BriaCell Presents Positive Clinical Data at ASCO 2026
Rhea-AI Summary
BriaCell (Nasdaq:BCTX) reported Phase 2 and ongoing Phase 3 data for its Bria-IMT™ + checkpoint inhibitor regimen in heavily pretreated metastatic breast cancer at ASCO 2026.
Phase 2 Phase 3–regimen patients showed median OS of 16.6 months, >55% 1‑year and >27% 2‑year survival, with favorable safety, preserved quality of life, and blood-based biomarker correlations with progression-free survival.
AI-generated analysis. Not financial advice.
Positive
- Phase 3 regimen median overall survival 16.6 months in Phase 2
- Over 55% 1-year and over 27% 2-year survival with Phase 3 regimen
- Median OS 13.3 months when CPI started in Cycle 1 vs 7.4 in Cycle 2
- No treatment-related discontinuations and no unexpected safety signals reported
- Blinded Phase 3 data show preserved quality of life and meaningful TWiST
- Stable or decreased CAMLs in 60–65% significantly correlated with better PFS
Negative
- Patient population heavily pretreated with median 6 prior systemic therapies
- Baseline CTC positivity associated with more rapid disease progression
Market Reaction – BCTX
Following this news, BCTX has declined 9.20%, reflecting a notable negative market reaction. Our momentum scanner has triggered 6 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $3.31. This price movement has removed approximately $2M from the company's valuation.
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Key Figures
Market Reality Check
Peers on Argus
BCTX was up 1.68% while closely scored biotech peers in sector data mostly showed declines today (e.g., ADAP -17.57%, IMNN -9.17%, PRTG -10.39%). Momentum scanner flags IMNN and BIVI moving up, opposite the scanner’s labeled target direction, reinforcing stock-specific drivers.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| 2026-05-26 | DSMB recommendation | Positive | -2.0% | DSMB issued another positive safety recommendation with no trial changes. |
| 2026-05-22 | ASCO data preview | Positive | -6.2% | ASCO 2026 data showed 16.6‑month median OS and tolerable safety profile. |
| 2026-05-13 | Site expansion | Positive | +2.5% | Added Penn’s Abramson Cancer Center as a Phase 3 clinical site. |
| 2026-05-12 | Enrollment update | Positive | -1.9% | Reported >315 screened and >230 enrolled in pivotal Bria‑ABC trial. |
| 2026-05-07 | Site expansion | Positive | -1.2% | NYU Langone’s Perlmutter Cancer Center joined as a Phase 3 trial site. |
Recent clinical-trial headlines for Bria-IMT and the pivotal Bria-ABC study have often been followed by negative next‑day moves despite constructive clinical progress.
Over the past month, BriaCell has repeatedly highlighted advancement of its Bria‑IMT regimen in metastatic breast cancer. Clinical‑trial news included site additions at major cancer centers, enrollment milestones (>230 patients screened/enrolled), and multiple DSMB reviews with no safety concerns. ASCO‑related disclosures showed encouraging median overall survival and quality‑of‑life data. Yet, historical 24‑hour reactions to these clinical updates have skewed negative, suggesting a pattern of cautious trading around Bria‑IMT trial progress even when newsflow is constructive.
Historical Comparison
In the past month, BCTX released 5 clinical-trial updates averaging a -1.77% next-day move. Today’s modest +1.68% reaction to new ASCO survival/biomarker data is slightly more constructive than prior clinical headlines.
Same-tag events trace steady Bria-IMT Phase 3 progress: new top-tier sites, rising enrollment beyond 230 patients, repeated DSMB confirmations, and increasingly detailed ASCO survival and biomarker data for the Bria-ABC study.
Market Pulse Summary
This announcement details encouraging Phase 2 and blinded Phase 3 data for Bria‑IMT plus a checkpoint inhibitor in heavily pretreated metastatic breast cancer, including median overall survival of 16.6 months and >55% 1‑year survival with the Phase 3 regimen. Quality‑of‑life and TWiST findings suggest benefit without major added toxicity, while CTC and CAML dynamics emerge as potential predictive biomarkers. Investors may watch future Bria‑ABC readouts, durability of long‑term survival, and validation of these blood‑based markers.
