Close X


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

Logo
Programme
Acronym HORIZON-HLTH-DISEASE
Type of Fund Direct Management
Description of programme
"Horizon Europe - Cluster 1 - Destination 3: Tackling diseases and reducing disease burden"

Calls for proposals under this destination are directed towards the Key Strategic Orientation KSO-D ‘Creating a more resilient, inclusive and democratic European society’ of Horizon Europe’s Strategic Plan 2021-2024. Research and innovation supported under this destination should contribute to the impact area ‘Good health and high-quality accessible healthcare’ and in particular to the following expected impact, set out in the Strategic Plan for the health cluster: ‘health care providers are able to better tackle and manage diseases (infectious diseases, including poverty-related and neglected diseases, non-communicable and rare diseases) and reduce the disease burden on patients effectively thanks to better understanding and treatment of diseases, more effective and innovative health technologies, better ability and preparedness to manage epidemic outbreaks and improved patient safety’. In addition, research and innovation supported under this destination could also contribute to the following impact areas: ‘A resilient EU prepared for emerging threats’, ‘Climate change mitigation and adaptation’, and ‘High quality digital services for all’.

Communicable and non-communicable diseases cause the greatest amounts of premature death and disability in the EU and worldwide. They pose a major health, societal and economic threat and burden. Many people are still suffering from these diseases and too often dying prematurely. Non-communicable diseases, including mental illnesses and neurodegenerative diseases, are responsible for up to 80% of EU health care costs[[Currently, around 50 million people in the EU are estimated to suffer from two or more chronic conditions, and most of these people are over 65. Every day, 22 500 people die in Europe from those diseases, counting of 87% of all deaths. They account for 550 000 premature deaths of people of working age with an estimated €115 billion economic loss per year (0.8% of GDP).]]. These costs are spent on the treatment of such diseases that to a large extent are preventable. Furthermore, only around 3% of the health care budgets are currently spent on preventive measures although there is a huge potential for prevention. Infectious diseases, including infections resistant to antimicrobials, remain a major threat to public health in the EU but also to global health security. Deaths caused by antimicrobial resistance (AMR) could exceed 10 million per year worldwide according to some predictions[[AMR is estimated to be responsible for 25 000 deaths per year in the EU alone and 700 000 deaths per year globally. It has been estimated that AMR might cause more deaths than cancer by 2050.]].

To further advance, there is an urgent need for research and innovation to develop new prevention measures, public health interventions, diagnostics, vaccines, therapies, alternatives to antimicrobials, as well as to improve existing prevention strategies to create tangible impacts, taking into account sex/gender-related issues. This will require international cooperation to pool the best expertise and know-how available worldwide, to access world-class research infrastructures and to leverage critical scales of investments on priority needs through a better alignment with other funders of international cooperation in health research and innovation. The continuation of international partnerships and cooperation with international organisations is particularly needed to combat infectious diseases, to address antimicrobial resistances, to respond to major unmet medical needs for global health security, including the global burden of non-communicable diseases, and to strengthen patient safety.

In this work programme, destination 3 will focus on major societal challenges linked to the Commission’s political priorities such as the fight against cancer and other non-communicable diseases, better diagnosis and treatment of rare diseases, preparedness and response to and surveillance of health threats and epidemics, reduction of the number of antimicrobial-resistant infections, improving vaccination rates, demographic change, mental health and digital empowerment in health literacy. In particular, the topics under this destination will support activities aiming at: i) better understanding of diseases, their drivers and consequences, including pain and the causative links between health determinants and diseases, and better evidence-base for policy-making; ii) better methodologies and diagnostics that allow timely and accurate diagnosis, identification of personalised treatment options and assessment of health outcomes, including for patients with a rare disease; iii) development and validation of effective intervention for better surveillance, prevention, detection, treatment and crisis management of infectious disease threats; iv) innovative health technologies developed and tested in clinical practice, including personalised medicine approaches and use of digital tools to optimise clinical workflows; v) new and advanced therapies for non-communicable diseases, including rare diseases developed in particular for those without approved options, supported by strategies to make them affordable for the public payer; and vi) scientific evidence for improved/tailored policies and legal frameworks and to inform major policy initiatives at global level (e.g. WHO Framework Convention on Tobacco Control; UNEA Pollution Implementation Plan).

