BriaCell 2024 SABCS® Poster Highlights Ability of Bria-IMT™ Regimen to Increase Cancer-Fighting Immune Cells in Metastatic Breast Cancer
BriaCell Therapeutics (Nasdaq: BCTX) presented positive results from their phase 2 study of Bria-IMT™ plus CPI regimen at the 2024 San Antonio Breast Cancer Symposium. Using CD8 ImmunoPET imaging technology, the study demonstrated the treatment's ability to turn 'cold' tumors 'hot' by increasing cancer-fighting CD8+ T cells infiltration in metastatic breast cancer tumors and lymph nodes.
Key findings from 6 heavily pre-treated patients after 27 weeks included: treatment was generally well-tolerated, tumor marker reduction in 2 patients, 50% of patients showed decreased neutrophil/lymphocyte ratio, and evidence of immune system activation. These results support BriaCell's ongoing pivotal Phase 3 study in metastatic breast cancer.
BriaCell Therapeutics (Nasdaq: BCTX) ha presentato risultati positivi dal loro studio di fase 2 su Bria-IMT™ più il regime CPI al Simposio sulla Cancro al Seno di San Antonio 2024. Utilizzando la tecnologia di imaging CD8 ImmunoPET, lo studio ha dimostrato la capacità del trattamento di trasformare i tumori 'freddi' in 'caldi' aumentando l'infiltrazione delle cellule T CD8+ che combattono il cancro nei tumori metastatici al seno e nei linfonodi.
I principali risultati di 6 pazienti fortemente pre-trattati dopo 27 settimane includevano: il trattamento è stato generalmente ben tollerato, riduzione dei marcatori tumorali in 2 pazienti, il 50% dei pazienti ha mostrato una diminuzione del rapporto neutrofili/linfociti e evidenza di attivazione del sistema immunitario. Questi risultati supportano lo studio pivotale di fase 3 in corso di BriaCell sul cancro al seno metastatic.
BriaCell Therapeutics (Nasdaq: BCTX) presentó resultados positivos de su estudio de fase 2 de Bria-IMT™ más régimen CPI en el Simposio sobre Cáncer de Mama de San Antonio 2024. Utilizando la tecnología de imagen CD8 ImmunoPET, el estudio demostró la capacidad del tratamiento para convertir tumores 'fríos' en 'calientes' al aumentar la infiltración de células T CD8+ que combaten el cáncer en tumores metastásicos de mama y ganglios linfáticos.
Los hallazgos clave de 6 pacientes con un historial de tratamientos intensivos tras 27 semanas incluyeron: el tratamiento fue generalmente bien tolerado, reducción de marcadores tumorales en 2 pacientes, el 50% de los pacientes mostró una disminución en la relación neutrófilos/linfocitos, y evidencias de activación del sistema inmunológico. Estos resultados respaldan el estudio pivotal de fase 3 en curso de BriaCell en cáncer de mama metastásico.
BriaCell Therapeutics (Nasdaq: BCTX)는 2024년 샌안토니오 유방암 심포지엄에서 Bria-IMT™와 CPI 요법의 2상 연구에서 긍정적인 결과를 발표했습니다. CD8 ImmunoPET 이미징 기술을 사용하여, 이 연구는 치료가 전이성 유방암 종양 및 림프절에 있는 암과 싸우는 CD8+ T 세포 침투를 증가시켜 '차가운' 종양을 '뜨거운' 종양으로 전환하는 능력을 입증했습니다.
27주 후에 6명의 고강도 치료를 받은 환자들로부터의 주요 발견 include: 치료는 일반적으로 잘 견디게 되었으며, 2명의 환자에서 종양표지자 감소가 있었고, 50%의 환자에서 호중구/림프구 비율 감소가 나타났으며, 면역계 활성화의 증거가 있었습니다. 이러한 결과는 BriaCell의 전이성 유방암에 대한 진행 중인 중요한 3상 연구를 뒷받침합니다.
