BriaCell Announces Successful Completion of Phase I Portion of Clinical Study in Advanced Breast Cancer; Randomized Phase II Efficacy Evaluation Progressing
October 21 2022 - 9:00AM
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 the completion of the Phase I part
of the clinical trial of its lead candidate, Bria-IMT™, in
combination with Incyte’s PD-1 inhibitor, retifanlimab, in advanced
breast cancer. The efficacy and survival data of the treated
patients is being evaluated in the Phase II part of the study which
was recently awarded the FDA’s fast track designation. Under an FDA
approved protocol, another arm has recently been added to the Phase
II study to evaluate the effects of dosing schedules for patients
in the study.
“We are very impressed by the clinical data
showing a favorable safety profile for our treatment in advanced
breast cancer patients who have failed other therapies,” commented
Dr. Del Priore, BriaCell’s Chief Medical Officer. “We look forward
to further advancing this program and sharing the data in the
coming months.”
The Phase I portion of the trial, with the
primary goal of assessing safety and tolerability of the
combination, enrolled 12 subjects who had previously failed at
least two prior lines of therapy, characterized as a
difficult-to-treat patient population. The combination treatment
had a favorable safety profile and appeared well-tolerated with no
dose-limiting toxicities.
Now progressing through the Phase II part of the
clinical trial, a randomized controlled design will be used to
allow comparison of the effectiveness of the treatment regimens
between the two arms of the study with different dosing
schedules.
BriaCell is on schedule to meet with the FDA
later this year to discuss the design of a key registration
study.
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 the completion of the Phase II
portion of the study; the potential success of the Bria-IMT™
program; the effect(s) of Bria-IMT™ on patients;; the ability of
the Company to further advance its clinical study; and the nature
and frequency of communications with the FDA. 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 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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