BriaCell Presentations Highlight Positive Clinical Data for Bria-IMT™ at ASCO 2026
- Final Phase 2 Bria-IMT median overall survival (OS) is 16.6 months (with Phase 3 formulation)
- Positive Quality of Life (QOL) data from the ongoing Phase 3 study in heavily pre-treated metastatic breast cancer (MBC) patients
- Biomarker analyses from the ongoing Phase 3 study confirm predictors of anti-cancer response seen in Phase 2
PHILADELPHIA and VANCOUVER, British Columbia, May 22, 2026 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (NASDAQ:BCTX, BCTXL)) (TSX:BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, is pleased to announce positive clinical data from three clinical data poster presentations and three publication-only abstracts at the 2026 ASCO Annual Meeting, taking place May 29–June 2, 2026 at McCormick Place, Chicago, Illinois. The presentations will include two poster presentations featuring data from BriaCell's ongoing pivotal Phase 3 study of Bria-IMT plus an immune checkpoint inhibitor, Bria-ABC (ClinicalTrials.gov identifier: NCT06072612), and one poster highlighting further analyses of Phase 2 data.
"These data from the ongoing pivotal Phase 3 Bria-ABC study highlight Bria-IMT's potential to preserve quality of life, limit toxicity, and potentially support self-administration — benefits that would be clinically meaningful for patients," stated Adam M. Brufsky, MD, PhD, FACP, Professor of Medicine at the University of Pittsburgh School of Medicine and Medical Director of the Magee-Women's Cancer Program.
"The Phase 2 study of the combination of a whole-cell vaccine with anti-PD-1 demonstrated a tolerable safety profile and the emergence of a long-term survivor cohort inclusive of the heavily pre-treated nature of these patients," stated Saranya Chumsri, M.D., principal investigator in the Phase 3 study of Bria-IMT+CPI, and Professor of Oncology at Mayo Clinic Florida. "I'm proud to do this work that brings new attention to metastatic breast cancer patients who have few or no remaining treatment options."
"Our positive clinical data across six presentations or abstracts at the ASCO 2026 Annual Meeting highlight the progress we are making in our clinical programs," noted William V. Williams, MD, BriaCell's President & CEO. "These data reflect our commitment to advancing innovative therapeutic options for patients with cancer patients who need better treatments."
The details of the presentations and publish-only abstracts are listed below.
Abstract Title: Survival with Bria-IMT + CPI in advanced metastatic breast cancer at 12 and 24 months.
Session Type/Title: Poster Session - Breast Cancer—Metastatic
Poster Board: 222
Date and Time: June 1, 2026, 1:30 PM-4:30 PM CDT
Clinical Data: 32 Phase 2 Bria-IMT patients were randomized to receive immune checkpoint inhibitor (CPI) in the first cycle or delayed to the second cycle. Two Bria-IMT formulations were also evaluated. Patients had median age of 61 (range 41-80) and had received median 6 prior therapies (range 2-13). Median overall survival (OS) was 13.3 vs. 7.4 months for starting CPI in cycle 1 versus cycle 2. In patients who developed an immune response as measured by delayed-type hypersensitivity (DTH) positive vs. negative, OS was 11.9 vs. 4.7 months, with 48% 12-months survival vs 0.0% 12-month survival. Patients with circulating tumor cells (CTCs) <5 vs. > 5 at baseline had median OS of 16.6 vs. 5.5 months. Median OS was 16.6 months for the formulation selected for the Phase 3 study with 52% of patients surviving at 12-months. The 12-month survival rate was 44% and the 24-month rate was 26%. There were no treatment-related discontinuations and no unexpected safety signals.
Conclusions: In heavily pretreated MBC patients, Bria-IMT demonstrated a tolerable safety profile and the emergence of a long-term survivor cohort. Durable survival rates were observed beyond 12 and 24 months. Differential survival favored the Phase 3 formulation, DTH positivity, lower baseline circulating tumor cell (CTC) levels, and early CPI sequencing. These findings support prospective validation of DTH and CTC as predictive biomarkers for effectiveness of the Bria-IMT regimen and the continued use of the Phase 3formulation in the ongoing Phase 3 study Bria-ABC.
