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 DeanManager, Corporate DevelopmentEmail:
farrah@BriaCell.com Phone: 1-888-485-6340
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