BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX:
BCT) (“BriaCell” or the “Company”), a clinical-stage
biotechnology company specializing in targeted immunotherapies for
cancer, presented positive safety/tolerability and efficacy data
from its lead product candidate, Bria-IMT™, summarized in three
poster sessions during the 2022 San Antonio Breast Cancer
Symposium® (SABCS).
Mayo Clinic Professor and Principal Clinical
Investigator, Saranya Chumsri, M.D., stated in an audio summary of
the poster: “First, this is a heavily pretreated group of end-stage
metastatic breast cancer (“MBC”) patients. For many of these
patients, other therapies don’t exist or cannot be tolerated.
Bria-IMT™ does not have any theoretical cross-resistance or
overlapping toxicity with other MBC treatments, which is why it is
so encouraging to see responses across all MBC subtypes and a very
manageable adverse event experience.”
“We are impressed with the positive
clinical and quality of life data in this very difficult-to-treat
patient population who have failed multiple prior treatments. We’re
delighted that many patients stayed on our study longer than their
last therapy, suggesting the Bria-IMT™ combination regimen is both
well tolerated and clinically effective,” stated Dr. William V.
Williams, BriaCell’s President and CEO. “These results have
positive implications, both for our ongoing, randomized phase II
study and for planned meetings with the FDA on the design of our
pivotal study. Advanced MBC remains one of the most difficult
cancers to treat. There remains an urgent, unmet medical need to
find well-tolerated and effective treatments for these gravely ill
cancer patients who have only months to live and cannot tolerate
the harsh side effects of other cancer treatments.”
The posters are summarized below and linked
here: https://briacell.com/scientific-publications/.
Poster 1: Combination
Study EfficacyTitle: Allogeneic,
Antigen-Presenting, GM-CSF-Secreting, SV-BR-1-GM Whole Cell
Therapeutic Vaccine in Advanced Metastatic Breast
CancerPoster ID: P3-07-12
Summary: 22 advanced metastatic breast cancer
patients were treated with the Bria-IMT™ regimen with PD-1
inhibitors: 11 patients with pembrolizumab and 12 patients with
retifanlimab, with one patient transitioning from one combination
to another. Patients had previously been heavily pre-treated with a
median of 6.5 prior therapies.
Efficacy Data in all 22
patients:
- As previously disclosed, clinical
benefits were observed across multiple subtypes of advanced
metastatic breast cancer patients, especially in patients with
hormone receptor positive (“HR+”) cancer, a very large segment of
the patient population.
- Significant tumor reductions were
reported in patients treated in combination with either
pembrolizumab (Merck) (3 out of 5 evaluable patients) or
retifanlimab (Incyte) (3 out of 5 evaluable patients), suggesting
additive or synergistic effects of the Bria-IMT™ combination
regimen with PD-1 inhibitors. Most patients experienced progression
free survival (“PFS”) that was similar or better than their last
therapy, suggesting the clinical effectiveness of the Bria-IMT™
combination regimen. More positive data is expected as patients
remain on the study.
- New subset of
top-responding patients: A clinical benefit rate (“CBR”)
of 63% (5 out of 8 evaluable patients), PFS of 5.8 ± 2.9
months, and objective response rate (“ORR”) of 25% were observed in
a subset of patients with grade I/II HR+ cancers, suggesting a
potentially better responding subgroup of patients. It is
noteworthy to mention that this represents a large segment of the
patient population.
- As previously reported, 70% of
evaluable patients treated in the combination regimen with
retifanlimab showed either disease control or PFS benefits compared
with their most recent prior therapy regimen. A disease control
rate (“DCR”) of 57% (4 out of 7 evaluable patients) represents the
percentage of patients who have achieved certain clinical end
points (i.e. complete response, partial response or stable
disease). DCR is a cross study metric commonly used in cancer
clinical trials to evaluate the clinical effectiveness of a
treatment. Importantly, DCRs were higher in patients who matched
Bria-IMT™ at one or more HLA type, supporting our strategy of
developing off-the-shelf personalized treatments for cancer
patients.
Quality of Life Data: Patients
who experienced disease control reported “better quality of life”
scores and “less pain” with the BriaCell combination regimen.
“Better quality of life”, and “less pain” are life changing factors
for patients with advanced metastatic breast cancer who have
already failed several prior therapies and face a very short
survival outlook.
To summarize, our positive clinical and quality
of life data to date suggest an additive or synergistic effect of
Bria-IMT™ with PD-1 inhibitors in advanced metastatic breast cancer
patients and supports our strategy of using the Bria-IMT™
combination regimen with PD-1 inhibitors. We look forward to
sharing additional data in the coming months, as patients continue
to remain in the study and are recruited into the randomized
phase II part of the study.
