BriaCell Presents Benchmark Beating Survival and Clinical Benefit at AACR 2025; Advancements in Next Generation Bria-OTS+™ Development
BriaCell Therapeutics Corp. (NASDAQ: BCTX) has presented positive Phase 2 data for its Bria-IMT™ immunotherapy in metastatic breast cancer at AACR 2025. Key highlights include:
- Clinical benefit observed in 83% of patients receiving Phase 3 formulation
- Overall survival reached 17.3 months for HR+ patients and 11.44 months for triple negative breast cancer
- 50% overall response rate for patients with intracranial metastases, with 75% clinical benefit rate
- Clinical benefit rates ranging from 45% to 100% based on subtype
The study included 54 metastatic breast cancer patients, with 37 receiving the current Phase 3 formulation. Patients were heavily pre-treated with a median of 6 prior treatments. The company also presented data on its enhanced Bria-OTS+ platform, which includes additional immune-activating factors for breast and prostate cancer programs.
BriaCell Therapeutics Corp. (NASDAQ: BCTX) ha presentato dati positivi di Fase 2 per la sua immunoterapia Bria-IMT™ nel carcinoma mammario metastatico all'AACR 2025. Gli aspetti principali includono:
- Beneficio clinico osservato nell'83% dei pazienti trattati con la formulazione di Fase 3
- Sopravvivenza globale di 17,3 mesi per i pazienti HR+ e 11,44 mesi per il carcinoma mammario triplo negativo
- Tasso di risposta complessivo del 50% per i pazienti con metastasi intracraniche, con un tasso di beneficio clinico del 75%
- Tassi di beneficio clinico variabili dal 45% al 100% a seconda del sottotipo
Lo studio ha coinvolto 54 pazienti con carcinoma mammario metastatico, di cui 37 trattati con la formulazione attuale di Fase 3. I pazienti erano fortemente pre-trattati, con una mediana di 6 trattamenti precedenti. L'azienda ha inoltre presentato dati sulla piattaforma migliorata Bria-OTS+, che include fattori aggiuntivi di attivazione immunitaria per i programmi su carcinoma mammario e prostatico.
BriaCell Therapeutics Corp. (NASDAQ: BCTX) ha presentado datos positivos de Fase 2 para su inmunoterapia Bria-IMT™ en cáncer de mama metastásico en el AACR 2025. Los puntos clave incluyen:
- Beneficio clínico observado en el 83% de los pacientes que recibieron la formulación de Fase 3
- Supervivencia global de 17,3 meses para pacientes HR+ y 11,44 meses para cáncer de mama triple negativo
- Tasa de respuesta global del 50% para pacientes con metástasis intracraneales, con una tasa de beneficio clínico del 75%
- Tasas de beneficio clínico que varían del 45% al 100% según el subtipo
El estudio incluyó a 54 pacientes con cáncer de mama metastásico, de los cuales 37 recibieron la formulación actual de Fase 3. Los pacientes estaban fuertemente pretratados, con una mediana de 6 tratamientos previos. La compañía también presentó datos sobre su plataforma mejorada Bria-OTS+, que incluye factores adicionales de activación inmune para los programas de cáncer de mama y próstata.
BriaCell Therapeutics Corp. (NASDAQ: BCTX)는 AACR 2025에서 전이성 유방암에 대한 Bria-IMT™ 면역치료제의 2상 긍정적 데이터를 발표했습니다. 주요 내용은 다음과 같습니다:
- 3상 제형을 투여받은 환자의 83%에서 임상적 이점 관찰
- HR+ 환자의 전체 생존 기간 17.3개월, 삼중음성 유방암 환자는 11.44개월
- 두개내 전이가 있는 환자의 전체 반응률 50%, 임상적 이점률 75%
- 아형에 따라 45%에서 100%까지 임상적 이점률 차이
본 연구에는 전이성 유방암 환자 54명이 참여했으며, 이 중 37명이 현재 3상 제형을 투여받았습니다. 환자들은 평균 6회의 이전 치료를 받은 상태였습니다. 회사는 또한 유방암 및 전립선암 프로그램을 위한 추가 면역 활성 인자를 포함한 향상된 Bria-OTS+ 플랫폼 데이터도 발표했습니다.
