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• Median overall survival of 17.3 months in Bria-IMT™ treated patients with hormone receptor positive (HR+) metastatic breast cancer markedly exceeds historical data of 14.4 months in TRODELVY ® (sacituzumab govitecan-hziy) in similar heavily pre-treated patients
• Survival data in triple negative breast cancer patients treated with the BriaCell regimen was comparable to TRODELVY ®
• No Bria-IMT related discontinuations reported to date
PHILADELPHIA and VANCOUVER, British Columbia, April 16, 2025 (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, announces new positive survival data in its Phase 2 study of Bria-IMT plus check point inhibitors (CPI), outperforming ADC drugs in hormone receptor positive (HR+) metastatic breast cancer (MBC) patients.
In BriaCell’s Phase 2 clinical study in late-stage MBC, 25 of 37 patients treated with the ongoing pivotal Phase 3 Bria-IMT formulation were identified as having HR+ breast cancer. As shown in Table 1, the survival data of these 25 patients (17.3 months) exceeds those of the current ADC standard of care TRODELVY ® (14.4 months). The survival data for the Bria-IMT regimen + immune check point inhibitor in the triple negative breast cancer (TNBC), characterized by the absence of estrogen (ER), progesterone (PR) and human epidermal growth factor (HER2) receptors, was similar to TRODELVY ® but still markedly higher (70%) than those of chemotherapy.
“We are truly impressed with the survival benefit data of the regimen that exceeds or meets those of TRODELVY ® in HR+ and TNBC metastatic breast cancer patients, respectively. Bria-IMT appears to be very well-tolerated,” stated Dr. William V. Williams, BriaCell’s President and CEO. “We look forward to further confirming this clinical data in our ongoing pivotal Phase 3 study with overall survival as its primary endpoint.”
“HR+ and TNBC metastatic breast cancer represent a significant proportion of the patient population and are the most difficult patient groups to treat. They have limited therapeutic options and overall survival of only a few months,” commented Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. “Our clinical data supports our hypothesis that the Bria-IMT regimen + CPI has the potential to address the unmet medical needs of HR+ and TNBC MBC patients and provide an effective and well-tolerated therapeutic option.”
Table 1: Comparable Analysis of median overall survival (estimated using the Kaplan-Meier method) for the BriaCell Phase 2 study of BriaCell’s Bria-IMT™ plus CPI versus other drugs in MBC patient subsets * Patients treated with the Phase 3 formulation ** Number of prior chemotherapy-containing regimens 1. https://www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.pdf
Abbreviations: HR+: hormone receptor-positive TNBC: Triple-negative breast cancer (lacks the estrogen receptor, progesterone receptor, and lacks or has low levels of human epidermal growth factor receptor 2 (HER2))
The Phase 2 study enrolled 54 heavily pre-treated metastatic breast cancer patients (median number of prior treatments = 6) who received the Bria-IMT regimen plus checkpoint inhibitor. Of these 54 patients, 37 were treated with the formulation currently being used in BriaCell’s ongoing pivotal Phase 3 study in metastatic breast cancer (listed on ClinicalTrials.gov as NCT06072612 ). No Bria-IMT related discontinuations have been reported to date.
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/ .
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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 statements about: BriaCell further confirming positive clinical data in its ongoing pivotal Phase 3 study; BriaCell’s further clinical development of Bria-IMT™; the Company’s beliefs regarding the results of BriaCell’s pivotal Phase 3 study; and the Company’s beliefs that the Bria-IMT™ regimen + CPI has the potential to address the unmet medical needs of HR+ and TNBC MBC patients and provide an effective and well-tolerated therapeutic option, 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. sedarplus .ca 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.
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