Abstract Title: Quality of life and treatment tolerability of Bria-IMT + CPI in metastatic breast cancer.
Session Type/Title: Poster Session - Breast Cancer—Metastatic
Poster Board: 221
Date and Time: June 1, 2026, 1:30 PM-4:30 PM CDT
Summary: Heavily pretreated MBC patients in the pivotal Bria-ABC demonstrated stable global health and key functional domains. Measurements included quality of life (QOL) and time without symptoms or toxicity (TWiST). Blinded data indicated that QOL was largely preserved in a heavily pretreated population with prior antibody-drug conjugate (ADC), check point inhibitor (CPI), and cyclin-dependent kinase 4/6 (CDK4/6) inhibitor exposure. Clinical data demonstrates meaningful benefits without significant toxicity. Ongoing follow up will further characterize durability of patient-reported outcomes and clinical correlation. Data further supports decentralized care and potential home self-administration of the Bria-IMT+CPI regimen.
Abstract Title: Monitoring blood-based biomarkers as early predictors of progression-free survival in a randomized Bria-ABC Phase 3 trial for advanced metastatic breast cancer: An ongoing analysis.
Session Type/Title: Poster Session - Developmental Therapeutics—Immunotherapy
Poster Board: 442
Date and Time: May 30, 2026, 1:30 PM-4:30 PM CDT
Summary: In an ongoing analysis of heavily treated MBC patients, we observed that in the entire blinded population, 65% of patients had stability/drop in Cancer-Associated Macrophage-Like cells (CAMLs) and this significantly correlated with better progression free survival (PFS). Treatment arm specific comparisons will not be unblinded until completion of the designated milestone (144 mortalities).
Publication-Only Abstract Title: Cell-based second-generation immunotherapy BC1 in metastatic breast cancer.
Summary: Dose escalation from 20M to 60M and combination with CPI showed tolerable intradermal BC1, Bria-OTS, and potential clinical benefit in refractory MBC patients. One patient received 17 cycles with 12 months of disease control. Expansion cohorts will assess HLA match, DTH, dose optimization, and combination activity. Based on very early preliminary data, BC1, Bria-OTS™ first generation, is a potential new option for late-stage cancer patients with minimal toxicity and potential home administration as a single agent. Clinical trial information: NCT06471673.
Publication-Only Abstract Title: Liquid biopsy to stratify metastatic breast cancer progression risk using multi-analyte cell subtyping prior to systemic therapy.
Summary: Circulating tumor cells were uncommon in metastatic breast cancer patients but correlated with very poor clinical outcomes. In parallel analysis, CAMLs were common with CAML size correlating with increasingly poorer outcomes. By combining CTC & CAML subtypes, MBC patients were more accurately stratified by risk of progression and death. Additional multivariate studies correlating treatment class and tumor response rates are ongoing.
Publication-Only Abstract Title: Monitoring PD-L1 expression in circulating cancer associated cells for prediction of clinical outcomes in metastatic breast cancer patients treated with immune checkpoint inhibitors.
Summary: In this study of MBC patients treated with programmed death-ligand 1 (PD-L1) immune checkpoint inhibitors (ICIs), tissue combined positive score (for PD-L1) did not correlate with PD-L1 expression in CTCs or tumor-macrophage fusion cells. Further, neither Combined Positive Score (CPS) nor baseline PD-L1 in CTC/ tumor-macrophage fusion cells (TMFCs) predicted clinical outcomes in ICI therapies. However, PD-L1 in CTC/TMFCs~40 days post-induction of ICI did predict better response rates. While this study suggests predictive value of monitoring PD-L1 in blood during ICI therapies, further studies are required to refine and validate these findings.
Following the presentation, copies of the posters will be made available at https://briacell.com/scientific-publications/.
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 about the presentation of three clinical data posters and three publication-only abstracts at the 2026 ASCO Annual Meeting, and the contents of such posters, including final Phase 2 Bria-IMT survival data, quality of life data from the ongoing Phase 3 study, and biomarker analyses, 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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Contact Information
Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
info@briacell.com
Investor Relations Contact:
investors@briacell.com