Poster 2: CTCs/CAMLs
Biomarker ToolsTitle: Decreases in Circulating
Tumor Associated Cells Predict PFS and OS in a Pooled Analysis of
Phase I Clinical Trials Using SV-BR-1-GM Therapy with or without
Immune Check Point Inhibitors in Metastatic Breast Cancer
PatientsPoster ID: P1-05-28
Found in the blood of 90% of the advanced
metastatic breast cancer patients, Cancer Associated Macrophage
Like cells (“CAMLs”) (Adams DL, et al. JCO abstr 3056, 2022
40:suppl 16), are suggested as an additional marker, along with
Circulating Tumor Cells (“CTCs”), for predicting, evaluating, and
monitoring patients’ responsiveness (i.e., clinical benefit,
including survival benefit) to the Bria-IMT™ regimen.
Our findings support that utilizing the
CTCs/CAMLs system provides BriaCell with a powerful biomarker tool
to potentially select, evaluate, and monitor patients’ clinical
responses to the Bria-IMT™ regimen, and could improve the
probability of success in clinical studies. Most importantly, PFS
and overall survival (OS) data from our findings suggest long term
clinical benefit in patients treated with the Bria-IMT™ regimen in
a subset of patients.
Poster 3: Enhancing
Personalized Immunotherapy
(Bria-OTS2.0)Title: Turning Tumor Cells into
Antigen-Presenting Cells for Cancer
ImmunotherapyPoster ID: P3-06-08
BriaCell expects the next generation (enhanced
version) of our off-the-shelf personalized immunotherapies
(Bria-OTS2.0) to be more effective in activating patients’ immune
cells, leading to faster and more effective tumor destruction in
patients.
Development of a novel personalized (HLA matched
with patients) immunotherapy (Bria-OTS2.0) that is off-the-shelf
(i.e. premade), may represent a significant milestone in the field
of personalized cancer immunotherapy. We expect superior patient
efficacy using Bria-OTS2.0 because (1) it is personalized to each
patient by design (HLA matching), (2) it produces multiple immune
boosting factors to further activate immune cells in patients, and
3) it is manufactured in advance, and therefore available to
patients upon completion of a simple, rapid, and inexpensive HLA
typing saliva test.
BriaCell will seek to further evaluate
Bria-OTS2.0’s activity in advanced metastatic breast cancer
patients.
About BriaCell Therapeutics
Corp.
BriaCell is an immuno-oncology-focused
biotechnology company developing targeted and effective approaches
for the management of cancer. More information is available at
https://briacell.com/.
Safe Harbor
This press release contains “forward-looking
statements” that are subject to substantial risks and
uncertainties. All statements, other than statements of historical
fact, contained in this press release are forward-looking
statements. Forward-looking statements contained in this press
release may be identified by the use of words such as “anticipate,”
“believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,”
“seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,”
“target,” “aim,” “should,” “will,” “would,” or the negative of
these words or other similar expressions, although not all
forward-looking statements contain these words. Examples of
forward-looking statements in this news release include statements
that the Company makes regarding the expectation of additional
clinical data from the ongoing study; the potential of using the
CTCs/CAMLs system as a biomarker tool to improve the probability of
success in clinical studies; the long term clinical benefits of the
Bria-IMT™ regiment on patients; the potential opportunity for
treatment in terminal patients; the effect(s) of Bria-IMT™ on
patients, including the ability of Bria-IMT™ to control disease,
shrink tumors, and produce potential survival benefit; the clinical
efficacy of the Bria-IMT™ combination treatment; the effectiveness
of BriaCell’s treatment without harmful side effects; the potential
success of the Bria-IMT™ program and the ability of the Company to
further advance its clinical study. Forward-looking statements are
based on BriaCell’s current expectations and are subject to
inherent uncertainties, risks, and assumptions that are difficult
to predict. Further, certain forward-looking statements are based
on assumptions as to future events that may not prove to be
accurate. These and other risks and uncertainties are described
more fully under the heading “Risks and Uncertainties” in the
Company’s most recent Management’s Discussion and Analysis, under
the heading "Risk Factors" in the Company’s most recent Annual
Information Form, and under “Risks and Uncertainties” in the
Company’s other filings with the Canadian securities regulatory
authorities and the U.S. Securities and Exchange Commission, all of
which are available under the Company’s profiles on SEDAR at
www.sedar.com and on EDGAR at
www.sec.gov. Forward-looking statements contained
in this announcement are made as of this date, and BriaCell
Therapeutics Corp. undertakes no duty to update such information
except as required under applicable law.
Neither the Toronto Stock Exchange nor its
Regulation Services Provider (as that term is defined in the
policies of the Toronto Stock Exchange) accepts responsibility for
the adequacy or accuracy of this release.
Contact Information
Company Contact:William V.
Williams, MDPresident &
CEO1-888-485-6340info@briacell.com
Media Relations:Jules
AbrahamDirector of Public RelationsCORE
IR917-885-7378julesa@coreir.com
Investor Relations Contact:CORE
IRinvestors@briacell.com
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