BriaCell Bria-OTS™ Phase 1/2 Study Clears Safety Evaluation; Doses First Patient in Combination with Checkpoint Inhibitor
BriaCell Therapeutics (NASDAQ: BCTX) has announced significant progress in its Phase 1/2 study of Bria-OTS, a personalized immunotherapy for metastatic breast cancer. The therapy has successfully cleared its safety evaluation in the monotherapy setting and has now begun dosing patients in combination with checkpoint inhibitors. Notably, the first monotherapy patient showed complete resolution of lung metastasis and remains in the study.
The study will evaluate Bria-OTS with checkpoint inhibitors in up to 12 patients with metastatic breast cancer, focusing on safety and objective response rate as primary endpoints. This follows a successful three-patient monotherapy safety run-in. BriaCell also plans to evaluate Bria-OTS+, an optimized version, for multiple cancer types including breast and prostate cancers.
BriaCell Therapeutics (NASDAQ: BCTX) ha annunciato importanti progressi nello studio di Fase 1/2 di Bria-OTS, un'immunoterapia personalizzata per il carcinoma mammario metastatico. La terapia ha superato con successo la valutazione di sicurezza in monoterapia e ha ora iniziato a somministrare il trattamento in combinazione con inibitori dei checkpoint. In particolare, il primo paziente trattato in monoterapia ha mostrato una completa risoluzione delle metastasi polmonari e continua a partecipare allo studio.
Lo studio valuterà Bria-OTS in combinazione con inibitori dei checkpoint in un massimo di 12 pazienti con carcinoma mammario metastatico, concentrandosi sulla sicurezza e sul tasso di risposta obiettiva come endpoint primari. Questo segue una fase iniziale di sicurezza con tre pazienti in monoterapia. BriaCell prevede inoltre di valutare Bria-OTS+, una versione ottimizzata, per diversi tipi di tumore, inclusi i tumori al seno e alla prostata.
BriaCell Therapeutics (NASDAQ: BCTX) ha anunciado avances significativos en su estudio de Fase 1/2 de Bria-OTS, una inmunoterapia personalizada para el cáncer de mama metastásico. La terapia ha superado con éxito la evaluación de seguridad en monoterapia y ahora ha comenzado a administrar dosis a pacientes en combinación con inhibidores de puntos de control inmunitario. Cabe destacar que el primer paciente en monoterapia mostró una resolución completa de las metástasis pulmonares y sigue en el estudio.
El estudio evaluará Bria-OTS junto con inhibidores de puntos de control en hasta 12 pacientes con cáncer de mama metastásico, enfocándose en la seguridad y la tasa de respuesta objetiva como criterios principales. Esto sigue a una fase inicial de seguridad exitosa con tres pacientes en monoterapia. BriaCell también planea evaluar Bria-OTS+, una versión optimizada, para múltiples tipos de cáncer, incluidos los de mama y próstata.
BriaCell Therapeutics (NASDAQ: BCTX)는 전이성 유방암을 위한 맞춤형 면역치료제인 Bria-OTS의 1/2상 임상시험에서 중요한 진전을 발표했습니다. 이 치료제는 단독 투여 시 안전성 평가를 성공적으로 통과했으며, 현재는 체크포인트 억제제와 병용하여 환자 투여를 시작했습니다. 특히, 단독 투여를 받은 첫 환자는 폐 전이가 완전히 사라졌으며, 현재도 연구에 참여 중입니다.
본 연구는 전이성 유방암 환자 최대 12명을 대상으로 Bria-OTS와 체크포인트 억제제 병용 요법의 안전성과 객관적 반응률을 주요 평가 지표로 삼아 진행됩니다. 이는 단독 투여 3명에 대한 안전성 초기 평가가 성공적으로 완료된 데 따른 것입니다. BriaCell은 또한 최적화된 버전인 Bria-OTS+를 유방암과 전립선암 등 다양한 암종에 대해 평가할 계획입니다.
BriaCell Therapeutics (NASDAQ : BCTX) a annoncé des progrès significatifs dans son étude de phase 1/2 sur Bria-OTS, une immunothérapie personnalisée pour le cancer du sein métastatique. Le traitement a réussi son évaluation de sécurité en monothérapie et a désormais commencé à administrer des doses aux patients en association avec des inhibiteurs de points de contrôle. Notamment, le premier patient en monothérapie a présenté une résolution complète des métastases pulmonaires et reste dans l'étude.
L'étude évaluera Bria-OTS en combinaison avec des inhibiteurs de points de contrôle chez jusqu'à 12 patients atteints de cancer du sein métastatique, en se concentrant sur la sécurité et le taux de réponse objective comme critères principaux. Cela fait suite à une phase initiale de sécurité réussie avec trois patients en monothérapie. BriaCell prévoit également d'évaluer Bria-OTS+, une version optimisée, pour plusieurs types de cancers, y compris le sein et la prostate.
BriaCell Therapeutics (NASDAQ: BCTX) hat bedeutende Fortschritte in seiner Phase-1/2-Studie zu Bria-OTS, einer personalisierten Immuntherapie für metastasierten Brustkrebs, bekannt gegeben. Die Therapie hat die Sicherheitsbewertung in der Monotherapie erfolgreich bestanden und beginnt nun mit der Behandlung von Patienten in Kombination mit Checkpoint-Inhibitoren. Bemerkenswert ist, dass der erste Patient in der Monotherapie eine vollständige Rückbildung der Lungenmetastasen zeigte und weiterhin an der Studie teilnimmt.
