BriaCell Adds Mayo Clinic to Phase 3 Study in Metastatic Breast Cancer
BriaCell Therapeutics (NASDAQ: BCTX) has announced the addition of Mayo Clinic as a clinical site for its pivotal Phase 3 study in metastatic breast cancer. The study now encompasses 69 active clinical sites across 15 states.
The Phase 3 trial is evaluating Bria-IMT™ plus immune checkpoint inhibitor versus physician's choice in advanced metastatic breast cancer. The study's primary endpoint will analyze interim data after 144 patient events (deaths), comparing overall survival between treatment groups. The company recently reported positive Phase 2 survival data at ASCO 2025, and the Bria-IMT combination regimen has received FDA Fast Track designation.
BriaCell Therapeutics (NASDAQ: BCTX) ha annunciato l'aggiunta della Mayo Clinic come sito clinico per il suo studio cruciale di Fase 3 sul cancro al seno metastatico. Lo studio ora include 69 siti clinici attivi in 15 stati.
La sperimentazione di Fase 3 sta valutando Bria-IMT™ più inibitore del checkpoint immunitario rispetto alla scelta del medico nel cancro al seno metastatico avanzato. L'endpoint primario dello studio analizzerà i dati intermedi dopo 144 eventi pazienti (decessi), confrontando la sopravvivenza globale tra i gruppi di trattamento. L'azienda ha recentemente riportato dati positivi di sopravvivenza di Fase 2 all'ASCO 2025, e il regime combinato Bria-IMT ha ricevuto la designazione Fast Track dalla FDA.
BriaCell Therapeutics (NASDAQ: BCTX) ha anunciado la incorporación de la Mayo Clinic como sitio clínico para su estudio pivotal de Fase 3 en cáncer de mama metastásico. El estudio ahora abarca 69 sitios clínicos activos en 15 estados.
El ensayo de Fase 3 está evaluando Bria-IMT™ más un inhibidor del punto de control inmunitario frente a la elección del médico en cáncer de mama metastásico avanzado. El objetivo principal del estudio analizará datos interinos tras 144 eventos de pacientes (muertes), comparando la supervivencia global entre los grupos de tratamiento. La empresa informó recientemente datos positivos de supervivencia de Fase 2 en ASCO 2025, y el régimen combinado Bria-IMT ha recibido la designación Fast Track de la FDA.
BriaCell Therapeutics (NASDAQ: BCTX)가 전이성 유방암에 대한 중대한 3상 임상시험에 Mayo Clinic을 임상 사이트로 추가했다고 발표했습니다. 이 연구는 현재 15개 주에 걸쳐 69개의 활성 임상 사이트를 포함하고 있습니다.
3상 시험은 Bria-IMT™와 면역 체크포인트 억제제를 고급 전이성 유방암에서 의사의 선택 치료와 비교 평가하고 있습니다. 연구의 주요 평가지표는 144명의 환자 사건(사망) 후 중간 데이터를 분석하여 치료 그룹 간 전체 생존율을 비교하는 것입니다. 회사는 최근 ASCO 2025에서 긍정적인 2상 생존 데이터 발표했으며, Bria-IMT 병용 요법은 FDA 패스트 트랙 지정을 받았습니다.
BriaCell Therapeutics (NASDAQ : BCTX) a annoncé l'ajout de la Mayo Clinic en tant que site clinique pour son étude pivot de phase 3 sur le cancer du sein métastatique. L'étude comprend désormais 69 sites cliniques actifs répartis dans 15 États.
L'essai de phase 3 évalue Bria-IMT™ associé à un inhibiteur de point de contrôle immunitaire par rapport au choix du médecin dans le cancer du sein métastatique avancé. Le critère principal de l'étude analysera les données intermédiaires après 144 événements patients (décès), comparant la survie globale entre les groupes de traitement. La société a récemment présenté des données positives de survie de phase 2 lors de l'ASCO 2025, et le régime combiné Bria-IMT a reçu la désignation Fast Track de la FDA.
BriaCell Therapeutics (NASDAQ: BCTX) hat die Aufnahme der Mayo Clinic als klinischen Standort für seine entscheidende Phase-3-Studie bei metastasiertem Brustkrebs bekannt gegeben. Die Studie umfasst nun 69 aktive klinische Standorte in 15 Bundesstaaten.
