BriaCell Presents Benchmark Beating Survival and Clinical Benefit at AACR 2025; Advancements in Next Generation Bria-OTS+™ Development
April 28 2025 - 7:30AM
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, is presenting positive data from its Phase 2 study of lead
product candidate, Bria-IMT™, in metastatic breast cancer, and from
its preclinical Bria-OTS+ platform at the 2025 American Association
for Cancer Research (AACR) Annual Meeting taking place from April
25th – 30th at McCormick Place Convention Center, Chicago, IL. In
addition, Phase 3 early biomarker data will be presented as a late
breaking abstract.
The posters are summarized below and linked
here: https://briacell.com/scientific-publications/.
Title: Survival outcomes in a
randomized phase 2
of Bria-IMT: An allogeneic
whole cell cancer vaccineSession
Title: Phase II and Phase III Clinical
TrialsSession Start: 4/28/2025 2:00 PM – 5:00
PM CSTLocation: Poster Section
50Poster Board Number: 18Abstract
Presentation Number: CT100
“We are thrilled to share impressive survival
and clinical efficacy data at AACR on the advantages of using
Bria-IMT plus checkpoint inhibitor in heavily treated patients who
have failed multiple prior treatments, including ADCs and CPIs,”
stated lead author, Saranya Chumsri, MD, Principal Investigator and
Professor of Oncology, Mayo Clinic. “Treatment options have been
limited for patients who progress after ADC therapy, making this a
particularly challenging clinical setting. Our clinical findings
support the use of Bria-IMT as a well-tolerated, alternative
treatment option for these very difficult-to-treat patients with
unmet medical needs.”
“The excellent survival responses reported in
patients with different tumor types in the Phase 2 study is very
exciting, and we look forward to seeing these promising data
replicate in the pivotal Phase 3 study,” stated Dr. William V.
Williams, BriaCell’s President & CEO.
Of 54 metastatic breast cancer patients in the
Phase 2 study, 37 patients received Bria-IMT formulation that is
currently being used in BriaCell’s ongoing pivotal Phase 3 study
(ClinicalTrials.gov as NCT06072612). Patients
have been heavily pre-treated a median of 6 prior treatments --
including Antibody-Drug Conjugates (ADCs) and check point
inhibitors (CPIs).
- Clinical benefit rates [CR, PR, SD]
ranged from 45% to 100% based on subtype
- Decrease in size or no change in all
tumors noted in 83% of patients receiving Phase 3 formulation
- Overall survival (OS) with the Phase 3
formulation was 17.3 months for HR+ patients and 11.44 months for
patients with triple negative breast cancer (TNBC)
- Overall response rate (ORR) for
patients with intracranial metastases was 50% with a 75% clinical
benefit rate
- Safety profile: No unexpected adverse
events, no treatment related discontinuation of therapy
Title: Bria-OTS+: A versatile
therapeutic platform for inducing anti-cancer
immunitySession
Category: ImmunologySession
Title: Vaccines, In Situ Vaccines, and Vaccine
CombinationsSession Date and Time: 4/28/2025
2:00 – 5:00 PM CSTLocation: Poster Section
39Poster Board Number: 29Published
Abstract Number: 3553
Miguel A. Lopez-Lago, PhD, BriaCell’s Chief
Scientific Officer, commented, “We are very excited with the
anti-cancer activity of Bria-OTS+ and expect the platform will
enable the delivery of powerful and long-lasting immune activity
against cancer.”
“This data further validates the mechanism of
action of our next-generation Bria-OTS+ platform. Additional immune
activating factors are expected to enhance efficacy, and we look
forward to replicating these results clinically as we advance our
next generation Bria-BRES+ breast cancer and Bria-PROS+ prostate
cancer programs,” stated Dr. William V. Williams, BriaCell’s
President and CEO.
Bria-OTS+ is an immunotherapy platform and
enhanced version of Bria-OTS™, BriaCell’s personalized
pre-manufactured immunotherapy already demonstrating tremendous
results as announced on April 24 2025. Bria-OTS+ immunotherapy
expresses multiple immune-activating cytokines and co-stimulatory
molecules in addition to immune-boosting granulocyte-macrophage
colony-stimulating factor (GM-CSF). Bria-BRES+™ for breast cancer
and Bria-PROS+™ for prostate cancer are expected to be investigated
in BriaCell’s upcoming Phase 1/2a clinical studies.
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 about: BriaCell presenting positive
data from its Phase 2 study of lead product candidate, Bria-IMT, in
metastatic breast cancer, and from its preclinical Bria-OTS+
platform at the AACR as well as Phase 3 early biomarker data being
presented at the AACR as a late breaking abstract; whether BriaCell
will be able to see prior results replicated in the pivotal Phase 3
study; BriaCell's expectations that the Bria-OTS+ platform will
enable the delivery of powerful and long-lasting immune activity
against cancer; whether additional immune activating factors will
enhance efficacy of the Bria-OTS+ platform; whether prior results
will be replicated in clinical studies of the next generation
Bria-BRES+ breast cancer and Bria-PROS+ prostate cancer programs;
and expectations for what will be investigated in BriaCell’s
planned Phase 1/2a clinical studies; 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.sedarplus.ca 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
Investor Relations
Contact:investors@briacell.com
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