E!11880 Validation of a novel immune response capturing platform for immunotherapy development and monitoring.

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. The ImmunoMonitor project is addressing an unmet medical need with a solution to capture and monitor a patient's immune response over time using blood samples. Advances in next-generation sequencing (NGS) allow to take ?snapshots? of patient´s immune response by sequencing DNA or RNA from immune cells (i.e., the 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 response to immunotherapies. In the IMMUNOMONITOR project 5 partners have joined forces to validate a data analysis and visualization software solution for treatment response monitoring of cancer vaccines based on a unique approach to over-time immune repertoire sequencing data analysis. The clinical validation studies included Ultimovacs´ cancer vaccine UV1 tested in lung cancer and malignant melanoma. The project was initiated in July 2018 and came to an end September 2021. The project succeeded in integrating longitudinal NGS data from multi-center cancer vaccine studies and harmonizing accompanying clinical data as basis for the development of novel NGS analysis algorithms. Ultimovacs successfully contributed to the project in accordance with the project description and provided blood samples for analysis in the establishment of the software´s pre-clinical and clinical analysis modules and the validation of the clinical analysis module. Overall, the project has successfully established novel NGS analysis algorithms for characterization of immune metrics like diversity and clonality, however the applicability of these algorithms for use as response monitoring tools for specific cancer vaccines seems to be somewhat limited by the enormous diversity of the immune repertoire which will require further considerations before the software will function as a tool for evaluation of response to cancer vaccines over time

Prosjektet har gitt klinikk- og immunresponsdata på UV1 vaksinen som belyser sammenhengen mellom immunrespons mot vaksinen og klinisk nytte for pasientene. Prosjektet har gitt data som veileder videre utvikling av kreftvaksinen, støtte regulatorisk godkjenning og data som kan muliggjøre identifisering av prediktive biomarkører for respons på vaksinebehandlingen.

The goal of the IMMUNOMONITOR project is to validate a data analysis and visualization software solution for treatment response monitoring of cancer immunotherapies based on over-time immune repertoire sequencing analysis. 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. The consortium is addressing an 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 to take ‘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 analyse and visualize the immune response. IMMUNOMONITOR will be validated using data from clinical trials investigating cancer vaccines in patients with malignant melanoma and lung cancer.