BriaCell Announces Resolution of Lung Metastasis in First Patient treated with Bria-OTS™
BriaCell Therapeutics (NASDAQ: BCTX) has announced remarkable results from their first patient treated with Bria-OTS™, their personalized off-the-shelf immunotherapy for metastatic breast cancer. The 78-year-old patient, who had previously failed multiple therapies, showed complete resolution of lung metastasis after just 2 months (4 doses) of treatment, with stable disease elsewhere.
The patient, enrolled on Nov 21, 2024, had extensive metastases in bone, lymph node, and lung. The treatment demonstrated excellent tolerability with no reported toxicity. This unprecedented result was achieved using the lowest dose level in the ongoing Phase 1/2a study.
The company is conducting a Phase 1/2a dose escalation study to evaluate Bria-OTS™ both as monotherapy and in combination with an immune checkpoint inhibitor. The study targets patients with recurrent metastatic breast cancer who have failed at least two prior systemic therapies.
BriaCell Therapeutics (NASDAQ: BCTX) ha annunciato risultati straordinari riguardo il primo paziente trattato con Bria-OTS™, la loro immunoterapia personalizzata pronta all'uso per il cancro al seno metastatico. Il paziente di 78 anni, che aveva precedentemente fallito in molteplici terapie, ha mostrato una completa risoluzione delle metastasi polmonari dopo solo 2 mesi (4 dosi) di trattamento, con una malattia stabile altrove.
Il paziente, arruolato il 21 novembre 2024, presentava metastasi estese nelle ossa, nei linfonodi e nei polmoni. Il trattamento ha dimostrato eccellente tollerabilità senza tossicità riportata. Questo risultato senza precedenti è stato ottenuto utilizzando il livello di dose più basso nello studio in corso di Fase 1/2a.
L'azienda sta conducendo uno studio di escalation della dose di Fase 1/2a per valutare Bria-OTS™ sia come monoterapia che in combinazione con un inibitore del checkpoint immunitario. Lo studio è rivolto a pazienti con cancro al seno metastatico ricorrente che hanno fallito almeno due precedenti terapie sistemiche.
BriaCell Therapeutics (NASDAQ: BCTX) ha anunciado resultados notables de su primer paciente tratado con Bria-OTS™, su inmunoterapia personalizada lista para usar para el cáncer de mama metastásico. El paciente de 78 años, que había fallado en múltiples terapias anteriormente, mostró una completa resolución de la metástasis pulmonar después de solo 2 meses (4 dosis) de tratamiento, con enfermedad estable en otras partes.
El paciente, que fue inscrito el 21 de noviembre de 2024, tenía metástasis extensas en huesos, ganglios linfáticos y pulmones. El tratamiento demostró una excelente tolerabilidad sin toxicidad reportada. Este resultado sin precedentes se logró utilizando el nivel de dosis más bajo en el estudio en curso de Fase 1/2a.
La compañía está llevando a cabo un estudio de escalada de dosis de Fase 1/2a para evaluar Bria-OTS™ tanto como monoterapia como en combinación con un inhibidor de punto de control inmunitario. El estudio se dirige a pacientes con cáncer de mama metastásico recidivante que han fallado al menos en dos terapias sistémicas previas.
BriaCell Therapeutics (NASDAQ: BCTX)는 전이성 유방암을 위한 맞춤형 면역 요법인 Bria-OTS™로 치료받은 첫 번째 환자의 놀라운 결과를 발표했습니다. 78세 환자는 이전에 여러 치료에서 실패했으며, 치료 후 단 2개월(4회 투여) 만에 폐 전이가 완전히 해결되었고 다른 부위에서는 안정된 상태를 보였습니다.
2024년 11월 21일에 등록된 이 환자는 뼈, 림프절 및 폐에 광범위한 전이가 있었습니다. 치료는 보고된 독성이 없으며 우수한 내약성을 나타냈습니다. 이러한 전례 없는 결과는 진행 중인 1/2a 단계 연구에서 가장 낮은 용량 수준을 사용하여 달성되었습니다.
회사는 Bria-OTS™를 단독 요법과 면역 점검 억제제와의 병용 요법으로 평가하는 1/2a 단계 용량 증량 연구를 진행 중입니다. 이 연구는 최소 두 가지 이전 전신 치료에 실패한 재발성 전이성 유방암 환자를 대상으로 하고 있습니다.
BriaCell Therapeutics (NASDAQ: BCTX) a annoncé des résultats remarquables concernant son premier patient traité avec Bria-OTS™, leur immunothérapie personnalisée prête à l'emploi pour le cancer du sein métastatique. Le patient, âgé de 78 ans et ayant échoué dans plusieurs traitements auparavant, a montré une résolution complète de la métastase pulmonaire après seulement 2 mois (4 doses) de traitement, avec une maladie stable ailleurs.
