BriaCell Announces Positive Recommendation from Data Safety Monitoring Board for Pivotal Phase 3 Study in Metastatic Breast Cancer
BriaCell Therapeutics (NASDAQ: BCTX) has received a positive safety review recommendation from the independent Data Safety Monitoring Board (DSMB) for its pivotal Phase 3 study of Bria-IMT™ plus immune checkpoint inhibitor in metastatic breast cancer. This marks the third consecutive positive recommendation from the DSMB, which found no safety concerns and recommended the study continue without modifications.
The study is being conducted under FDA Fast Track Designation, highlighting the significant unmet medical need in metastatic breast cancer patients. The DSMB reviews occur quarterly as per study protocol, and this latest recommendation further validates the favorable safety profile of BriaCell's immunotherapy treatment.
BriaCell Therapeutics (NASDAQ: BCTX) ha ricevuto una raccomandazione positiva sulla sicurezza dall'indipendente Data Safety Monitoring Board (DSMB) per il suo studio pivotale di Fase 3 su Bria-IMT™ in combinazione con un inibitore del checkpoint immunitario nel carcinoma mammario metastatico. Questa rappresenta la terza raccomandazione positiva consecutiva da parte del DSMB, che non ha riscontrato problemi di sicurezza e ha suggerito di proseguire lo studio senza modifiche.
Lo studio è condotto sotto la designazione FDA Fast Track, a sottolineare l'importante necessità medica insoddisfatta nei pazienti con carcinoma mammario metastatico. Le revisioni del DSMB avvengono trimestralmente secondo il protocollo dello studio, e questa ultima raccomandazione conferma ulteriormente il profilo di sicurezza favorevole della terapia immunitaria di BriaCell.
BriaCell Therapeutics (NASDAQ: BCTX) ha recibido una recomendación positiva sobre la seguridad por parte de la Junta Independiente de Supervisión de Datos (DSMB) para su estudio pivotal de Fase 3 de Bria-IMT™ más inhibidor del punto de control inmunitario en cáncer de mama metastásico. Esta es la tercera recomendación positiva consecutiva del DSMB, que no encontró preocupaciones de seguridad y recomendó continuar el estudio sin modificaciones.
El estudio se está realizando bajo la designación FDA Fast Track, destacando la significativa necesidad médica no satisfecha en pacientes con cáncer de mama metastásico. Las revisiones del DSMB se realizan trimestralmente según el protocolo del estudio, y esta última recomendación valida aún más el perfil de seguridad favorable del tratamiento inmunoterapéutico de BriaCell.
BriaCell Therapeutics (NASDAQ: BCTX)는 전이성 유방암에서 Bria-IMT™와 면역 체크포인트 억제제의 중대한 3상 임상시험에 대해 독립적인 데이터 안전성 모니터링 위원회(DSMB)로부터 긍정적인 안전성 검토 권고를 받았습니다. 이는 DSMB로부터 받은 세 번째 연속 긍정적 권고로, 안전성 문제를 발견하지 못했고 연구를 수정 없이 계속 진행할 것을 권고했습니다.
이 연구는 FDA 패스트 트랙 지정 하에 수행되고 있으며, 전이성 유방암 환자의 중대한 미충족 의료 수요를 강조합니다. DSMB 검토는 연구 프로토콜에 따라 분기별로 이루어지며, 이번 최신 권고는 BriaCell의 면역치료제의 우수한 안전성 프로필을 더욱 입증합니다.
BriaCell Therapeutics (NASDAQ : BCTX) a reçu une recommandation positive concernant la sécurité de la part du comité indépendant de surveillance des données (DSMB) pour son étude pivot de phase 3 sur Bria-IMT™ associé à un inhibiteur de point de contrôle immunitaire dans le cancer du sein métastatique. Il s'agit de la troisième recommandation positive consécutive du DSMB, qui n'a relevé aucun problème de sécurité et a recommandé la poursuite de l'étude sans modifications.
