BriaCell Therapeutics Corp. ("
BriaCell" or the
"
Company") (TSX-V:BCT) (OTCQB:BCTXF), an
immuno-oncology focused biotechnology company with a proprietary
targeted immunotherapy technology, announces the presentation of
initial safety data in the combination study of its lead candidate,
Bria-IMT™, with pembrolizumab [KEYTRUDA®; manufactured by Merck
& Co., Inc. (NYSE: MRK)] and confirmation of positive proof of
concept data of Bria-IMT™ for advanced breast cancer at the 2018
San Antonio Breast Cancer Symposium (SABCS®). The combination study
is listed in ClinicalTrials.gov as NCT03328026.
“I am very excited about our data continuing to
show robust biological activity of Bria-IMT™ in advanced breast
cancer,” commented Dr. Bill Williams, BriaCell’s president &
CEO. “These findings also reinforce our product development
strategy for Bria-OTS™, BriaCell’s novel off-the-shelf personalized
immunotherapy, by showing predictability of the anti-tumor
responses in patients using a relatively simple and inexpensive HLA
test.
“Based on the data of three proof of concept
studies to-date, Bria-IMT™ has shown the ability to produce
powerful immune responses and elicit tumor regression even in
heavily pre-treated patients with very advanced disease. We are
highly confident of our strategy to use Bria-IMT™ in combination
with KEYTRUDA®, an approved treatment for multiple cancer
indications, and expect synergistic activity of this combination in
patients with advanced breast cancer. We look forward to additional
clinical data and expect to share details at upcoming scientific
meetings.”
Highlights of the Poster Presentation at
SABCS®
Initial safety data on the Bria-IMT™/KEYTRUDA®
combination study and additional confirmatory Phase I/IIa data from
the Bria-IMT™ monotherapy study, a subset of which was the subject
of a previous press release, was presented this morning in detail
by Saveri Bhattacharya, DO, assistant professor of Medical Oncology
at Thomas Jefferson University and researcher at the NCI-designated
Sidney Kimmel Cancer Center – Jefferson Health.
Title: Initial safety and
efficacy of a phase I/IIa trial of a modified whole tumor cell
targeted immunotherapy in patients with advanced breast cancer
Bria-IMT™ Combination Study with
KEYTRUDA®: In the combination therapy study, five patients
have been treated with the Bria-IMT™/KEYTRUDA® combination to date.
Initial data on the combination of the Bria-IMT™ regimen with
KEYTRUDA® suggests the combination is very safe and well tolerated.
The study remains ongoing.
BriaCell is on track to present initial efficacy
data on the combination in 1Q19.
Bria-IMT™ Phase I/IIa Monotherapy
Study: Twenty-three patients have been dosed with
Bria-IMT™ in the monotherapy study. The patients were very heavily
pre-treated and had advanced breast cancer with a median of four
prior systemic therapy regimens. Treatment was generally safe and
well tolerated with no related grade >3 or unexpected adverse
events. The most common adverse event was expected minor local
irritation at the injection sites. Efficacy data showed tumor
shrinkage in three patients, all of whom matched Bria-IMT™ at least
at one HLA type. One patient, the top respondent, previously
received seven chemotherapy regimens, and had tumors in the liver,
bone and 20 different breast cancer nodules in the lungs. She
matched Bria-IMT™ at Class I & II HLA types. Imaging analysis
at three months showed disappearance or reduction of all 20 tumors
in the lungs. This response was maintained at six months. Another
patient matched Bria-IMT™ at one HLA type and had tumor reduction
in the skin. A third patient had tumor reduction in the breast.
Biological activity was also seen in several patients as evidenced
by decreases in circulating cancer-associated cells, potentially
also indicating anti-tumor activity of the Bria-IMT™ regimen. This
was more frequently seen in patients with HLA matching to
Bria-IMT™. In summary, all patients with tumor shrinkage matched
with Bria-IMT™ at one or more HLA type, suggesting HLA matching may
be a good predictor of anti-tumor activity of Bria-IMT™ in advanced
breast cancer patients.
Activation of T cells, an important component of
the immune system, was measured by delayed-type hypersensitivity
(DTH) testing during treatment. Even though 60% of the
patients could not mount a DTH response to a common yeast,
Bria-IMT™ treatment elicited a DTH response in 59% of the patients
and this was particularly robust in the patients with tumor
regression. This indicates Bria-IMT™ elicits a robust immune
response in these patient population.
Following the presentation, copies of the
abstract and the poster will be posted on
http://briacell.com/investor-relations/presentations/.
About SABCS®
Since its inception in 1977, San Antonio Breast
Cancer Symposium (SABCS®) has grown to a five-day program that
covers the latest research on the experimental biology, etiology,
prevention, diagnosis, and treatment of breast cancer and
premalignant breast disease. The Symposium is attended by a large
international audience of researchers, health professionals,
physicians, oncologists, and those with a special interest in
breast cancer from over 90 countries.
To complement the clinical focus of the annual
SABCS®, Baylor College of Medicine became a joint sponsor of SABCS®
in 2005. Additionally, the Cancer Therapy & Research Center
(CTRC) at UT Health Science Center San Antonio and American
Association for Cancer Research (AACR), a prestigious scientific
organization known for its basic, translational and clinical cancer
research, began collaboration with SABC® in 2007. The Symposium was
renamed the CTRC-AACR San Antonio Breast Cancer Symposium.
For additional information on 2018 SABCS®,
please visit: https://www.sabcs.org.
About BriaCell
BriaCell is an immuno-oncology focused
biotechnology company developing targeted and safe approaches for
the management of cancer.
BriaCell is currently conducting a Phase I/IIa
clinical trial of Bria-IMT™, its lead candidate, in a combination
study with pembrolizumab [KEYTRUDA®; manufactured by Merck &
Co., Inc.]. The combination study is listed in ClinicalTrials.gov
as NCT03328026.
BriaCell is developing Bria-OTS™, an
off-the-shelf personalized immunotherapy, for advanced breast
cancer. Bria-OTS™ immunotherapy treatments are personalized to
match the patient without the need for personalized manufacturing.
Bria-OTS™, which is expected to cover over 90% of the patient
population, is designed to produce a potent and selective immune
response against the cancer of each patient while eliminating the
time, expense, and complex manufacturing logistics associated with
other personalized immunotherapies.
For additional information on BriaCell, please
visit website: http://www.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.
Neither TSX Venture Exchange nor its Regulation
Services Provider (as that term is defined in the policies of the
TSX Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
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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