BERKELEY, Calif. and VANCOUVER, British Columbia, Nov. 06, 2017 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp.
("BriaCell" or the "Company") (TSX-V:BCT) (OTCQB:BCTXF), 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-α2b {Intron A; manufactured by Merck & Co., Inc. (NYSE:MRK)}. 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. (NYSE:MRK)] or ipilimumab [Yervoy; manufactured by Bristol-Myers
Squibb Company (NYSE:BMY)]. 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
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. (NYSE:MRK)] or ipilimumab [Yervoy; manufactured by Bristol-Myers Squibb Company
(NYSE:BMY)] 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 (PKCδ) inhibitors. PKCδ is important for
maintaining cancers transformed by mutations of the RAS gene. PKCδ 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 www.sedar.com.
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.
Contact Information
For further information, please contact:
BriaCell Therapeutics Corp.:
Farrah Dean
Manager, Corporate Development
Email: farrah@BriaCell.com
Phone: 1-888-485-6340
