GSS EU Science Funding Gateway

Proposals are expected to address some of the following research gaps for the development of the next generation of effective and safe immunotherapies:

• Preclinical development and study of new immunotherapeutic agents in vitro and in relevant animal model(s) of the disease(s). This includes understanding of the therapy’s agent(s) mode of action, its toxicity, the development of related potency assay(s), and its/their validation in vitro and in vivo. A robust regulatory and Health Technology Assessment (HTA) strategy should be in place at the start of the proposal.
• Off-the-shelf therapies, including the cell-based therapies, will be considered as assets during the evaluation.
• Proposals could include proof-of-concept (PoC)/first-in-human studies for testing the new therapies, with a clear regulatory and clinical pathway and should address as appropriate the therapy-related potential for adverse side effects. PoC and clinical studies in humans should take sex, gender, age and socio-economic factors into account, where relevant.
• Development of a standardised framework for assays and data usage to enable a robust assessment of the safety and efficacy.
• In case treatments are already available for the proposed targeted disease(s), a justification of the need for development of a new immunotherapy treatment is requested.
• The proposed action should include a pathway of the necessary steps to ensure sustainable therapeutic agent production (considering intellectual property management if relevant) and uptake by health systems and rapid access to patients.

Projects may consider the use of the nanobiotechnology infrastructure platform of the European Commission’s Joint Research Centre, in particular for the accurate physicochemical characterization of therapeutic proteins and antibodies.