BriaCell Therapeutics (Nasdaq: BCTX) a présenté des résultats positifs de son étude de phase 2 sur Bria-IMT™ plus le régime CPI lors du Symposium de San Antonio sur le cancer du sein 2024. En utilisant la technologie d'imagerie CD8 ImmunoPET, l'étude a démontré la capacité du traitement à transformer des tumeurs 'froides' en 'chaudes' en augmentant l'infiltration des cellules T CD8+ combattant le cancer dans les tumeurs mammaires métastatiques et les ganglions lymphatiques.
Les principales conclusions de 6 patients ayant subi un traitement intensif après 27 semaines comprenaient : le traitement a été généralement bien toléré, réduction des marqueurs tumoraux chez 2 patients, 50 % des patients ont montré un rapport neutrophiles/lymphocytes diminué et des preuves d'activation du système immunitaire. Ces résultats soutiennent l'étude pivotante de phase 3 en cours de BriaCell sur le cancer du sein métastatique.
BriaCell Therapeutics (Nasdaq: BCTX) präsentierte positive Ergebnisse aus ihrer Phase-2-Studie zu Bria-IMT™ plus CPI-Regime auf dem San Antonio Breast Cancer Symposium 2024. Mit der CD8 ImmunoPET-Bildgebungstechnologie zeigte die Studie die Fähigkeit der Behandlung, 'kalte' Tumoren in 'heiße' umzuwandeln, indem die Infiltration krebsbekämpfender CD8+ T-Zellen in metastasierenden Brusttumoren und Lymphknoten erhöht wurde.
Wichtige Ergebnisse von 6 stark vorbehandelten Patienten nach 27 Wochen umfassten: Die Behandlung wurde allgemein gut vertragen, ein Rückgang der Tumormarker bei 2 Patienten, 50% der Patienten zeigten ein vermindertes Neutrophil/Lymphozyten-Verhältnis und Hinweise auf eine Aktivierung des Immunsystems. Diese Ergebnisse unterstützen die laufende entscheidende Phase-3-Studie von BriaCell bei metastasiertem Brustkrebs.
- Treatment demonstrated ability to activate immune response in metastatic breast cancer patients
- 50% of patients (3/6) showed decreased neutrophil/lymphocyte ratio, indicating immune system activation
- Tumor marker reduction observed in 2 patients
- Treatment was generally well-tolerated
- Small patient sample size (only 6 patients) in the study
- efficacy data with tumor marker reduction in only 2 out of 6 patients
Insights
Key findings from the 6-patient study show:
- Tumor marker reductions in
33% of patients - Immune system activation in
50% of patients (decreased NLR ratio) - Evidence of systemic immune response
The imaging validation of immune cell infiltration into tumors correlating with clinical benefits strengthens the scientific rationale for the ongoing Phase 3 trial. However, the small sample size and heavily pretreated patient population (median 7 prior treatments) should be considered when interpreting these results.
The technology's potential to differentiate between pseudo progression and true progression could be particularly valuable for clinical decision-making. This diagnostic capability, combined with the observed clinical benefits in heavily pretreated patients, enhances the therapy's competitive position in the crowded breast cancer market. The correlation between imaging results and clinical responses also provides a strong foundation for the ongoing Phase 3 trial, potentially increasing its probability of success.
- BriaCell reports influx of cancer fighting CD8+ “killer” T cell into metastatic breast cancer tumors and lymph organs turning “Cold” tumors and lymph nodes “Hot” on ImmunoPET imaging in cancer patients treated with Bria-IMT™ plus an immune checkpoint inhibitor (CPI)
- Imaging confirms clinical responses seen in metastatic breast cancer correlate with increase in CD8+ “killer” T Cells in lesions and lymph nodes
PHILADELPHIA and VANCOUVER, British Columbia, Dec. 13, 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, highlights the infiltration of cancer fighting immune cells into tumors, using leading CD8 ImmunoPET imaging technology, in its poster presentation at the 2024 San Antonio Breast Cancer Symposium ® at Henry B. Gonzalez Convention Center, San Antonio, TX.
