BriaCell Partners with Waisman Biomanufacturing to Manufacture and Supply Prostate Cancer Immunotherapy
July 05 2022 - 9:00AM
BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX:
BCT) (“BriaCell” or the “Company”), a clinical-stage
biotechnology company specializing in targeted immunotherapies for
cancer, has entered a manufacturing service agreement with Waisman
Biomanufacturing at the University of Wisconsin–Madison (Waisman),
to manufacture Bria-Pros™, BriaCell’s off-the-shelf personalized
immunotherapy for prostate cancer, for anticipated use in clinical
studies. Waisman is a leading contract manufacturing organization
(CMO) with experience in the manufacturing of cellular therapies
for clinical trials.
Under the terms of the agreement, Waisman will
be responsible for good manufacturing practice (GMP) manufacturing
of Bria-Pros™ for anticipated use in clinical studies. Waisman’s
expert team will be working closely with BriaCell’s scientific and
product development teams to ensure timely production of Bria-Pros™
in compliance with applicable regulatory requirements by the
FDA.
Bria-Pros™ is a novel off-the-shelf personalized
immunotherapy for prostate cancer. It includes multiple Human
leukocyte antigen (HLA)-specific immunotherapy cell lines that will
be administered to patients based on each patient’s HLA
type. BriaCell has been developing Bria-Pros™ as a potentially
safe and effective personalized immunotherapy treatment for
advanced prostate cancer.
BriaCell’s Phase I/II trial in prostate cancer
is expected to follow upon the completion of the manufacturing,
testing, and the related regulatory filings.
“We are very excited to partner with the
scientists and experts at Waisman, a leading CMO with extensive
experience in the manufacturing of clinical grade cellular
therapies, to ensure the rapid production of high-quality
immunotherapy supplies for our upcoming clinical trial in prostate
cancer. Additionally, this agreement will provide a starting point
for our future service agreements as we expand our personalized
immunotherapy pipeline into other cancer fields,” stated Dr.
Williams, BriaCell’s President & CEO. “We believe that our
novel off-the-shelf personalized immunotherapy may offer a safe and
effective targeted personalized treatment option for advanced
prostate cancer patients who failed the current standard of care,”
Dr. Williams added.
According to 2022 Cancer Facts & Figures,
prostate cancer, aside from lung cancer, is the most common cancer
among men. With an estimated 268,490 new cases diagnosed,
34,500 of men are expected to die of prostate cancer in 2022
making it the second leading cause of cancer death among men.
Current treatments for metastatic prostate cancer include
immunotherapy, hormone therapy, chemotherapy and targeted
treatments. However, none of these treatments are curative. Novel
approaches are needed for advanced prostate cancer.
About Waisman
Biomanufacturing
With its state-of-art production facility in
Madison, WI, and its expert personnel, Waisman Biomanufacturing has
become a leading GMP contract manufacturing organization (CMO)
which manufactures a wide range of biotherapeutics for clinical
trials. The products include gene therapies, cell therapeutics, and
both therapeutic and prophylactic vaccines. More information is
available at: https://gmpbio.org.
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 that the Company makes regarding: (i) the timely
production of Bria-Pros™ in compliance with applicable regulatory
requirements by the FDA; (ii) the timing, occurrence, and results
of BriaCell’s Phase I/II clinical trials in prostate cancer; (iii)
any expected outcomes of BriaCell's contract with Waisman; and (iv)
the potential to develop a safe and effective immunotherapy for
advanced prostate cancer. 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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