In view of increasing the impact of EU investments under Horizon Europe, the European Commission welcomes and supports cooperation between EU-funded projects to enable cross-fertilisation and other synergies. This could range from networking to joint activities such as the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. Opportunities for potential synergies exist between projects funded under the same topic but also between other projects funded under another topic, cluster or pillar of Horizon Europe (but also with ongoing projects funded under Horizon 2020). In particular, this could involve projects related to European health research infrastructures (under pillar I of Horizon Europe), the EIC strategic challenges on health and EIT-KIC Health (under pillar III of Horizon Europe), or in areas cutting across the health and other clusters (under pillar II of Horizon Europe). For instance, with cluster 3 “Civil security for society” such as on health security/emergencies (preparedness and response, medical counter measures, epidemic outbreaks/pandemics, natural disasters and technological incidents, bioterrorism); with cluster 4 “Digital, Industry and Space” such as on decision-support systems or on geo-observation and monitoring (e.g. of disease vectors, epidemics); or with cluster 6 “Food, bioeconomy, natural resources, agriculture and environment” such as on health security and AMR (one-health: human/animal/plant/soil/water health).

Some research and innovation actions under Destination 3 should deliver relevant complementary inputs to the announced “Europe’s Beating Cancer Plan”[[https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12154-Europe-s-Beating-Cancer-Plan]], contributing to actions covering the entire cancer care pathway, including prevention, early detection, diagnosis, treatment, cancer data monitoring, as well as quality of life of cancer patients and survivors. Furthermore, synergies and complementarities will be sought between Destination 3 and the implementation of the EU4Health Programme (2021-2027)[[https://ec.europa.eu/health/funding/eu4health_en]]. These synergies and complementarities could be achieved, notably through mechanisms based on feedback loops, enabling on the one hand to identify policy needs that should be prioritised in research and innovation actions and facilitating on the other hand the implementation of research results into policy actions and clinical practice, thereby providing an integrated response across sectors and policy fields.

Expected impacts:

Proposals for topics under this destination should set out a credible pathway to contributing to tackling diseases and reducing disease burden, and more specifically to several of the following impacts:

  • Health burden of diseases in the EU and worldwide is reduced through effective disease management, including through the development and integration of innovative diagnostic and therapeutic approaches, personalised medicine approaches, digital and other people-centred solutions for health care. In particular, patients are diagnosed early and accurately and receive effective, cost-efficient and affordable treatment, including patients with a rare disease, due to effective translation of research results into new diagnostic tools and therapies.
  • Premature mortality from non-communicable diseases is reduced by one third (by 2030), mental health and well-being is promoted, and the voluntary targets of the WHO Global Action Plan for the Prevention and Control of NCDs 2013-2020 are attained (by 2025), with an immediate impact on the related disease burden (DALYs)[[WHO Global Action Plan for the Prevention and Control of NCDs 2013-2020 (resolution WHA66.10), https://www.who.int/nmh/events/ncd_action_plan/en.]],[[Including for instance the following voluntary targets (against the 2010 baseline): A 25% relative reduction in the overall mortality from cardiovascular diseases, cancer, diabetes, or chronic respiratory diseases; Halt the rise in diabetes and obesity; An 80% availability of the affordable basic technologies and essential medicines, including generics, required to treat major non-communicable diseases in both public and private facilities.]],[[Disability-adjusted life year (DALY) is a quantitative indicator of overall disease burden, expressed as the number of years lost due to ill-health, disability or early death.]].
  • Health care systems benefit from strengthened research and innovation expertise, human capacities and know-how for combatting communicable and non-communicable diseases, including through international cooperation. In particular, they are better prepared to respond rapidly and effectively to health emergencies and are able to prevent and manage communicable diseases transmissions epidemics, including within healthcare settings.
  • Citizens benefit from reduced (cross-border) health threat of epidemics and AMR pathogens, in the EU and worldwide[[WHO global action plan on antimicrobial resistance, 2015.]],[[EU One Health Action Plan against AMR, 2017.]]. In particular, the epidemics of AIDS, tuberculosis, malaria and neglected tropical diseases are contained and hepatitis, water-borne diseases and other communicable diseases are being combated[[Target 3.3 of the UN’s Sustainable Development Goals, 2015.]].
  • Patients and citizens are knowledgeable of disease threats, involved and empowered to make and shape decisions for their health, and better adhere to knowledge-based disease management strategies and policies (especially for controlling outbreaks and emergencies).

The EU benefits from high visibility, leadership and standing in international fora on global health and global health security, especially in partnership with Africa.

Link Link to Programme
Call
Pre-clinical development of the next generation of immunotherapies for diseases or disorders with unmet medical needs
Description of call
"Pre-clinical development of the next generation of immunotherapies for diseases or disorders with unmet medical needs"

Expected Outcome

  • The scientific and clinical communities make effective use of the pre-clinical validation of new immunotherapies for high burden diseases or disorders with unmet medical needs.
  • The scientific and clinical communities have access to new knowledge allowing for a better understanding of the mode of action of the next generation of immunotherapies and/or combinatorial treatments, which enables further development and optimisation of treatments.
  • The scientific and clinical communities have access to and use new personalized models (in vitro and in vivo) for high burden diseases or disorders as well as protocols for the next generation of immunotherapies.
  • Health care professionals have access to and use new evidence-based safety and efficacy guidelines for immunotherapies. Proof-of-clinical concept, when applicable, as single or combinatorial treatment, should be compared to existing approaches.

