BriaCell Provides Phase 3 Clinical Engagement Update in Metastatic Breast Cancer Pivotal Study
October 15 2024 - 7:50AM
BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT)
(“BriaCell” or the “Company”), a clinical-stage biotechnology
company that develops novel immunotherapies to transform cancer
care, today provides a clinical engagement update of its pivotal
Phase 3 study of Bria-IMT™ in combination with immune check point
inhibitor in metastatic breast cancer (MBC). The study will enroll
up to 354 patients randomized 1:1 to the BriaCell combination
regimen or physician’s choice and will include a small number
(n=50) of patients randomized to Bria-IMT™ monotherapy.
“We are very pleased to report that patient
enrollment is on track for expected completion by mid-2025. We
anticipate the interim data analysis of the ongoing pivotal Phase 3
study will confirm the effectiveness of the Bria-IMT™ combination
regimen in patients with metastatic breast cancer who failed
approved therapies,” stated Dr. William V. Williams, BriaCell’s
President and CEO.
“Despite multiple approved drugs, breast cancer
remains the second-leading cause of cancer death in American
women,” stated Giuseppe Del Priore, MD, MPH, BriaCell’s Chief
Medical Officer. “We are determined to make our novel immunotherapy
available to breast cancer patients whose medical needs remain
unmet.”
35 clinical sites (18 main and 17 satellite) are
active and enrolling patients in BriaCell’s pivotal Phase 3 study
in metastatic breast cancer. Additional sites are in various stages
of start-up.
Interim data will be analyzed once 144 events
(deaths) occur, comparing the overall survival (OS) in patients
treated with the Bria-IMT™ combination regimen versus those treated
with physician’s choice as the primary endpoint. Positive results
of the pivotal Phase 3 study could result in full approval and
marketing authorization for Bria-IMT™ in MBC patients. Secondary
analyses include comparison of the Bria-IMT™ combination regimen vs
Bria-IMT™ monotherapy. BriaCell recently announced impressive Phase
2 survival data in a similar MBC patient population. The Bria-IMT™
combination regimen has received FDA Fast Track designation.
For additional information on BriaCell’s pivotal
Phase 3 study of Bria-IMT™ and an immune check point inhibitor
in metastatic breast cancer, please visit ClinicalTrials.gov
NCT06072612.
About BriaCell Therapeutics
Corp.
BriaCell is a clinical-stage biotechnology
company that develops novel immunotherapies to transform cancer
care. 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, including statements about: the Company’s beliefs about
expected timing and completion of patient enrollment in BriaCell’s
pivotal Phase 3 clinical study in metastatic breast cancer and the
Company’s future reporting of specific patient enrolment numbers;
the Company’s proposed analysis of interim data, and the Company’s
belief that such interim data will confirm the effectiveness of the
Bria-IMT™ combination regimen in certain patients; the Company’s
beliefs regarding the availability of the Bria-IMT™ immunotherapy
to patients whose medical needs remain unmet; and the Company’s
belief that the results of the Phase 3 study could result in full
approval and marketing authorization for Bria-IMT™, 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.sedarplus.ca 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 AbrahamCORE
IRjulesa@coreir.com
Investor Relations Contact:CORE
IRinvestors@briacell.com
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