• 71% intracranial objective response rate (iORR) in BriaCell patients with Central Nervous System (CNS) metastases support clinical efficacy of Bria-IMT™, alone and in combination with an immune checkpoint inhibitor (CPI)
• Tumor reductions observed in heavily pretreated patients highlight potential clinical benefit of Bria-IMT™ in managing CNS metastases

PHILADELPHIA and VANCOUVER, British Columbia, Dec. 28, 2023 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, is pleased to report marked 71% intracranial objective response rate (iORR) in advanced breast cancer patients suffering from central nervous system (CNS) metastases and treated with BriaCell’s Bria-IMT™ regimen. iORR is defined as the percentage of patients who achieve either a complete response (complete disappearance) or partial response (volume reduction of 30% or more) in intracranial tumors.

Breast cancer metastasis (spread of the cancer) to the CNS presents a significant clinical challenge, often leading to poor prognosis and early death. BriaCell has recently conducted a retrospective analysis in breast cancer patients with CNS metastases enrolled across both its Bria-IMT™ monotherapy and combination therapy with CPI studies and found remarkable clinical responses.

“We have accumulated positive clinical responses in five patients with intracranial metastases, which generally are extremely difficult to treat, and have a very poor prognosis. This antitumor activity furthers our excitement in our ongoing Phase 3 pivotal trial studying the Bria-IMT™ regimen in advanced breast cancer,” stated Dr. William V. Williams, BriaCell’s President and CEO.

“The CNS tumor reductions demonstrated in five of seven advanced breast cancer patients are particularly compelling given the history of unsuccessful treatment of CNS metastases in this patient population,” stated Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer.

BriaCell Clinical Data in Advanced Metastatic Breast Cancer Patients with CNS Metastases
The Bria-IMT™ Regimen (Alone or Combined with a CPI)

• CNS lesions improved in 71% of patients (5 of 7), supporting clinical efficacy of the Bria-IMT™ regimen
• Findings provide evidence for the efficacy of the Bria-IMT™ regimen, both alone and in combination with CPI, in CNS metastases patients
• Heavily pretreated metastatic breast cancer patients had failed multiple prior treatments including one patient who had failed treatments with 2 antibody-drug conjugates
• Regression of CNS metastatic tumors was observed across all breast cancer subtypes in heavily pretreated patients highlighting the potential of the Bria-IMT™ regimen in managing CNS metastases

BriaCell is adding a pre-planned subgroup analysis of patients with CNS metastases to its pivotal Phase 3 study in advanced metastatic breast cancer patients. This could provide an additional indication for market approval of Bria-IMT™.

About BriaCell Therapeutics Corp.

BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. 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. Forward-looking statements, including those presented in today’s press release, 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, MD
President & CEO
1-888-485-6340
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Media Relations:
Jules Abraham
Director of Public Relations
CORE IR
917-885-7378
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Investor Relations Contact:
CORE IR
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