L'étude est menée sous la désignation FDA Fast Track, soulignant le besoin médical important non satisfait chez les patientes atteintes de cancer du sein métastatique. Les revues du DSMB ont lieu trimestriellement selon le protocole de l'étude, et cette dernière recommandation confirme davantage le profil de sécurité favorable du traitement immunothérapeutique de BriaCell.
BriaCell Therapeutics (NASDAQ: BCTX) hat eine positive Sicherheitsbewertung von dem unabhängigen Data Safety Monitoring Board (DSMB) für seine wegweisende Phase-3-Studie zu Bria-IMT™ plus Immun-Checkpoint-Inhibitor bei metastasiertem Brustkrebs erhalten. Dies ist die dritte positive Empfehlung in Folge vom DSMB, das keine Sicherheitsbedenken festgestellt hat und empfiehlt, die Studie ohne Änderungen fortzusetzen.
Die Studie wird unter der FDA Fast Track-Zulassung durchgeführt, was den erheblichen ungedeckten medizinischen Bedarf bei Patientinnen mit metastasiertem Brustkrebs hervorhebt. Die DSMB-Überprüfungen finden vierteljährlich gemäß Studienprotokoll statt, und diese jüngste Empfehlung bestätigt erneut das günstige Sicherheitsprofil der Immuntherapie von BriaCell.
- Third consecutive positive DSMB safety review recommendation
- FDA Fast Track Designation status maintained
- No safety concerns identified in Phase 3 trial
- Study continues without required modifications
- None.
Insights
BriaCell's Phase 3 breast cancer immunotherapy trial passes third DSMB safety review, maintaining Fast Track status—significant milestone for late-stage development.
This third consecutive positive recommendation from the Data Safety Monitoring Board (DSMB) represents a meaningful milestone in BriaCell's pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor for metastatic breast cancer. The DSMB's decision to continue the trial without modifications indicates the therapy maintains a favorable safety profile through multiple review cycles—a critical hurdle in late-stage oncology drug development.
The study's FDA Fast Track designation underscores the significant unmet need in metastatic breast cancer treatment, potentially allowing for expedited review and earlier patient access if efficacy data proves compelling. While this DSMB review focused exclusively on safety rather than efficacy outcomes, maintaining clean safety signals at this stage is essential for the trial's progression toward potential approval.
It's worth noting that quarterly DSMB reviews are standard protocol for this study type, and this represents the third consecutive favorable assessment. The absence of safety signals that would require protocol modifications suggests the treatment combination is being well-tolerated by the study population. For an immunotherapy approach in metastatic breast cancer—where treatment options remain limited and immune-related adverse events are common concerns—this consistent safety profile strengthens the therapy's potential clinical utility.
Though this announcement provides no efficacy data, the continued smooth progression of this pivotal trial maintains BriaCell's development timeline and suggests their novel immunotherapy approach remains viable for addressing this challenging cancer indication.
- Independent DSMB identifies no safety concerns, and recommends continuation of BriaCell’s pivotal Phase 3 study of Bria-IMT™ plus immune check point inhibitor
- Review marks third consecutive positive recommendation by DSMB
- Study is being conducted under FDA Fast Track Designation
PHILADELPHIA and VANCOUVER, British Columbia, June 24, 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 report that the independent Data Safety Monitoring Board (DSMB) has completed its third scheduled safety data review of BriaCell’s pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor (CPI) in 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 as per the study protocol, and this marks the third consecutive positive recommendation from the DSMB affirming the favorable safety profile observed to date. Bria Cell’s 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 this patient population.
“The third consecutive DSMB review is a meaningful milestone in our Phase 3 trial, which continues to highlight the excellent safety and tolerability profile of BriaCell’s regimen,” commented Dr. William V. Williams, BriaCell’s President & CEO. “This latest positive review further strengthens our confidence in Bria-IMT’s potential as a transformative immunotherapy for patients with metastatic breast cancer.”
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 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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