BriaCell Reports 100% Resolution of Brain Metastasis in Breast Cancer Patient with “Eye-Bulging” Tumor
BriaCell Therapeutics Corp. (Nasdaq: BCTX, TSX: BCT) reports remarkable results from its Phase 2 study of Bria-IMT™ plus an immune checkpoint inhibitor regimen in metastatic breast cancer. A heavily pre-treated patient, who had failed 8 prior regimens including ADC therapy, showed complete resolution of right temporal lobe brain metastasis and significant reduction of an 'Eye-Bulging' orbital tumor.
Key highlights:
- 100% resolution of brain metastasis after 8 and 11 months of treatment
- Sustained drop in tumor markers
- Patient has completed 17 treatment cycles over 12 months
- Near-complete resolution of breast cancer tumor in the right orbit
Dr. William V. Williams, BriaCell's CEO, stated that these findings could transform treatment for metastatic breast cancer patients with brain metastasis. The company is now evaluating this patient subgroup in their ongoing pivotal Phase 3 study.
BriaCell Therapeutics Corp. (Nasdaq: BCTX, TSX: BCT) riporta risultati straordinari dal suo studio di Fase 2 su Bria-IMT™ combinato con un regime di inibitori del checkpoint immunitario nel cancro mammario metastatico. Un paziente con un'ampia previa somministrazione di trattamenti, che ha fallito 8 regimi precedenti inclusa la terapia ADC, ha mostrato una completa risoluzione della metastasi cerebrale nel lobo temporale destro e una significativa riduzione di un tumore orbitale 'Occhi in fuori'.
Punti chiave:
- Risoluzione del 100% delle metastasi cerebrali dopo 8 e 11 mesi di trattamento
- Riduzione sostenuta dei marcatori tumorali
- Il paziente ha completato 17 cicli di trattamento in 12 mesi
- Risoluzione quasi completa del tumore mammario nell'orbita destra
Il Dr. William V. Williams, CEO di BriaCell, ha dichiarato che queste scoperte potrebbero trasformare il trattamento per i pazienti con cancro mammario metastatico e metastasi cerebrali. La società sta ora valutando questo sottogruppo di pazienti nel loro studio pivotale di Fase 3 in corso.
BriaCell Therapeutics Corp. (Nasdaq: BCTX, TSX: BCT) informa sobre resultados notables de su estudio de Fase 2 de Bria-IMT™ más un régimen de inhibidores de puntos de control inmunitarios en el cáncer de mama metastásico. Un paciente con un tratamiento previo intensivo, que ha fallado en 8 regímenes anteriores, incluida la terapia ADC, mostró una resolución completa de la metástasis cerebral en el lóbulo temporal derecho y una reducción significativa de un tumor orbital de 'Ojos saltones'.
Aspectos destacados:
- Resolución del 100% de las metástasis cerebrales después de 8 y 11 meses de tratamiento
- Disminución sostenida de los marcadores tumorales
- El paciente ha completado 17 ciclos de tratamiento en 12 meses
- Resolución casi completa del tumor de cáncer de mama en la órbita derecha
El Dr. William V. Williams, CEO de BriaCell, afirmó que estos hallazgos podrían transformar el tratamiento para pacientes con cáncer de mama metastásico y metástasis cerebral. La compañía está ahora evaluando este subgrupo de pacientes en su estudio pivotal de Fase 3 en curso.
브리아셀 테라퓨틱스 주식회사 (Nasdaq: BCTX, TSX: BCT)는 전이성 유방암에서 Bria-IMT™와 면역 체크포인트 억제제 요법의 2상 연구에서 주목할 만한 결과를 보고합니다. 8개의 이전 요법,ADC 요법을 포함하여 여러 차례 치료를 받은 환자가 오른쪽 측두엽 뇌 전이의 완전한 해소와 '눈이 튀어나온' 안와 종양의 상당한 감소를 보였습니다.
