Precision Diagnostics for Predicting Therapy Response to Bispecific Antibodies

Project Information

Interact-ALL

Grant agreement ID: 101185344

DOI

10.3030/101185344

Project closed

EC signature date 29 October 2024

Start date 1 January 2025

End date 30 June 2026

Funded under

• European Research Council (ERC)

Total cost

No data

EU contribution

€ 150 000,00

Coordinated by

CHARITE - UNIVERSITAETSMEDIZIN BERLIN
Germany

Periodic Reporting for period 1 - Interact-ALL (Precision Diagnostics for Predicting Therapy Response to Bispecific Antibodies)

Reporting period: 2025-01-01 to 2026-06-30

Summary of the context and overall objectives of the project

Immunotherapies have transformed the treatment of many cancers by harnessing the patient's own immune system to eliminate malignant cells. Despite these major advances, not all patients benefit equally from these therapies, and there are currently only limited tools available to predict which patients are most likely to respond. As a result, some patients receive treatments that are ineffective for them while being exposed to unnecessary side effects, and healthcare systems incur considerable costs associated with expensive therapies. Improving the ability to identify patients who are most likely to benefit from a specific immunotherapy is therefore an important step towards more personalized and efficient healthcare.
The objective of this project was to develop and evaluate a novel diagnostic approach capable of predicting patient response to a key immunotherapy used in the treatment of acute lymphoblastic leukemia. Building on a novel technology that quantifies interactions between immune cells - the mechanistic basis of this immunotherapy - the project aimed to validate newly identified predictive biomarkers and establish the foundation for assay development and clinical evaluation. In parallel, the project sought to advance the scientific, technical, and strategic groundwork required for future clinical implementation and commercial translation of the technology.
The expected long-term impact is to enable more informed treatment decisions, thereby improving patient outcomes while reducing unnecessary treatments and healthcare costs. Beyond this specific application, the project establishes a general framework that may support the development of future precision diagnostics for other immunotherapies and diseases.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The project successfully completed the majority of planned scientific and technical activities required to validate and advance the diagnostic technology toward clinical application. The predictive biomarkers identified in previous research were successfully validated in a retrospective patient cohort. These results confirmed the robustness and reproducibility of the approach across patient populations, substantially strengthening the scientific evidence supporting its predictive value. Importantly, the project provides the first demonstration that quantitative measurements of cellular interactions can serve as effective biomarkers for predicting response to immunotherapy. Building on these findings, activities supporting future implementation of the assay in routine clinical diagnostics were initiated. The project also prepared for prospective clinical validation of the assay in collaboration with clinical partners. As anticipated for prospective clinical studies, patient recruitment and clinical follow-up extend beyond the duration of the current project. Consequently, this work will continue after the completion of the present funding period.
In parallel with the scientific and technical work, preparatory activities were undertaken to facilitate future clinical translation. These included evaluation of regulatory pathways, assessment of commercialization opportunities, and strategic planning for implementation in routine diagnostics. Together, these activities complement the technical achievements and establish a solid foundation for subsequent development and clinical adoption of the technology.
Overall, the project achieved its principal scientific and technical objectives by validating the underlying biomarkers, significantly increasing the technology's maturity, and establishing a strong foundation for prospective clinical validation, regulatory approval, and eventual implementation in routine clinical practice.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The project advances the state of the art by introducing a new diagnostic concept that not only analyzes individual immune cells but also captures interactions between different immune cell populations as predictors of treatment response. This represents an innovative approach to precision medicine that complements existing biomarker strategies and may improve the ability to personalize immunotherapy in the future.
Although the technology has demonstrated encouraging performance in retrospective validation studies, additional work is required before clinical implementation. Ongoing prospective validation will further evaluate the clinical performance of the assay, while future studies will support broader clinical adoption, and evaluation in larger patient populations. Continued collaboration with clinical partners and industry will be required to facilitate these next development steps.
The project has also strengthened the basis for future translation through the establishment of an intellectual property strategy and continued engagement with potential industrial partners. Together, these activities create favorable conditions for further development while ensuring that the scientific advances generated during the project can ultimately benefit patients and healthcare systems.