breast cancer patients.
The Phase I/IIa study evaluates the safety and activity of BriaVax™ in patients with advanced breast cancer. To boost the anti-tumor effects of BriaVax™, the patients are pre-treated with low dose cyclophosphamide and post-vaccine interferon-2b {Intron A; manufactured by Merck & Co., Inc. At the request of the FDA, the first three patients were dosed sequentially with a sufficient amount of time between patients to evaluate any potential safety issues from the vaccine. That portion of the study was completed in September 2017, and the study was opened to additional patients marking the beginning of the Phase IIa portion of the study. So far, an additional 3 patients have been enrolled and dosed with BriaVax™, bringing the total number of patients dosed to date to 6.
Recruitment continues to proceed as projected, despite the challenges presented in recruiting late stage cancer patients. The study remains on track to announce data on the first 10 patients in the first quarter of 2018. The development of BriaDx™, a companion diagnostic test to identify the patients for whom BriaVax™ treatment would be most effective, is proceeding in parallel to this study. BriaCell has generated intriguing preliminary data that appears consistent with the observations from the Phase I pilot study previously performed by Dr. Wiseman, BriaCell's scientific founder.
Patients who develop progressive disease during the BriaVax™ phase I/IIa study are eligible to participate in the BriaVax™ roll-over combination study (listed in ClinicalTrials.gov as NCT03328026) which evaluates BriaVax™ in combination with either pembrolizumab [Keytruda; manufactured by Merck & Co., Inc. or ipilimumab [Yervoy; manufactured by Bristol-Myers Squibb Company. These FDA-approved immune checkpoint inhibitors are expected to boost the anti-tumor activity of BriaVax™ thereby providing additional clinical benefit to the patients. Enrollment in the roll-over study may commence as early as first quarter of 2018.
BriaVax™ is currently being investigated in three (3) US-based clinical sites, recruiting patients for the Phase I/IIa and roll-over combination studies. The sites include: 1) Santa Rosa, St. Joseph Health-Sonoma County, CA, 2) Florida Cancer Care, Plantation, FL, and 3) The Everett Clinic and Providence Regional Medical Center, Everett, WA. These sites are working closely with Cancer Insight, LLC, BriaCell's contract research organization. Additional sites are planned to be opened over the course of the coming months.
About BriaVax™
BriaVax™ is a whole-cell breast cancer vaccine genetically engineered to release granulocyte-macrophage colony-stimulating factor (GM-CSF), a substance that activates the immune system. Previously, a small Phase I study documented very prompt and near complete regression of metastatic breast cancer in the breast, lung, soft tissue, and even the brain.
About BriaVax™ Clinical Studies
Phase I/IIa Study: The ongoing open-label Phase I/IIa study evaluates the BriaVax™ regimen in up to 40 advanced stage breast cancer patients. This trial is listed in ClinicalTrials.gov as NCT03066947. The primary objective of the Phase I/IIa clinical trial is to evaluate the safety of BriaVax™, and the principal secondary objective is to assess the tumor size reduction. Tumor size is monitored every two to three months during the study. Additionally, progression-free survival (PFS) and overall survival (OS) are evaluated in the study. Interim data for the first 10 patients is expected in the first quarter of 2018.
For additional details regarding the Phase I/IIa clinical trial, please visit: https://www.clinicaltrials.gov/ct2/show/NCT03066947 (link is external)
Roll-over Combination Study: The roll-over combination study allows patients who develop progressive disease during the BriaVax™ phase I/IIa study to continue receiving the potential clinical benefits of BriaVax™ by being treated with BriaVax™ in combination with either pembrolizumab or ipilimumab. This trial is listed in ClinicalTrials.gov as NCT03328026.
For additional details regarding the roll-over combination clinical trial, please visit: https://clinicaltrials.gov/ct2/show/NCT03328026?term=BriaCell&rank=1.
About BriaCell
BriaCell is an immuno-oncology focused biotechnology company developing a targeted and safe approach to the management of cancer. 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 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 potent approach with the potential to prevent cancer recurrence.
BriaVax™, the Company's lead product candidate, is a whole-cell breast cancer vaccine genetically engineered to release granulocyte-macrophage colony-stimulating factor (GM-CSF), a substance that activates the immune system by allowing the body to recognize and eliminate cancerous cells by inducing tumor-directed T cell and potentially antibody responses.
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 breast cancer. Most notably, one patient with metastatic breast cancer responded to BriaVax™ with substantial reduction in tumor burden including breast, lung, soft tissue and brain metastases. The company is currently conducting a Phase I/IIa clinical trial for BriaVax™ in patients with advanced breast cancer. This trial is listed in ClinicalTrials.gov as NCT03066947. The trial is being conducted along with the co-development of BriaDx™, the Company's companion diagnostic test. The interim data for the first 10 patients is expected by the first quarter of 2018. Additionally, the FDA recently approved the roll-over combination study of BriaVax™ with pembrolizumab [Keytruda; manufactured by Merck & Co., Inc. or ipilimumab [Yervoy; manufactured by Bristol-Myers Squibb Company for patients previously treated with BriaVax™ in the Company's ongoing Phase I/IIa clinical trial in advanced breast cancer. The roll-over trial is listed in ClinicalTrials.gov as NCT03328026.
BriaCell is also developing novel, selective protein kinase C delta (PKC) inhibitors. PKC is important for maintaining cancers transformed by mutations of the RAS gene. PKC inhibitors have shown activity in a number of pre-clinical models of RAS transformed cancers including breast, pancreatic, non-small cell lung cancer and neuroendocrine tumors (such as carcinoid tumors).
For additional information on BriaCell, please visit our website: http://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 http://www.sedar.com (link is external).
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.
