BriaCell Therapeutics Corp. ("BriaCell" or the "Company")
(TSX-V:BCT) (OTCQB:BCTXF), a clinical-stage biotechnology
company specializing in targeted immunotherapies for advanced
breast cancer, is pleased to announce the presentation results of
clinical studies with its lead product candidate,
Bria-IMT™, summarized in two poster sessions during the 2019
San Antonio Breast Cancer Symposium® (SABCS).
The December 12th poster summarized data of the
Bria-IMT™ monotherapy study and the ongoing Phase I/IIa clinical
study of Bria-IMT™ in combination with immune checkpoint inhibitors
including pembrolizumab (KEYTRUDA®; manufactured by Merck &
Co., Inc.), and more recently, Incyte’s INCMGA00012, in advanced
breast cancer. The December 13th poster presentation this evening
will address early predictors of effectiveness of the Bria-IMT™
regimen in advanced breast cancer.
Details and results on the poster presentations
are summarized below:
Presentation Title:
Efficacy and safety of a modified whole tumor cell targeted
immunotherapy in patients with advanced breast cancer alone and in
combination with immune checkpoint inhibitors
Session
Date: Thursday, December
12, 2019 at 6:00 p.m. ET Summarized Data:
- Eleven patients enrolled in the combination of the Bria-IMT™
regimen with KEYTRUDA®. Of 10 women with data available, BriaCell
reasonably anticipated a response in 3 patients after assessment of
immune response capability, HLA match and tumor differentiation
(described further below). Tumor shrinkage was noted in 2 of
these 3 patients.
- The remarkable responder treated with the combination of
Bria-IMT™ with KEYTRUDA® disclosed on September 19, 2019 remains on
study, and she has now transitioned to combination with Incyte’s
INCMGA00012 – she had a 26% reduction in the breast cancer tumor
size in the adrenal gland, and a 35% tumor size reduction in all
tumor sites.
- Tumor reduction in Bria-IMT™ and KEYTRUDA® combination in a
patient without HLA matching as disclosed on April 3, 2019. Notably
this patient had a moderately well-differentiated tumor.
- Analysis of the combination study data indicates that women
with tumors that are moderately-well differentiated (that look more
like normal breast tissue) have a high rate of tumor shrinkage (25%
or more tumor shrinkage in 2 of 3 patients). Notably, the Bria-IMT™
cell line was derived from a patient who ALSO had a moderately-well
differentiated tumor. This points to a new way to select the
patients most likely to respond in addition to our HLA matching
hypothesis.
- Reanalysis of BriaCell’s 2018 monotherapy study data shows
that, of 6 patients with moderately or well differentiated tumors,
2 of the 6 had definite tumor shrinkage. Two of the 6
patients had 2 or more HLA matches; the same 2 with definite tumor
shrinkage.
- Initial information on the first patient treated with the
combination of the Bria-IMT™ regimen with INCMGA00012 shows no
serious adverse events and preliminary clinical benefit.
Recruitment is ongoing.
Presentation Title:
Circulating cancer associated macrophage-like cells (CAMLs) are
early predictors of response to new line therapies in metastatic
breast cancerSession
Date: Friday, December 13,
2019 at 6:00 p.m. ETSummarized Data:
- In this poster, cancer associated macrophage-like cells (CAML),
specialized myeloid cells found in peripheral blood and associated
with the presence of solid tumors, was measured to determine their
prevalence, specificity, and sensitivity in advanced breast cancer
patients who were treated with Bria-IMT™ regimen.
- Patients with decreases in CAML size during treatment with the
Bria-IMT™ regimen, alone or in combination with KEYTRUDA®, or other
therapies, appear to be more likely to respond to treatment with
tumor reduction and have a longer disease-free survival.
Copies of the posters will be posted at the
following:
https://briacell.com/novel-technology/scientific-publications/.
"We are intrigued by the initial data for
Bria-IMT™ in combination with checkpoint inhibitors in advanced
breast cancer patients suggesting additive or synergistic effects,"
said Dr. Bill Williams, President & CEO of BriaCell. "The
identification of a novel subset of patients with a very high
response rate, if confirmed with further clinical evaluation, will
allow us to focus our development plans on the patients most likely
to benefit. We plan to provide additional data as we continue to
treat breast cancer patients with novel combinations of Bria-IMT™
with checkpoint inhibitors."
About BriaCell
BriaCell is an immuno-oncology focused
biotechnology company developing targeted and safe approaches for
the management of cancer.
BriaCell is conducting a Phase I/IIa clinical
trial of Bria-IMT™, BriaCell’s lead candidate, in a Combination
Study with immune checkpoint inhibitors such as the Incyte drugs
INCMGA00012 (an anti-PD-1 antibody similar to pembrolizumab
[KEYTRUDA®; manufactured by Merck & Co., Inc. (NYSE: MRK)]) and
epacadostat, an orally bioavailable small-molecule inhibitor of
indoleamine 2,3-dioxygenase 1 (IDO1). The combination study is
listed in ClinicalTrials.gov as NCT03328026.
BriaCell currently has a non-exclusive clinical
trial collaboration with Incyte Corporation to evaluate the effects
of combinations of novel clinical candidates. Under the agreement,
Incyte and BriaCell will be evaluating novel combinations of
compounds from Incyte’s development portfolio with BriaCell’s drug
candidates in advanced breast cancer patients.
BriaCell is also 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 99 percent 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: https://briacell.com/.
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 2019 SABCS®,
please visit: https://www.sabcs.org.
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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