Full Press Release Details
Announces New Patent Issuance, Bria-OTS IND Timing Guidance, and Additional Clinical Sites to Boost Enrolment
| BriaCell's new patent protects its novel personalized off-the-shelf cell-based technology for breast cancer and multiple other cancer indications until 2040. | |
| BriaCell expects to initiate its Bria-OTS clinical study under an Investigational New Drug Application (IND) in the first half of 2023, in accordance with FDA guidance. | |
| Two additional clinical sites are now active in Phase II Bria-IMT study to broaden patient access: Carle Cancer Institute in Urbana, Illinois and the American Oncology Network, LLC (AON) in Baltimore, Maryland. |
PA and VANCOUVER, British Columbia, January 10, 2023- 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
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
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).
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.
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/.
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.
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.
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 |
BriaCell Therapeutics Corp.
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/.
press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements,
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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
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