BriaCell Announces New Patent Issuance, Bria-OTS™ IND Timing Guidance, and Additional Clinical Sites to Boost Enrolment
January 10 2023 - 09:00AM
GlobeNewswire Inc.
BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT)
(“BriaCell” or the “Company”), a clinical-stage biotechnology
company specializing in targeted immunotherapies for cancer, is
pleased to announce that it has received an Issue Notification from
the United States Patent and Trademark Office for the composition
of matter and method of use of its personalized off-the-shelf
cell-based immunotherapy for cancer. The patent will issue on
January 24, 2023 as US Patent No. 11,559,574 with the term
extending to May 25, 2040. Additionally, BriaCell was awarded an
Australian patent (Patent No. 2017224232, extends to February 27,
2037) covering composition of matter and method of use for its
whole-cell cancer immunotherapy technology in Australia.
“We are extremely excited with the new patent
for our novel personalized off-the-shelf cancer immunotherapy
technology, which provides patent protection for the Bria-OTS™
immunotherapy cell lines under development and further validates
and extends our whole-cell cancer immunotherapy technology. This is
particularly important because the patent protection is not for one
single type of cancer, but rather applies to multiple cancer
indications,” stated Dr. William V. Williams, BriaCell’s President
and CEO. “Unlike other personalized treatments in the marketplace
and under development, our pre-made personalized cancer
immunotherapies would allow more rapid treatments and may
significantly extend the lives of late-stage cancer patients. We
are working diligently to efficiently develop our personalized
off-the-shelf immunotherapies for multiple cancers to bring hope to
many late-stage cancer patients with no other treatment
options.”
Intellectual Property: US
Patent No. 11,559,574, titled “Whole-cell cancer vaccines and
methods for selection thereof,” will issue on January 24, 2023, and
covers the composition of matter and method of use of BriaCell’s
personalized off-the-shelf whole-cell immunotherapies. The novel
technology involves the development of several HLA specific
whole-cell immunotherapies in advance, and selection of the
appropriate off-the-shelf (i.e. pre-made) immunotherapies for each
patient (i.e. personalized therapy) based on the patient’s HLA type
using a fast and easy saliva test. Once issued, the patent will
provide intellectual property protection through May 25, 2040, and
a patent term extension under Hatch-Waxman potentially applies
(which would extend such protection for an additional five
years).
Additionally, BriaCell was awarded Australian
Patent No. 2017224232, titled “Whole-cell cancer vaccines and
methods for selection thereof,” for claims covering composition of
matter and method of use for BriaCell’s whole-cell immunotherapy
for cancer in Australia.
BriaCell currently holds multiple issued patents
and pending patent applications to cover its whole-cell
immunotherapy’s composition of matter and method of use worldwide.
For a summary of BriaCell’s issued patents, please visit
https://briacell.com/patents/.
Bria-OTS™ Program Timelines:
FDA has provided guidance regarding the development of cells and
final cell-bank testing for BriaCell’s Bria-OTS™ clinical-grade
cell lines. Once completed in accordance with FDA’s requirements,
BriaCell expects to initiate the Bria-OTS™ study under an
Investigational New Drug Application (IND) in the first half of
2023.
Additional Clinical Sites:
BriaCell is pleased to announce that it has added Carle Cancer
Institute, Urbana, Illinois, and the American Oncology Network, LLC
(AON), Baltimore, Maryland, as two additional clinical sites for
the screening and enrollment of advanced breast cancer patients in
the randomized Phase II study of BriaCell’s lead candidate,
Bria-IMT™, with Incyte’s PD-1 inhibitor, retifanlimab.
The following clinical sites are actively
enrolling patients for BriaCell’s ongoing Phase II combination
study:
- Carle Cancer Institute, Urbana,
Illinois
- American Oncology Network, LLC (AON),
Baltimore, Maryland
- Mayo Clinic, Jacksonville,
Florida
- Hoag, Newport Beach, California
- Sylvester Comprehensive Cancer Center,
part of UHealth – the University of Miami Health System, Miami,
Florida
- Atlantic Health System, Morristown and
Overlook Hospitals, Morristown and Summit, New Jersey
- Tranquil Clinical Research, Webster,
Texas
- Mary Crowley Cancer Research center,
Dallas, Texas
- Providence Medical Group, Santa Rosa,
California
- Cancer Center of Kansas, Wichita,
Kansas
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
that the Company makes regarding the initiation of the Company's
Bria-OTS™ clinical study under an Investigational New Drug
Application in the first half of 2023; the ability to treat
patients more rapidly with pre-made personalized immunotherapies;
the potential ability to significantly improve survival outcomes in
late-stage cancer patients; and the potential patent term extension
under Hatch-Waxman. 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
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