BriaCell Receives Positive Recommendation from Data Safety Monitoring Board (DSMB) for Phase 3 Study in Metastatic Breast Cancer
BriaCell (NASDAQ: BCTX) said an independent Data Safety Monitoring Board issued its fourth consecutive positive recommendation after reviewing safety data from the pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor in metastatic breast cancer (NCT06072612). The DSMB identified no safety concerns and recommended the study continue without modifications. The study is conducted under FDA Fast Track designation. DSMB meetings occur quarterly; this is the fourth positive quarterly review. Management highlighted confidence in the regimen's safety and tolerability and reiterated commitment to advancing the trial for patients with urgent unmet needs.
BriaCell (NASDAQ: BCTX) ha dichiarato che un comitato indipendente per la sorveglianza della sicurezza dei dati ha emesso la sua quarta raccomandazione positiva consecutiva dopo aver esaminato i dati di sicurezza dallo studio chiave di fase 3 di Bria-IMT più inibitore del checkpoint immunitario nel cancro al seno metastatico (NCT06072612). Il DSMB ha identificato nessuna preoccupazione per la sicurezza e ha raccomandato che lo studio prosegua senza modifiche. lo studio è condotto con la designazione FDA Fast Track. Le riunioni del DSMB avvengono trimestralmente; questa è la quarta revisione trimestrale positiva. La direzione ha sottolineato la fiducia nella sicurezza e tollerabilità del regime e ha ribadito l'impegno a portare avanti la sperimentazione per i pazienti con bisogni urgenti non soddisfatti.
BriaCell (NASDAQ: BCTX) dijo que un Consejo Independiente de Monitoreo de Seguridad de Datos emitió su cuarta recomendación positiva consecutiva tras revisar los datos de seguridad del ensayo pivotal de fase 3 de Bria-IMT más inhibidor de punto de control inmunitario en cáncer de mama metastásico (NCT06072612). El DSMB identificó ninguna preocupación de seguridad y recomendó que el estudio continuara sin modificaciones. El estudio se realiza bajo la designación FDA Fast Track. Las reuniones del DSMB ocurren trimestralmente; esta es la cuarta revisión trimestral positiva. La dirección destacó la confianza en la seguridad y tolerabilidad del régimen y reiteró su compromiso de avanzar en el ensayo para pacientes con necesidades insatisfechas y urgentes.
BriaCell (NASDAQ: BCTX)는 독립적인 데이터 안전성 모니터링 위원회가 연속 네 번째 긍정적 권고를 제시했다고 밝혔다. 이는 전이성 유방암(NCT06072612)에서의 Bria-IMT와 면역 점검점 억제제의 결정적 3상 연구의 안전성 데이터를 검토한 결과이다. DSMB는 안전 문제 없음을 확인하고 연구를 수정 없이 계속할 것을 권고했다. 연구는 FDA Fast Track 지정 아래 수행된다. DSMB 회의는 분기마다 열리며, 이번이 네 번째 긍정적 분기 검토다. 경영진은 이 요법의 안전성과 내약성에 대한 확신을 강조했고, 시급한 미충족 환자들을 위한 시험을 진행하겠다는 다짐을 재확인했다.
BriaCell (NASDAQ: BCTX) a déclaré qu'un Independent Data Safety Monitoring Board a émis sa quatrième recommandation positive consécutive après avoir examiné les données de sécurité de l'étude pivot de phase 3 de Bria-IMT plus inhibiteur des points de contrôle immunitaire dans le cancer du sein métastatique (NCT06072612). Le DSMB a identifié aucune préoccupation de sécurité et a recommandé que l'étude se poursuive sans modifications. L'étude est conduite sous la désignation FDA Fast Track. Les réunions du DSMB ont lieu trimestriellement; il s'agit de la quatrième revue trimestrielle positive. La direction a souligné sa confiance dans la sécurité et la tolérance du régime et a réitéré son engagement à faire progresser l'essai pour les patients présentant des besoins non satisfaits et urgents.
BriaCell (NASDAQ: BCTX) sagte, dass ein unabhängiges Data Safety Monitoring Board seine vierte aufeinanderfolgende positive Empfehlung nach der Überprüfung der Sicherheitsdaten aus der entscheidenden Phase-3-Studie von Bria-IMT plus Immun-Checkpunkt-Inhibitor beim metastasierenden Brustkrebs (NCT06072612) abgegeben habe. Das DSMB identifizierte keine Sicherheitsbedenken und empfahl, dass die Studie unverändert fortgesetzt werde. Die Studie wird unter der FDA Fast Track-Zulassung durchgeführt. DSMB-Sitzungen finden vierteljählich statt; dies ist die vierte positive vierteljährliche Überprüfung. Das Management hob das Vertrauen in die Sicherheit und Verträglichkeit des Regiments hervor und bekräftigte das Engagement, die Prüfung für Patienten mit dringendem ungedecktem Bedarf voranzutreiben.
