BriaCell Announces Positive End of Phase II Meeting with the FDA for Bria-IMT™ Combination in Advanced Metastatic Breast Cancer
January 18 2023 - 08:47AM
GlobeNewswire Inc.
BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT)
(“BriaCell” or the “Company”), a clinical-stage biotechnology
company specializing in targeted immunotherapies for cancer, is
pleased to announce that it has received agreement and positive
feedback from its End of Phase II meeting with the FDA regarding
BriaCell’s lead clinical candidate, Bria-IMT™ in combination with a
checkpoint inhibitor (under Fast Track designation), in advanced
metastatic breast cancer.
BriaCell and the FDA have agreed on the primary
end point, the essential elements of the study design, and the type
of patients to be enrolled in BriaCell’s upcoming pivotal clinical
study. This pivotal registration study will be enrolling advanced
metastatic breast cancer patients for whom no approved treatment
options exist.
Registration study success could lead to a
Biologics License Application (BLA) submission for the approval of
the combination regimen for commercialization in advanced
metastatic breast cancer.
“The importance of this milestone speaks for
itself and is yet another major step towards our goal to become one
of the leading immuno-oncology companies,” stated Dr. William V.
Williams, BriaCell’s President and CEO. “Jumping directly into a
pivotal study shortly after receiving Fast Track status has greatly
advanced our lead clinical program timetable with the ultimate goal
of commercializing our novel immunotherapy approach for women with
no approved treatment options.”
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 to the Company upcoming pivotal
clinical study and the potential for the Company to make a
Biologics License Application for the approval of the combination
regimen. 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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