BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT)
(“BriaCell” or the “Company”), a clinical-stage biotechnology
company specializing in targeted immunotherapies for cancer, is
presenting positive clinical data from its lead product candidate,
Bria-IMT™, summarized in four poster sessions during the 2023
American Association for Cancer Research (AACR) Annual Meeting held
from April 14 – 19, 2023 at Orange County Convention Center,
Orlando, Florida.
“Our data highlights the potential clinical
value of the Bria-MT™ regimen in patients with advanced metastatic
breast cancer after receiving multiple prior therapies,” said
Carmen Calfa, M.D., of the Sylvester Comprehensive Cancer Center at
the University of Miami, Associate Professor of Clinical Medicine,
Principal Clinical Investigator, and co-author of the study of
Bria-IMT™ in combination with PD-1 inhibitors pembrolizumab and
retifanlimab. “These results are promising and the fact that
patients have had a great quality of life thus far is remarkable.
We are hopeful that this novel immunotherapy proves to be an
effective therapy for our patients.”
“Our clinical findings continue to confirm our
approach for our upcoming pivotal trial of Bria-IMT™ combination
regimen,” commented Dr. William V. Williams, BriaCell’s President
and CEO. “With over 40,000 annual deaths in the U.S. alone,
advanced metastatic breast cancer remains an unmet medical need.
Patients who have only months to live tend to avoid current
therapies that are proven ineffective and are associated with
excessive toxicities. BriaCell’s regimen has shown robust clinical
efficacy, better than expected survival outcomes, and an excellent
safety profile in this very difficult to treat patient cohort. We
are seeing benefits in patients who failed other treatments and/or
cannot tolerate the harsh side effects of other therapies.”
The posters are summarized below and linked
here: https://briacell.com/scientific-publications/.
Poster 1 – Title: Whole cell antigen
presenting immune stimulating cells (Bria-IMT™) for the treatment
of metastatic breast cancerAbstract Presentation
Number: CT143
Strong Progression Free Survival and
Clinical Benefit
Progression Free Survival (PFS) is the length of
time during which a patient’s cancer does not get worse and is used
as a key survival and efficacy measurement. PFS benefit was
observed in BriaCell’s combination regimen (with PD-1 inhibitor
pembrolizumab (n=11) or retifanlimab (n=20)), as measured by PFS
difference from a patient’s previous therapy (prior to enrolment in
BriaCell’s study). Most patients’ PFS values were similar or higher
than those of their prior regimen, a positive finding that
suggests better tolerability, clinical effectiveness, and survival
time. Patients treated with Bria-IMT™ remained on treatment for a
longer period of time than expected. BriaCell’s patient cohort
would have typically experienced shorter time on therapy with each
subsequent line of treatment, given their advanced cancer
stage.
Survival Update:
Of 18 patients recruited since the study
reopened in 2021, 15 remain alive. This compares extremely
well with overall survival of 6.7-9.8 months in other similar
studies.1
The data suggest a survival benefit in this
group of difficult to treat patients who had failed multiple prior
treatments and who had a typical life expectancy of 6 months or
less.
Anergic vs. Non-Anergic
Patients:
Cancer cells, which can actively weaken the
immune system, thus avoid being detected by the patient’s immune
system, allowing them to grow and spread. This is a particularly
pronounced problem in anergic patients (those unable to develop an
immune response) who have very weak immune systems. Delayed-type
hypersensitivity (DTH) test was used to determine immune responses
to Bria-IMT™ as a measure of immune system activation/boost in
patients treated with BriaCell’s combination regimen.
15 out of 27 (56%) evaluable patients from
BriaCell’s combination study were anergic (i.e. weak immune
systems). Following the treatment with the Bria-IMT™ combination
regimen, 70% of anergic patients and 89% of non-anergic patients
showed immune system activation/boost.
The Bria-IMT™ regimen activated/boosted the
immune system and produced clinical benefit in both non-anergic and
anergic patients with more (i.e. double) clinical benefit in
patients who developed an immune response to Bria-IMT™.
These observations are particularly meaningful
for anergic patients with weakened immune systems who have failed
to respond to multiple prior treatments.
Hormone Receptor Positive (HR+)
Patients: Survival and clinical benefits were
observed across multiple subtypes of advanced metastatic breast
cancer patients, especially in patients with hormone receptor
positive (HR+) cancer, a very large segment of the patient
population. No immunotherapies have been shown to work in
this group of patients. 8 out of 17 HR+ patients
experienced progression-free survival benefits in the BriaCell
combination study.
More positive data is expected as current
patients continue to remain in our study, and new patients are
being enrolled.
Poster 2 –
Title: Engineering semi-allogeneic whole
cancer vaccines with enhanced immunogenicity for the treatment of
advanced solid tumorsPublished Abstract
Number: 685
BriaCell has developed Bria-OTS2.0 or Bria-APTC,
the next generation (enhanced version) of Bria-OTS™, BriaCell’s
off-the-shelf personalized immunotherapy for advanced metastatic
breast cancer. It expresses other immune activating cytokine
molecules in addition to its immune boosting granulocyte-macrophage
colony-stimulating factor (GM-CSF). As expected, Bria-OTS2.0 was
significantly more effective than Bria-OTS™ in activating naïve
T-cells, potentially suggesting faster acting mechanisms of action
and better potency. Bria-OTS2.0 may deliver significant clinical
efficacy and survival benefits in advanced metastatic breast cancer
for the following reasons:
Dual mechanisms of action to achieve
strong immune response and clinical activity: The unique
mechanism of action allows both direct activation of T-cells, and
indirect activation (i.e., by producing immune activating factors)
of the immune cells for a more potent and faster acting anti-tumor
activity.
BriaCell continues to develop Bria-OTS2.0 to
enhance the potency of the initial version of Bria-OTS™ which is
planned to be used in its upcoming phase I/IIa clinical study. The
pre-made design should allow fast and cost-effective treatment of
patients within days following a simple, rapid, and inexpensive HLA
typing saliva test.
The following two posters were presented in a
collaboration led by a team from Creatv MicroTech, Inc., an
oncology diagnostic company. Both posters show potential easy to
conduct diagnostic tests to predict clinical benefit in patients
with advanced metastatic breast cancer.
Poster 3 –
Title: Tumor macrophage fusion cells
detected in the circulation of metastatic breast cancer patients is
prognostic for rapid progression and
deathPublished Abstract Number:
2310
Poster 4 – Title: Micronuclei in
circulating stromal cells correlates with PD-L1 expression and
predicts progression in metastatic breast
cancerPublished Abstract Number:
304
About BriaCell Therapeutics
Corp.
BriaCell 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/.
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. Examples of
forward-looking statements in this news release include statements
about: (i) BriaCell’s participation at the American Association for
Cancer Research (AACR) 2023 Annual Meeting; (ii) the potential
clinical value of Bria-IMT™; (iii) the clinical efficacy, survival
rates and safety profile associated with BriaCell’s regimen; (iv)
the potential content of posters presented at AACR with respect to
refreshed survival outcome updates, new patient data related to
tolerability, clinical effectiveness and survival time, among other
things, and potential late-breaking discoveries; (v) the ability of
Bria-OTS2.0 to be faster acting and have better potency than
Bria-OTS™; (vi) the ability of Bria-OTS2.0 to deliver significant
clinical efficacy and survival benefits; and (vii) the continued
development of Bria-OTS2.0. 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 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
1 Kazmi 2020; Adams 2022, O’Shaughnessy
2022.
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