BriaCell to Present Positive Clinical Biomarker Data of Phase 3 Study at ESMO 2025
BriaCell (Nasdaq: BCTX) will present positive clinical biomarker data from its ongoing pivotal Phase 3 BRIA-ABC study of Bria-IMT plus an immune checkpoint inhibitor in metastatic breast cancer at ESMO 2025 on Oct 20, 2025.
In a blinded analysis of 68 evaluable patients (median 6 prior lines), patients who developed a positive delayed-type hypersensitivity (DTH) response showed a significant improvement in progression-free survival (p=0.0002). No new safety or tolerability issues were identified; common AEs: fatigue 22.8%, anemia 22.8%, nausea 21.5%.
Primary OS interim analysis will occur at 144 patient deaths; Bria-IMT has FDA Fast Track designation.
BriaCell (Nasdaq: BCTX) presenterà dati biomarcatori clinici positivi dello studio pivot BRIA-ABC di fase 3 in corso su Bria-IMT più un inibitore del checkpoint immunitario nel cancro metastatico al seno all'ESMO 2025 il 20 ottobre 2025.
In un'analisi in cieco su 68 pazienti valutabili (mediana di 6 linee di trattamento precedenti), i pazienti che hanno sviluppato una risposta di ipersensibilità ritardata positiva (DTH) hanno mostrato un significativo miglioramento della sopravvivenza libera da progressione (p=0,0002). Non sono emerse nuove problematiche di sicurezza o tollerabilità; eventi avversi comuni: affaticamento 22,8%, anemia 22,8%, nausea 21,5%.
L'analisi intermedia primaria della OS avverrà a 144 decessi; Bria-IMT ha la designazione Fast Track da parte della FDA.
BriaCell (Nasdaq: BCTX) presentará datos positivos de biomarcadores clínicos del estudio pivotal de fase 3 BRIA-ABC de Bria-IMT más un inhibidor de punto de control inmunitario en cáncer de mama metastásico en ESMO 2025 el 20 de octubre de 2025.
En un análisis ciego de 68 pacientes evaluables (mediana de 6 líneas previas), los pacientes que desarrollaron una respuesta de hipersensibilidad retardada (DTH) positiva mostraron una mejora significativa en la supervivencia libre de progresión (p=0,0002). No se identificaron nuevos problemas de seguridad o tolerabilidad; efectos adversos comunes: fatiga 22,8%, anemia 22,8%, náuseas 21,5%.
El análisis interino primario de OS tendrá lugar tras 144 defunciones; Bria-IMT cuenta con designación Fast Track de la FDA.
BriaCell (Nasdaq: BCTX)은 진행 중인 핵심 다기관 3상 BRIA-ABC 연구에서 Bria-IMT와 면역 체크포인트 억제제를 병용한 전이성 유방암에 대한 긍정적인 임상 바이오마커 데이터를 ESMO 2025에서 2025년 10월 20일 발표할 예정입니다.
평가 가능한 68명의 환자(중간값 6회의 이전 치료)에 대한 블라인드 분석에서 양성 지연형 과민반응(DTH) 반응을 보인 환자들은 무진행 생존 기간(PFS)이 유의하게 개선되었으며(p=0.0002), 새로운 안전성 또는 내약성 문제는 확인되지 않았습니다. 일반적인 부작용으로는 피로 22.8%, 빈혈 22.8%, 메스꺼움 21.5%가 보고되었습니다.
OS의 주요 중간 분석은 144명의 사망에서 이루어지며, Bria-IMT는 FDA의 패스트 트랙 지정을 받았습니다.
BriaCell (Nasdaq: BCTX) présentera des données positives de biomarqueurs cliniques issues de son étude pivot de phase 3 BRIA-ABC sur Bria-IMT plus un inhibiteur de point de contrôle immunitaire dans le cancer du sein métastatique lors de l'ESMO 2025 le 20 octobre 2025.
Dans une analyse en aveugle de 68 patients évaluable (médiane de 6 lignes de traitement antérieures), les patients ayant développé une réponse d'hypersensibilité retardée (DTH) positive ont montré une amélioration significative de la survie sans progression (p=0,0002). Aucun nouveau problème de sécurité ou de tolérance n'a été identifié; effets indésirables fréquents : fatigue 22,8 %, anémie 22,8 %, nausées 21,5 %.
L'analyse intermédiaire primaire de la survie globale aura lieu après 144 décès; Bria-IMT bénéficie d'une désignation Fast Track par la FDA.
BriaCell (Nasdaq: BCTX) wird positive klinische Biomarker-Daten aus ihrer laufenden, pivotalen Phase-3-Studie BRIA-ABC zu Bria-IMT plus einem Immun-Checkpoint-Inhibitor bei metastasiertem Brustkrebs auf ESMO 2025 am 20. Oktober 2025 vorstellen.
In einer blinderen Analyse von 68 bewertbaren Patienten (Median 6 vorangegangene Behandlungen) zeigten Patienten, die eine positive verzögerte Typ-Hypersensitivität (DTH) Reaktion entwickelten, eine signifikante Verbesserung des progressionsfreien Überlebens (p=0,0002). Es wurden keine neuen Sicherheits- oder Verträglichkeitsprobleme identifiziert; häufige Nebenwirkungen: Fatigue 22,8 %, Anämie 22,8 %, Übelkeit 21,5 %.
Die primäre OS-Interim-Analyse erfolgt nach 144 Todesfällen; Bria-IMT hat die FDA-Fast-Track-Deklaration.
BriaCell (Nasdaq: BCTX) ستقدم بيانات حيوية إكلينيكية إيجابية من دراستها المحورية من المرحلة الثالثة BRIA-ABC حول Bria-IMT مع مثبِّط نقطة تفتيش مناعي في سرطان الثدي النقيلي خلال ESMO 2025 في 20 أكتوبر 2025.