BriaCell Therapeutics Corp. (NASDAQ : BCTX) a présenté des données positives de Phase 2 pour son immunothérapie Bria-IMT™ dans le cancer du sein métastatique lors de l'AACR 2025. Les points clés incluent :
- Bénéfice clinique observé chez 83 % des patients recevant la formulation de Phase 3
- Survie globale de 17,3 mois pour les patients HR+ et de 11,44 mois pour le cancer du sein triple négatif
- Taux de réponse globale de 50 % chez les patients avec des métastases intracrâniennes, avec un taux de bénéfice clinique de 75 %
- Taux de bénéfice clinique allant de 45 % à 100 % selon le sous-type
Cette étude a inclus 54 patients atteints de cancer du sein métastatique, dont 37 ont reçu la formulation actuelle de Phase 3. Les patients étaient fortement prétraités, avec une médiane de 6 traitements antérieurs. La société a également présenté des données sur sa plateforme améliorée Bria-OTS+, qui inclut des facteurs supplémentaires d’activation immunitaire pour les programmes de cancer du sein et de la prostate.
BriaCell Therapeutics Corp. (NASDAQ: BCTX) hat auf der AACR 2025 positive Phase-2-Daten für seine Bria-IMT™ Immuntherapie bei metastasiertem Brustkrebs vorgestellt. Wichtige Highlights sind:
- Klinischer Nutzen bei 83 % der Patienten, die die Phase-3-Formulierung erhielten
- Gesamtüberleben von 17,3 Monaten bei HR+ Patienten und 11,44 Monaten bei triple-negativem Brustkrebs
- Gesamtansprechrate von 50 % bei Patienten mit intrakraniellen Metastasen, mit einer klinischen Nutzenrate von 75 %
- Klinische Nutzenraten zwischen 45 % und 100 % je nach Subtyp
Die Studie umfasste 54 Patientinnen mit metastasiertem Brustkrebs, von denen 37 die aktuelle Phase-3-Formulierung erhielten. Die Patienten waren stark vorbehandelt mit einer Medianzahl von 6 vorherigen Therapien. Das Unternehmen präsentierte zudem Daten zu seiner verbesserten Bria-OTS+ Plattform, die zusätzliche immunaktivierende Faktoren für Programme bei Brust- und Prostatakrebs beinhaltet.
- Strong clinical benefit rate of 83% in Phase 3 formulation cohort
- Impressive 17.3-month overall survival in HR+ patients
- 50% response rate in patients with brain metastases
- No treatment-related discontinuations reported
- Enhanced Bria-OTS+ platform shows promising anti-cancer activity
- Shorter 11.44-month survival rate in triple negative breast cancer patients
- Patients required median of 6 prior treatments before showing response
Insights
BriaCell's Bria-IMT shows exceptional clinical benefit in heavily pre-treated breast cancer patients, including brain metastases, with promising next-generation platform advancing.
The Phase 2 data presented by BriaCell reveals remarkable efficacy signals in an extremely challenging patient population. These metastatic breast cancer patients had received a median of 6 prior treatments, including modern therapies like ADCs and checkpoint inhibitors, representing a setting where treatment options are typically exhausted.
The clinical benefit rates of 45-100% depending on cancer subtype significantly exceed expectations for such heavily pretreated patients. Particularly striking is the 83% disease control rate (tumor shrinkage or stabilization) in patients receiving the Phase 3 formulation. For context, response rates in patients who have progressed after multiple lines of therapy, including ADCs, are typically in the 10-20% range.
The overall survival of 17.3 months for HR+ patients and 11.44 months for triple-negative patients represents meaningful prolongation of life in this setting. Most impressive is the 50% response rate for patients with brain metastases, with a 75% clinical benefit rate. Brain metastases are notoriously resistant to treatment, with most therapies showing single-digit response rates, making this finding potentially practice-changing if confirmed in Phase 3.
The favorable safety profile with no treatment-related discontinuations is critical for quality of life in metastatic patients. This tolerability advantage could position Bria-IMT as an attractive option after ADC failure, where cumulative toxicity is often limiting.
The next-generation Bria-OTS+ platform with enhanced immune activation represents significant pipeline expansion potential, with breast cancer (Bria-BRES+) and prostate cancer (Bria-PROS+) applications already identified for clinical development.
- Overall survival and clinical benefit in Phase 2 continue to outperform historical benchmarks, including very heavily pretreated patients
- Clinical benefit observed in
83% of evaluable patient sub-group treated with the phase 3 formulation - Improved new Bria-OTS+ platform provides powerful innate and adaptive immune system activation
- Phase 3 biomarker data to be presented on Wed April 30 from 9:00 AM - 12:00 PM CST; Abstract # LB408
PHILADELPHIA and VANCOUVER, British Columbia, April 28, 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, is presenting positive data from its Phase 2 study of lead product candidate, Bria-IMT™, in metastatic breast cancer, and from its preclinical Bria-OTS+ platform at the 2025 American Association for Cancer Research (AACR) Annual Meeting taking place from April 25th – 30th at McCormick Place Convention Center, Chicago, IL. In addition, Phase 3 early biomarker data will be presented as a late breaking abstract.
