BriaCell Highlights Additional Phase 3 Clinical Sites Including Los Angeles Cancer Network and Smilow Cancer Hospital at Yale New Haven
BriaCell Therapeutics (NASDAQ: BCTX) has expanded its pivotal Phase 3 clinical trial for advanced metastatic breast cancer treatment by adding two major cancer centers: Los Angeles Cancer Network and Smilow Cancer Hospital at Yale New Haven, contributing 30 additional satellite locations. The study now encompasses 58 active clinical sites across 15 states.
The trial evaluates BriaCell's lead candidate Bria-IMT™ plus immune checkpoint inhibitor versus physician's choice. Patient enrollment is expected to complete by late 2025 or early 2026, with potential top-line data release in H1-2026. The study's primary endpoint will analyze overall survival after 144 patient events, with positive results potentially leading to full approval and marketing authorization.
BriaCell Therapeutics (NASDAQ: BCTX) ha ampliato il suo studio clinico di Fase 3 fondamentale per il trattamento del cancro al seno metastatico avanzato, aggiungendo due importanti centri oncologici: Los Angeles Cancer Network e Smilow Cancer Hospital presso Yale New Haven, che apportano ulteriori 30 sedi satelliti. Lo studio ora comprende 58 siti clinici attivi in 15 stati.
Il trial valuta il candidato principale di BriaCell, Bria-IMT™ in combinazione con un inibitore del checkpoint immunitario, rispetto alla scelta del medico. Si prevede che l'arruolamento dei pazienti si concluda entro la fine del 2025 o l'inizio del 2026, con possibile rilascio dei dati principali nella prima metà del 2026. L'endpoint primario dello studio analizzerà la sopravvivenza globale dopo 144 eventi nei pazienti, con risultati positivi che potrebbero portare all'approvazione completa e all'autorizzazione alla commercializzazione.
BriaCell Therapeutics (NASDAQ: BCTX) ha ampliado su ensayo clínico pivotal de Fase 3 para el tratamiento del cáncer de mama metastásico avanzado, incorporando dos importantes centros oncológicos: Los Angeles Cancer Network y Smilow Cancer Hospital en Yale New Haven, sumando 30 ubicaciones satélite adicionales. El estudio ahora abarca 58 sitios clínicos activos en 15 estados.
El ensayo evalúa el candidato principal de BriaCell, Bria-IMT™ más inhibidor de puntos de control inmunitarios, frente a la elección del médico. Se espera que la inscripción de pacientes finalice 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 analizará la supervivencia global tras 144 eventos en pacientes, y resultados positivos podrían conducir a la aprobación completa y autorización para comercialización.
BriaCell Therapeutics (NASDAQ: BCTX)는 진행성 전이성 유방암 치료를 위한 중대한 3상 임상시험에 두 개의 주요 암 센터인 로스앤젤레스 암 네트워크와 예일 뉴헤이븐의 스마일로우 암 병원을 추가하여 30개의 추가 위성 기관을 확보했습니다. 현재 이 연구는 15개 주에 걸쳐 58개의 활성 임상 사이트를 포함하고 있습니다.
본 임상시험은 BriaCell의 주력 후보물질인 Bria-IMT™와 면역관문억제제 병용요법을 의사의 선택 치료와 비교 평가합니다. 환자 등록은 2025년 말 또는 2026년 초에 완료될 예정이며, 2026년 상반기에 주요 결과가 발표될 가능성이 있습니다. 연구의 주요 평가 지표는 144건의 환자 사건 발생 후 전체 생존율을 분석하며, 긍정적인 결과가 나오면 완전 승인 및 판매 허가로 이어질 수 있습니다.
BriaCell Therapeutics (NASDAQ : BCTX) a étendu son essai clinique pivot de phase 3 pour le traitement du cancer du sein métastatique avancé en ajoutant deux centres de cancérologie majeurs : Los Angeles Cancer Network et Smilow Cancer Hospital à Yale New Haven, apportant 30 sites satellites supplémentaires. L'étude compte désormais 58 sites cliniques actifs répartis dans 15 États.
L'essai évalue le candidat principal de BriaCell, Bria-IMT™ associé à un inhibiteur de point de contrôle immunitaire, par rapport au choix du médecin. Le recrutement des patients devrait s'achever d'ici fin 2025 ou début 2026, avec une possible publication des données principales au premier semestre 2026. Le critère principal de l'étude analysera la survie globale après 144 événements chez les patients, des résultats positifs pouvant conduire à une approbation complète et une autorisation de mise sur le marché.
