BriaCell Enrollment Pace Accelerating in Phase 3 Clinical Study in Advanced Metastatic Breast Cancer (Bria-ABC)
BriaCell Therapeutics (Nasdaq: BCTX) reports accelerating enrollment in its pivotal Phase 3 clinical study for advanced metastatic breast cancer treatment. The study has enrolled over 75 patients across 54 clinical sites in 15 states, evaluating Bria-IMT plus immune checkpoint inhibitor versus physician's choice.
The company expects to complete patient enrollment by late 2025 or early 2026, with potential top-line data release in H1-2026. The study's primary endpoint compares overall survival between treatment groups, with interim analysis planned after 144 patient events. The Bria-IMT combination regimen has received FDA Fast Track designation, and positive Phase 3 results could lead to full approval and marketing authorization for metastatic breast cancer treatment.
BriaCell Therapeutics (Nasdaq: BCTX) annuncia un'accelerazione nell'arruolamento dei pazienti nel suo fondamentale studio clinico di Fase 3 per il trattamento del carcinoma mammario metastatico avanzato. Lo studio ha coinvolto oltre 75 pazienti in 54 centri clinici distribuiti in 15 stati, confrontando Bria-IMT più un inibitore del checkpoint immunitario con la scelta del medico.
L'azienda prevede di completare l'arruolamento dei pazienti entro la fine del 2025 o l'inizio del 2026, con un possibile rilascio dei dati principali nella prima metà del 2026. L'endpoint primario dello studio confronta la sopravvivenza globale tra i gruppi di trattamento, con un'analisi intermedia pianificata dopo 144 eventi nei pazienti. Il regime combinato Bria-IMT ha ottenuto la designazione Fast Track dalla FDA e risultati positivi in Fase 3 potrebbero portare all'approvazione completa e all'autorizzazione alla commercializzazione per il trattamento del carcinoma mammario metastatico.
BriaCell Therapeutics (Nasdaq: BCTX) informa sobre una aceleración en el reclutamiento de pacientes en su crucial estudio clínico de Fase 3 para el tratamiento del cáncer de mama metastásico avanzado. El estudio ha inscrito a más de 75 pacientes en 54 sitios clínicos en 15 estados, evaluando Bria-IMT más un inhibidor del punto de control inmunitario frente a la elección del médico.
La compañía espera completar la inscripción de pacientes a finales de 2025 o principios de 2026, con posible publicación de datos principales en el primer semestre de 2026. El objetivo principal del estudio compara la supervivencia global entre los grupos de tratamiento, con un análisis intermedio planificado tras 144 eventos en pacientes. El régimen combinado Bria-IMT ha recibido la designación Fast Track de la FDA, y resultados positivos en Fase 3 podrían conducir a la aprobación completa y autorización de comercialización para el tratamiento del cáncer de mama metastásico.
BriaCell Therapeutics (나스닥: BCTX)는 진행성 전이성 유방암 치료를 위한 중대한 3상 임상시험 환자 등록이 가속화되고 있다고 보고했습니다. 이 연구는 15개 주의 54개 임상 사이트에서 75명 이상의 환자를 등록했으며, Bria-IMT와 면역 체크포인트 억제제 병용요법을 의사의 선택 치료와 비교합니다.
회사는 2025년 말 또는 2026년 초까지 환자 등록을 완료할 것으로 예상하며, 2026년 상반기에 주요 결과 데이터를 발표할 가능성이 있습니다. 연구의 주요 평가 변수는 치료 그룹 간 전체 생존율 비교이며, 144명의 환자 이벤트 후 중간 분석이 계획되어 있습니다. Bria-IMT 병용 요법은 FDA의 패스트트랙 지정(Fast Track designation)을 받았으며, 3상 긍정적 결과는 전이성 유방암 치료에 대한 완전 승인 및 시판 허가로 이어질 수 있습니다.
BriaCell Therapeutics (Nasdaq : BCTX) annonce une accélération du recrutement dans son étude clinique pivot de Phase 3 pour le traitement du cancer du sein métastatique avancé. L'étude a recruté plus de 75 patients dans 54 centres cliniques répartis dans 15 États, évaluant Bria-IMT en association avec un inhibiteur de point de contrôle immunitaire contre le choix du médecin.
L'entreprise prévoit de terminer le recrutement des patients d'ici fin 2025 ou début 2026, avec une possible publication des données principales au premier semestre 2026. Le critère principal de l'étude compare la survie globale entre les groupes de traitement, une analyse intermédiaire étant prévue après 144 événements patients. Le régime combiné Bria-IMT a reçu la désignation Fast Track de la FDA, et des résultats positifs en Phase 3 pourraient conduire à une approbation complète et à une autorisation de mise sur le marché pour le traitement du cancer du sein métastatique.
BriaCell Therapeutics (Nasdaq: BCTX) berichtet über eine beschleunigte Patientenaufnahme in seiner entscheidenden Phase-3-Studie zur Behandlung von fortgeschrittenem metastasiertem Brustkrebs. Die Studie hat über 75 Patienten an 54 Studienzentren in 15 Bundesstaaten eingeschlossen und bewertet Bria-IMT in Kombination mit einem Immun-Checkpoint-Inhibitor im Vergleich zur Arztwahl.
