Full Press Release Details
Approves BriaCell's Pivotal Registrational Study Design in Advanced Metastatic Breast Cancer
PA and VANCOUVER, British Columbia, June 27, 2023- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell"
or the "Company"), a clinical-stage immunotherapy company driven to fight cancer and improve patients' lives, announces
that it has received approval from FDA on its pivotal registrational study design for Bria-IMT in combination with a checkpoint
inhibitor in advanced metastatic breast cancer.
has approved the study design, the primary and secondary endpoints, and patient population in BriaCell's upcoming pivotal
registration clinical study. The study will include advanced metastatic breast cancer patients who have exhausted all other treatment
trial will be a randomized, open-label study comparing the Bria-IMT combination regimen with an immune check point inhibitor
in one arm with treatment of physicians' choice in another arm in advanced metastatic breast cancer. A third smaller arm with the
Bria-IMT regimen alone will be included in the study to address FDA's combination drug assessment requirements. Upon
achieving statistically significant milestones, BriaCell may apply for full approval of the Bria-IMT combination regimen following
the Biologics Licensing Application (BLA) filing process.
"FDA approval of our study design represents a major milestone towards our goal of making a huge impact in the lives of advanced metastatic
breast cancer patients who have failed currently approved therapies," stated Dr. William V. Williams, BriaCell's President
are extremely grateful that the FDA Office of Oncologic Diseases has approved our strategy and has provided us with a route to
accelerate the development of our novel immunotherapy in this difficult-to-treat patient population. A successful study may significantly
transform the approach to treat advanced breast cancer," added Dr. Giuseppe Del Priore, BriaCell's Chief Medical
Officer. "We are working closely with FDA to further accelerate the development of our lead candidate and eventual market authorization."
recruitment and dosing will commence in summer 2023.
BriaCell Therapeutics Corp.
is a clinical stage immunotherapy company developing novel treatments that boost the ability of the body's own cancer fighting
cells to destroy cancer. More information is available at https://briacell.com/.
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 possibility of accelerated approval,
(ii) eligibility of the Bria-IMT combination regimen with a checkpoint inhibitor for BLA filing, (iii) the ability of the study
to achieve statistically significant improvement in patient survival compared with treatment of physicians' choice, (iv) eventual
market authorization for BriaCell's lead candidate, and (v) the timing of patient recruitment and dosing 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.
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.
Director of Public Relations