Le patient, inscrit le 21 novembre 2024, présentait des métastases étendues dans les os, les ganglions lymphatiques et les poumons. Le traitement a montré une excellente tolérance sans toxicité rapportée. Ce résultat sans précédent a été obtenu en utilisant le niveau de dose le plus bas dans l'étude en cours de phase 1/2a.
L'entreprise mène une étude d'escalade de dose en phase 1/2a pour évaluer Bria-OTS™ tant comme monothérapie que combiné à un inhibiteur de point de contrôle immunitaire. L'étude cible les patients atteints de cancer du sein métastatique récurrent ayant échoué à au moins deux thérapies systémiques précédentes.
BriaCell Therapeutics (NASDAQ: BCTX) hat bemerkenswerte Ergebnisse des ersten Patienten bekannt gegeben, der mit Bria-OTS™, ihrer personalisierten off-the-shelf Immuntherapie gegen metastasierenden Brustkrebs, behandelt wurde. Der 78-jährige Patient, der zuvor in mehreren Therapien versagt hatte, zeigte nach lediglich 2 Monaten (4 Dosen) eine vollständige Auflösung der Lungenmetastasen, während die Erkrankung an anderer Stelle stabil blieb.
Der Patient, der am 21. November 2024 eingeschrieben wurde, hatte umfangreiche Metastasen in den Knochen, Lymphknoten und in der Lunge. Die Behandlung erwies sich als hervorragend verträglich, ohne berichtete Toxizität. Dieses beispiellose Ergebnis wurde mit der niedrigsten Dosisstufe in der laufenden Phase 1/2a-Studie erreicht.
Das Unternehmen führt eine Phase 1/2a-Dosiserhöhungstudie durch, um Bria-OTS™ sowohl als Monotherapie als auch in Kombination mit einem Immun-Checkpoint-Inhibitor zu bewerten. Die Studie richtet sich an Patienten mit wiederkehrendem metastasierenden Brustkrebs, die mindestens zwei vorherige systemische Therapien nicht erfolgreich waren.
- Complete resolution of lung metastasis in first patient after only 2 months of treatment
- No toxicity reported in treatment
- Patient showed stable disease in other metastatic areas
- Treatment effective even at lowest dose level
- None.
Insights
The reported clinical response represents a remarkable breakthrough in personalized immunotherapy for several key reasons. The complete resolution of lung metastasis after just 4 doses in a heavily pretreated 78-year-old patient is particularly noteworthy, as elderly patients typically show reduced immune responses and treatment tolerance. The fact that this was achieved at the lowest dose level in the Phase 1/2a study suggests significant potential for improved efficacy at higher doses.
The technical achievement here is substantial - Bria-OTS™ represents an advancement over the company's lead candidate Bria-IMT™, offering a personalized off-the-shelf approach that could potentially address the limitations of current immunotherapy options. In the context of metastatic breast cancer treatment, where antibody-drug conjugates (ADCs) and checkpoint inhibitors (CPIs) often show efficacy, this early result is particularly encouraging.
Several aspects warrant attention: 1) The rapid onset of response (2 months) compared to typical immunotherapy timelines 2) The clean safety profile, critical for potential combination strategies 3) The company's planned expansion into other indications including prostate cancer, melanoma and lung cancer. The upcoming combination phase with checkpoint inhibitors could potentially enhance efficacy further.
While this is a single patient result requiring validation across a broader population, the comprehensive response observed - particularly in resolving metastatic disease - positions Bria-OTS™ as a potentially significant advancement in personalized cancer immunotherapy. The planned expansion into multiple cancer types suggests confidence in the platform's broader applicability.
This early clinical success potentially represents a significant value inflection point for BriaCell's platform technology. The metastatic breast cancer market alone represents a multi-billion dollar opportunity, with significant unmet need particularly in heavily pretreated patients. The personalized off-the-shelf approach could offer important advantages in terms of manufacturing scalability and cost-effectiveness compared to traditional personalized therapies.
The demonstrated efficacy at the lowest dose level in the first treated patient could have several strategic implications: 1) Potential for accelerated development if robust responses continue 2) Earlier partnership opportunities given proof-of-concept validation 3) Enhanced platform value supporting expansion into additional indications.
Critical factors for investors to monitor include: 1) Reproducibility of results in additional patients 2) Dose-response relationships in the ongoing Phase 1/2a study 3) Timeline to potential combination studies with checkpoint inhibitors 4) Manufacturing scale-up capabilities 5) Patent protection and competitive positioning. The planned expansion into prostate cancer, melanoma and lung cancer could significantly expand the addressable market opportunity.
