Full Press Release Details
CEO Letter to Shareholders
| Positive FDA feedback on our pivotal study for lead clinical candidate Bria-IMT in combination with a checkpoint inhibitor could greatly accelerate the path to commercialization. | |
| Successful completion of the pivotal study could be followed by a Biologics License Application submission and commercialization. | |
| Pivotal study's primary endpoint to be linked to survival improvement. |
PA and VANCOUVER, British Columbia, January 24, 2023- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell"
or the "Company"), a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, today issues
a letter to shareholders from Dr. William V. Williams, BriaCell's President and CEO.
BriaCell Shareholders,
am writing this letter to share our tremendous excitement with our recent Bria-IMT FDA milestone, and to provide insights into
our upcoming Bria-OTS personalized treatment program. We strongly believe our novel immunotherapy candidates will transform the
way we treat cancer patients.
Lead Program and Value Driver: Bria-IMT
week, we received positive feedback from the FDA and are progressing towards our pivotal study initiation for Bria-IMT in
combination with an immune checkpoint inhibitor in advanced metastatic breast cancer (under Fast Track designation). Rather than working
through multi-year Phase II and Phase III trials, successful completion of the pivotal study would allow us to subsequently submit a
Biologics License Application and greatly accelerate the path to commercialization.
FDA agreed on the eligible patient population for the study: breast cancer patients who have failed the available approved therapies.
These are women in desperate need of therapy to extend their lives. The FDA also agreed on our preferred primary endpoint of survival
improvement in comparison to the patient 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 in women who have progressed through multiple regimes. These women need help!
are speeding up clinical preparations in parallel as we finalize the pivotal study protocol with the FDA in the coming months. We have
boosted our Bria-IMT production batches and testing capabilities required for larger scale
patient dosing. Frequent and responsive FDA communication under our Fast Track status has greatly accelerated protocol review
and feedback timelines. We could initiate patient dosing as early as the second quarter of 2023.
recently reported cash position is US$37 million. Subject to finalizing the pivotal study protocol and associated costs, we are in the
enviable position of being able to drive this program forward without the need to raise additional financing.
from our Top Responders: Our Bria-OTS Program
BriaCell's newly issued patent, protecting the composition of matter and method of use of BriaCell's personalized
off-the-shelf whole-cell immunotherapies, BriaCell expects to begin dosing advanced metastatic breast cancer patients in its Bria-OTS
Phase I/IIa clinical study in the first half of 2023.
believe this unique approach will maximize patient responses by "HLA matching" each patient, identifying her human leukocyte
antigen (HLA) type prior to dosing through a simple saliva test. We then treat her with pre-manufactured cells that correspond to her
HLA type. We call this matching approach Bria-OTS or Off-The-Shelf. This novel treatment approach came about when we found that
the HLA type of our previously disclosed top responders matched with the Bria-IMT cell-line HLA type.
treatment will be "personalized" because the cell therapy will match the HLA type of the patient, even though it is pre-manufactured.
a physician who has been involved in drug development for over 25 years, I can state without hesitation that I am absolutely thrilled
with our recent progress and very proud of the world-class team we have assembled at BriaCell. We continue to strive towards solutions
for cancer patients whose medical needs are unmet and look forward to sharing more exciting news with you in the coming months.
want to end this letter by thanking all our shareholders who have continued to support us throughout our journey, as well as our employees,
board members, scientific advisory board, collaborators, and clinical teams who have worked tirelessly to make these clinical advancements
possible. Finally, I would like to 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 a great year in 2023.
BriaCell Therapeutics Corp.
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/.
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 ability of the pivotal study to greatly accelerate the path to commercialization; the potential for the Company to make
a Biologics License application for the approval of the combination regimen; the potential initiation of patient dosing in the first
half of 2023; the ability to drive the pivotal study program forward without the need to raise additional funding; and the Company's
ability to address alleged illegal activities intended to depress the Company's share price. 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
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.