BriaCell Doses First Patient in Phase I/IIa Study Evaluating Bria-IMT™ in Combination with INCMGA00012 and Epacadostat in P...
October 07 2019 - 6:30AM
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 announced that it has initiated dosing in a Phase
I/IIa clinical study of its lead product candidate, Bria-IMT™, in
combination with Incyte’s INCMGA00012 and epacadostat in patients
with advanced breast cancer whose disease has progressed following
standard of care therapies. No effective treatment options for this
patient population currently exists making advanced breast cancer
an unmet medical need.
The study design includes an initial group of
patients to be treated with the Bria-IMT™ regimen in combination
with INCMGA00012 to establish safety. A subsequent group of
patients will be treated with the triple combination of the
Bria-IMT™ with INCMGA00012 and epacadostat. The starting dose of
epacadostat has been established to be safe when given in
combination with INCMGA00012 in patients with cancer. The
goal is to remove cancer-induced suppression of the immune system
(i.e., taking the foot off the brakes that the cancer puts on the
immune system) thereby awakening the immune response. This
should permit the potent immune responses induced by the Bria-IMT™
regimen (i.e., putting the foot on the gas pedal) to attack the
cancer.
“The initiation of Bria-IMT™ clinical study is a
major milestone for BriaCell, marking the launch of BriaCell’s
first clinical collaboration with Incyte. This Phase I/IIa clinical
trial of Bria-IMT™ builds upon the early clinical findings of our
novel immunotherapy, as well as biomarker analysis from patients
who benefitted the most in our monotherapy trial with Bria-IMT™
versus those who did not,” said Dr. Bill Williams, President &
CEO of BriaCell. “Both INCMGA00012 and epacadostat have been shown
to reverse cancer-induced suppression of immune cells, making them
a rational performance booster for Bria-IMT™ in the clinical study.
We are pleased with the initiation of the clinical study and expect
to report preliminary safety data in 4Q 2019.”
About the Study Phase I/IIa
clinical trial is an open-label, multi-center study to evaluate the
safety and efficacy of Bria-IMT™ in combination with INCMGA00012,
and epacadostat in patients with advanced breast cancer. In the
initial stage, BriaCell expects to enroll up to 24 patients with
advanced breast cancer. The primary endpoint is safety and overall
response rate (ORR) and secondary endpoints include duration of
response, progression free survival (PFS) and overall survival
(OS). Additional analysis will include evaluation of potential
predictive biomarkers including HLA. BriaCell expects to report
preliminary efficacy and biomarker findings on up to 30
patients.
For further information on the clinical trial,
please visit https://clinicaltrials.gov (Identifier:
NCT03328026).
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/.
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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