Today’s poster shows influx of cancer fighting immune cells into tumors and lymphatic tissue leading to cancer cell destruction following treatment with the Bria-IMT™ plus CPI regimen. BriaCell employed this advanced imaging technology as a precision diagnostic tool to monitor patients’ immune system responses in its phase 2 study, establishing the ability of the Bria-IMT™ regimen to induce tumor infiltration with CD8+ “killer” T cells. These results suggest a potential value of CD8 ImmunoPET in identifying pseudo progression in patients with clinical benefit vs tumor progression. CD8+ T cell infiltration also correlated with a marked reduction in tumor markers, indicating clinical benefit, in some patients.
“We are excited to successfully utilize innovative technology such as CD8 ImmunoPET imaging to gain insight into the mechanism of action and potential strength of the BriaCell immunotherapy program,” stated Russ Kuker, MD, Associate Professor of Clinical Radiology at the University of Miami Miller School of Medicine and author of the P5-10-12 poster.
“By employing more accurate precision imaging techniques, we have been able to document the mechanism of action of the Bria-IMT™ regimen as we progress this therapy to revolutionize the way we treat cancer patients and improve patient outcomes,” noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer.
The details about the poster presentation are as follows:
Abstract Number: SESS-1069
Title: Bria-IMT CD8+ tumor infiltrating lymphocytes turn “Cold” tumor “Hot” in metastatic breast cancer
Time: Friday, December 13, 2024 12:00 PM – 2:00 PM CST
Presentation ID: P5-10-12
CD8 ImmunoPET imaging, an imaging analysis technology, is used to mark CD8+ T-cells (also known as cytotoxic “killer” T cells) that are important components of the immune system and key to cancer cell detection and destruction.
Bria-IMT™ plus CPI produced cancer-fighting CD8+ T cells infiltration into metastatic tumors and lymphoid tissue, leading to cancer destruction - turning “Cold” tumors and lymph nodes “Hot” on ImmunoPET imaging
Using metastatic site-specific CD8+ PET imaging technology, BriaCell reports the following in 6 patients treated {median # of prior treatments = 7; prior lines of treatment included antibody-drug conjugates (ADCs) and CPIs} with Bria-IMT™ plus CPI after 9 cycles (27weeks) of treatment:
- Treatment generally well tolerated
- Reduction in tumor markers in 2 patients who had cold tumors turn hot
- 3 out of the 6 patients (
50% ) showed a decrease in neutrophil/lymphocyte ratio (NLR) at cycle 2 when compared to baseline values suggesting immune system activation of the patients - Evidence of “cold” tumors and lymph nodes becoming “hot” suggesting immune system activation in the patients
- Immune system activation results in increased migration of cancer-fighting CD8+ T-cells into MBC tumors and lymphatic tissue, leading to destruction of cancer cells
- Immune response following peripheral non-lesional Bria-IMT™ therapy suggests systemic activation of the immune system
- Clinical and CD8+ T cell response support the clinical benefit of the Bria-IMT™ plus CPI regimen in cancer patients
In summary, advanced ImmunoPET imaging technology correlates with clinical benefit with the Bria-IMT™ combination regimen in metastatic breast cancer and suggests possible use in identifying immunotherapy responsive tumors. These findings support the continued use of the Bria-IMT™ combination regimen in BriaCell’s ongoing pivotal Phase 3 study (listed on ClinicalTrials.gov as NCT06072612) in MBC.
To view the posters, please visit 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’s phase 2 study results suggesting a potential value of CD8 ImmunoPET in identifying pseudo progression in patients with clinical benefit vs tumor progression; the Bria-IMT™ regimen having the ability to revolutionize the treatment of cancer patients and improve patient outcomes; and the potential use of the Bria-IMT™ combination regimen in identifying immunotherapy responsive tumors are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements, such as those 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
FAQ
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