Die Studie wird Bria-OTS in Kombination mit Checkpoint-Inhibitoren bei bis zu 12 Patienten mit metastasiertem Brustkrebs evaluieren, wobei Sicherheit und objektive Ansprechrate als primäre Endpunkte im Fokus stehen. Dies folgt auf eine erfolgreiche Sicherheitsphase mit drei Patienten in der Monotherapie. BriaCell plant außerdem, Bria-OTS+, eine optimierte Version, für mehrere Krebsarten, einschließlich Brust- und Prostatakrebs, zu evaluieren.
- Successful safety clearance in Phase 1/2 monotherapy study
- First patient showed complete resolution of lung metastasis
- Expansion into combination therapy with checkpoint inhibitors
- Plans to develop optimized version (Bria-OTS+) for multiple cancer types
- Small initial patient population (up to 12 patients) for combination study
- Early-stage trial (Phase 1/2) with significant development path ahead
Insights
BriaCell's Bria-OTS cleared safety hurdles and showed promising early efficacy with tumor resolution, advancing to combination therapy phase.
BriaCell's announcement represents a significant clinical milestone for their personalized immunotherapy platform. The completion of the monotherapy safety run-in with just three patients indicates the treatment was well-tolerated, allowing rapid progression to the combination phase. This accelerated timeline suggests confidence in the therapy's safety profile.
The complete resolution of lung metastasis in the first monotherapy patient is particularly noteworthy. In metastatic breast cancer, complete responses are uncommon, especially in patients with lung involvement. While this is just a single patient, such dramatic tumor resolution signals potentially meaningful clinical activity that warrants further investigation.
The transition to combination with checkpoint inhibitors is strategically sound. Checkpoint inhibitors work by removing the "brakes" on the immune system, while Bria-OTS likely stimulates the "accelerator" by enhancing tumor-specific immune responses. This mechanistic synergy could potentially overcome resistance to either therapy alone.
The planned evaluation in up to 12 patients with objective response rate as a primary endpoint suggests the company is focused on demonstrating preliminary efficacy rather than just safety. This relatively small sample size is appropriate for early-phase testing but means results will be preliminary.
Importantly, the mention of patients who haven't responded to antibody-drug conjugates (ADCs) or checkpoint inhibitors indicates BriaCell is targeting a patient population with high unmet need, as these are among the newest and most effective therapies for metastatic breast cancer. The development of Bria-OTS+™ for multiple cancer types also suggests the company sees broad potential applications for their platform technology.
- Bria-OTS has cleared its safety evaluation in the Phase 1/2 study monotherapy dosage setting
- Phase 1/2 study has now transitioned to dosing patients in combination with checkpoint inhibitor in metastatic breast cancer
- First Bria-OTS monotherapy patient remains on study with confirmed resolution of lung metastasis
PHILADELPHIA and VANCOUVER, British Columbia, May 27, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ; TSX: BCT), a clinical-stage biotechnology company advancing personalized immunotherapies for cancer, today announced that Bria-OTS has cleared its safety evaluation in the Phase 1/2 monotherapy study and has now transitioned to dosing patients in combination with a checkpoint inhibitor (CPI). The first patient has been dosed in the checkpoint inhibitor combination cohort of the ongoing Phase 1/2 study of Bria-OTS (NCT06471673) in metastatic breast cancer.
Bria-OTS, a personalized next-generation version of Bria-IMT™—currently in a pivotal Phase 3 trial—is designed to enhance immune responses against tumors. The CPI combination cohort follows the successful completion of a three-patient monotherapy safety run-in. Notably, the first monotherapy patient remains on study with complete resolution of lung metastasis.
“The encouraging responses seen will give us reason to believe that combining Bria-OTS with a checkpoint inhibitor could yield even greater anti-tumor activity,” said Neal S. Chawla, MD, Director at the Sarcoma Oncology Center, Santa Monica, Ca., and Principal Investigator for the Bria-OTS study. “This approach may offer a new option for patients who have not responded to existing to antibody-drug-conjugates (ADCs) or checkpoint inhibitors. We are excited to further explore the therapeutic potential of the Bria-OTS platform.”
“Initiating the CPI combination cohort marks a significant milestone for BriaCell,” added Dr. William V. Williams, BriaCell’s President and CEO. “We believe Bria-OTS has the potential to address major gaps in current cancer care, and this step brings us closer to offering a much-needed personalized immunotherapy for difficult-to-treat cancers.”
The ongoing study will assess Bria-OTS in combination with a CPI in up to 12 patients with metastatic breast cancer, with safety and objective response rate (ORR) as primary endpoints. BriaCell also plans to evaluate Bria-OTS+™, a further optimized version of the platform, across multiple cancer types including breast and prostate cancers.
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 include: the belief that combining Bria-OTS with a checkpoint inhibitor could yield even greater anti-tumor activity; the Bria-OTS approach offering a new option for patients who have not responded to existing to antibody-drug-conjugates (ADCs) or checkpoint inhibitors; BriaCell further exploring the therapeutic potential of the Bria-OTS platform; Bria-OTS having the potential to address major gaps in current cancer care and offering a personalized immunotherapy for difficult-to-treat cancers; the ongoing study assessing Bria-OTS in combination with a CPI in up to 12 patients with metastatic breast cancer, with safety and objective response rate (ORR) as primary endpoints; and BriaCell planning to evaluate Bria-OTS+ across multiple cancer types including breast and prostate cancers. Forward-looking statements 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. 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
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