BriaCell Adds UCLA Health as Key Site in Pivotal Phase 3 Breast Cancer Study
BriaCell Therapeutics (NASDAQ: BCTX) has announced the addition of UCLA Health Jonsson Comprehensive Cancer Center as a key site for its pivotal Phase 3 clinical study (Bria-ABC). The study evaluates Bria-IMT™ combined with a checkpoint inhibitor versus physician's choice in advanced metastatic breast cancer patients.
The trial's interim analysis will be conducted after 144 patient events, with overall survival as the primary endpoint. Building on positive Phase 2 survival data presented at ASCO 2025, the study has received FDA Fast Track designation. BriaCell expects to share top-line data in 2026.
BriaCell Therapeutics (NASDAQ: BCTX) ha annunciato l'inserimento del UCLA Health Jonsson Comprehensive Cancer Center come sito chiave per il suo studio clinico di Fase 3 fondamentale (Bria-ABC). Lo studio valuta Bria-IMT™ in combinazione con un inibitore del checkpoint rispetto alla scelta del medico in pazienti con carcinoma mammario metastatico avanzato.
L'analisi intermedia dello studio sarà effettuata dopo 144 eventi nei pazienti, con la sopravvivenza globale come endpoint principale. Basandosi sui dati positivi di sopravvivenza della Fase 2 presentati all'ASCO 2025, lo studio ha ottenuto la designazione Fast Track dalla FDA. BriaCell prevede di condividere i dati principali nel 2026.
BriaCell Therapeutics (NASDAQ: BCTX) ha anunciado la incorporación del UCLA Health Jonsson Comprehensive Cancer Center como un sitio clave para su estudio clínico pivotal de Fase 3 (Bria-ABC). El estudio evalúa Bria-IMT™ combinado con un inhibidor de puntos de control frente a la elección del médico en pacientes con cáncer de mama metastásico avanzado.
El análisis intermedio del ensayo se realizará después de 144 eventos en pacientes, teniendo la supervivencia global como objetivo principal. Basándose en datos positivos de supervivencia de la Fase 2 presentados en ASCO 2025, el estudio ha recibido la designación Fast Track de la FDA. BriaCell espera compartir los datos principales en 2026.
BriaCell Therapeutics (NASDAQ: BCTX)는 주요 임상 3상 연구(Bria-ABC)의 핵심 기관으로 UCLA Health Jonsson Comprehensive Cancer Center를 추가했다고 발표했습니다. 이 연구는 진행성 전이성 유방암 환자에서 Bria-IMT™와 체크포인트 억제제 병용요법을 의사의 선택과 비교 평가합니다.
임상시험의 중간 분석은 144명의 환자 사건 발생 후 실시되며, 전체 생존율이 주요 평가 지표입니다. ASCO 2025에서 발표된 긍정적인 2상 생존 데이터에 기반해, 본 연구는 FDA 패스트트랙 지정을 받았습니다. BriaCell은 2026년에 주요 결과 데이터를 발표할 예정입니다.
BriaCell Therapeutics (NASDAQ : BCTX) a annoncé l'ajout du UCLA Health Jonsson Comprehensive Cancer Center en tant que site clé pour son étude clinique pivot de phase 3 (Bria-ABC). L'étude évalue Bria-IMT™ combiné à un inhibiteur de point de contrôle versus le choix du médecin chez des patients atteints d'un cancer du sein métastatique avancé.
L'analyse intermédiaire de l'essai sera réalisée après 144 événements patients, la survie globale étant le critère principal. S'appuyant sur des données positives de survie de phase 2 présentées à l'ASCO 2025, l'étude a reçu la désignation Fast Track de la FDA. BriaCell prévoit de communiquer les données principales en 2026.
BriaCell Therapeutics (NASDAQ: BCTX) hat das UCLA Health Jonsson Comprehensive Cancer Center als wichtigen Standort für seine entscheidende Phase-3-Studie (Bria-ABC) hinzugefügt. Die Studie bewertet Bria-IMT™ in Kombination mit einem Checkpoint-Inhibitor im Vergleich zur Wahl des Arztes bei Patienten mit fortgeschrittenem metastasiertem Brustkrebs.
Die Zwischenanalyse der Studie erfolgt nach 144 Patientenevents, wobei das Gesamtüberleben der primäre Endpunkt ist. Aufbauend auf positiven Überlebensdaten der Phase 2, die auf der ASCO 2025 präsentiert wurden, hat die Studie die Fast Track-Zulassung der FDA erhalten. BriaCell erwartet, die wichtigsten Daten im Jahr 2026 zu veröffentlichen.
