Advancing precision oncology with biomarker strategies

In the dynamic, high-stakes fields of oncology, drug discovery, and development, success frequently depends on precision medicine:

• ‘Precision’ means comprehending disease biology, targeting pathways, and, most importantly, choosing appropriate patients.
• This precision-driven strategy relies on one vital pillar: biomarkers.

Image Credit: Shutterstock.com/Premreuthai 

The power of biomarkers in oncology drug discovery

Biomarkers serve as measurable indicators of biological states and conditions. In oncology, these valuable tools direct decision-making throughout the drug discovery and development continuum, covering early discovery and mechanism-of-action research to clinical development and beyond.

Their utility includes:

• Patient stratification: Biomarkers help insure that investigational treatments are evaluated in more relevant patient populations.
• Predictive and prognostic insights: Biomarkers can help developers assess treatment response potential or disease progression, supporting more informed trial design and regulatory decision-making.
• Target engagement assays: They assist in optimizing therapeutic candidates during both the preclinical and clinical phases of pharmaceutical development, supporting dose selection and ascertaining their intended biological impacts.
• Efficacy biomarker assays: Biomarkers deliver insights into biological responses to therapeutic interventions and validate the mechanism of action.

The increasing complexity of cancer biology, including tumor heterogeneity and microenvironment dynamics, makes biomarker development crucial.

Why Evotec?

As the oncology field accelerates toward more personalized and data-rich drug development, Evotec is positioned as a strategic partner uniquely equipped to incorporate biomarker discovery into each phase of the oncology pipeline.

Integrated biomarker approach, from bench to bedside and vice versa

Evotec develops holistic biomarker approaches for both standalone and integrated drug discovery projects across the oncology and immuno-oncology fields, supporting smoother transitions from preclinical discovery to clinical implementation. Their capabilities cover the entire biomarker lifecycle:

• Early strategic planning, including patient segment identification and PK/PD verification
• Exploratory and GCP-level assay development customized for clinical translation
• Support for GxP and non-GxP biomarker testing in clinical trial samples

This end-to-end framework enables accurate drug and patient selection, two essential determinants of clinical success.

Integrated expertise and technology platforms

With a team of more than 80 dedicated translational biomarker experts, Evotec provides comprehensive scientific and operational capabilities, including cutting-edge 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: State-of-the-art technologies such as quantitative mass spectrometry, Proteograph^™, and Olink for detailed profiling
• High-sensitivity immunoassays: Innovative systems including MSD, Quanterix, SMCxPro, NULISA, and Luminex for nuanced protein and cellular evaluations
• Flow cytometry and 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 for biomarker contextualization in the tumor microenvironment
• Image evaluation: Automated high-content image evaluation and ROI annotation using deep learning

By using this holistic toolkit, Evotec builds high-fidelity assays for a broad range of readouts, including genomic, transcriptomic, proteomic, and spatial, providing partners with a broad, multi-dimensional view of candidate activity and potential.

Access to human samples and clinical insights

A significant bottleneck in biomarker development is gaining access to relevant, well-characterized human samples. Evotec overcomes this obstacle through strategic partnerships with clinical centers, commercial sources, and dedicated biobanks:

• Prospective and retrospective sampling across more than 20 oncology indications
• Over 1,000 patient sample collections per year, ensuring statistical robustness
• Dedicated human samples biorepository
• Clinical consultancy via physicians and histopathologists

These assets help bridge the translational gap and validate biomarker hypotheses in practical patient populations.

AI-driven biomarker discovery and evaluation

Evotec leverages artificial intelligence and machine learning (AI and ML) tools to reveal hidden patterns in intricate datasets. The company’s integrated analytics platforms improve biomarker discovery, patient segmentation, and predictive modeling, converting data into actionable insights with greater efficiency and interpretability.

Verified track record and commitment to innovation

In 2024 alone, Evotec assisted the development of over 25 exploratory biomarkers across the field of oncology. This track record is a testament to the company’s agility, scientific rigor, and collaborative approach. Evotec works as a scientific partner, supporting biomarker strategies from discovery through clinical development.

A strategic partner for oncology innovators

For leaders and researchers in pharma and biotech, collaborating with a biomarker-focused organization such as Evotec offers transformative advantages. The company’s combination of innovative science, operational quality, and translational insight allows oncology programs to:

• Identify and validate biomarker hypotheses with greater confidence
• Speed up IND and clinical trial readiness
• Enhance the probability of clinical success via informed patient selection
• Optimize resource allocation through data-driven decision-making

In an industry where accuracy is essential, biomarkers are key, and Evotec helps partners translate biomarker insights into actionable oncology development decisions.

About Evotec

Evotec’s mission is to discover and develop highly effective therapeutics and make them globally available to the patients who need them. To this end, Evotec has established itself as a global platform company, leveraging its data-driven multimodality platform for both proprietary as well as partnered research, and applying a unique combination of innovative technologies for the discovery and development of first-in-class and best-in-class pharmaceutical products. Its network of partners includes all Top 20 Pharma and hundreds of biotechnology companies, academic institutions, and other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including, e.g., neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and make them accessible to patients worldwide. To-date, the Company has established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development.

Evotec operates globally with more than 4,500 highly qualified people at 17 sites in six countries across Europe and the USA. The Company’s sites in Hamburg (HQ), Cologne, Goettingen, Halle/Westphalia and Munich (Germany), Lyon and Toulouse (France), Abingdon and Alderley Park (UK), Modena and Verona (Italy), Orth (Austria), as well as in Branford, Princeton, Redmond, Seattle and Framingham (USA) offer highly synergistic technologies and services and operate as complementary clusters of excellence.

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