- Lung metastasis (from metastatic breast cancer) resolved - after only 2 months (4 doses) of treatment with Bria-OTS™ monotherapy
- No toxicity related to the treatment; Patient remains on study
- Unprecedented result in first patient dosed supports Bria-OTS™ personalized immunotherapy approach
- Ongoing Phase 1/2a dose escalation study to evaluate Bria-OTS™, BriaCell's personalized off-the-shelf immunotherapy in metastatic breast cancer
PHILADELPHIA and VANCOUVER, British Columbia, Feb. 03, 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 pleased to announce an unprecedented clinical response including resolution of a lung metastasis (breast cancer tumor that spread to the lung) with stable disease elsewhere. This patient is the first metastatic breast cancer (MBC) patient treated with Bria-OTS™.
Bria-OTS™ is a personalized off-the-shelf immunotherapy, currently under investigation in a Phase 1/2a dose escalation study (ClinicalTrials.gov identifier: NCT06471673) in metastatic recurrent breast cancer. Bria-OTS™ represents a personalized, next generation, advancement of BriaCell’s lead candidate Bria-IMT™ which is currently in a pivotal Phase 3 study for metastatic breast cancer.
Figure 1: Treatment with Bria-OTS™ monotherapy resulted in
1 Note that the other white dots in the lungs are blood vessels.
As shown in Figure 1, the lesion in the patient’s right lung (left side of the image) is no longer detectable on the images taken 2 months after treatment with Bria-OTS™ monotherapy.
This 78-year-old woman with metastatic breast cancer (hormone receptor positive, HER2 negative) had failed several prior lines of therapy and received the lowest dose level in the Phase 1/2a Bria-OTS™ study. At enrollment on Nov 21, 2024, she had extensive metastases including multiple bone, lymph node and lung metastases. Following 4 injections with Bria-OTS™ every 2 weeks, the lung metastasis completely resolved, and she had stable disease elsewhere.
“Despite recent advancements in cancer treatment with antibody-drug-conjugates (ADCs) and immune check point inhibitors (CPIs), metastatic breast cancer remains an unmet medical need as many patients do not respond to these treatments,” stated Dr. Neal Chawla, Associate Director of Clinical Research at the Sarcoma Oncology Center, and Principal Investigator for the Bria-OTS™ study. “We are very impressed by the clinical response observed showing rapid and robust clinical activity in addition to excellent tolerability in the first patient treated with Bria-OTS™ and look forward to reproducing these results in other cancer patients in the study.”
“This data supports our hypothesis of personalized immunotherapy with Bria-OTS™, potentially leading to new and effective treatment of metastatic breast cancer,” stated Dr. William V. Williams, BriaCell’s President and CEO. “We hope to transform the way we treat cancer patients with our novel personalized off-the-shelf immunotherapy approach.”
“Resolution of metastatic lung disease in this breast cancer patient highlights the clinical effectiveness of Bria-OTS™, and its therapeutic potential in MBC,” commented Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. “This result represents a major step towards advancing our innovative technology platform and our goal of offering safe and effective treatment to MBC patients and our plans to extend into prostate cancer, melanoma, and lung cancer.”
The Phase 1/2a clinical trial is initially evaluating the safety and efficacy of Bria-OTS™ as monotherapy and, later, in combination with an immune checkpoint inhibitor in metastatic breast cancer. Key inclusion criteria include recurrent metastatic breast cancer and at least two failed prior attempts of systemic therapy (e.g., chemotherapy). The study design includes a dose escalation monotherapy phase followed by an expansion phase that will include combination therapy with an immune check point inhibitor.
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 statements regarding: BriaCell reproducing similar results in other cancer patients in BriaCell’s Phase 1/2a Bria-OTS™ study; Bria-OTS™ potentially leading to new and effective treatment of metastatic breast cancer; BriaCell transforming the way we treat cancer patients with its novel personalized off-the-shelf immunotherapy approach; the clinical effectiveness of Bria-OTS™ and its therapeutic potential in MBC; BriaCell’s technology offering a safe and effective treatment to MBC patients; BriaCell’s plans to extend into prostate cancer, melanoma, and lung cancer; and BriaCell’s Phase 1/2a clinical trial initially evaluating the safety and efficacy of Bria-OTS™ as monotherapy and later in combination with an immune checkpoint inhibitor in metastatic breast cancer. 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
Media Relations:
Jules Abraham
CORE IR
julesa@coreir.com
Investor Relations Contact:
CORE IR
investors@briacell.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/90d9b907-91ef-40c5-ac9f-87ff883327f6
FAQ
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