In the dynamic and high-stakes field of oncology, drug discovery and development, the difference between success and failure often hinges on precision medicine:

• ‘Precision’ means understanding disease biology, targeting pathways, and, most critically, selecting the right patients.
• This precision-driven approach rests one fundamental pillar—the biomarkers.

Biomarkers are measurable indicators of biological states and conditions. In oncology, they are indispensable tools that guide decision-making across the drug discovery and development continuum from early discovery, mechanism-of-action studies to clinical development and beyond.

Their 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 ascertaining their desired biological effects.
• Efficacy Biomarkers Assays: Biomarkers provide insights into biological responses to therapeutic interventions, and validation of mechanism-of-action.

The growing complexity of cancer biology, including tumor heterogeneity and microenvironment dynamics, makes biomarker development not just valuable, but essential.

As the oncology field accelerates toward increasingly personalized, data-rich drug development, Evotec stands out as a strategic partner who is uniquely positioned to integrate biomarker discovery into every stage of the oncology pipeline.

We design comprehensive biomarker strategies for standalone and integrated drug discovery projects across the oncology and immuno-oncology area, ensuring seamless transitions from preclinical discovery to clinical execution. Our capabilities span the full biomarker lifecycle:

• Early Strategic Planning, including patient segment identification and PK/PD validation.
• Exploratory and GCP-Level Assay Development tailored for clinical translation.
• Support for GxP and Non-GxP Biomarker Testing in clinical trial samples.

This end-to-end framework supports precise drug and patient selection, two of the most critical levers for clinical success.

With over 80 dedicated experts in translational biomarkers, Evotec brings deep scientific and operational expertise, including state-of-the-art platforms:

• Molecular Biology: Bulk RNAseq, DNAseq, scRNAseq, RNA gene signature using Fluidigm technology, spatial transcriptomics and high-throughput qPCR for insights into gene expression.
• Proteomics and Metabolomics: Cutting-edge technologies such as quantitative mass spectrometry, Proteograph™, and Olink for comprehensive profiling.
• High-Sensitivity Immunoassays: Advanced systems including MSD, Quanterix, SMCxPro, NULISA, and Luminex for nuanced protein and cellular analyses.
• Flow Cytometry & Blood Cell Isolation: BD FACSVerse, BD FACSLyric, Thermo Attune NxT, MACS technology for cell isolation and characterization.
• Histology: immunohistochemistry and immunofluorescence, in-situ hybridization, multiplexed digital imaging, spatial proteomics and tissue microarrays to contextualize biomarkers in the tumor microenvironment.
• Image Analysis: Automated high content image analysis and annotation of ROIs using deep learning.

This comprehensive toolkit enables Evotec to develop high-fidelity assays for a variety of readouts—genomic, transcriptomic, proteomic, and spatial, providing partners a 360° view of their candidates' activity and potential.

A major barrier in biomarker development is access to relevant, well-characterized human samples. Evotec addresses this challenge through strategic collaborations with clinical centers, commercial sources and dedicated biobanks:

• Prospective and Retrospective Sampling across 20+ oncology indications.
• 1,000+ Patient Sample Acquisitions per Year, ensuring statistical robustness.
• Dedicated Human Samples Biorepository.
• Clinical Consultancy via Physicians and Histopathologists.

These assets help bridging the translational gap and validating biomarker hypotheses in real-world patient populations.

Evotec leverages AI/ML tools to unlock hidden patterns in complex data sets. Our integrated analytics platforms enhance biomarker discovery, patient segmentation, and predictive modeling, turning data into actionable insights with greater speed and precision.

In 2024 alone, Evotec supported the development of more than 25 exploratory biomarkers across oncology. This track record speaks to our agility, scientific rigor, and collaborative approach. We are not just a service provider, we are your partner in discovery.

For scientists and leaders in pharma and biotech, partnering with a biomarker-focused powerhouse like Evotec is not just advantageous, it is transformative. Our blend of cutting-edge science, operational excellence, and translational insight enables oncology programs to:

• Identify and validate drug targets with higher confidence.
• Accelerate IND and clinical trial readiness.
• Increase the likelihood of clinical success through informed patient selection.
• Optimize resource allocation with data-driven decision-making.

In an era where precision is paramount, biomarkers are the key—and Evotec is the force to unlock 

Whether you are advancing a novel oncology or immuno-oncology agent or exploring combination strategies in solid or liquid tumors, Evotec’s biomarker expertise can help you to make smarter, faster, and more informed decisions. Learn more at Evotec Biomarkers or reach out at info@evotec.com to the oncology team.