BriaCell Showcases Robust Anti-Cancer Activity of Personalized Off-the-Shelf Immunotherapy Pipeline at the 2024 SITC Conference
BriaCell Therapeutics presented preclinical data showing strong anti-cancer activity of its next-generation immunotherapies, Bria-BRES+™ and Bria-PROS+™, at the 2024 SITC Conference. Both candidates effectively activated key components of the innate immune system and demonstrated ability to destroy breast and prostate cancer cells in preclinical models. The therapies are part of the Bria-OTS+™ platform, which represents an advancement in personalized, off-the-shelf cell-based immunotherapy. The company is currently conducting a Phase 1/2 study of first-generation Bria-OTS™ in metastatic breast cancer, with next-generation products expected to enter clinical trials in 1H2025.
BriaCell Therapeutics ha presentato dati preclinici che evidenziano una forte attività anti-cancro delle sue immunoterapie di nuova generazione, Bria-BRES+™ e Bria-PROS+™, durante la Conferenza SITC 2024. Entrambi i candidati hanno attivato efficacemente componenti chiave del sistema immunitario innato e hanno dimostrato la capacità di distruggere le cellule del cancro al seno e alla prostata in modelli preclinici. Le terapie fanno parte della piattaforma Bria-OTS+™, che rappresenta un avanzamento nella terapia immunitaria personalizzata e pronta all'uso basata su cellule. L'azienda sta attualmente conducendo uno studio di Fase 1/2 del Bria-OTS™ di prima generazione nel cancro al seno metastatico, con i prodotti di nuova generazione che dovrebbero entrare in studi clinici nella prima metà del 2025.
BriaCell Therapeutics presentó datos preclínicos que muestran una fuerte actividad anticancerígena de sus inmunoterapias de próxima generación, Bria-BRES+™ y Bria-PROS+™, en la Conferencia SITC 2024. Ambos candidatos activaron efectivamente componentes clave del sistema inmunológico innato y demostraron la capacidad de destruir células de cáncer de mama y próstata en modelos preclínicos. Las terapias son parte de la plataforma Bria-OTS+™, que representa un avance en la inmunoterapia personalizada y lista para usar basada en células. La empresa está llevando a cabo actualmente un estudio de Fase 1/2 del Bria-OTS™ de primera generación en cáncer de mama metastásico, con los productos de nueva generación que se espera entren en ensayos clínicos en la primera mitad de 2025.
BriaCell Therapeutics는 2024 SITC 회의에서 차세대 면역 요법 Bria-BRES+™와 Bria-PROS+™의 강력한 항암 활동을 보여주는 전임상 데이터를 발표했습니다. 두 후보 모두 선천 면역 체계의 주요 구성 요소를 효과적으로 활성화했으며, 전임상 모델에서 유방암 및 전립선암 세포를 파괴할 수 있는 능력을 보여주었습니다. 이 요법은 세포 기반 맞춤형 오프 더 셀프 면역 요법에서 한 단계 발전을 나타내는 Bria-OTS+™ 플랫폼의 일환입니다. 현재 회사는 전이성 유방암에 대한 1/2상 초기 세대 Bria-OTS™ 연구를 진행하고 있으며, 차세대 제품은 2025년 상반기에 임상 시험에 들어갈 예정입니다.
BriaCell Therapeutics a présenté des données précliniques montrant une forte activité anticancéreuse de ses immunothérapies de nouvelle génération, Bria-BRES+™ et Bria-PROS+™, lors de la Conférence SITC 2024. Les deux candidats ont activé efficacement des éléments clés du système immunitaire inné et ont démontré leur capacité à détruire les cellules de cancer du sein et de la prostate dans des modèles précliniques. Les thérapies font partie de la plateforme Bria-OTS+™, qui représente une avancée dans la thérapie immunitaire personnalisée et prête à l'emploi basée sur les cellules. L'entreprise mène actuellement une étude de Phase 1/2 sur le Bria-OTS™ de première génération dans le cancer du sein métastatique, avec des produits de nouvelle génération qui devraient entrer dans des essais cliniques au cours du premier semestre 2025.