في تحليل مُعمّى، شمل 68 مريضة قابلة للتقييم (متوسط 6 خطوط علاج سابقة)، أظهر المرضى الذين طوروا استجابة فرْقَة فرْد ”DTH“ إيجابية تحسنًا ملحوظًا في البقاء الخالي من تقدم الورم (p=0.0002). لم تُعرَف أي مشاكل سلامة جديدة أو تحمل؛ الآثار الجانبية الشائعة: إعياء 22.8%، فقر الدم 22.8%، غثيان 21.5%.
سيحدث التحليل الوسيط الأول لبقاء المرض على OS عند 144 وفاة؛ Bria-IMT لديها تفويض Fast Track من FDA.
BriaCell (纳斯达克代码：BCTX) 将在 ESMO 2025 于 2025 年 10 月 20 日展示其进行中的关键三期 BRIA-ABC 研究中关于 Bria-IMT 以及免疫检查点抑制剂在转移性乳腺癌中的积极临床生物标志物数据。
在对68名可评估患者（中位数前线治疗6轮）的盲法分析中，发展出正向延迟型超敏反应（DTH）的患者在无进展生存期（PFS）方面显示出显著改善（p=0.0002）。未发现新的安全性或耐受性问题；常见不良事件：疲劳 22.8%、贫血 22.8%、恶心 21.5%。
OS 的初步中期分析将在144例患者死亡时进行；Bria-IMT 已获得 FDA 的快速通道（Fast Track）指定。
- Biomarker-linked PFS improvement: p=0.0002
- Data from 68 evaluable patients (median 6 prior lines)
- No treatment-related discontinuations due to AEs
- FDA Fast Track designation for Bria-IMT
- Primary OS interim analysis pending at 144 patient deaths
- High prior-line population: median 6 prior therapies may limit generalizability
- Reported common AEs: fatigue 22.8%, anemia 22.8%, nausea 21.5%
Insights
Phase 3 biomarker signal links DTH response to longer PFS; safety appears unchanged in interim data.
BriaCell reports that in an interim cohort of 68 evaluable patients with a median of six prior lines of therapy, a treatment‑agnostic subgroup who developed a positive delayed‑type hypersensitivity response showed a statistically significant improvement in progression‑free survival, with p=0.0002. The company also reports no new safety or tolerability issues and lists common adverse events as fatigue
This finding describes a plausible predictive biomarker rather than a primary efficacy readout; the study remains powered for overall survival with an interim OS analysis planned at
- Biomarkers identified in Phase 2 study demonstrate similar trends in ongoing pivotal Phase 3 study of Bria-IMT™ in metastatic breast cancer (MBC)
- Positive delayed-type hypersensitivity (DTH) – a potential biomarker predictive of improved clinical outcomes – significantly associated with longer progression-free survival (PFS) in a blinded analysis of all current Phase 3 patients
- No new safety or tolerability issues identified
PHILADELPHIA and VANCOUVER, British Columbia, Oct. 13, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, will be presenting positive clinical biomarker data of its ongoing pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer at its poster presentation at the European Society for Medical Oncology (ESMO) Congress 2025 Annual Meeting taking place October 17 – 21 in Berlin, Germany.
The details of the poster presentation is listed below.
#3928: Feasibility and Biomarker Validation of an International Randomized Phase 3 Trial of Bria-IMT Cell Therapy in Late Stage MBC (BRIA-ABC)
Presentation Number: 570P
Speaker: Dr. Giuseppe Del Priore
Date and Time: Oct 20, 2025, at 12:00 - 1:00 pm CET
Presentation venue: Messe Berlin, Messedamm 22, 14055 Berlin, Germany, Hall 25
Abstract Summary
In BriaCell’s pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer, patients are randomized 1:1:1 to Bria-IMT + CPI, Physician’s Choice, or Bria-IMT monotherapy. As of the time of the abstract submission, data in 68 evaluable patients, with a median of 6 prior lines of treatment (2–13), was available. Additional data will be presented at the ESMO conference.
Clinical efficacy data: Treatment arm agnostic biomarker positive subgroups showed significant improvement in progression free survival in patients who developed an immune response to Bria-IMT (as measured by delayed type hypersensitivity) (p=0.0002).
Tolerability profile: Bria-IMT was well tolerated with no treatment-related discontinuations due to adverse events (AEs). Most common AEs include fatigue
About BriaCell’s Pivotal Phase 3 Clinical Study of Bria-IMT Combination Regimen in MBC patients
BriaCell’s pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer is ongoing.
Interim data will be analyzed once 144 patient events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT combination regimen versus those treated with physician’s choice as the primary endpoint. Positive results of the pivotal Phase 3 study could result in full approval and marketing authorization for Bria-IMT in MBC patients. BriaCell reported positive Phase 2 survival data in a similar MBC patient population treated with the same Bria-IMT combination regimen. The Bria-IMT combination regimen has received FDA Fast Track designation.
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.
Following the presentations, copies of the presentations will be posted on https://briacell.com/scientific-publications/.
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 presenting clinical data presentations at the ESMO Congress 2025; and the contents of all such presentations 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.
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
When and where will BriaCell (BCTX) present Phase 3 biomarker data at ESMO 2025?
What biomarker finding did BriaCell report for BCTX in the Phase 3 BRIA-ABC study?
How many patients and prior treatments were included in the Phase 3 interim biomarker analysis for BCTX?
What safety and tolerability results did BriaCell report for Bria-IMT in the Phase 3 study?
What is the primary endpoint timing for BriaCell's Phase 3 BRIA-ABC study (BCTX)?
Could positive Phase 3 BRIA-ABC results lead to approval for Bria-IMT (BCTX)?
