BriaCell Therapeutics Corp.
("BriaCell" or the
"Company") (TSX-V:BCT) (OTCQB:BCTXF), an
immuno-oncology focused biotechnology company with a proprietary
vaccine technology, is pleased to provide an update on its
collaborative and internal research as well as manufacturing
activities.
Collaborations
The Company has recently initiated a research
collaboration with Dr. Maurizio Provenzano, MD, PhD, based at the
University of Zurich, Switzerland. Objective of this
collaboration is to assess, among others, whether a novel type of
immune stimulator predicted to home to sites of malignant disease
has additive or synergistic effects in combination with BriaVax™, a
whole-cell vaccine for breast cancer. “This collaboration offers an
exciting opportunity to develop novel immuno-oncology drugs
predicted to turn on cancer-fighting T cells,” commented Dr. Markus
Lacher, BriaCell’s head of R&D. “In contrast to conventional
immune checkpoint inhibitors, the proprietary drug type is designed
to activate more selectively the T cells with an actual potential
to destroy the patients’ tumors and consequentially to turn on
lower numbers of side effect-causing T cells with other
specificities,” he continued.
Product Manufacturing
A critical part of the Company’s product
development efforts is the oversight of BriaVax’s manufacturing in
external facilities that follow Good Manufacturing Practice (GMP).
As such, to facilitate clinical trial logistics, KBI Biopharma,
Inc. (The Woodlands, TX), one of two manufacturing sites for
BriaVax™, is developing a novel formulation of the vaccine
permitting cold-chain (dry ice or colder) transport to the clinical
sites and stockpiling of fully formulated vaccine at the clinical
sites or in nearby locations. The current formulation of BriaVax™
is available at the UC Davis GMP Facility (Sacramento, CA) and
requires transport at 2-8°C to the clinical sites where it needs to
be inoculated within 24 hours after completion of the formulation
process.
BriaCell’s Internal R&D Activities
In Berkeley, CA Laboratory
BriaCell’s internal R&D expansion included
the hiring of Ms. Sanne Graeve as a Senior Research Associate. Ms.
Graeve acts as BriaCell’s laboratory manager. Of note is her
experience with Cell Therapy at the Universitair Medisch Centrum
(UMC) Utrecht in the Netherlands where she – following GMP
procedures – prepared different cell products used for the
treatment of patients.
For strong anti-tumor activity, it is believed
that BriaVax™ needs to release granulocyte macrophage
colony-stimulating factor (GM-CSF). The Company has recently
cloned BriaVax™ and is currently expanding numerous clones to
obtain greater cell numbers for GM-CSF testing. Selected
clones are planned to undergo further expansion to develop master
cell banks and eventually clinical product. It is envisioned that
such BriaVax™ clones will maintain a lower degree of lot-to-lot
variability and perhaps more potent anti-tumor activity than
current-day BriaVax™.
In another project, the Company is developing
additional whole-cell breast cancer vaccines based on the SV-BR-1
cell line, which is the parent cell line of BriaVax™. These
additional vaccines are predicted to simplify the individual
treatment cycles requiring fewer patient visits and lowering costs.
Additionally, certain features are planned to target breast cancer
patient populations with particular immunologic properties that
might not receive optimal benefits from the current version of
BriaVax™. The hands-on aspects of this “next-gen BriaVax™” project
have recently been initiated with the generation of plasmids
carrying the first two genes of interest by a commercial
fee-for-service vendor. These plasmids are expected to be utilized
for cell line engineering at the Company’s Berkeley, CA laboratory
by the end of September 2017.
To transition to bioreactor-based, high-yield
manufacturing, in yet another project, BriaVax™ cells are being
evaluated for their ability to multiply under new culture
conditions. In particular, cells have been successfully cultured in
serum-free medium, a first step for commercial large-scale
production as nonadherent cultures. This is important for the
planned commercial production of BriaVax™.
The Company’s Berkeley laboratory is also suited
to establish assays to measure biomarkers in the blood of patients
participating in the Company’s Phase I/IIa clinical trial for
advanced breast cancer (ClinicalTrials.gov identifier:
NCT03066947). At this point, one such assay – aimed at quantitating
antibodies binding to BriaVax™ in patient blood – is under
establishment with encouraging preliminary results.
About BriaCell
BriaCell is an immuno-oncology focused
biotechnology company developing a targeted and safe approach to
the management of cancer. BriaCell's mission is to serve late-stage
cancer patients with no available treatment options.
Immunotherapy has come to the forefront of the
fight against cancer, harnessing the body's own immune system in
recognizing and selectively destroying the cancer cells while
sparing normal ones. Immunotherapy, in addition to generally being
more targeted and less toxic than commonly used types of
chemotherapy, is also thought to be a strong type of approach aimed
at preventing cancer recurrence.
BriaVax™, the Company's lead product candidate,
is a whole-cell breast cancer vaccine genetically engineered to
release granulocyte macrophage colony-stimulating factor (GM-CSF),
a substance that activates the immune system by allowing the body
to recognize and eliminate cancerous cells by inducing
tumor-directed T cell and potentially antibody responses.
The results of two previous Phase I clinical
trials (one with the precursor cell line not genetically engineered
to produce GM-CSF and one with BriaVax™) have been encouraging in
patients with advanced breast cancer. Most notably, one patient
with metastatic breast cancer responded to BriaVax™ with
substantial reduction in tumor burden including lung and brain
metastases. The company is currently conducting a Phase I/IIa
clinical trial for BriaVax™ in patients with advanced breast cancer
whose disease has progressed following at least one prior treatment
course. This trial is listed in ClinicalTrials.gov as
NCT03066947. The trial is being conducted along with the
co-development of BriaDx™, our companion diagnostic test. The
interim data for the first 10 patients is expected by the first
quarter of 2018.
For additional information on BriaCell, please
visit our website: http://briacell.com
About the Phase I/IIa Clinical
Trial
In a previous Phase I setting, a patient with
metastatic breast cancer responded to BriaVax™ with objective
reduction in tumor burden. To expand on this finding, after
updating the clinical protocol of the original investigational new
drug (IND) application, an open-label Phase I/IIa clinical trial
enrolling up to 24 late-stage breast cancer patients with recurrent
and/or metastatic disease has been launched. Patients will be
administered BriaVax™ every two weeks for the first month of
treatment, then monthly up to one year.
The primary objective of the Phase I/IIa
clinical trial is to evaluate the safety of BriaVax™ in study
subjects, and the principal secondary objective is an evaluation of
the tumor size reduction. Tumor response will be monitored every
three months during the study. The trial will also evaluate
progression-free survival (PFS) and overall survival (OS).
For additional details regarding the clinical
trial, please visit:
https://www.clinicaltrials.gov/ct2/show/NCT03066947
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.
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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