BriaCell Presents Development Details of Bria-OTS™ Platform Technology at the American Association for Cancer Research (AACR) Annual Meeting 2022
April 12 2022 - 4:30PM
BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX:
BCT) (“BriaCell” or the “Company”), a clinical-stage
biotechnology company specializing in targeted immunotherapies for
cancer, presented the development details of its novel
off-the-shelf (OTS) personalized immunotherapy, Bria-OTS™,
summarized in a poster session held at the American Association for
Cancer Research (AACR) Annual Meeting 2022 in New Orleans,
Louisiana.
“Excitement is taking root within BriaCell as we
progress towards our upcoming Bria-OTS™ clinical trial, where we
will be matching our immunotherapy to each patient's HLA type with
the goal of increasing the likelihood of clinical benefit,”
remarked Dr. Miguel A. Lopez-Lago, Senior Director, R&D. “We
intend to treat each patient with a personalized formulation, based
on a simple saliva test that determines each patient's HLA
types.”
Poster presentation details are summarized
below:
Poster Title: Toward a
Personalized Off-the-Shelf Cellular Immunotherapy for Cancer
Summary:
- BriaCell’s lead candidate, the
Bria-IMT™ regimen, has produced a safe and effective immune
response and disease control in heavily pre-treated advanced breast
cancer patients. These patients had failed multiple prior
regimens.
- Patients that match the Bria-IMT™
immunotherapy treatment at least at 1 HLA type were more likely to
experience clinical benefit.
- Therefore, BriaCell generated
genetically modified Bria-IMT™ cell lines that expressed an
extended repertoire of HLA types to be able to match the majority
of patients with the therapy and increase the likelihood of
response. This new cellular therapy has been termed Bria-OTS™.
- The Bria-OTS™ novel approach
produces a personalized cancer immunotherapy treatment that is
off-the-shelf (i.e. pre-manufactured and ready for use); thus,
avoiding treatment delays and bypassing the complex manufacturing
process of some other personalized immunotherapies.
- Once administered to patients,
Bria-OTS™ immunotherapies are postulated to activate the patient’s
immune system to recognize and eliminate cancerous cells by both
activating tumor-directed T cells, and potentially antibody
responses. A schematic video showing the proposed mechanism is
available here: https://briacell.com/moa/.
- The AACR poster discloses the
specific alleles selected and the strategy for performing the
genetic engineering. BriaCell anticipates treating each patient
with the appropriate pre-manufactured Bria-OTS™ formulation based
on each patient’s HLA-type. This off-the-shelf process would forego
the complex, expensive and demanding manufacturing procedures
associated with other personalized immunotherapies.
Bria-OTS™ immunotherapy
design
Patients that match Bria-IMT™ cell line at
least at 1 HLA allele are more likely to derive clinical benefit.
Therefore, BriaCell has genetically modified the
Bria-IMT™ cell line to match more patients. Based on
population analysis, BriaCell has genetically engineered the
Bria-IMT™ parent cell line to express 8 Class I and 7 Class II HLA
types. The Class I and Class II regions refer to the
genes coding for molecules HLA-A, -B, -C, and HLA-DR, -DQ, –DP,
respectively. Four cell lines have been developed, each engineered
to express four HLA alleles: two HLA-A alleles and two HLA-DRB
alleles. The new cell therapy would be able to match >99% of the
population at least at one HLA type.
Manufacturing of Bria-OTS™
immunotherapies for upcoming clinical trial
- Bria-OTS™ cell lines developed at
BriaCell facilities have been transferred to a cGMP facility for
testing and clinical production in preparation for the upcoming
clinical trial in advance breast cancer.
- BriaCell is currently conducting
extensive testing on the Bria-OTS™ immunotherapy products in
compliance with the most recent guidelines of the Center for
Biologics Evaluation and Research (CBER) division of the FDA— to
ensure patient safety.
- BriaCell expects Bria-OTS™ to enter
an open-label Phase I/IIa clinical trial designed to evaluate its
safety and efficacy in patients with advanced breast cancer. The
clinical trial will be managed by Cancer Insight, LLC.
A copy of the poster has been posted at the
following: https://briacell.com/scientific-publications/.
Personalized breast cancer treatment
using Bria-OTS™
To increase the likelihood of therapeutic
response, BriaCell will treat each patient with the optimized
premanufactured Bria-OTS™ formulation, based on individual specific
HLA type. A simple saliva test that determines HLA types will be
used to categorize patients. In BriaCell’s current and active
Bria-IMT™ Phase I/IIa clinical trial, BriaCell had previously
reported average overall survival benefit of 13.4 months in
patients with 2+ HLA matches (average of 5 prior regimens)1 versus
7.2-9.8 months in historical comparison treatment trials (2 prior
regimens)2.
(1) |
BriaCell treats severely sick patients, as indicated by the “prior
regimens” figures, indicating the number of therapies these
patients had failed prior to treatment with Bria-IMT™. |
(2) |
Overall survival of 7.2-9.8 months was reported in similar patients
with metastatic breast cancer who have failed 2 prior therapy
attempts (third line setting); Kazmi S, et al. Breast Cancer Res
Treat. 2020 Aug 17. To more accurately present survival data,
BriaCell has included only those women able to mount an immune
response. |
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, among
others, statements the Company makes regarding: (i) the outcome of
the testing and clinical production of the Bria-OTS™ cell lines,
(ii) the safety and efficacy of any potential treatment regime with
Bria-OTS™, and (iii) when and whether Bria-OTS™ will enter an
open-label Phase I/IIa clinical trial. 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 our 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 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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