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, today announces that Dr. Williams, BriaCell’s President
& CEO, presented clinical updates of its Phase I/IIa clinical
trial of Bria-IMT™, BriaCell’s lead candidate, in a Combination
Study with pembrolizumab [KEYTRUDA®; manufactured by Merck &
Co., Inc. (NYSE: MRK)] in patients with advanced breast cancer at
the 2nd Annual Next Gen Immuno-Oncology Congress, taking place at
Hilton Garden Inn, Philadelphia Center City. The Combination Study
is listed in ClinicalTrials.gov as NCT03328026.
Background
BriaCell had hypothesized that combining
Bria-IMT™, which attacks the tumor in a targeted way, with immune
“checkpoint inhibitors”, such as KEYTRUDA®, which act
by awakening the immune system, would lead to more powerful
anti-cancer activity compared to that of Bria-IMT™ alone in
advanced breast cancer patients. Along with efficacy data
presented today, initial efficacy data for the first six patients
of the Combination Study, announced on April 3, 2019, supports
BriaCell’s hypothesis.
Remarkable Responder
The top responder (“Remarkable
Responder”) in the Combination Study experienced a highly
remarkable reduction in breast cancer tumors. She is an
advanced breast cancer patient who had failed 12 prior regimens
with 16 agents (13 chemotherapy agents and 3 hormonal agents). She
showed one of the best immune responses and displayed a highly
remarkable reduction in breast cancer tumors (metastases) in the
adrenal gland and the outer lining of the brain during the
Combination Study. Prior to enrollment in the Combination
Study, the Remarkable Responder had progressive cancer in spite of
aggressive treatment with some of the newest therapies. She
remains on the Combination Study treatment.
BriaCell’s “matching hypothesis” has been
further strengthened: The Remarkable Responder matched Bria-IMT™ at
2 HLA loci (HLA-C and HLA-DRB3). BriaCell’s immunotherapy
treatment appears most effective when the patient’s HLA-type
matches the Bria-IMT™ HLA-type as concluded in prior Phase IIa
proof-of-concept work. The data presented today also noted
that the Bria-IMT™ regimen administered with KEYTRUDA® was safe and
well tolerated. The women who showed the best clinical responses to
the combination of the Bria-IMT™ regimen with KEYTRUDA® also showed
the best immune responses including a cellular immune response
(i.e. activated T cells that fight the cancer) and a humoral immune
response (i.e. produced antibodies that target the tumor
cells).
In BriaCell’s view, the presentation of the
Remarkable Responder’s tumor reduction required public disclosure
to avoid selective disclosure of material information. Rather
than reporting incremental patient data going forward, it is
BriaCell’s intent to present more fulsome patient data sets at
major cancer conferences, such as the San Antonio Breast Cancer
Symposium on December 10-14, 2019.
A copy of the presentation document is posted on
https://briacell.com/investor-relations/presentations/.
“We are thrilled to see these impressive
clinical findings in the Combination Study that confirm our
hypothesis of clinical benefit (i.e. tumor shrinkage without
serious side effects) in advanced breast cancer patients who had
failed multiple prior treatments. In our view, these results
support the clinical efficacy (i.e. additive or synergistic
effects) that we previously observed in advanced breast cancer
patients," commented Dr. Williams.
“I am very pleased with these exciting findings,
demonstrating unprecedented activity of the Bria-IMT™ regimen in
combination with KEYTRUDA® in these very heavily pre-treated
patients,” noted Dr. Charles Wiseman, BriaCell’s Scientific Founder
and Director. “Advanced breast cancer patients, especially those
with brain metastases, have very few effective treatment
options. While more detailed study is needed, the possibility
of shrinking brain-associated metastases is unparalleled. The
current novel combination has shown the ability to shrink tumors,
improve the quality of the patients’ lives, and perhaps even extend
the lifespan of the patients,” Dr. Wiseman added.
About the 2nd Annual Next Gen
Immuno-Oncology Congress
The use of immune-based treatments such as
antibody drug conjugates, immune checkpoint inhibitors, bispecific
antibodies and cell therapies have gained has gained momentum in
the past few years making immuno-oncology is one of the hottest
fields of biopharma.
The Congress gathers academicians, researchers
and scientists from research institutes, pharmaceuticals,
bio-pharmaceutical and biotechnology companies to discuss the
latest updates in the field of immune-oncology.
For further information on the 2nd Annual Next
Gen Immuno-Oncology Congress, please visit:
https://events.marketsandmarkets.com/2-annual-marketsandmarkets-next-gen-immuno-oncology-congress/.
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™, BriaCell’s lead candidate, in a
Combination Study with immune checkpoint inhibitors such as
pembrolizumab [KEYTRUDA®; manufactured by Merck & Co., Inc.
(NYSE: MRK)]. The Combination Study is listed in ClinicalTrials.gov
as NCT03328026.
BriaCell also 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 Bria-IMT™ in
advanced breast cancer patients.
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 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/.
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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