BriaCell Initiates Patient Enrollment in First-in-Human Study of Bria-OTS™ in Advanced Metastatic Breast Cancer
May 30 2024 - 8:00AM
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, announces initiation of a first-in-human, Phase 1/2 study
evaluating safety and efficacy of Bria-OTS™, BriaCell’s
personalized off-the-shelf next generation immunotherapy, as
monotherapy and in combination with PD-1 inhibitor tislelizumab, in
advanced metastatic breast cancer.
“Advancing Bria-OTS™ as our second novel
immunotherapy candidate into the clinic is a significant milestone
for BriaCell. We believe personalization through our Bria-OTS™
immunotherapy platform will produce more potent and long-lasting
responses than previously observed, with potential synergistic
effects with the immune check point inhibitor,” stated Dr. William
V. Williams, BriaCell’s President & CEO. “We are grateful to
our scientific and clinical teams for the successful completion of
the Institutional Review Board (IRB), Clinical Trial Site Agreement
(CTA), and obtaining FDA authorization for the Investigational New
Drug (IND) filings, as well as to our investors and collaborators
for their support in bringing Bria-OTS™ one step closer to cancer
patients.”
Giuseppe Del Priore, MD, MPH, BriaCell’s Chief
Medical Officer stated, “The off-the-shelf nature of our treatment
will allow the patients to be treated rapidly – which can be
life changing for advanced metastatic breast cancer patients.
Additionally, we expect the preferred safety profile of our
personalized immunotherapy, Bria-OTS™, to improve the quality of
life and add months and even years to the lives of these heavily
pretreated patients, a distinctive combination of benefits in
late-stage cancer care.”
About Bria-OTS™ Platform
Awarded numerous US and international patents
and supported by clinical data of Bria-IMT™, BriaCell’s lead
clinical candidate - currently in a pivotal Phase 3 study for
advanced metastatic breast cancer
(ClinicalTrials.gov NCT06072612), Bria-OTS™
is BriaCell’s personalized off-the-shelf immunotherapy platform,
and the basis for BriaCell’s “OTS” strategy. Bria-OTS™ for advanced
metastatic breast cancer is the first use of this platform. Similar
cell lines are in development for prostate cancer (Bria-PROS+™),
lung cancer (Bria-LUNG+™), and melanoma (Bria-MEL+™).
An Investigational New Drug Application (IND) is
currently open for the Bria-OTS™ breast cancer therapy also known
as, Bria-BRES™ for advanced metastatic breast cancer. Bria-BRES™
will initiate a bucket trial (i.e. a study that investigates
multiple product candidates in a single study) with other cancer
indications.
Bria-OTS™ received a Small Business Innovation
Research (SBIR) award from the National Cancer Institute
(NCI). More information is available at
https://briacell.com/briaots/.
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 those about BriaCell's personalization
through the Bria-OTS™ immunotherapy platform producing more potent
and long-lasting responses than previously observed, with potential
synergistic effects with the immune check point inhibitor; the
preferred safety profile of Bria-OTS™ improving the quality of life
and increasing the lifespan of heavily pretreated patients; and
Bria-BRES™ initiating a bucket trial with other cancer indications,
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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