Second Data Safety Monitoring Board Issues Positive Recommendation to Continue BriaCell’s Phase 3 Study in Metastatic Breast Cancer
BriaCell Therapeutics (Nasdaq: BCTX) received a positive recommendation from the Data Safety Monitoring Board (DSMB) for its pivotal Phase 3 study of Bria-IMT™ plus immune checkpoint inhibitor in metastatic breast cancer. The DSMB, an independent expert group, completed its second safety data review and found no safety concerns, recommending the continuation of the ongoing study without modifications.
The study is being conducted under Fast Track Designation from the FDA. The company's management expressed satisfaction with the safety and tolerability profile of the Bria-IMT plus immune checkpoint inhibitor combination therapy, viewing the DSMB's recommendation as an encouraging sign for their novel immunotherapy approach to treating metastatic breast cancer.
BriaCell Therapeutics (Nasdaq: BCTX) ha ricevuto una raccomandazione positiva dal Data Safety Monitoring Board (DSMB) per il suo studio cruciale di Fase 3 su Bria-IMT™ in combinazione con un inibitore del checkpoint immunitario nel cancro al seno metastatico. Il DSMB, un gruppo di esperti indipendenti, ha completato la sua seconda revisione dei dati di sicurezza e non ha riscontrato preoccupazioni, raccomandando la continuazione dello studio in corso senza modifiche.
Lo studio è condotto sotto la Designazione Fast Track della FDA. La direzione dell'azienda ha espresso soddisfazione per il profilo di sicurezza e tollerabilità della terapia combinata Bria-IMT più inibitore del checkpoint immunitario, considerando la raccomandazione del DSMB come un segnale incoraggiante per il loro approccio innovativo all'immunoterapia nel trattamento del cancro al seno metastatico.
BriaCell Therapeutics (Nasdaq: BCTX) recibió una recomendación positiva del Data Safety Monitoring Board (DSMB) para su estudio pivotal de Fase 3 de Bria-IMT™ más un inhibidor del checkpoint inmunitario en cáncer de mama metastásico. El DSMB, un grupo de expertos independientes, completó su segunda revisión de datos de seguridad y no encontró preocupaciones, recomendando la continuación del estudio en curso sin modificaciones.
El estudio se está llevando a cabo bajo la Designación de Vía Rápida de la FDA. La dirección de la empresa expresó satisfacción con el perfil de seguridad y tolerabilidad de la terapia combinada Bria-IMT más el inhibidor del checkpoint inmunitario, considerando la recomendación del DSMB como una señal alentadora para su enfoque innovador de inmunoterapia en el tratamiento del cáncer de mama metastásico.
BriaCell Therapeutics (Nasdaq: BCTX)는 전이성 유방암에서 Bria-IMT™와 면역 체크포인트 억제제를 포함한 주요 3상 연구에 대해 데이터 안전성 모니터링 위원회(DSMB)로부터 긍정적인 권고를 받았습니다. DSMB는 독립적인 전문가 그룹으로, 두 번째 안전성 데이터 검토를 완료하고 안전성 문제를 발견하지 못했으며, 진행 중인 연구의 수정 없이 계속할 것을 권장했습니다.
이 연구는 FDA의 신속 승인 하에 진행되고 있습니다. 회사 경영진은 Bria-IMT와 면역 체크포인트 억제제 조합 요법의 안전성 및 내약성 프로필에 대해 만족감을 표명하며, DSMB의 권고를 전이성 유방암 치료를 위한 새로운 면역 요법 접근 방식에 대한 고무적인 신호로 보고 있습니다.
BriaCell Therapeutics (Nasdaq: BCTX) a reçu une recommandation positive du Data Safety Monitoring Board (DSMB) pour son étude pivot de Phase 3 sur Bria-IMT™ plus un inhibiteur de checkpoint immunitaire dans le cancer du sein métastatique. Le DSMB, un groupe d'experts indépendants, a terminé sa deuxième révision des données de sécurité et n'a trouvé aucune préoccupation en matière de sécurité, recommandant la poursuite de l'étude en cours sans modifications.
L'étude est menée sous la Désignation Fast Track de la FDA. La direction de l'entreprise a exprimé sa satisfaction quant au profil de sécurité et de tolérance du traitement combiné Bria-IMT plus inhibiteur de checkpoint immunitaire, considérant la recommandation du DSMB comme un signe encourageant pour leur approche novatrice de l'immunothérapie dans le traitement du cancer du sein métastatique.
