BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT)
(“BriaCell” or the “Company”), a clinical-stage biotechnology
company specializing in targeted immunotherapies for cancer,
recognizes that October is Breast Cancer Awareness Month, an annual
campaign to increase awareness of the disease. Despite the current
advancements in breast cancer support, prevention, detection,
diagnosis, treatment, and care – the fact that there are an
estimated 43,700 breast cancer deaths per year in the U.S.
highlights the need for more effective treatments.
Breast Cancer: Facts & Statistics
(U.S.)According to the American Cancer Society Facts and
Figures 2023 report:
- Breast cancer is the most
frequently diagnosed cancer in the United States with 297,790 women
and 2,800 men expected to be diagnosed with invasive breast cancer
in 2023. The overall risk of a woman in the United States
developing breast cancer sometime in her life is about 13%. This
means there is an approximately 1 in 8 chance she will develop
breast cancer;
- Approximately 43,170 women and 530
men are expected to die of breast cancer in the U.S. in 2023,
making breast cancer the 2nd leading cause of cancer death in women
(after lung cancer) in the U.S.
Note from BriaCell CEO
Dear BriaCell Shareholders,
I am writing this letter during Breast Cancer
Awareness month to alert all to the devastation of advanced breast
cancer. While the focus of the month is on early detection, as it
should be, I highlight our recent accomplishments in the fight
against advanced breast cancer, an incurable disease. In advanced
metastatic breast cancer patients who have failed other therapies,
life expectancy can be weeks to months. We strongly believe our
novel immunotherapy candidates have the potential to transform the
way we treat breast cancer patients.
Our Lead Program and Value Driver:
Bria-IMT™
This year has brought several positive clinical
and developmental milestones that we are delighted to share with
you.
We recently reported benchmark-beating patient
survival and clinical benefit in advanced metastatic breast
cancer with median overall survival of 13.5 months in
BriaCell’s advanced metastatic breast cancer patients (vs. 6.7-9.8
months for similar patients reported in the literature).
In a partnership with experts at the multicenter
New York Cancer & Blood Specialists (NYCBS), we are pleased to
announce that our pivotal Phase 3 study of Bria-IMT™ in combination
with an immune checkpoint inhibitor in advanced metastatic breast
cancer (under FDA Fast Track designation) is enrolling patients.
Positive results from the pivotal study (listed on
ClinicalTrials.gov as NCT06072612) could allow commercialization of
Bria-IMT™.
The FDA has agreed on our primary endpoint
related to mortality improvement with Bria-IMT™ regimen in
comparison to physician’s choice of treatment. Note that the
average survival in this very sick patient population is under one
year and as little as weeks or months in women who have progressed
through multiple regimens. The importance of helping these patients
is of critical concern. These women have significant unmet medical
need for new and effective therapies.
We also 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 clearance, 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.
Hosting a Discussion with World-Renowned
Breast Cancer Expert Oncologists
BriaCell will be hosting a Key Opinion Leader
roundtable to discuss the current treatment challenges and
Bria-IMT™ regimen as a potential solution featuring world-renowned
breast cancer oncologists, Adam M. Brufsky, MD, PhD, FACP from
University of Pittsburgh School of Medicine and Saranya Chumsri, MD
from the Mayo Clinic, on October 26, 2023.
As a member of BriaCell’s clinical team,
involved in 19 previous drug approvals, I can attest that I am
truly thrilled with our progress to date and very proud of our
outstanding team of physicians and scientists – together we strive
to find solutions for cancer patients whose medical needs are
unmet.
I wanted to end this letter with thanking all
our shareholders who have continued to support us throughout our
journey, our employees, board members, scientific advisory board,
collaborators, and clinical teams who have worked tirelessly to
make these clinical advancements possible, and finally offer our
sincerest thanks to our patients and their families for their
patience and trust in our science and technology. I am looking
forward to sharing more news with you as our journey continues.
Yours very truly,William V. Williams,
MDPresident & CEOBriaCell Therapeutics Corp.
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 relating to: BriaCell’s pivotal Phase 3
study of the Bria-IMT™ regimen, any potential outcomes related to
the letter of intent from Dr. Massimo Cristofanilli, and the
upcoming Key Opinion Leader roundtable, 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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