Turning promising oncology innovations into clinical realities requires an expert-driven oncology biomarker strategy. Evotec's platform combines 80+ experts with access to 1,000+ patient sample acquisitions annually across 20+ cancer indications to deliver precise, clinically validated biomarker strategies.
Translational Oncology Biomarkers Platform at Evotec
Evotec develops oncology and immuno-oncology biomarker strategies that deliver translational biomarker readouts applicable to clinical samples. These enable accurate target identification, patient stratification, and therapeutic response monitoring.
Our translational oncology biomarker framework encompasses:
- Expert guidance & proven success: Leveraging decades of experience to drive translational biomarker development
- Biomarker discovery & validation: Multiple dedicated platforms for high-sensitivity biomarker analysis, focused on oncology
- Design and execution of biomarker strategy & AI/ML databases and cohorts: Utilize AI/ML tools to unlock hidden patterns in complex data sets
- Access to translatable and specialized models: In vivo & ex vivo pre-clinical models, including human and patient-derived samples
- Support for clinical trial measurements under non-GCP & GCP: Supporting clinical studies and storage of materials
Evotec collaborates with partners to improve clinical success, providing strategic guidance for precise biomarker assay development and patient‑selection decisions.
Oncology Biomarkers Drive Precision Cancer Medicine
Biomarkers are measurable indicators of biological states and conditions. In oncology, they are critical in driving precision medicine, guiding decision-making across the drug discovery and development continuum from early discovery and mechanism-of-action studies to clinical development and beyond. For example, the discovery of BRAF mutations in melanoma has improved prognostic assessment and now plays a central role in guiding personalized treatment.
Oncology biomarker utility spans:
- Patient Stratification: Biomarkers ensure that investigational therapies are tested in the most appropriate patient populations
- Predictive and Prognostic Insights: Biomarkers allow clinicians and developers to forecast treatment outcomes or disease progression, facilitating efficient trial design and regulatory success
- Target Engagement Assays: They help optimize drug candidates in both preclinical and clinical stages of drug development, supporting dose selection and confirming their desired biological effects
- Efficacy Biomarkers Assays: Biomarkers provide insights into biological responses to therapeutic interventions and validation of the mechanism-of-action
Given their critical role, biomarkers must undergo rigorous analytical and clinical validation before they can be applied in routine clinical use.
Why Choose Evotec for Oncology Biomarkers?
Our translational oncology biomarker services support both standalone and integrated drug discovery projects, offering end-to-end solutions, from biomarker discovery and validation to clinical assay deployment under GCP or non-GCP conditions.
Our Scale & Expertise
- 80+ experts dedicated to translational biomarkers
- >25 exploratory biomarkers developed in oncology in 2024
- >20 oncology indications for sample access
- >1,000 patient sample acquisitions per year for oncology
By leveraging advanced platforms in genomics, transcriptomics, proteomics, flow cytometry, immunoassays, and histology, as well as strategic access to human samples, we verify that every biomarker strategy is robust, scalable, and clinically relevant.
Whether your team is optimizing early-phase development or advancing through clinical trials, our scientist-to-scientist collaboration means you receive strategic guidance across biomarker strategy, assay design, execution, and regulatory pathways.
Our Oncology Biomarker Capabilities & Solutions
Our translational oncology capabilities span discovery to clinical application. We deliver stage-specific strategic guidance, access to human samples, and advanced operational platforms that deliver regulatory readiness and physiologically relevant testing (Figure 1).