BriaCell Therapeutics stellte auf der SITC-Konferenz 2024 präklinische Daten vor, die eine starke Anti-Krebs-Wirkung seiner Immuntherapien der nächsten Generation, Bria-BRES+™ und Bria-PROS+™, zeigen. Beide Kandidaten aktivierten effektiv die wichtigsten Komponenten des angeborenen Immunsystems und zeigten die Fähigkeit, Brust- und Prostatakrebszellen in präklinischen Modellen zu zerstören. Die Therapien sind Teil der Plattform Bria-OTS+™, die einen Fortschritt in der personalisierten, sofort einsatzbereiten Zellbasierten Immuntherapie darstellt. Das Unternehmen führt derzeit eine Phase 1/2-Studie zur ersten Generation von Bria-OTS™ bei metastasiertem Brustkrebs durch, wobei die Produkte der nächsten Generation voraussichtlich im 1. Halbjahr 2025 in klinische Studien eintreten werden.
- Strong anti-cancer activity demonstrated in preclinical models
- Effective activation of both innate and adaptive immune responses
- Platform designed for personalized and ready-to-use therapy
- Phase 1/2 trial of first-generation product already underway
- Next-generation products planned for clinical trials in 1H2025
- Products still in early development stages with no clinical efficacy data yet
- Clinical success not guaranteed despite promising preclinical results
Insights
The preclinical data for Bria-OTS+™ platform demonstrates significant potential in cancer immunotherapy. Key findings show that both Bria-BRES+™ and Bria-PROS+™ effectively activate dual immune responses - both innate (NK cells, NKT cells) and adaptive immunity. This dual-action approach is particularly noteworthy as it addresses a major limitation in current cancer treatments: immune escape mechanisms.
The platform's personalized, off-the-shelf design combining multiple immune-activating components (cytokines, co-stimulatory molecules, GM-CSF) represents a sophisticated approach to cancer treatment. The preclinical results showing cancer cell destruction and potential for durable responses are promising, though early-stage. The planned clinical transition in 1H2025 for prostate cancer treatment will be important for validating these preclinical findings.
- BriaCell’s clinical candidates for next generation breast cancer (Bria-BRES+™) and prostate cancer (Bria-PROS+™) generate robust anti-cancer activity in preclinical models
- Novel therapy activates both innate and adaptive immune systems
- Proof of concept Phase 1/2 Study of Bria-BRES™ in metastatic breast cancer currently underway
PHILADELPHIA and VANCOUVER, British Columbia, Nov. 08, 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, today is pleased to report preclinical data showing strong anti-cancer activity of its next generation, personalized, off-the-shelf, cell-based breast and prostate cancer immunotherapies, Bria-BRES+™ and Bria-PROS+™, respectively, during a poster session at the 2024 Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting, held November 6-10, 2024, in Houston, TX.
Bria-OTS+™ is an Off-The-Shelf (i.e. pre-manufactured and ready for use) cell-based personalized immunotherapy platform for cancer. First generation Bria-OTS™ immunotherapy is HLA matched to individual patients and expresses a variety of cancer-related antigens, including Tumor-Associated Antigens (TAAs) and Post-Translational Modifications (PTMs). Bria-OTS+™ further expresses multiple immune activating cytokines and co-stimulatory molecules in addition to immune boosting granulocyte-macrophage colony-stimulating factor (GM-CSF). The Bria-OTS+™ platform technology includes both Bria-BRES+™ and Bria-PROS+™, expansions of the Bria-OTS™ program.
“Bria-OTS+™ represents a significant advancement in the fight against cancer, leveraging gene-modified allogeneic tumor cells as a comprehensive immunotherapeutic platform. This innovative approach is set to address major challenges in cancer therapy, including effective antigen selection, T-cell immune escape, and manufacturing complexities. The development of Bria-OTS+™ builds on the success of BriaCell's initial platform, Bria-IMT™, which has shown promising clinical results in metastatic breast cancer,” commented Miguel A. Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer.
