Item 7.01 Regulation FD Disclosure.
On January 10, 2023, BriaCell Therapeutics Corp. (the "Company") issued a press
release announcing that the United States Patent and Trademark Office has
provided the Company with an Issue Notification for Patent Application no.
16/110,317, "Whole-cell cancer vaccines and methods for selection thereof,"
covering the composition of matter and method of use of the Company's
personalized off-the-shell cell-based immunotherapy for cancer (the
"Immunotherapy"). Once issued, the resulting patent, U.S. Patent No. 11,559,574,
will provide intellectual property protection for the Immunotherapy from January
24, 2023, through May 25, 2040. The Company simultaneously revealed that it was
awarded Australian Patent no. 2017224232, which provides intellectual property
protection for the Immunotherapy through February 27, 2037.
The Company further disclosed that it has received guidance from the FDA
regarding the development of cells and final cell-bank testing for the Company's
Bria-OTS™ clinical-grade cell lines. Once completed in accordance with FDA's
requirements, the Company expects to initiate the Bria-OTS™ study under an
Investigational New Drug Application (IND) in the first half of 2023.
Finally, the Company announced that it had added the Carle Cancer Institute and
the American Oncology Network, LLC, as additional 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.
A copy of the press release is attached as Exhibit 99.1.
The information in this Item 7.01 disclosure, including Exhibit 99.1, is being
furnished and shall not be deemed "filed" for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise
subject to the liabilities under that Section. In addition, the information in
this Item 7.01 disclosure, including Exhibit 99.1, shall not be incorporated by
reference into the filings of the Company under the Securities Act of 1933, as
amended, or the Exchange Act, except as shall be expressly set forth by specific
reference in such filing.
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