BriaCell Initiates Pivotal Phase 3 Study of Bria-IMT™ in Advanced Metastatic Breast Cancer
October 03 2023 - 9:00AM
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 announces that its registration-enabling pivotal Phase
3 study of its lead clinical candidate, Bria-IMT™, in combination
with an immune check point inhibitor, is fully approved by
the Institutional Review Board (IRB) and will soon enroll
patients with advanced metastatic breast cancer.
“Timely initiation of our pivotal study is a key
milestone for us further confirming our expedited timeline for FDA
approval of our immunotherapy,” stated Dr. William V. Williams,
BriaCell’s President and CEO. “Based on our recently announced
benchmark beating survival data, we strongly believe that our novel
immunotherapy may transform the way we treat advanced metastatic
breast cancer patients, and we look forward to sharing additional
development milestones in the coming months.”
The study will evaluate the efficacy and safety
of the Bria-IMT™ combination regimen in patients who have failed at
least two approved therapies for the disease.
Bria-IMT™ is currently under Fast Track
Designation by the U.S. FDA intended to accelerate the review
process of novel treatments that address unmet medical needs.
Positive completion of the pivotal study, following review by FDA,
could lead to full approval of the Bria-IMT™ immune checkpoint
inhibitor combination in advanced metastatic breast cancer.
FDA has agreed that improvement in overall
survival in the Bria-IMT™ combination arm as compared to the
physician’s choice of treatment arm will be the primary endpoint of
the study. The study will enroll 177 patients in the Bria-IMT™
combination therapy arm and 177 patients in the treatment of
physician’s choice arm. To gather additional information on the
Bria-IMT™ regimen alone, 50 patients will be enrolled in this
regimen and will be eligible for combination therapy following
their initial post treatment evaluation. We expect frequent and
responsive FDA communication under our Fast Track status during our
pivotal Phase 3 study.
The successful completion of the pivotal study
would allow BriaCell to subsequently submit a Biologics License
Application and accelerate the path to commercialization.
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, including statements relating to enrollment of patients
in the study of the Bria-IMT™ combination regimen in advanced
metastatic breast cancer, the potential of the study of the
Bria-IMT™ combination regimen in advanced metastatic breast cancer
to result in full approval and marketing authorization for
Bria-IMT™, the survival benefit and tolerability of the Bria-IMT™
regimen in advanced metastatic breast cancer patients and the
additive and/or synergistic effects of immune check point
inhibitors with Bria-IMT™, the potential for its novel
immunotherapy to transform the way that advanced metastatic breast
cancer patients are treated, the duration of the study, the
possibility and timing of a Biologics License Application to
accelerate the path to commercialization.
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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