Das Unternehmen erwartet, die Patientenaufnahme bis Ende 2025 oder Anfang 2026 abzuschließen, mit einer möglichen Veröffentlichung der wichtigsten Studiendaten im ersten Halbjahr 2026. Der primäre Endpunkt der Studie vergleicht das Gesamtüberleben zwischen den Behandlungsgruppen, eine Zwischenanalyse ist nach 144 Patientenereignissen geplant. Das Bria-IMT-Kombinationsregime hat die Fast Track-Designation der FDA erhalten, und positive Ergebnisse der Phase 3 könnten zur vollständigen Zulassung und Markteinführung für die Behandlung von metastasiertem Brustkrebs führen.
- Strong enrollment pace with over 75 patients enrolled in Phase 3 trial
- FDA Fast Track designation obtained for Bria-IMT combination
- Wide clinical site coverage across 54 locations in 15 states
- Previous Phase 2 showed positive survival data in similar patient population
- Final trial results not expected until H1-2026
- Requires 144 patient deaths for interim analysis
Insights
BriaCell shows accelerating enrollment in Phase 3 breast cancer trial, indicating strong operational execution toward potential 2026 data readout.
BriaCell's Phase 3 study of Bria-IMT plus checkpoint inhibitor in metastatic breast cancer is showing significant enrollment progress with
The trial design comparing the Bria-IMT regimen to physician's choice uses overall survival as the primary endpoint - the gold standard for oncology approvals. An interim analysis is planned after 144 patient events (deaths), which will provide the first comparative efficacy signal.
The projected timeline for enrollment completion in late 2025/early 2026 and potential topline data as early as H1-2026 appears reasonable given the current enrollment pace. The FDA Fast Track designation previously granted to this regimen acknowledges the unmet need in advanced metastatic breast cancer and could facilitate more frequent FDA interactions during development.
The company references positive Phase 2 survival data using the same Bria-IMT combination regimen, which provides rationale for advancing to Phase 3, though specific efficacy metrics from that earlier study aren't detailed in this announcement.
BriaCell's accelerating Phase 3 enrollment provides clear timeline visibility for a potentially value-driving data readout in H1-2026.
This enrollment update demonstrates BriaCell's operational execution in advancing its lead asset. With
The clear timeline projection - enrollment completion by late 2025/early 2026 and potential topline data in H1-2026 - provides investors with visibility on this key clinical catalyst. For biotechnology companies, meeting or beating clinical timelines is a positive operational indicator.
The Phase 3 trial represents a potential inflection point, as positive results "could result in full approval and marketing authorization for Bria-IMT in MBC patients." The FDA Fast Track designation previously granted could potentially expedite the regulatory review process if data are supportive.
While accelerating enrollment is encouraging, the ultimate value driver will be the trial's efficacy results. The specified primary endpoint of overall survival requires sufficient events to reach statistical conclusions, making the H1-2026 timeline for topline data reasonable based on current enrollment trajectories.
- Over 75 patients enrolled in BriaCell’s pivotal Phase 3 study of Bria-IMT™ plus immune check point inhibitor in metastatic breast cancer (MBC)
- 54 clinical sites across 15 states currently enrolling patients including Sylvester Comprehensive Cancer Center, Cancer Care Northwest, Hematology Oncology Associates of Fredericksburg, Northwestern University, Manhattan Hematology/Oncology Associates, New York Cancer and Bood Specialists, and Texas Oncology-Baylor Charles A. Sammons Cancer Center
PHILADELPHIA and VANCOUVER, British Columbia, April 22, 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, is pleased to announce that its ongoing pivotal Phase 3 clinical study (listed on ClinicalTrials.gov as NCT06072612) has consented over 100 and has enrolled over 75 patients. BriaCell anticipates completing patient enrollment in late 2025 or early 2026, and may report top line data as early as H1-2026.
BriaCell’s pivotal Phase 3 clinical study is evaluating BriaCell’s lead clinical candidate, Bria-IMT, plus immune check point inhibitor versus physician’s choice in advanced metastatic breast cancer (Bria-ABC).
“We are pleased at the expanding patient enrollment in our Phase 3 study, and expect this to continue to grow,” stated Dr. William V. Williams, BriaCell’s President & CEO. “We believe our novel therapeutic approach has the potential to transform cancer care for metastatic breast cancer patients, and are determined to bring our novel immunotherapy to market to help these patients.”
“Enrollment pace and clinical investigator interest in our Bria-ABC study is above any I have seen,” noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. “We would like to thank our dedicated clinical investigators and patients for participating in this important study. Through their efforts, we will advance our novel cancer immunotherapy to other MBC patients whose medical needs remain unmet.”
About BriaCell’s Pivotal Phase 3 Clinical Study of Bria-IMT Combination Regimen in MBC patients
Fifty-four clinical sites in the US are actively enrolling patients in BriaCell’s pivotal Phase 3 study in metastatic breast cancer. Additional sites are in various stages of start-up.
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. Positive results of the pivotal Phase 3 study could result in full approval and marketing authorization for Bria-IMT in MBC patients. BriaCell recently 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 anticipated expansion of patient enrollment, timeline for completing patient enrollment and timeline for reporting top line data in its ongoing pivotal Phase 3 clinical study; the Company’s beliefs regarding its ability to bring their novel immunotherapy to the market; the Company’s beliefs regarding the Bria-IMT combination regimen’s potential to transform cancer care for metastatic breast cancer patients; the Company offering its novel cancer immunotherapy to other metastatic breast cancer patients; the Company’s plans and timelines regarding its analysis of interim data on the Bria-IMT combination regimen, and how such data will be analyzed; and the Company’s beliefs regarding Bria-IMT receiving full approval and marketing authorization for metastatic breast cancer patients, 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, such as those 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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