BriaCell Reports Positive Survival Data in Advanced Metastatic Breast Cancer
24 February 2023 - 12:00AM
BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT)
(“BriaCell” or the “Company”), a clinical-stage biotechnology
company specializing in targeted immunotherapies for cancer, today
reports updated survival data from its previously disclosed group
of 12 patients (11 patients enrolled in 2021/2022) in the ongoing
Phase II clinical trial evaluating Bria-IMT™ in combination with
Incyte’s retifanlimab for the treatment of advanced metastatic
breast cancer.
- 9 of 11 (82%) patients remain alive
from 2021/2022 dosing, suggesting strong survival benefits.
- 7 of 11 (64%) patients showed
either disease control or progression-free survival (“PFS”)
benefits compared with their most recent prior therapy regimen
suggesting clinical benefit, including survival and delayed cancer
progression in this very difficult to treat patient
population.
- Median PFS of 3.5 months (with one
subject ongoing) compares favorably with other recent studies of
patients with advanced disease including other approved agents in
earlier lines of therapy (Tripathy “ATTAIN” 2022, Perez 2015
“BEACON”, Cortes 2018, O’Shaughnessy 2022 “ASCENT”).
- Regimen remains well tolerated with
no dose limiting toxicities.
“This is working, and it’s working well. We had
high hopes going into this clinical read-out, and the survival
numbers have even exceeded our expectations. With 9 of 11
women still alive, this has a material impact for the patients and
their loved ones, especially since some patients may have had only
weeks or months to live prior to our treatment,” stated Dr. William
V. Williams, BriaCell’s President and CEO. “This survival update
bodes well for our upcoming pivotal trial, since the FDA has agreed
to survival benefits as the primary endpoint.”
This clinical data from BriaCell’s combination
regimen highlights survival benefits in a cohort (3rd line or
later) with a life expectancy of merely months or weeks in some
cases. Patients in this cohort had failed a median of 5 other
treatments prior to enrolling in BriaCell’s study. Other reportable
benefits such as less pain and better quality of life were also
observed in these patients.
Subsets of top-responding
patients: 4 of 5 patients with Grade I/II cancer, and 6 of
8 hormone receptor positive (HR+) patients had either disease
control or improved PFS suggesting potentially better responding
subgroup/s of patients. These subgroups represent large segments of
the advanced breast cancer patient population.
Enrollment update: 9 additional
patients have been screened/enrolled in the study, incremental to
the 12 patients announced in December 2022. With patients
continuing to enroll and remain on the treatment, more data
including overall survival data will be disclosed at regular
intervals.
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. 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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