Treatment response monitoring for cancer immunotherapies using immune repertoire analysis

Biomax joins four partners in the IMMUNOMONITOR cancer research project, which aims to validate a data analysis and visualization software solution for treatment response monitoring of cancer immunotherapies based on over-time immune repertoire sequencing analysis.

Biomax will drive the integration of longitudinal NGS data from multi-center cancer vaccine studies and accompanying clinical data capturing systems into the BioXM platform. The study data will be harmonized and used to develop novel NGS analysis algorithms.

The rise of immunotherapy has been one of the most promising developments for cancer treatment in decades. Immunotherapies such as cancer vaccines, cell therapies and antibodies, empower the body’s own immune system to fight cancer. However, promising immunotherapies like Pembrolizumab cost €100,000 per patient and are only effective in ~20% of treated patients. Expensive immunotherapies are driving the average treatment cost per patient up from €5,000 a decade ago to over €10,000 nowadays. While a growing number of immunotherapies have been approved, no adequate diagnostic tests are available to capture the desired immune response and to monitor if the therapy is effective in an individual patient.

The IMMUNOMONITOR consortium addresses this unmet medical need with a software solution to capture and monitor a patient’s over-time immune response using blood samples. Advances in Next-Generation Sequencing (NGS) allow taking ‘snapshots’ of a patient’s immune response by sequencing DNA or RNA from patient’s immune cells (i.e., immune repertoire). The enormous diversity of immune repertoires results in a staggering amount of data, which cannot be handled by existing tools for NGS data analysis. IMMUNOMONITOR uses advanced bioinformatics algorithms to generate an ‘immune fingerprint’ using NGS big data analysis for monitoring of immunotherapies. The consortium will deliver a user-friendly and secure bioinformatics platform to analyze and visualize the immune response. IMMUNOMONITOR will be validated using two cancer vaccines for malignant melanoma and lung cancer, respectively. This personalized approach will enable clinicians to tailor immunotherapies to the patient’s immune response, which significantly increases the chance of success.

For its part in the project, Biomax will set up the BioXM Knowledge Management Environment to integrate the different modalities involved in immunomonitoring (clinical and experimental data, sample data, immunomonitoring, immunosequencing, and analysis results). The BioXM platform provides ISO 27001-conforming secure storage of such data with encryption, access control and auditing. A semantic concept for data integration will be developed and interfaces for data exchange, overviews and visualization will be configured and refined in collaboration with the partners.

Existing data capturing systems for clinical and laboratory data (electronic case report forms, electronic health records, laboratory information systems) will be integrated into the BioXM platform based on established clinical interoperability standards.

Biomax will also provide data validation and harmonization for the project to improve the comparability of the data and the validity of results. Data validation is required to address the issues of data quality that arise when integrating data from multiple sites, including cross-data inconsistencies, missing values, values out of range, and categorization of data. Data harmonization addresses the heterogeneous requirements, priorities, historic procedures, cultural/geographical and technological differences in the data of multiple centers.

The IMMUNOMONITOR consortium is funded by a EUROSTARS grant. This European consortium consists of five collaborating partners:

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