주요 하이라이트:
- 8개월 및 11개월 치료 후 100% 뇌전이 해소
- 종양 표지자의 지속적인 감소
- 환자는 12개월 동안 17회의 치료 사이클을 완료했습니다
- 오른쪽 안와의 유방암 종양 거의 완전 해소
브리아셀의 CEO인 윌리엄 V. 윌리엄스 박사는 이러한 발견이 뇌 전이가 있는 전이성 유방암 환자 치료를 혁신할 수 있다고 언급했습니다. 회사는 현재 이 환자 하위 집단을 지속 중인 중요 3상 연구에서 평가하고 있습니다.
BriaCell Therapeutics Corp. (Nasdaq: BCTX, TSX: BCT) rapporte des résultats remarquables de son étude de phase 2 sur Bria-IMT™ plus un régime d'inhibiteurs des points de contrôle immunitaires dans le cancer du sein métastatique. Un patient lourdement prétraité, qui avait échoué à 8 régimes antérieurs y compris la thérapie ADC, a montré une résolution complète de la métastase cérébrale au lobe temporal droit et une réduction significative d'une tumeur orbitale 'Yeux saillants'.
Points clés :
- Résolution à 100% des métastases cérébrales après 8 et 11 mois de traitement
- Chute soutenue des marqueurs tumoraux
- Le patient a complété 17 cycles de traitement sur 12 mois
- Résolution quasi complète de la tumeur du sein dans l'orbite droite
Le Dr. William V. Williams, PDG de BriaCell, a déclaré que ces résultats pourraient transformer le traitement des patients atteints de cancer du sein métastatique avec des métastases cérébrales. La société évalue maintenant ce sous-groupe de patients dans son étude pivotale de phase 3 en cours.
BriaCell Therapeutics Corp. (Nasdaq: BCTX, TSX: BCT) berichtet von bemerkenswerten Ergebnissen aus seiner Phase-2-Studie zu Bria-IMT™ plus einem Regime von Immun-Checkpoint-Inhibitoren bei metastasiertem Brustkrebs. Ein stark vorbehandelter Patient, der in 8 früheren Regimen einschließlich der ADC-Therapie gescheitert war, zeigte eine vollständige Auflösung der Hirnmetastasen im rechten Temporallappen sowie eine signifikante Reduzierung eines 'ausgebeulten' orbitalen Tumors.
Wesentliche Höhepunkte:
- 100% Auflösung der Hirnmetastasen nach 8 und 11 Monaten Behandlung
- Nachhaltiger Rückgang der Tumormarker
- Der Patient hat 17 Behandlungszyklen über 12 Monate abgeschlossen
- Nahezu vollständige Auflösung des Brusttumors in der rechten Orbita
Dr. William V. Williams, CEO von BriaCell, erklärte, dass diese Ergebnisse die Behandlung von metastasierten Brustkrebspatienten mit Hirnmetastasen transformieren könnten. Das Unternehmen bewertet nun diese Patientengruppe in seiner laufenden entscheidenden Phase-3-Studie.
- Complete resolution of right temporal lobe brain metastasis in a heavily pre-treated patient
- Significant reduction of 'Eye-Bulging' orbital tumor
- Sustained drop in tumor markers confirming marked tumor reduction
- Patient has completed 17 treatment cycles over 12 months, indicating excellent tolerability
- Potential application of Bria-IMT™ in treating metastatic breast cancer patients with brain metastasis
- None.
Insights
This report of complete resolution of brain metastasis in a metastatic breast cancer patient is highly significant. Brain metastases are notoriously difficult to treat and often have a poor prognosis. The 100% resolution of the temporal lobe lesion and near-complete resolution of the orbital tumor are remarkable outcomes, especially in a heavily pre-treated patient who had failed 8 prior regimens including advanced therapies like ADCs.
The sustained response over 12 months of treatment, with continued tumor marker decline, suggests durable efficacy. This is particularly impressive given the patient's extensive prior treatment history. The ability of Bria-IMT™ to penetrate the blood-brain barrier and effectively treat CNS metastases could be a game-changer in metastatic breast cancer management.
While this is a single case, the dramatic response in a challenging clinical scenario warrants close attention to the ongoing Phase 3 trial results, especially in the brain metastasis subgroup. If replicated, it could position Bria-IMT™ as a valuable new option for patients with alternatives.