The posters are summarized below and linked here: https://briacell.com/scientific-publications/.
Title: Survival outcomes in a randomized phase 2 of Bria-IMT: An allogeneic whole cell cancer vaccine
Session Title: Phase II and Phase III Clinical Trials
Session Start: 4/28/2025 2:00 PM – 5:00 PM CST
Location: Poster Section 50
Poster Board Number: 18
Abstract Presentation Number: CT100
“We are thrilled to share impressive survival and clinical efficacy data at AACR on the advantages of using Bria-IMT plus checkpoint inhibitor in heavily treated patients who have failed multiple prior treatments, including ADCs and CPIs,” stated lead author, Saranya Chumsri, MD, Principal Investigator and Professor of Oncology, Mayo Clinic. “Treatment options have been limited for patients who progress after ADC therapy, making this a particularly challenging clinical setting. Our clinical findings support the use of Bria-IMT as a well-tolerated, alternative treatment option for these very difficult-to-treat patients with unmet medical needs.”
“The excellent survival responses reported in patients with different tumor types in the Phase 2 study is very exciting, and we look forward to seeing these promising data replicate in the pivotal Phase 3 study,” stated Dr. William V. Williams, BriaCell’s President & CEO.
Of 54 metastatic breast cancer patients in the Phase 2 study, 37 patients received Bria-IMT formulation that is currently being used in BriaCell’s ongoing pivotal Phase 3 study (ClinicalTrials.gov as NCT06072612). Patients have been heavily pre-treated a median of 6 prior treatments -- including Antibody-Drug Conjugates (ADCs) and check point inhibitors (CPIs).
- Clinical benefit rates [CR, PR, SD] ranged from
45% to100% based on subtype - Decrease in size or no change in all tumors noted in
83% of patients receiving Phase 3 formulation - Overall survival (OS) with the Phase 3 formulation was 17.3 months for HR+ patients and 11.44 months for patients with triple negative breast cancer (TNBC)
- Overall response rate (ORR) for patients with intracranial metastases was
50% with a75% clinical benefit rate - Safety profile: No unexpected adverse events, no treatment related discontinuation of therapy
Title: Bria-OTS+: A versatile therapeutic platform for inducing anti-cancer immunity
Session Category: Immunology
Session Title: Vaccines, In Situ Vaccines, and Vaccine Combinations
Session Date and Time: 4/28/2025 2:00 – 5:00 PM CST
Location: Poster Section 39
Poster Board Number: 29
Published Abstract Number: 3553
Miguel A. Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer, commented, “We are very excited with the anti-cancer activity of Bria-OTS+ and expect the platform will enable the delivery of powerful and long-lasting immune activity against cancer.”
“This data further validates the mechanism of action of our next-generation Bria-OTS+ platform. Additional immune activating factors are expected to enhance efficacy, and we look forward to replicating these results clinically as we advance our next generation Bria-BRES+ breast cancer and Bria-PROS+ prostate cancer programs,” stated Dr. William V. Williams, BriaCell’s President and CEO.
Bria-OTS+ is an immunotherapy platform and enhanced version of Bria-OTS™, BriaCell’s personalized pre-manufactured immunotherapy already demonstrating tremendous results as announced on April 24 2025. Bria-OTS+ immunotherapy expresses multiple immune-activating cytokines and co-stimulatory molecules in addition to immune-boosting granulocyte-macrophage colony-stimulating factor (GM-CSF). Bria-BRES+™ for breast cancer and Bria-PROS+™ for prostate cancer are expected to be investigated in BriaCell’s upcoming Phase 1/2a clinical studies.
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 positive data from its Phase 2 study of lead product candidate, Bria-IMT, in metastatic breast cancer, and from its preclinical Bria-OTS+ platform at the AACR as well as Phase 3 early biomarker data being presented at the AACR as a late breaking abstract; whether BriaCell will be able to see prior results replicated in the pivotal Phase 3 study; BriaCell's expectations that the Bria-OTS+ platform will enable the delivery of powerful and long-lasting immune activity against cancer; whether additional immune activating factors will enhance efficacy of the Bria-OTS+ platform; whether prior results will be replicated in clinical studies of the next generation Bria-BRES+ breast cancer and Bria-PROS+ prostate cancer programs; and expectations for what will be investigated in BriaCell’s planned Phase 1/2a clinical studies; 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
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