Targeted immune intervention for the management of non-response and relapse

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The action generated by this topic aims to provide better control of immune-mediated diseases, in particular:

• characterise human immune-mediated diseases;
• profile and analyse immune cells obtained from non-blood tissues;
• discover individual disease and cross-disease biomarkers predictive of treatment response, non-response, relapse and flare-up;
• perform early phase clinical trials (e.g. enriched study populations for certain molecular pathways; adaptive and basket trial designs etc.) and identify potential novel patient-centric treatment approaches. The focus will be on patients from well-characterised immune-mediated diseases (SLE, RA, MS, UC, CD, Asthma and COPD).

The ultimate goal is to develop a translational research platform that will improve patient management and personalised treatment by identification/validation of predictive biomarkers for non-response, rapid progression and remission. This would lead to an increased likelihood of treatment success with decreased costs for both patients & society and pharmaceutical companies.

For full details of the topic, please refer to the call text

A large number of patients suffering from immune-mediated diseases fail to respond well or at all to current standard-of-care treatments or quickly relapse while on, or following, treatment. Currently, one of the most challenging questions in human immunology is to understand whether it is possible to accurately predict which patients will fail to respond to treatment, which patients will sustain a longer term treatment response, or which patients will suddenly flare up during periods of disease control. At present, there is a lack of a mechanistic understanding of non-response combined with an absence of biomarkers to predict clinical responses. Detailed analysis of clinical samples before and during treatment would enable breakthrough discoveries on the mechanisms, the clinical management of non-response, and the identification of patients prone to relapse. The topic addresses the challenge of translating insights from treatment non-response and disease exacerbation into new treatment paradigms at the individual patient level.

For full details of the topic, please refer to the call text

The proposed precision-immunology approach is expected to achieve a reduction in failure rates in early clinical trials and to provide access for novel therapeutics to the most appropriate patient populations. Insights gained from this study will inform the design of platform trials for single indications with multiple mechanisms, further supporting precision medicine approaches. In addition, a more accurate definition of subcategories of auto-immune disorders and their responses to particular therapies on an individual patient level will fuel novel target discovery, decrease phase 2 proof of concept (POC) attrition, and decrease the costs of development to achieve regulatory approval and appropriate reimbursement.

To this end, the action generated by this topic would be a powerful and unique instrument, with the capability to significantly move forward the development of a consensus on the best treatment options for defined subgroups of patients with high unmet medical needs, such as patients suffering from immune-mediated diseases. Furthermore, beyond advancing our understanding of the disease, informing personalised approaches to patient care, and delivering potential novel treatments, the topic has the potential to establish Europe in a leadership position in this field of biology and medicine.

Small and medium-sized enterprises (SMEs) can be of great benefit to IMI2 JU projects. Their involvement in the action might offer a complementary perspective to industry and academia, and help deliver the long-term impact of the action.