BriaCell Therapeutics Corp (BCTX)

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$BCTX News Out - BriaCell Reports Robust Overall Survival and Clinical Benefit Data at ASCO 2025
Three BriaCell posters and one publish-only abstract highlight robust clinical data from Bria-IMT™ and Bria-OTS™ studies in metastatic breast cancer (MBC)
Median Overall Survival of 17.3 months in Phase 2 study patients treated with Phase 3 formulation (since 2022) is superior to outcomes reported for comparable patients in the literature
Meaningful Clinical Benefit observed in all MBC subtypes, including HER2+, HR+/HER2-, and triple-negative breast cancer (TNBC)
Overall survival and clinical benefit data reported meets or exceeds that of FDA-approved therapies in comparable patients
No treatment-related discontinuations

PHILADELPHIA and VANCOUVER, British Columbia, June 02, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ), (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, today presents clinical data in three clinical poster presentations and one publish-only abstract at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. BriaCell has featured robust survival and clinical benefit data from its Bria-IMT Phase 2 clinical study, clinical progress data from its ongoing pivotal Bria-IMT Phase 3 study (ClinicalTrials.gov identifier: NCT06072612), and Phase 1/2 study of Bria-OTS (ClinicalTrials.gov identifier: NCT06471673) in metastatic breast cancer.

“Prolonging survival and providing meaningful clinical benefit for patients whose disease has demonstrated resistance to multiple treatment options remains a critical unmet need in breast cancer. These Bria-IMT regimen results are promising for individuals with metastatic breast cancer,” said Sara A. Hurvitz, MD, FACP, Senior Vice President, Director of the Clinical Research Division, and Smith Family Endowed Chair in Women’s Health at Fred Hutch Cancer Center, as well as Professor and Head of the Division of Hematology and Oncology at the University of Washington, Seattle, WA, and co-author of one of the clinical posters. “The low incidence of all grade and grade 3/4 adverse events is particularly notable.”

“We are thrilled with our Phase 2 overall survival and clinical benefit data which meets and exceeds those of FDA approved drugs — even in very heavily pre-treated patients in our study,” noted Dr. William V. Williams, BriaCell’s President & CEO. “We look forward to further confirming these impressive results in our ongoing pivotal Phase 3 study with the ultimate goal of bringing novel treatments to cancer patients in need.”

The details of the poster presentation sessions and publish-only abstract are listed below.

Poster Title: Update on phase III pivotal trial of Bria-IMT + CPI vs physician’s choice in advanced metastatic breast cancer (BRIA-ABC)
Session Date and Time: June 2, 2025 9:00 AM-12:00 PM CDT
Abstract Number for Publication: TPS1138
Poster Board Number: 108a
Session Type and Title: Poster Session – Breast Cancer—Metastatic

“Trial in Progress” poster presents early enrollment data and the overall design of the Phase 3 pivotal trial along with updated clinical outcomes from the Phase 2 Bria-IMT study.

Poster Title: Bria-IMT + checkpoint inhibitor: Phase I/II survival results compared to benchmark trials in metastatic breast cancer
Session Date and Time: June 2, 2025 9:00 AM-12:00 PM CDT
Abstract Number for Publication: 1096
Poster Board Number: 75
Session Type and Title: Poster Session – Breast Cancer—Metastatic

In the Phase 2 study of Bria-IMT combined with an immune checkpoint inhibitor (CPI) in 54 heavily pre-treated metastatic breast cancer (MBC) patients (median of six prior systemic therapies; range 2–13), Bria-IMT demonstrated promising efficacy and safety. Notably, 44% of patients had failed a prior antibody-drug conjugate, and 20% had failed a prior CPI. Among these patients, the overall clinical benefit rate (CBR; defined as CR, PR, or SD) was 55%, with CBRs of 100% in HER2+, 55% in HR+/HER2-, and 45% in triple-negative breast cancer (TNBC) subgroups, indicating antitumor activity across MBC subtypes. Additionally, patients treated with the selected Phase 3 formulation (without IFN?; N=37) experienced significantly improved overall survival (13.9 vs. 6.93 months; P=0.01) compared to those receiving the alternate formulation, highlighting the potential of Bria-IMT for advancing in clinical development.

Read more here : https://www.globenewswire.com/news-release/2025/06/02/3091756/0/en/BriaCell-Reports-Robust-Overall-Survival-and-Clinical-Benefit-Data-at-ASCO-2025.html