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 that it has accepted a letter of intent from Dr.
Massimo Cristofanilli, Director of Breast Medical Oncology and
Associate Director of Precision Medicine in the Sandra and Edward
Meyer Cancer Center at Weill Cornell Medicine, outlining the
parties’ plans and commitment, upon regulatory approval, to
initiate a Phase 2 investigator-initiated clinical study to
evaluate BriaCell’s novel immunotherapy, Bria-IMT™, in combination
with a check point inhibitor (CPI), in early stage, newly
diagnosed, high-risk triple negative breast cancer (TNBC) patients
in the neoadjuvant setting.
“We are beyond excited to work with a world
class research team at Weill Cornell Medicine led by Dr.
Cristofanilli,” stated Dr. Williams, BriaCell’s President &
CEO. “We are grateful for this collaboration on Bria-IMT™ as a
much-needed oncology treatment solution for early stage TNBC
patients and will gladly support the Phase 2 clinical study by
providing Bria-IMT™ and expertise.”
“Bria-IMT™ combination regimen’s recently
reported clinical data shows a favorable safety and efficacy
profile in heavily pre-treated advanced metastatic breast cancer
patients,” Dr. Cristofanilli said. “We look forward to testing its
potential impact in earlier stage high-risk TNBC patients in this
setting.”
“Through this study, we anticipate furthering
our understanding of the Bria-IMT™’s mechanism of action and its
potential use in early stage TNBC patients,” stated Dr. Giuseppe
Del Priore, BriaCell’s CMO. “Given the extremely poor survival
outlook of TNBC patients, our goal remains to improve the survival
and quality of life in this group of patients who are fighting this
aggressive and extremely deadly disease.”
The clinical trial is designed to address the
urgent and unmet need in high-risk TNBC patients who failed the
current standard of care, a neoadjuvant regimen combination with
check point inhibitors.
The clinical trial is designed to evaluate the
safety, and efficacy of the Bria-IMT™ combination regimen with CPI
in early TNBC patients who completed neoadjuvant therapy and did
not achieve pathological complete remission (pCR). The primary
endpoint of event-free survival (EFS) will be compared to the EFS
of 55% in the historical control from Keynote 522 (Schmid et al,
NEJM 2022; 386:556-567).
About TNBC
TNBC, accounts for 10-15% of all breast cancers,
refers to the most invasive, fastest-growing, and fastest-spreading
breast cancer at which the cancer cells don’t express estrogen,
progesterone, or a protein called HER2 (i.e., test “negative” on
all 3 and hence the name “triple negative”), the historical factors
used in diagnosis and treatments of breast cancer. TNBC patients
have fewer treatment options and tend to have a worse prognosis and
survival outlook.
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/.
About Weill Cornell
Medicine
Since its inception on April 14, 1898, Weill
Cornell Medicine has become one of the world’s leading medical
institutions and clinical research centers. More information is
available at https://weill.cornell.edu/.
About New York-Presbyterian
Hospital
With over 200 locations of hospitals, primary
and specialty care clinics and medical groups, New
York-Presbyterian is one of the top United States medical
institutions offering most comprehensive, integrated academic
healthcare systems in Greater New York area. For more information,
visit www.nyp.org.
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 in relation to (i) the timing and completion
of the Phase 2 investigator-initiated clinical study to evaluate
Bria-IMT™; and (ii) the results of the Phase 2 clinical study
including an understanding of the Bria-IMT™'s mechanism of action
and its potential use in early stage TNBC patients, 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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