“We are thrilled with our pre-clinical data confirming the expected high potency and potential for long-lasting anti-tumor activity of our novel next-generation immunotherapy in multiple cancer models,” commented Dr. William V. Williams, BriaCell’s President and CEO. “We believe that activating both adaptive and innate immune systems is a novel and highly effective approach for cancer treatment and look forward to generating proof of concept data in our ongoing Phase 1/2 study of Bria-OTS™ in metastatic breast cancer, and other cancers.”
The poster is summarized below and linked here: https://briacell.com/scientific-publications/.
Title: Bria-OTS+™: A Cellular Cancer Vaccine Platform Targeting Innate and Adaptive Immunity
Location: Exhibit Halls A B George R. Brown Convention Center, Houston, TX
Date and Time: Friday, Nov. 8, 2024, 9:00 am -7:00 pm CST
Results:
- Both Bria-BRES+™ (clinical candidate for breast cancer) and Bria-PROS+™ (clinical candidate for prostate cancer) activated key components of the innate immune system, the body’s first line of defense against cancer, including Natural Killer (NK) cells and NKT cells in preclinical cancer models.
- Activation of the innate immune system by Bria-BRES+™ and Bria-PROS+™ was mediated by CD86, IL-12, NKG2D and inhibited by HLA class I molecules
- Bria-BRES+™ and Bria-PROS+™ both effectively activated immune cells to destroy breast cancer and prostate cancer cells in a pre-clinical cancer model
- Both Bria-BRES+™ and Bria-PROS+™ activated key adaptive immune responses demonstrating immunological memory and suggesting potent and durable anti-cancer effects in cancer patients
Conclusion:
The characteristics of the next generation Bria-OTS+™ immunotherapy platform include the following:
- Engages multiple facets of the adaptive immune response
- Activates components of the innate immune system
- Specifically activates Natural Killer (NK) cells to offset cancer immune escape caused by the loss of human leukocyte antigens (HLA)
- Designed for both personalized and ready-to-use therapy with long-term stability
- Simplified intradermal administration (injection into the skin)
- Targeted mechanism of action expected drive high efficacy with a favorable side effect profile
“The preclinical data demonstrating targeted activation of both the innate and adaptive immune systems suggest potential efficacy and safety across multiple cancer indications,” stated Adam M. Brufsky, MD, PhD, FACP, Professor of Medicine at the University of Pittsburgh School of Medicine and Medical Director of the Magee-Women's Cancer Program. “Personalized off-the-shelf cancer immunotherapy is an especially exciting treatment modality that would benefit many cancer patients.”
BriaCell is currently conducting its Phase 1/2 Study of Bria-OTS™ (first generation product), also known as Bria-BRES™, in metastatic breast cancer (listed on ClinicalTrials.gov as NCT06471673). This is a bucket trial with other cancer indications expected to be added soon. The next generation (Bria-OTS+™) is expected to enter the clinic in 1H2025 starting with Bria-PROS+™ for prostate cancer.
Bria-OTS+™ leverages advanced biomanufacturing techniques, ensuring scalability and cost-effectiveness, crucial for rapid global deployment. It is designed to target a range of cancer types and strong intellectual property strategy protects Bria-OTS+™ innovations and strengthens BriaCell’s competitive position. Bria-OTS+™ is designed as an open-ended, modular platform, allowing for continuous refinement and the addition of new components. This flexibility enables BriaCell to rapidly adapt to emerging scientific insights and therapeutic needs, ensuring long-term relevance and effectiveness.
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 Bria-OTS+™ addressing certain challenges in cancer therapy, such as effective antigen selection, T-cell immune escape, and manufacturing complexities; BriaCell generating proof of concept data in the ongoing Phase 1/2 study of Bria-OTS+™ in various cancers, such as metastatic breast cancer; the preclinical data of Bria-OTS+™ demonstrating potential efficacy and safety across multiple cancer indications; BriaCell’s personalized off-the-shelf immunotherapy benefiting many cancer patients; BriaCell continuing its clinical study investigations of its novel targeted immunotherapy candidates, including the addition of new cancer indications; and BriaCell’s anticipated timeline of clinical studies on Bria-OTS+™ and Bria-PROS+™, 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, 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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