BriaCell Reports 12.0 Months Overall Survival Benefit in Advanced Breast Cancer; 100% Resolution of ‘Eye-Bulging’ Tumor
June 02 2021 - 06:12AM
BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW)
(TSX-V:BCT) (“BriaCell” or the “Company”), a
clinical-stage biotechnology company specializing in targeted
immunotherapies for advanced breast cancer, today provides an
update on the overall survival (OS) data on its previously
disclosed advanced breast cancer patients. These women were treated
with BriaCell’s lead candidate Bria-IMT™ as monotherapy and also in
combination with checkpoint inhibitors, including pembrolizumab
(KEYTRUDA®; manufactured by Merck & Co., Inc.) and Incyte’s
retifanlimab (manufactured and provided under a corporate
collaboration with Incyte Corporation).
HLA-Typing: Cells with HLA
(human leukocyte antigen) molecules on their surface determine and
trigger the body’s immune response. BriaCell’s immunotherapy
treatment appears most effective when the patient’s HLA-type
matches with Bria-IMT™, allowing BriaCell to potentially identify
patients most likely to respond. HLA-typing is a simple and widely
available test.
Tumor Grade: BriaCell has noted
clinical benefit in its patients with grade I and grade II tumors,
suggesting another subgroup of patients for whom BriaCell’s
treatment would be most effective.
BriaCell Treatment 1 |
|
Leading Treatment Comparison
2 |
N = |
Filter |
Prior Regimens |
Overall Survival |
vs. |
Prior Regimens |
Overall Survival |
7 |
Combination Therapy |
9 |
12.0 months |
|
2 |
7.2 - 9.8 months |
9 |
1+ HLA |
8 |
12.1 months |
|
|
|
5 |
2+ HLA |
5 |
13.4 months |
|
|
|
6 |
Tumor Grade I/II |
12 |
12.5 months |
|
|
|
Patient 06-005 3 |
2 HLA; Grade II |
13 |
21.4 months |
|
|
|
1) BriaCell treats severely sick patients, as
indicated by the “Prior Regimens” column. To more accurately
present survival data, BriaCell has included only those women able
to mount an immune response. Patients from both the monotherapy and
combination therapy are included unless otherwise indicated.2)
Overall survival of 7.2-9.8 months in similar patients with
metastatic breast cancer who have failed 2 prior therapy attempts
(third line setting); Kazmi S, et al. Breast Cancer Res Treat. 2020
Aug 17.3) Remarkable Responder highlighted; included within subsets
“Tumor Grade I/II” and “2+ HLA”.
Highlighting BriaCell’s
Top Responder:Initially announced
on Sep. 19, 2019 and subsequently on Jan. 13, 2020, BriaCell has
continued to emphasize this patient’s positive response to
BriaCell’s treatment. Prior to BriaCell’s treatment, the patient
had received 12 regimens with 16 agents (incl. 13 chemotherapies),
yet her condition worsened and included a gruesome orbital tumor
that metastasized behind her left eye and caused the eye to bulge
from its socket (proptosis). After just six months of
BriaCell’s treatment, the orbital tumor had been completely
eliminated, and she survived for over 21 months, a significant
clinical benefit.
Figure 1: The figure shows MRI
scans of the top responder patient. The arrows on the images
(baseline scans) show the location of the orbital tumors. As shown
on the images on the right hand side, the tumors were eliminated
following 6 months of treatment with the Bria-IMT combination
regimen.
In the figure above,
and with tumors indicated by white arrows, complete resolution of
the orbital tumor was observed after six months on BriaCell’s
treatment. Of note, she had two HLA matches with Bria-IMT™ and a
grade II tumor, supporting BriaCell’s hypotheses outlined
above.
"Women with advanced breast cancer often are
fighting a deadly disease that does not respond to
currently-available treatments," said Dr. Bill Williams, BriaCell’s
President and CEO. "We are pleased to report that our immunotherapy
regimen appears to offer clinical benefit for these patients in
desperate need of new therapy options."
About BriaCell Therapeutics
Corp.
BriaCell is an immuno-oncology focused
biotechnology company developing targeted and effective approaches
for the management of cancer.
For additional information on BriaCell, please
visit: https://briacell.com/.
Forward Looking Statements
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. 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
“Risks and Uncertainties” and 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 our 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 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
Company Contact:William V.
Williams, MD
President &
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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