Scope:

Immunotherapy is defined as a treatment able to stimulate or restore the ability of the immune (defence) system to fight infection, disease or disorder. It has proved to be a valuable medical treatment notably when preventive interventions are not available. 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 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 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.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. This could also involve networking and joint activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider to cover the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Commission may take on the role of facilitator for networking and exchanges, including with relevant stakeholders, if appropriate.

Projects could 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.

Link Link to Call
Thematic Focus Clustering, Development Cooperation, Economic Cooperation, Research & Innovation, Technology Transfer & Exchange, Health, Social Affairs, Sports, Capacity Building, Cooperation Networks, Institutional Cooperation, Equal Rights, Human Rights, People with Disabilities, Social Inclusion, Community Integration, European Citizenship, Shared Services
Funding area EU Member States
Overseas Countries and Territories (OCTs)
United States of America
Origin of Applicant EU Member States
Overseas Countries and Territories (OCTs)
United States of America
Eligible applicants Education and Training Centres, Federal State / Region / City / Municipality / Local Authority, Research Institution, Lobby Group / Professional Association / Trade Union, International Organization, Small and Medium Sized Enterprises, SMEs (between 10 and 249 employees), Microenterprises (fewer than 10 employees), NGO / NPO, Public Services, National Government, Other, Start Up Company, University, Enterprise (more than 250 employees or not defined), Association
Applicant details

eligible non-EU countries:

  • countries associated to Horizon Europe
At the date of the publication of the work programme, there are no countries associated to Horizon Europe. Considering the Union’s interest to retain, in principle, relations with the countries associated to Horizon 2020, most third countries associated to Horizon 2020 are expected to be associated to Horizon Europe with an intention to secure uninterrupted continuity between Horizon 2020 and Horizon Europe. In addition, other third countries can also become associated to Horizon Europe during the programme. For the purposes of the eligibility conditions, applicants established in Horizon 2020 Associated Countries or in other third countries negotiating association to Horizon Europe will be treated as entities established in an Associated Country, if the Horizon Europe association agreement with the third country concerned applies at the time of signature of the grant agreement.

  • low-and middle-income countries

Legal entities which are established in countries not listed above will be eligible for funding if provided for in the specific call conditions, or if their participation is considered essential for implementing the action by the granting authority.

Specific cases:

  • Affiliated entities - Affiliated entities are eligible for funding if they are established in one of the countries listed above.
  • EU bodies - Legal entities created under EU law may also be eligible to receive funding, unless their basic act states otherwise.
  • International organisations - International European research organisations are eligible to receive funding. Unless their participation is considered essential for implementing the action by the granting authority, other international organisations are not eligible to receive funding. International organisations with headquarters in a Member State or Associated Country are eligible to receive funding for ‘Training and mobility’actions and when provided for in the specific call conditions.
Project Partner Yes
Project Partner Details

Unless otherwise provided for in the specific call conditions , legal entities forming a consortium are eligible to participate in actions provided that the consortium includes:

  • at least one independent legal entity established in a Member State;and
  • at least two other independent legal entities, each established in different Member States or Associated Countries.
Call opens 06.10.2021
Call closes 01.02.2022
Further info

Proposal page limits and layout:

  • Part A to be filled in directly online  (administrative information, summarised budget, call-specific questions, etc.)
  • Part B to be downloaded from the Portal submission system, completed and re-uploaded as a PDF in the system

This call is subject of a two-stage procedure. In the first stage, applicants will be requested to submit only an outline application. Successful applicants will be invited to submit a full application for the second stage.

Page limit - part B: 45 pages - The limit for a first-stage application is 10 pages.

Type of Funding Grants
Financial details
Expected EU contribution per projectThe Commission estimates that an EU contribution of around EUR 6.00 million would allow these outcomes to be addressed appropriately. Nonetheless, this does not preclude submission and selection of a proposal requesting different amounts.
Indicative budgetThe total indicative budget for the topic is EUR 60.00 million.
Typ of ActionResearch and Innovation Actions (RIA)
Funding rate100%
Submission Proposals must be submitted electronically via the Funding & Tenders Portal Electronic Submission System. Paper submissions are NOTpossible.

Register now and benefit from additional services - it is free of cost!

News

Published on 19.10.2021

Socio-economic risks of climate change in Europe

Horizon Europe - Cluster 5 - Destination 1: Climate sciences and responses for the transformation towards climate neutrality

Link to Call

Published on 19.10.2021

Social science for land-use strategies in the context of climate change and biodiversity challenges

Horizon Europe - Cluster 5 - Destination 1: Climate sciences and responses for the transformation towards climate neutrality

Link to Call
Loading Animation