These results are highly promising for BriaCell and could significantly impact its market position. The complete resolution of brain metastasis and sustained response in a heavily pre-treated patient address a critical unmet need in metastatic breast cancer treatment. This could potentially expand BriaCell's addressable market to include patients with brain metastases, a notoriously difficult-to-treat population.
Investors should note several key points:
- The durability of response (12 months and ongoing) suggests potential for long-term treatment and revenue generation.
- Success in brain metastases could differentiate Bria-IMT™ from competitors and potentially command premium pricing.
- The favorable safety profile, allowing for extended treatment, is important for chronic therapy in oncology.
While these results are from a single patient in a Phase 2 study, they provide a strong rationale for the ongoing Phase 3 trial. Positive Phase 3 results, particularly in the brain metastasis subgroup, could be a significant catalyst for BriaCell's stock. However, investors should remain cautious until larger-scale data confirm these promising early results.
- Dramatic anti-tumor response includes complete resolution of right temporal lobe brain metastasis in patient with “Eye-Bulging” metastatic breast cancer
- Heavily pre-treated patient had failed 8 prior regimens including antibody-drug conjugate (ADC) therapy and continues to receive BriaCell treatment
PHILADELPHIA and VANCOUVER, British Columbia, Oct. 01, 2024 (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 report dramatic anti-tumor response including complete resolution of temporal lobe breast cancer metastasis in a patient treated in the Phase 2 study of BriaCell’s Bria-IMT™ plus an immune checkpoint inhibitor regimen. The patient demonstrated an initial partial response at 2 months in the brain lesion with no detectable disease following 8 and 11 months of treatment.
The heavily pre-treated patient who had failed 8 prior regimens including ADC therapy, previously demonstrated significant reduction of her “Eye-Bulging” orbital tumor and continues treatment with the Bria-IMT™ regimen. She has completed 17 cycles of treatment and has been on BriaCell’s Phase 2 study for 12 months. Also noteworthy is a sustained drop in her tumor markers, confirming the imaging results of marked tumor reduction.
Figure 1: Bria-IMT™ regimen resulted in
As shown in Figure 1, the right temporal lobe lesion is no longer detectable on the images taken at 8 months and 11 months on the Bria-IMT™ combination regimen. The orbital lesion has continued to shrink markedly (Figure 2). In addition, her tumor markers (blood tests that correlate with the amount of tumor in the body) remain markedly decreased from her pre-treatment levels.
Figure 2: Bria-IMT™ regimen resulted in near complete resolution of breast cancer tumor in the right orbit (behind the eye)
“Bria-IMT™’s potential therapeutic impact is unprecedented in metastatic breast cancer (MBC) in a brain metastasis setting. Our clinical findings, demonstrating significant tumor shrinkage in metastatic brain legions, may transform the way we treat MBC patients with brain metastasis, and offers hope to cancer patients and their families fighting this devastating disease,” stated Dr. William V. Williams, BriaCell’s President and CEO. “These results support Bria-IMT™ as a potential new therapeutic option for MBC patients with brain metastasis. We look forward to evaluating the brain metastasis patient subgroup in our ongoing pivotal Phase 3 study in metastatic breast cancer.”
“We believe that the complete tumor resolution in this patient with brain metastasis, plus other cases of significant anti-cancer clinical responses in our Phase 2 MBC patients with brain metastasis, highlight the potential application of Bria-IMT™ in treating similar MBC patients,” commented Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. “The protracted time on therapy, now one year, attests to the excellent tolerability of the Bria-IMT™ regimen in combination with an immune checkpoint inhibitor which is being used in our pivotal Phase 3 study.”
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 replicating positive data in its ongoing pivotal Phase 3 study; BriaCell’s Bria-IMT™ regimen bringing relief to cancer patients whose medical needs remain unmet; and the Bria-IMT™ regimen becoming a therapeutic option for metastatic breast cancer patients, 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
Media Relations:
Jules Abraham
CORE IR
julesa@coreir.com
Investor Relations Contact:
CORE IR
investors@briacell.com
Photos accompanying this announcement are available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/0a328ad2-c48d-43bf-ae04-0b69da4d3f3f
https://www.globenewswire.com/NewsRoom/AttachmentNg/eea9560e-c63a-4001-a5b7-6a07caf3c91b
FAQ
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