BriaCell (NASDAQ: BCTX) قالت إن مجلس بيانات السلامة المستقل أصدر التوصية الإيجابية الرابعة المتتالية بعد مراجعة بيانات السلامة من دراسة المرحلة 3 الحاسمة لـ Bria-IMT بالإضافة إلى مثبّط نقطة فحص المناعة في سرطان الثدي المتقدّم (NCT06072612). حدد DSMB لا توجد مخاوف من السلامة وموصى بأن تستمر الدراسة بدون تعديلات. تُجرى الدراسة بموجب تصنيف FDA Fast Track. تُعقد اجتماعات DSMB ربع سنوية؛ هذه هي المراجعة الربع سنوية الإيجابية الرابعة. أبرزت الإدارة الثقة في أمان التحضير وتحمله وأكدت الالتزام بتقدم التجربة للمرضى ذوي الاحتياجات غير الملباة العاجلة.
BriaCell (NASDAQ: BCTX) 表示独立的数据安全性监测委员会在审查了关键的 Phase 3 研究数据后，针对 Bria-IMT 加上免疫检查点抑制剂在转移性乳腺癌中的研究，发出其 第四次连续积极建议。DSMB 发现 没有安全性问题，并建议研究不做修改地继续进行。 该研究在 FDA 快速通道（Fast Track） designation 下进行。DSMB 会议每季度举行；这是第四次积极的季度评审。管理层强调对该方案的安全性和耐受性充满信心，并重申推进试验以满足患者的迫切未被满足的需求的承诺。
- Fourth consecutive positive DSMB safety recommendation
- DSMB raised no safety concerns and recommended continuation
- Study conducted under FDA Fast Track designation
- No efficacy or interim efficacy results disclosed in this update
- Phase 3 study is ongoing; pivotal efficacy readout and timing not provided
Insights
Fourth consecutive DSMB safety recommendation supports continued Phase 3 enrollment but provides no efficacy readout.
BriaCell received the DSMB’s fourth consecutive positive recommendation to continue its pivotal Phase 3 study of Bria-IMT plus an immune checkpoint inhibitor; the board identified no safety concerns and recommended continuation without modifications. The study runs under FDA Fast Track designation, and DSMB reviews occur quarterly per the protocol.
The immediate business mechanism is preservation of the study timeline and data integrity: an uninterrupted Phase 3 avoids delays and the need for protocol amendments driven by safety issues. Key dependencies remain unchanged and factual: the announcement discloses only safety recommendations, not efficacy outcomes or endpoint performance, so clinical benefit and regulatory outcomes are not addressed here.
Risks and things to watch include the next scheduled DSMB review in about one quarter and any future communications that disclose efficacy or formal endpoints. Monitor subsequent DSMB statements and any protocol changes or disclosed efficacy data over the coming quarters to assess material impact on development value and regulatory prospects.
- Independent DSMB has identified no safety concerns, and recommends continuation of BriaCell’s pivotal Phase 3 study of Bria-IMT™ plus immune check point inhibitor
- Fourth consecutive positive DSMB recommendation supports the favorable safety profile observed to date
- Phase 3 study is being conducted under FDA Fast Track Designation, reflecting the significant unmet need in metastatic breast cancer
PHILADELPHIA and VANCOUVER, British Columbia, Oct. 22, 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, announces that the independent Data Safety Monitoring Board (DSMB) has issued its fourth consecutive positive recommendation following review of safety data from BriaCell’s pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor (CPI) in patients with metastatic breast cancer (NCT06072612).
Following its review, the DSMB raised no safety concerns and recommended that the study continue without modifications. DSMB meetings occur quarterly in accordance with the study protocol. BriaCell’s ongoing pivotal Phase 3 study is being conducted under Fast Track designation granted by the US Food and Drug Administration (FDA), reflecting the significant unmet medical need in metastatic breast cancer.
“Repeated consecutive DSMB positive recommendations further strengthen our confidence in the excellent safety and tolerability profile of the BriaCell regimen,” commented Dr. William V. Williams, BriaCell’s President & CEO. “We strongly believe in Bria-IMT’s potential to transform cancer care and remain determined to make it a reality for patients with metastatic breast cancer who face urgent medical needs.”
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 Bria-IMT’s safety and tolerability profile; and Bria-IMT’s potential as a transformative immunotherapy for patients with metastatic breast cancer, 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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