BriaCell Therapeutics (NASDAQ: BCTX) hat seine entscheidende Phase-3-Studie zur Behandlung von fortgeschrittenem metastasiertem Brustkrebs erweitert, indem zwei bedeutende Krebszentren hinzugefügt wurden: Los Angeles Cancer Network und Smilow Cancer Hospital an der Yale New Haven, die 30 zusätzliche Satellitenstandorte beitragen. Die Studie umfasst nun 58 aktive klinische Standorte in 15 Bundesstaaten.
Die Studie bewertet BriaCells führenden Kandidaten Bria-IMT™ plus Immun-Checkpoint-Inhibitor im Vergleich zur Wahl des Arztes. Die Patienteneinschreibung soll bis Ende 2025 oder Anfang 2026 abgeschlossen sein, mit einer möglichen Veröffentlichung der Hauptergebnisse im ersten Halbjahr 2026. Der primäre Endpunkt der Studie wird das Gesamtüberleben nach 144 Patientenevents analysieren; positive Ergebnisse könnten zu einer vollständigen Zulassung und Marktzulassung führen.
- None.
- Study completion dependent on 144 patient deaths for endpoint analysis
- Final results not expected until H1-2026
Insights
BriaCell's Phase 3 trial expansion signals strong investigator interest and potentially faster enrollment for their metastatic breast cancer immunotherapy.
BriaCell has significantly expanded its Phase 3 clinical trial network for Bria-IMT™, adding two major cancer centers - Los Angeles Cancer Network and Smilow Cancer Hospital at Yale New Haven - which together contribute 30 additional satellite locations. This expansion brings their total to 58 active clinical sites across 15 states, potentially accelerating patient recruitment for their metastatic breast cancer immunotherapy.
The company now anticipates completing enrollment by late 2025 or early 2026, with possible top-line data readout as early as H1-2026. The trial's primary endpoint focuses on overall survival, comparing the Bria-IMT™ plus immune checkpoint inhibitor combination versus physician's choice in advanced metastatic breast cancer patients.
This rapid clinical site expansion is particularly noteworthy as it suggests strong investigator interest in BriaCell's approach. The interim analysis will occur after 144 patient events (deaths), and positive results could lead to full FDA approval. The treatment has already received FDA Fast Track designation, which expedites the review process for drugs addressing serious conditions with unmet medical needs.
BriaCell's approach appears to show promise based on their recently announced positive Phase 2 survival data presented at ASCO 2025. The strategic addition of these established cancer networks with multiple satellite locations should enhance geographical accessibility for potential trial participants, potentially addressing one of the common barriers to clinical trial enrollment in oncology.
- Together, Los Angeles Cancer Network and Smilow Cancer Hospital at Yale New Haven add 30 satellite locations to enroll patients in BriaCell’s pivotal Phase 3 study
- BriaCell’s Phase 3 study currently has 58 active clinical sites across 15 states, including Smilow Cancer Hospital, Los Angeles Cancer Network, University of Arizona, DHR Health Oncology Institute, Sylvester Comprehensive Cancer Center, Cancer Care Northwest, Hematology Oncology Associates of Fredericksburg, Northwestern University, Manhattan Hematology/Oncology Associates, New York Cancer & Blood Specialists, and Texas Oncology-Baylor Charles A. Sammons Cancer Center
PHILADELPHIA and VANCOUVER, British Columbia, July 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, is pleased to announce the addition of two key large cancer centers to its ongoing pivotal Phase 3 clinical study (ClinicalTrials.gov as NCT06072612): Los Angeles Cancer Network and Smilow Cancer Hospital at New Haven. Each has 15 satellite locations. 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 (CPI) versus physician’s choice in advanced metastatic breast cancer (Bria-ABC).
“Clinical investigator interest in our Phase 3 study has exceeded our expectations which has significantly expanded patient access to our treatment,” stated Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. “This strong engagement reflects both the urgent unmet need in metastatic breast cancer and the dedication of our clinical partners.”
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 (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 anticipated completion date of patient enrollment for the Company’s ongoing pivotal Phase 3 clinical study; the anticipated timeline for reporting top line data for the Company’s pivotal Phase 3 study; the timing and results of interim data; and the final results of the pivotal Phase 3 study, 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
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