Figure 1. Evotec’s capabilities and solutions for translational biomarkers in oncology
Evotec’s Translational Biomarkers Strategy platform provides detailed strategic planning from early development through clinical validation, ensuring biomarkers align with regulatory requirements and clinical objectives, through:
- Early strategy document
- Indication/patient segment identification
- Exploratory/GCP assay set-up and validation
- Clinical biomarker assessment
The Human Samples Platform provides access to diverse, clinically relevant human samples with expert consultation to deliver biomarker validation in physiologically relevant contexts, and is achieved through:
- Strategic collaborations with clinical centers for prospective sampling
- Retrospective samples via commercial sources and dedicated biobanks
- Blood from healthy volunteers
- Consultancy with physicians and histopathologists
- Human samples biorepository
Operational Platforms dedicated to translational biomarkers combine exploratory and targeted technologies to deliver high-sensitivity biomarker detection from discovery through clinical application:
- Molecular Biology:
- Exploratory: bulk RNA-seq, DNA-seq, scRNA-seq
- Targeted: Direct qPCR, Fluidigm® signature, qPCR
- Proteomics & Metabolomics:
- Exploratory: High-end quantitative mass spectrometry, Proteograph™
- Targeted panels: Olink® Flex/Focus/Target48 & 96/Reveal/Explore
- High-Sensitivity and Flow Cytometry Platforms:
- Next-generation immunoassay systems: MSD, SMCxPro, Quanterix, NULISA
- Advanced cytometry tools: Jess, FACS, Luminex for precise cellular analysis
- Histology:
- IHC, immunofluorescence, and in-situ hybridization (multiplexing)
- Tissue micro-array
- Scan & digital analysis/histopathologist consultancy
- Biomarker Testing in Clinical Samples (under GCP and/or non-GCP):
- Extensive experience in developing biomarker assays that can be used in the preclinical phase and subsequently in clinical trials, whether under GCP or non-GCP conditions
- Evotec supports clinical trials by performing exploratory biomarker evaluations using various technologies
Case Study: From Whole Blood Assays to Clinical Trial Support
Evotec developed a translational target engagement (TE) assay to demonstrate the mechanistic activity of compound EXS21546 at clinically relevant doses, bridging preclinical findings with Phase I clinical validation.
Client Aim
Develop a TE assay to demonstrate that EXS21546 is mechanistically active at the right dose in the clinic.
Evotec's Strategy
We designed an ex vivo whole blood assay platform applicable to both preclinical models and clinical samples, enabling direct pharmacokinetic/pharmacodynamic (PK/PD) relationship assessment across development stages (Figure 2). This was achieved through three key stages:
1. Assay Development in Preclinical Models
- Developed and optimized whole blood assays in mouse models
- Established dose-response relationships and EC50 values (mouse EC50 = 556nM)
- Validated pCREB staining on CD8+ T-cells as a robust pharmacodynamic readout
2. Translation to Human Samples
- Adapted assay for human whole blood from healthy donors and patients
- Confirmed TE across dose ranges (human EC50 = 47nM)
- Validated assay sensitivity to detect differences between treated and non-treated patient cohorts
3. PK-PD Relationship Establishment
- Established PK-PD relationship using plasma drug concentration data integrated with pharmacodynamic response (pCREB inhibition in CD8+ T-cells)
Figure 2. Assay development in CD8+ T-cells to confirm target engagement (TE) across dose ranges
Clinical Application
The validated assay provided clear evidence that EXS21546 engaged its target at doses relevant to clinical use. In Phase I trials, it confirmed dose-dependent target engagement and validated the PK-PD relationship, providing confidence to progress the compound.
Establishing target engagement early informed dose selection and patient population decisions, optimizing clinical trial design and resource investment. Evotec worked collaboratively with the client from assay design through clinical validation to deliver mechanistic clarity at each stage.
Advance Your Oncology Biomarker Strategy with Evotec
Developing effective oncology biomarkers requires specialized tumor biology expertise and extensive patient sample access. Our team of 80+ biomarker experts works with 1,000+ patient samples annually across 20+ cancer indications.
We leverage platforms spanning genomics, transcriptomics, proteomics, flow cytometry, immunoassays, and histology to deliver clinically validated biomarker strategies from discovery through regulatory deployment. Through hands-on collaboration, we integrate strategic guidance with operational execution, creating precise, scalable, and regulatory-ready biomarker assays.
Ready to advance your oncology biomarker strategy?
Our translational biomarker team will discuss your indication, patient population, and regulatory pathway to design the optimal approach.