BriaCell Therapeutics (Nasdaq: BCTX) erhielt eine positive Empfehlung vom Data Safety Monitoring Board (DSMB) für seine entscheidende Phase 3-Studie zu Bria-IMT™ plus einem Immun-Checkpoint-Inhibitor bei metastasiertem Brustkrebs. Das DSMB, eine unabhängige Expertengruppe, hat seine zweite Sicherheitsdatenüberprüfung abgeschlossen und keine Sicherheitsbedenken festgestellt, sodass die Fortsetzung der laufenden Studie ohne Änderungen empfohlen wurde.
Die Studie wird unter der Fast-Track-Zulassung der FDA durchgeführt. Das Management des Unternehmens äußerte Zufriedenheit mit dem Sicherheits- und Verträglichkeitsprofil der Kombinationstherapie Bria-IMT plus Immun-Checkpoint-Inhibitor und betrachtet die Empfehlung des DSMB als ermutigendes Zeichen für ihren neuartigen Immuntherapieansatz zur Behandlung von metastasiertem Brustkrebs.
- DSMB found no safety concerns in Phase 3 trial
- Study continues without required modifications
- Fast Track Designation status maintained with FDA
- None.
Insights
BriaCell's announcement that the independent Data Safety Monitoring Board (DSMB) has issued a second positive recommendation to continue its Phase 3 metastatic breast cancer study represents a necessary but incremental milestone in the development of Bria-IMT plus immune checkpoint inhibitor therapy.
The DSMB review specifically assessed safety parameters, not efficacy outcomes. This distinction is important for investors to understand. While the absence of safety concerns allows the trial to proceed unmodified, it provides no indication about whether the treatment is actually effective against metastatic breast cancer. Approximately
The trial's Fast Track Designation from the FDA acknowledges the therapy addresses an unmet medical need and could expedite the regulatory review process if the study eventually demonstrates positive efficacy results. For BriaCell, a micro-cap biotech with approximately
What investors should monitor next are any signals regarding enrollment pace, timeline to interim efficacy analysis, and most importantly, any efficacy data readouts. The company indicated they plan to share additional updates "in the coming months," which suggests the trial is progressing according to its predetermined protocol.
- The Data Safety Monitoring Board (DSMB) identified no safety concerns, and recommended continuation of BriaCell’s pivotal Phase 3 study of Bria-IMT™ plus immune check point inhibitor in metastatic breast cancer
- The pivotal Phase 3 study is currently under Fast Track Designation with the Food and Drug Administration (FDA)
PHILADELPHIA and VANCOUVER, British Columbia, March 20, 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, announces that the external Data Safety Monitoring Board (DSMB), an independent group of experts who review and monitor the safety data of the BriaCell clinical study to determine if the study should continue, be modified, or be halted, has completed its second safety data review of BriaCell’s pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor (CPI) in metastatic breast cancer (NCT06072612) and recommended continuation of the ongoing study without any modifications. BriaCell’s pivotal Phase 3 study is currently being conducted under Fast Track Designation with the Food and Drug Administration (FDA).
“We are very pleased with the safety and tolerability profile of Bria-IMT plus immune checkpoint inhibitor (CPI) combination in metastatic breast cancer to date,” stated Dr. William V. Williams, BriaCell’s President & CEO. “The DSMB's second positive data review and recommendation to continue with patient enrollment in BriaCell’s pivotal Phase 3 study clinical trial is highly encouraging and further highlights the potential of our groundbreaking novel immunotherapy to treat this urgent medical need.”
“Metastatic breast cancer is a devastating disease for patients and their families, and the DSMB’s positive review represents an important step forward towards our goal of transforming cancer care, and improving patients’ survival and quality of life outcomes,” noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. “We look forward to sharing additional updates from BriaCell’s pivotal Phase 3 trial in the coming months.”
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 BriaCell’s clinical advancement of Bria-IMT as a safe and effective treatment option for metastatic cancer patients; the ability of Bria-IMT to transform cancer care in metastatic breast cancer patients; the potential use of the combination regimen for metastatic breast cancer patients; the potential of BriaCell’s novel immunotherapy to be a groundbreaking treatment for metastatic breast cancer; and BriaCell sharing additional updates about its pivotal Phase 3 trial in the coming months, 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
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