Scadenza: 1 February 2022
Scadenze successive:
Deadline model two-stage
Planned opening date
06 October 2021
Deadline dates
01 February 2022 17:00:00 Brussels time
06 September 2022 17:00:00 Brussels time
Topic:
Passive and active immunotherapies (such as antibody-based, RNA-based and cell-based therapies, respectively) are covered by this topic, which is aiming at the pre-clinical to first-in human development of next generation immunotherapies for unmet needs.
Proposals should build on existing knowledge in the field, when available, in order to save time and to avoid spilling resources, and could build on the knowledge of the interaction between the immune system (innate and adaptive arms) and the microbiota, or take advantage of key enabling technologies such as biotechnology and nanotechnology, advanced manufacturing, imaging, 5G, internet of things, artificial intelligence and existing databases.
The next generation of immunotherapies are needed in order to improve and diversify the capabilities of health care for several communicable and non-communicable diseases[1] that cannot be effectively tackled with the currently available treatments.
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 122 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. Phase II studies or later phase trials will not be supported.
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.
Programma:
HORIZON-RIA HORIZON Research and Innovation Actions
Ente finanziatore:
EU
Budget complessivo:
60.00 million
Who can participate:
To be eligible for funding, applicants must be established in one of the eligible countries, i.e.:
– the Member States of the European Union, including their outermost regions;
– the Overseas Countries and Territories (OCTs) linked to the Member States;
– eligible non-EU countries:
– countries associated to Horizon Europe;
– low- and middle-income countries
Partnership: Mandatory
Status:
Closed
Quota finanziabile:
100%
Topic:
Passive and active immunotherapies (such as antibody-based, RNA-based and cell-based therapies, respectively) are covered by this topic, which is aiming at the pre-clinical to first-in human development of next generation immunotherapies for unmet needs.
Proposals should build on existing knowledge in the field, when available, in order to save time and to avoid spilling resources, and could build on the knowledge of the interaction between the immune system (innate and adaptive arms) and the microbiota, or take advantage of key enabling technologies such as biotechnology and nanotechnology, advanced manufacturing, imaging, 5G, internet of things, artificial intelligence and existing databases.
The next generation of immunotherapies are needed in order to improve and diversify the capabilities of health care for several communicable and non-communicable diseases[1] that cannot be effectively tackled with the currently available treatments.
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 122 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. Phase II studies or later phase trials will not be supported.
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.
Who can participate:
To be eligible for funding, applicants must be established in one of the eligible countries, i.e.:
– the Member States of the European Union, including their outermost regions;
– the Overseas Countries and Territories (OCTs) linked to the Member States;
– eligible non-EU countries:
– countries associated to Horizon Europe;
– low- and middle-income countries
Programme:
HORIZON-RIA HORIZON Research and Innovation Actions
Consortium: Required
Status: Open
Total budget:
60.00 million
Funding rate:
100%
Notes:
The Commission estimates that an EU contribution of around EUR 6.00 million would allow these outcomes to be addressed appropriately
