BriaCell Receives Green-Light from Data Safety Monitoring Board for its Phase 3 Study in Metastatic Breast Cancer
BriaCell Therapeutics (Nasdaq: BCTX) received positive safety review 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 recommended continuation of the study without modifications, marking a significant milestone for the company's FDA Fast Track Designated trial. The independent review board found no safety concerns in enrolled patients, supporting BriaCell's advancement of its novel immunotherapy combination treatment.
BriaCell Therapeutics (Nasdaq: BCTX) ha ricevuto una revisione positiva della sicurezza dal Data Safety Monitoring Board (DSMB) per il suo studio di fase 3 cruciale su Bria-IMT™ in combinazione con un inibitore del checkpoint immunitario nel carcinoma mammario metastatico. Il DSMB ha raccomandato la continuazione dello studio senza modifiche, segnando un traguardo significativo per la sperimentazione designata come Fast Track dalla FDA. Il comitato di revisione indipendente non ha riscontrato problemi di sicurezza nei pazienti arruolati, supportando l'avanzamento da parte di BriaCell del suo innovativo trattamento combinato di immunoterapia.
BriaCell Therapeutics (Nasdaq: BCTX) recibió una revisión positiva de seguridad por parte del Data Safety Monitoring Board (DSMB) para su estudio de fase 3 pivotal de Bria-IMT™ más un inhibidor del checkpoint inmunitario en cáncer de mama metastásico. El DSMB recomendó continuar el estudio sin modificaciones, marcando un hito significativo para el ensayo designado como Fast Track por la FDA. La junta de revisión independiente no encontró preocupaciones de seguridad en los pacientes inscritos, apoyando el avance de BriaCell en su novedoso tratamiento combinado de inmunoterapia.
BriaCell Therapeutics (Nasdaq: BCTX)는 전이성 유방암 환자에서 면역 체크포인트 억제제와 함께하는 Bria-IMT™의 3상 연구에 대해 데이터 안전성 모니터링 위원회(DSMB)로부터 긍정적인 안전성 검토를 받았습니다. DSMB는 수정 없이 연구를 계속 진행할 것을 권고하였으며, 이는 회사의 FDA 신속 심사 지정 시험에 있어 중요한 이정표가 됩니다. 독립적인 검토 위원회는 등록된 환자에게 안전성 문제를 발견하지 못했으며, 이는 BriaCell의 혁신적인 면역 요법 조합 치료의 진행을 지지합니다.
BriaCell Therapeutics (Nasdaq: BCTX) a reçu un avis positif sur la sécurité de la part du Data Safety Monitoring Board (DSMB) pour son étude de phase 3 décisive sur Bria-IMT™ associée à un inhibiteur de checkpoint immunitaire dans le cancer du sein métastatique. Le DSMB a recommandé de poursuivre l'étude sans modifications, marquant une étape significative pour l'essai désigné comme Fast Track par la FDA. Le conseil de révision indépendant n'a trouvé aucun problème de sécurité chez les patients inclus, soutenant ainsi l'avancement par BriaCell de son nouveau traitement combiné en immunothérapie.
BriaCell Therapeutics (Nasdaq: BCTX) erhielt eine positive Sicherheitsbewertung vom Data Safety Monitoring Board (DSMB) für die entscheidende Phase-3-Studie von Bria-IMT™ in Kombination mit einem Immun-Checkpoint-Inhibitor bei metastasiertem Brustkrebs. Das DSMB empfahl die Fortsetzung der Studie ohne Änderungen, was einen signifikanten Meilenstein für die von der FDA als Fast Track eingestufte Studie darstellt. Das unabhängige Überprüfungsgremium fand keine Sicherheitsbedenken bei den eingeschlossenen Patienten, was den Fortschritt von BriaCells neuem immuntherapeutischen Kombinationsbehandlungsansatz unterstützt.
- DSMB found no safety concerns in Phase 3 trial
- Study continues without required modifications
- Maintains FDA Fast Track Designation status
- None.
Insights
The DSMB safety clearance for BriaCell's Phase 3 trial represents a important milestone in the development of Bria-IMT™. The continuation recommendation without protocol modifications suggests strong initial safety data for the immunotherapy combination with checkpoint inhibitors. This is particularly significant given the Fast Track Designation from the FDA, which could accelerate the approval process.
The trial's focus on metastatic breast cancer, a challenging indication with significant unmet medical needs, positions BriaCell in an important therapeutic space. While this safety review is positive, investors should note that efficacy data is still pending and will be the key determinant of commercial potential. The company's
- The Data Safety Monitoring Board (DSMB) stated no safety concerns, and recommended continuation of BriaCell’s pivotal Phase 3 study of Bria-IMT™ plus an 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, Dec. 02, 2024 (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 Data Safety Monitoring Board (DSMB), an independent group of experts who review and monitor safety data of a clinical study to determine if a study should continue, be modified, or be halted early, has completed its first review of safety events in patients enrolled in BriaCell’s pivotal randomized Phase 3 study of Bria-IMT™ plus an immune checkpoint inhibitor (CPI) combination regimen (NCT06072612). The DSMB issued a statement recommending continuation of the study in metastatic breast cancer patients. BriaCell’s pivotal Phase 3 study is currently being conducted under Fast Track Designation with the Food and Drug Administration (FDA).
“We are pleased with the DSMB’s recommendation for the continuation of BriaCell’s Phase 3 study without any protocol modification as a significant milestone towards clinical advancement of our novel immunotherapy as a safe and effective treatment option for metastatic breast cancer patients,” stated Dr. William V. Williams, BriaCell’s President & CEO.
“We strongly believe in the potential of our novel immunotherapy to transform cancer care for metastatic breast cancer patients, and the positive DSMB review reinforces our confidence in the potential use of the combination regimen in metastatic breast cancer patients,” noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer.
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; and the potential use of the combination regimen 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
Media Relations:
Jules Abraham
CORE IR
julesa@coreir.com
Investor Relations Contact:
CORE IR
investors@briacell.com
FAQ
What did the DSMB conclude about BriaCell's (BCTX) Phase 3 breast cancer trial?
What is the current FDA status of BriaCell's (BCTX) Phase 3 breast cancer study?
What type of cancer is BriaCell (BCTX) targeting in their Phase 3 trial?