- FDA Fast Track designation granted for Bria-IMT combination therapy
- Positive Phase 2 survival data supports the Phase 3 study design
- Partnership with prestigious UCLA Health expected to accelerate trial enrollment
- Clear timeline for top-line data release in 2026
- Phase 3 results dependent on 144 patient deaths for interim analysis
- Final results not expected until 2026, indicating a lengthy trial period
Insights
UCLA Health's addition to BriaCell's Phase 3 breast cancer trial strengthens recruitment capabilities and credibility for their promising immunotherapy.
BriaCell's addition of UCLA Health Jonsson Comprehensive Cancer Center to their pivotal Phase 3 trial represents a significant operational advancement for their Bria-IMT™ immunotherapy program. UCLA's multi-center capabilities should substantially bolster patient recruitment - a critical factor for maintaining the company's projected timeline of delivering top-line data in 2026.
The trial design itself merits attention: it directly compares the Bria-IMT™/checkpoint inhibitor combination against physician's choice in advanced metastatic breast cancer, with overall survival as the primary endpoint. This robust design builds upon their Phase 2 results presented at ASCO 2025, which showed encouraging survival data in a similar patient population.
Particularly noteworthy is the FDA Fast Track designation already secured for this treatment regimen, indicating regulatory recognition of both the unmet medical need in metastatic breast cancer and the therapy's potential. The planned interim analysis after 144 patient events (deaths) represents a methodologically sound approach to evaluating efficacy.
UCLA investigator Dr. McCann's characterization of the Phase 2 data as "encouraging" provides external validation from a respected academic institution. This partnership with a prestigious comprehensive cancer center not only accelerates enrollment but also enhances the study's credibility - a critical consideration for eventual regulatory review if the results prove positive.
The strategic addition of UCLA Health to BriaCell's Phase 3 breast cancer trial carries multiple operational advantages that strengthen the company's clinical development program. Large academic centers typically deliver faster recruitment rates and higher-quality data - addressing two critical success factors for late-stage oncology trials.
This expansion aligns with a well-designed clinical strategy. The company is building on their Phase 2 data (presented at ASCO 2025) with a pivotal trial using overall survival as the primary endpoint - the gold standard for oncology approvals. The interim analysis trigger point of 144 events suggests thorough statistical planning.
From a regulatory perspective, the Fast Track designation already secured for this combination regimen provides tangible benefits including more frequent FDA interactions and potential eligibility for priority review. These could accelerate the pathway to market if data proves positive.
The 2026 timeline for top-line data provides investors with a clear development milestone. Breast cancer remains one of the largest oncology markets, with metastatic disease representing a substantial unmet need despite recent therapeutic advances.
For context, successful immune-based approaches in solid tumors, particularly breast cancer, have been challenging to develop. If BriaCell's unique cell-based immunotherapy demonstrates survival advantages in this Phase 3 study, it would represent a significant clinical and commercial opportunity in a treatment landscape where novel mechanisms of action are increasingly valued.
PHILADELPHIA and VANCOUVER, British Columbia, July 31, 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 the addition of UCLA Health Jonsson Comprehensive Cancer Center, a leading cancer center in California, to its ongoing pivotal Phase 3 clinical study (Bria-ABC, NCT06072612) evaluating Bria-IMT™ in combination with a checkpoint inhibitor versus physician’s choice in patients with advanced metastatic breast cancer (MBC).
“The randomized Phase 2 data reported with the Bria-IMT combination regimen are encouraging, and we believe BriaCell’s Phase 3 study represents an opportunity for meaningful progress towards improving survival outcomes in patients with metastatic breast cancer,” stated Kelly E. McCann, MD, PhD, Breast Medical Oncologist, and Lead Investigator at UCLA Health Jonsson Comprehensive Cancer Center. “We are excited to support this important study and anticipate strong patient enrollment through our large multi-center clinical site.”
“The inclusion of UCLA Health underscores our strategy to partner with top-tier institutions to accelerate trial enrollment and execution,” said Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. “We remain confident in our timeline for sharing top-line data in 2026.”
Interim analysis of the pivotal Phase 3 study will be conducted after 144 patient events (deaths) have occurred, with overall survival (OS) as the primary endpoint. The study compares the Bria-IMT combination regimen with immune checkpoint inhibitor against physician’s choice in patients with advanced metastatic breast cancer. This design builds upon maturing positive survival data from BriaCell’s Phase 2 study, most recently presented at ASCO 2025, which evaluated the same combination in a similar MBC patient population. Notably, the Bria-IMT combination regimen has been granted FDA Fast Track designation, underscoring its potential to address a serious unmet medical need.
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 BriaCell’s Phase 3 study representing an opportunity for meaningful progress towards improving survival outcomes in patients with metastatic breast cancer; the Company’s anticipated strong patient enrollment through their large multi-center clinical site; the Company’s anticipated timeline for sharing top-line data; and the Company’s timeline for its analysis of interim data 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.
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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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