Die Phase-3-Studie bewertet Bria-IMT™ plus Immun-Checkpoint-Inhibitor im Vergleich zur Wahl des Arztes bei fortgeschrittenem metastasiertem Brustkrebs. Der primäre Endpunkt der Studie wird Zwischenanalysen nach 144 Patientenereignissen (Todesfällen) durchführen und das Gesamtüberleben zwischen den Behandlungsgruppen vergleichen. Das Unternehmen berichtete kürzlich positive Überlebensdaten aus Phase 2 auf der ASCO 2025, und das Bria-IMT-Kombinationsregime hat die Fast Track-Zulassung der FDA erhalten.
- Addition of prestigious Mayo Clinic as clinical site strengthens trial credibility
- Extensive network of 69 clinical sites across 15 states indicates strong trial enrollment potential
- FDA Fast Track designation highlights potential therapeutic significance
- Recent positive Phase 2 survival data supports treatment approach
- Need to wait for 144 patient deaths before interim analysis indicates lengthy trial timeline
- Complex combination therapy may face regulatory hurdles
Insights
Mayo Clinic joining BriaCell's Phase 3 breast cancer trial strengthens study credibility and could accelerate enrollment of their promising immunotherapy.
The addition of Mayo Clinic to BriaCell's pivotal Phase 3 study represents a significant enhancement to their clinical trial network, which now encompasses 69 active sites across 15 states. This expansion is particularly notable as Mayo Clinic also participated in BriaCell's Phase 2 study, suggesting continuity and confidence in the Bria-IMT™ immunotherapy approach.
The trial design compares BriaCell's lead candidate Bria-IMT™ plus an immune checkpoint inhibitor against physician's choice in metastatic breast cancer patients. The primary endpoint focuses on overall survival, with an interim analysis planned after 144 patient events (deaths). This is a clinically meaningful endpoint that regulatory authorities value highly.
What's particularly encouraging is that the company recently presented positive Phase 2 survival data at ASCO 2025 in a similar patient population using the same combination regimen. While specific data points aren't mentioned, this suggests promising efficacy signals that justified advancing to Phase 3.
The FDA Fast Track designation for this regimen is noteworthy, as it indicates the therapy addresses an unmet medical need in a serious condition. This designation can expedite both the development and review processes, potentially bringing this treatment to patients more quickly if efficacy is demonstrated.
The involvement of multiple prestigious cancer centers including Mayo Clinic, Northwestern University, and Sylvester Comprehensive Cancer Center adds substantial credibility to this trial and may facilitate more rapid patient enrollment, which is crucial for timely completion of the study and potential commercialization path.
PHILADELPHIA and VANCOUVER, British Columbia, July 15, 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, is pleased to announce the addition of a key clinical site, Mayo Clinic, to its ongoing pivotal Phase 3 clinical study (ClinicalTrials.gov as NCT06072612) in metastatic breast cancer.
BriaCell’s Phase 3 study now has 69 active clinical sites across 15 states, including Mayo Clinic, DHR Health Oncology Institute, Hematology Oncology Associates of Fredericksburg, Los Angeles Cancer Network, Manhattan Hematology/Oncology Associates, New York Cancer & Blood Specialists, Northwestern University, Smilow Cancer Hospital at Yale New Haven, Sylvester Comprehensive Cancer Center, Texas Oncology-Baylor Charles A. Sammons Cancer Center, and University of Arizona.
“We are very excited to be working with renowned clinical experts at a leading cancer center like Mayo Clinic, who also participated in BriaCell’s Phase 2 study,” stated Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. “We strongly believe that our novel immunotherapy has the potential to transform cancer care for patients and their families.”
BriaCell’s pivotal Phase 3 clinical study is evaluating BriaCell’s lead clinical candidate, Bria-IMT™, plus immune check point inhibitor (CPI) versus physician’s choice in advanced metastatic breast cancer (Bria-ABC).
Interim data will be analyzed once 144 patient events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT combination regimen versus those treated with physician’s choice as the primary endpoint. BriaCell recently (ASCO 2025) announced positive Phase 2 survival data in a similar MBC patient population treated with the same Bria-IMT combination regimen. The Bria-IMT combination regimen has received FDA Fast Track designation.
For additional information on BriaCell’s pivotal Phase 3 study of Bria-IMT and an immune check point inhibitor in metastatic breast cancer, please visit ClinicalTrials.gov NCT06072612.
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 Company’s beliefs regarding the potential of the Bria-IMT therapy to transform cancer care; the Company’s anticipated timeline for analyzing interim data; the Company’s analysis of interim data 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
FAQ
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