BriaCell Therapeutics Corp. ("BriaCell" or the "Company")
(TSX-V:BCT) (OTCQB:BCTXF), a clinical-stage biotechnology
company specializing in targeted immunotherapy for advanced breast
cancer, is pleased to announce it is finalizing the analysis of the
initial efficacy data of the first six patients in the combination
study of its lead candidate, Bria-IMT™, with pembrolizumab
(KEYTRUDA®; manufactured by Merck & Co., Inc.) in advanced
breast cancer. BriaCell plans to press release this data on
April 3, 2019, at 8:30 am ET. The information will be issued in
coincidence with BriaCell’s poster presentation at the American
Association for Cancer Research (AACR) Annual Meeting in Atlanta,
Georgia.
Rationale for the combination study of
Bria-IMT™ with KEYTRUDA®
In the earlier Phase I/IIa study of Bria-IMT™
(without KEYTRUDA™), BriaCell’s scientists noted that cancer cells
and cancer-associated cells in the blood of their patients with
advanced breast cancer had PD-L1 molecules on their surfaces.
PD-L1 is a protein that lowers immune system activity and may be a
way in which the breast cancer evades the immune response induced
by Bria-IMT™ treatment. BriaCell launched the combination study of
Bria-IMT™ with KEYTRUDA® for advanced breast cancer in October 2018
based on the idea that KEYTRUDA®, which blocks the actions of
PD-L1, should further enhance the immune activation of Bria-IMT™ in
these patients for the following reasons:
- KEYTRUDA® blocks PD-L1 activity,
hence “awakening” a component of the immune system in these
cancer patients.
- Bria-IMT™, which ”puts the foot on
the gas” of the immune system, should work well with
KEYTRUDA® in “awakening” the immune system of the patient,
and the combined action of the two may be greater than the sum of
their individual effects.
- BriaCell uses a similar concept to
that of a preclinical combination study conducted by Dr. James P.
Allison’s group, showing reduction in tumor size. Dr. Allison’s
findings led to the 2018 Nobel Prize in physiology or
medicine.
"The early efficacy data of the first six
patients in our Phase I/IIa study of Bria-IMT™ with KEYTRUDA®
represents an important milestone for BriaCell as a rapidly
advancing company with an innovative technology. Through the
combination study, we are learning more about the mechanism of
action of our novel immunotherapy, which will aid in assessment of
combining Bria-IMT™ with other drugs, including other checkpoint
inhibitors,” said Dr. Bill Williams, BriaCell’s president and
CEO.
“It is important to note that KEYTRUDA® alone
has not been approved for the treatment of advanced breast cancer,"
Dr. Williams added.
The details of BriaCell’s AACR poster are as follows:Abstract
Control Number: 3662 Title: Development of a personalized
off-the-shelf whole-cell immunotherapy for breast cancer Session
Category: Immunology Session Title: Immunomodulators and Response
to Therapy Date: Wednesday, April 3, 2019 Time: 8:00 a.m.–noon ET
Location: Georgia World Congress Center, Exhibit Hall B, Poster
Section 24 Poster Board Number: 21 Permanent Abstract Number:
4998
Following the presentation, a copy of the poster will be posted
on https://briacell.com/investor-relations/presentations/.
About Phase I/IIa Combination Study of
Bria-IMT™ with KEYTRUDA® in Advanced Breast Cancer
The FDA has approved the combination study of
Bria-IMT™ with KEYTRUDA®, an anti-PD-1 antibody, for patients who
show expression of PD-L1 or PD-L2 in their cancer. More
information on the combination study of Bria-IMT™ with KEYTRUDA®
will be available on ClinicalTrials.gov
(https://clinicaltrials.gov/ct2/show/NCT03328026).
About KEYTRUDA®
(pembrolizumab)
Manufactured by Merck & Co., Inc., KEYTRUDA®
(pembrolizumab) is a prescription medicine that may treat certain
cancers by working with the immune system. It has been approved for
the treatment of a number of cancer indications, excluding breast
cancer. For more information on pembrolizumab, please see:
http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf.
About AACR
The AACR was founded in Washington, D.C., May 7,
1907, by a group of 11 physicians and scientists intending “to
further the investigation and spread the knowledge of cancer.” To
prevent and cure cancer using research, education, communication,
collaboration, funding and advocacy has been the mission of AACR.
With its programs and services, AACR advances research in cancer
and related biomedical science by facilitating exchange of
knowledge and innovations among scientists and clinicians dedicated
to the fight against cancer, providing education and training in
oncology treatment and advancing cancer etiology, prevention, early
detection, diagnosis and treatment worldwide.
For more information on AACR, please visit:
https://www.aacr.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. (NYSE: MRK)]. 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 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: 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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