Key Terms
metastatic breast cancer medical
immune checkpoint inhibitor medical
circulating tumor cells medical
Cancer-Associated Macrophage-Like cells medical
antibody-drug conjugate medical
cyclin-dependent kinase 4/6 inhibitor medical
AI-generated analysis. Not financial advice.
- Final Bria-IMT™ Phase 2 data show
55% >1 year and27% >2-year survival in heavily pre-treated metastatic breast cancer (MBC) patients treated with Bria-IMT regimen selected for Phase 3 - TWiST analysis, which measures time without disease symptoms or significant treatment-related toxicity, showed clinically meaningful benefit in heavily pre-treated MBC patients in the ongoing Phase 3 study
- Biomarker analyses from the ongoing Phase 3 study further validates potential predictors of anti-cancer response initially reported in Phase 2 study
2026 ASCO Annual Meeting, May 29-June 2, 2026, at McCormick Place, Chicago, Illinois
PHILADELPHIA and VANCOUVER, British Columbia, June 01, 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, announces positive clinical data from three clinical data poster presentations 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 (ClinicalTrials.gov identifier: NCT06072612) and one poster highlighting further analyses of Phase 2 data.
“Late-stage metastatic breast cancer (MBC) is often associated with a poor prognosis and very short survival rates,” stated Saranya Chumsri, MD, principal investigator in the Phase 3 study of Bria-IMT+CPI, and Professor of Oncology at Mayo Clinic Florida. “We are pleased to report Phase 2 study median overall survival rates as high as 16.6 months and a high rate of long-term survival in our late-stage MBC patients including in patients resistant to multiple prior therapies.”
“BriaCell’s Phase 3 data are highly encouraging because they address one of the key challenges in treating late-stage breast cancer patients: delivering clinical benefit while limiting toxicity that can lead to voluntary treatment discontinuation,” 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.
“We are increasingly optimistic with the early quality of life and biomarker data from our ongoing pivotal Phase 3 Bria-ABC trial demonstrating sustained clinical activity in patients with advanced MBC who did not respond to multiple prior treatments,” noted William V. Williams, MD, BriaCell’s President & CEO.
The details of the presentations 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). Treatment was well tolerated with injection site reactions, mostly mild in severity, the most frequent side. The clinical benefit rate was
Median overall survival (“OS”) was 13.3 months for patients who initiated checkpoint inhibitor (“CPI”) therapy in Cycle 1 (as is being done in the Phase 3 Bria-ABC study) versus 7.4 months for those who initiated CPI therapy in Cycle 2 with estimated 12-month and 24-month OS rates being
Figure 1: Phase 2 study overall survival by sequence and formulation demonstrating extended OS with CPI at C1 and IP w/o IFNγ (Bria-IMT Phase 3 regimen)
Conclusions: In heavily pretreated MBC patients, Bria-IMT demonstrated an excellent 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 3 formulation in the ongoing Phase 3 study Bria-ABC. The clinical findings further confirmed the preferred formulation for the ongoing pivotal Phase 3 study.
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 study 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 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.
Study patients were heavily pretreated, consistent with BriaCell’s prior Phase 2 population, with a median of 6 prior systemic therapies (range: 2–14), including prior ADCs in
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,
Results:
- ≥1 circulating tumor cells (CTC)s were found in
25% at baseline (BL) and20% at the first on-treatment assessment(T1) - ≥1 Cancer-associated macrophage-like cells (CAMLs) were found in
93% at BL &93% at T1 - ≥1 CTC significantly correlated with progression free survival (PFS) at BL, but not at T1
- A decrease or stable CAML counts between BL and T1 (seen in
60% of patients) significantly correlated with better progression-free survival
In this ongoing blinded analysis of heavily pretreated metastatic breast cancer patients, stable or decreased CAML counts from baseline to Cycle 3 were observed in
Following the presentation, copies of the posters will be 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 at the 2026 ASCO Annual Meeting, and the contents of such posters, including final Phase 2 Bria-IMT survival data, quality of life and TWiST analyses 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.
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
info@briacell.com
Investor Relations Contact:
investors@briacell.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/31dfc6cf-bbf0-4255-9a71-332768a478f1
