TIAN related Biomarker Validation Service

Background

CART therapy has revolutionized the treatment of several hematological malignancies, demonstrating remarkable clinical response rates. While CAR-T cell therapies have shown remarkable clinical effect, they are associated with toxicities, including immune effector cell–associated neurotoxicity syndrome (ICANS), and cytokine release syndrome (CRS). Recent research has identified a distinct neurotoxicity syndrome, tumor inflammation-associated neurotoxicity (TIAN), particularly relevant in patients treated with cell therapies for tumors in the central nervous system (CNS).

The successful management of CAR-T cell therapy-induced toxicities, including TIAN, hinges on the ability to predict, detect, and monitor these adverse events effectively. Biomarker validation plays a crucial role in this process, providing objective measures of biological processes, disease states, or clinical effect to therapeutic interventions.

Fig.1 CAR-T therapy challenges.¹

TIAN related Biomarker Validation Service at Creative Biolabs

Creative Biolabs offers specialized biomarker validation services, focusing on TIAN, to support the development of effective CAR-T cell therapy toxicity management solutions. TIAN presents with unique clinical manifestations that differ from the systemic toxicities of CRS and ICANS. Effective management strategies require a deep understanding of the underlying pathophysiological mechanisms and the ability to identify patients at high risk of developing TIAN.

Our biomarker validation efforts are essential for:

• Predictive Biomarkers: Identifying biomarkers that can predict the likelihood of a patient developing TIAN before CAR-T cell therapy. This allows for proactive monitoring and early intervention.
• Diagnostic Biomarkers: Validating biomarkers that can accurately diagnose TIAN, distinguishing it from other neurological complications.
• Prognostic Biomarkers: Determining biomarkers that can predict the severity and clinical course of TIAN, guiding treatment decisions.
• Therapeutic Response Biomarkers: Identifying biomarkers that can monitor a patient's response to TIAN directed therapies, enabling personalized treatment strategies.

Service Content

Creative Biolabs' comprehensive biomarker validation service supports the entire biomarker lifecycle, from discovery to clinical application. We offer a range of platforms for biomarker quantification:

• Flow Cytometry: Multi-parameter analysis of cell surface and intracellular markers.
• ELISpot/FluoroSpot: Highly sensitive detection of cytokine-secreting cells.
• Immunoassays: Quantification of soluble biomarkers using ELISA, multiplex assays (e.g., Luminex), and other immunoassay formats.
• Mass Cytometry (CyTOF): High-dimensional analysis of single cells using heavy metal-labeled antibodies.
• Histopathology: Histological and pathological services
• Molecular Assays: Gene expression analysis (e.g., PCR, qRT-PCR) and next-generation sequencing (NGS).
• Mass Spectrometry: Quantitative analysis of proteins and metabolites.

Our services encompass:

• Assay Development: We develop customized assays tailored to specific TIAN related biomarkers.
• Assay Validation: Rigorous validation studies ensure accuracy, precision, sensitivity, and specificity.
• Clinical Trial Support: We provide end-to-end support for clinical trials, including sample management and testing.
• Data Analysis: We provide comprehensive data analysis and reporting services.

Service Highlights

• Technology: State-of-the-art platforms for high-quality results.
• Customization: Tailored solutions to meet specific client needs.
• End-to-End Solutions: Streamlined process from assay development to data analysis.
• Focus on TIAN: Specializing in TIAN, a critical and emerging challenge in CAR-T therapy.

FAQs

Contact Us

Creative Biolabs is committed to partnering with pharmaceutical and biotech companies to advance the development of effective CAR-T cell therapy toxicity management solutions. For inquiries about our biomarker validation services, please contact us.

Reference

1. Zhou, Delian et al. "Advances in CAR-T therapy for central nervous system tumors." Biomarker research vol. 12,1 132. 6 Nov. 2024, doi:10.1186/s40364-024-00679-6. Distributed under Open Access License CC BY 4.0, without modification.