BriaCell Therapeutics Corp. ("BriaCell" or the "Company")
(TSX-V:BCT) (OTCQB:BCTXD), a clinical-stage biotechnology
company specializing in targeted immunotherapy for advanced breast
cancer, today announced that Dr. Saveri Bhattacharya, a
board-certified medical oncologist and recognized expert in breast
cancer treatment at the Sidney Kimmel Cancer Center – Jefferson
Health in Philadelphia, PA, has been selected to receive support
from the Merck Investigator Studies Program (“MISP”). The
Investigator Grant is a highly coveted award granted by Merck &
Co., Inc. (“Merck”) (NYSE: MRK) to leading investigators with
highly innovative clinical studies.
The clinical study being supported is a Phase
I/IIa study of BriaCell’s lead clinical candidate, Bria-IMT™, in
combination with pembrolizumab (KEYTRUDA®; manufactured by Merck
& Co., Inc.). Merck will provide KEYTRUDA® for use in the
combination study. Patients who match with Bria-IMT™ at least at
one HLA type will be eligible for the trial.
Dr. Saveri Bhattacharya is an Assistant
Professor of Medical Oncology at Thomas Jefferson University, a
member of the NCI-designated Sidney Kimmel Cancer Center –
Jefferson Health, a board-certified oncologist experienced in
clinical trials in gynecologic oncology and women’s cancers, and a
recognized expert in the field of breast cancer treatment. She
graduated from Touro University College of Osteopathic Medicine in
2011 and completed her residency in Internal Medicine and
fellowship in Hematology/Oncology at The University of Pittsburgh
Medical Center. She is currently focused on the clinical trial
development in women’s cancers. Dr. Bhattacharya has an impressive
list of publications to her credit, including major review articles
in both breast cancer chemotherapy and immunotherapy.
The following summarizes the details of the
study:
Study Title: A Phase I/II Study
of the SV-BR-1-GM Regimen in HLA matched Metastatic Breast Cancer
Patients in Combination with PembrolizumabPrincipal
Investigator: Saveri Bhattacharya,
D.O.Title: Assistant
ProfessorLocation: Thomas Jefferson University,
Sidney Kimmel Cancer Center, Department of Medical Oncology, 1025
Walnut Street, College Building, Suite 700, Philadelphia, PA
19107
“We congratulate Dr. Bhattacharya on receiving
this highly competitive award that will accelerate evaluation of
the combination of Bria-IMT™ with KEYTRUDA®, which we believe has
the potential to create potent anti-tumor immune responses,” stated
Dr. Bill Williams, BriaCell’s President and CEO. “We are delighted
to collaborate with Merck, Dr. Bhattacharya and her clinical team
regarding our shared, enduring commitment to delivering novel
therapies to advanced breast cancer patients, a very important
unmet medical need.”
“This collaboration is an important step in the
continued validation of BriaCell’s innovative immuno-oncology
program,” commented Dr. Charles Wiseman, BriaCell’s Scientific
Founder and Director. “We look forward to combining our expertise
with the strong scientific and clinical expertise of Dr.
Bhattacharya and her team to advance the clinical development of
our immunotherapies. We are thankful to Merck for its support as we
continue to advance our clinical programs to bring hope to advanced
breast cancer patients and their families.”
Rationale for the combination study of
Bria-IMT™ with KEYTRUDA®
In late 2018, BriaCell announced positive proof
of concept data in a Phase I/IIa study of Bria-IMT™ in advanced
breast cancer, demonstrating excellent safety and efficacy in
patients with HLA matches with Bria-IMT™ (Link). Impressively, the
safety and efficacy data appeared similar or superior to that of
other advanced or approved drugs for breast cancer when they were
at a similar stage of clinical development.
Analysis of blood samples collected in the Phase
I/IIa study showed that circulating tumor-associated cells
expressed the immune checkpoint molecule programmed death-ligand 1
(“PD-L1”). PD-L1 molecules prevent immune cells from attacking
cancer cells. KEYTRUDA® blocks PD-1, which activates PD-L1, and
hence promotes the anti-tumor activity of the immune cells. Immune
checkpoint inhibitors, such as pembrolizumab (KEYTRUDA®;
anti-PD-1), are designed to improve immune activity in cancer
patients. These have come to the forefront in the fight
against cancer with substantial benefits for some patients.
KEYTRUDA® Combination:
BriaCell launched the combination study of Bria-IMT™ with
KEYTRUDA® for advanced breast cancer in October 2018 hypothesizing
that KEYTRUDA®, which blocks the actions of PD-L1, hence
“awakening” a component of the immune system, may further enhance
the immune activation of Bria-IMT™ in patients. The combined action
may be greater than the sum of their individual effects. Patients
will be treated with the combination of Bria-IMT™ and the anti-PD-1
antibody, KEYTRUDA®. BriaCell has already presented encouraging
preliminary data (Link) that suggest synergistic and/or additive
anti-tumor activity of the combination. In September 2019, BriaCell
announced a Remarkable Responder in the combination study of
Bria-IMT™ with KEYTRUDA® (Link). The study was subsequently
modified to use a combination of Bria-IMT™ with the Incyte PD-1
inhibitor (INCMGA00012) and epacadostat. The combination
with KEYTRUDA® was discontinued.
About Jefferson
Jefferson, located in the greater Philadelphia
region and southern New Jersey, is reimagining health care and
education to create unparalleled value. Jefferson is more than
30,000 people strong, dedicated to providing the highest-quality,
compassionate clinical care for patients, preparing tomorrow’s
professional leaders for 21st century careers, and discovering new
treatments to define the future of care. Thomas Jefferson
University, home of Sidney Kimmel Medical College, dates back to
1824 and today comprises 10 colleges and three schools offering 160
undergraduate and graduate programs to more than 8,100 students.
Jefferson Health serves patients through millions of encounters
each year at 14 hospitals (seven are Magnet® designated by the ANCC
for nursing excellence) and over 40 outpatient and urgent care
locations throughout the region.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
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