Pre-clinical development of the next generation of immunotherapies for diseases or disorders with unmet medical needs

Closed

Programme Category

EU Competitive Programmes

Programme Name

Horizon Europe (2021-2027)

Programme Description

Horizon Europe is the European Union (EU) funding programme for the period 2021 – 2027, which targets the sectors of research and innovation. The programme’s budget is around € 95.5 billion, of which € 5.4 billion is from NextGenerationEU to stimulate recovery and strengthen the EU’s resilience in the future, and € 4.5 billion is additional aid.

Programme Details

Identifier Code

HORIZON-HLTH-2022-DISEASE-06-02-two-stage

Call

Pre-clinical development of the next generation of immunotherapies for diseases or disorders with unmet medical needs

Summary

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 that cannot be effectively tackled with the currently available treatments.
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.

Detailed Call Description

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.

Call Total Budget

€ 60,00 million

Financing percentage by EU or other bodies / Level of Subsidy or Loan

100%

Contribution per project: €6,00 million

Thematic Categories

  • Health
  • Research, Technological Development and Innovation

Eligibility for Participation

  • Private Bodies
  • Researchers/Research Centers/Institutions
  • State-owned Enterprises

Call Opening Date

06/10/2021

Call Closing Date

01/02/2022

National Contact Point(s)

Research and Innovation Foundation
29a Andrea Michalakopoulou, 1075 Nicosia
P.O.Box 23422, 1683 Nicosia
Telephone: +357 22205000
Email Address: support@research.org.cy
Website: https://www.research.org.cy/en/

Mr Marinos Fotiadis
Contact Phone: 22 205 048
E-mail: mphotiades@research.org.cy
Website: https://www.research.org.cy/

Dr Ioannis Theodorou
Contact Phone: 22 205 038
E-mail: itheodorou@research.org.cy
Website: https://www.research.org.cy/

(Publish Date: 23/11/2021-for internal use only)

EU Contact Point

European Commission, Directorate-General for Research and Innovation

https://ec.europa.eu/info/departments/research-and-innovation_en#contact