Oncology and immuno-oncology are complex fields defined by tumor diversity, immune system variability, and heterogeneous patient responses. Biomarkers overcome these challenges by guiding target validation, patient selection, and monitoring therapy. They provide data-driven insights that ensure effective and personalized treatment.
At Evotec, biomarkers are integrated across every oncology and immuno-oncology program to enhance translational predictability and clinical outcomes, using molecular, histological, immunological, and proteomic data to accelerate precision medicine.
Evotec Expertise in Oncology Biomarkers
Evotec develops integrated biomarker strategies for oncology and immuno-oncology, ensuring assays align with therapeutic and regulatory goals.
- Multi-Platform Capabilities: Histology, proteomics, transcriptomics, Olink®, flow cytometry, Custom-designed immunoassays, and immune cell profiling.
- Clinical Sample Access: Collaborations with hospitals and biobanks for annotated tumor and blood materials to perform ex vivo treatment for biomarker validation.
- Validated Assay Development: From exploratory discovery to GCP-compliant validation.
- AI-Driven Insights: Using omics and clinical data to identify key biomarkers in oncology and immuno-oncology domains.
What's Unique at Evotec:
Integrated biomarker solutions combining real-world patient samples, state-of-the-art platforms, and leading scientific expertise in oncology and immuno-oncology.
Exploratory Biomarkers Evaluation in Clinical Trial Phase I
Background: The EVT801 program was developed by Evotec from target identification through IND. The client later acquired the compound for clinical development.
Client Goal: Support a Phase I clinical trial in collaboration with French hospitals and perform exploratory biomarker evaluations to inform future biomarker-driven development.
Evotec’s Contribution:
EVT801 Phase I Trial (NCT05114668): Evaluating safety, tolerability, and pharmacokinetics of EVT801.
- Approval obtained in 09/2021
- First Patient In: 10/2021 (Toulouse and Lyon sites)
- Completed in 11/2024
Exploratory Biomarker Analysis:
- Identification of responsive patient populations
- Early indication of efficacy through IHC/IF and mRNA tumor signatures
- Comprehensive immuno-monitoring for translational insights
Frequently Asked Questions
What types of oncology biomarkers does Evotec develop?
Evotec develops biomarkers across all major oncology categories, including diagnostic, predictive, pharmacodynamic, and efficacy biomarkers. These range from molecular signatures to protein and histological markers.
How does Evotec ensure the clinical relevance of oncology biomarkers?
Through partnerships with clinical centers, Evotec accesses high-quality patient samples linked to clinical outcomes, ensuring biomarkers are validated in real-world disease contexts.
What makes Evotec’s oncology biomarker platform unique?
Our integrated approach combines AI-guided biomarker strategy, end-to-end assay development, and expert clinical interpretation to ensure translatability from discovery to clinic.
Are Evotec’s oncology biomarkers GCP-compliant?
Yes. We offer both exploratory and GCP-compliant assay development and validation, ensuring regulatory adherence for biomarker data used in clinical decision-making.
How early should biomarker strategy be integrated into oncology R&D?
Ideally, biomarker planning should start during target validation or early preclinical stages to ensure data alignment across translational and clinical phases.
