Development of antibodies and antibody-derived proteins for the prevention and treatment of infectious diseases with epidemic potential
HORIZON Research and Innovation Actions
Basic Information
- Identifier
- HORIZON-HLTH-2025-01-DISEASE-03
- Programme
- Cluster 1 - Health (Single stage - 2025)
- Programme Period
- 2021 - 2027
- Status
- Closed (31094503)
- Opening Date
- May 22, 2025
- Deadline
- September 16, 2025
- Deadline Model
- single-stage
- Budget
- €40,000,000
- Min Grant Amount
- €6,000,000
- Max Grant Amount
- €8,000,000
- Expected Number of Grants
- 5
- Keywords
- HORIZON-HLTH-2025-01-DISEASE-03HORIZON-HLTH-2025-01Clinical development, Phase IHealth-related biotechnologyPharmaceutical developmentSmallpoxSuppression immunotherapies
Description
This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Tackling diseases and reducing disease burden”. To that end, proposals under this topic should aim to deliver results that are directed, tailored towards and contributing to all the following expected outcomes:
- The scientific and clinical communities have a better understanding of prophylactic and treatment options complementary to low molecular weight antiviral therapeutics for viruses with epidemic potential.
- The scientific and clinical communities have access to experimental antibodies and antibody-derived proteins for the prevention and treatment of emerging or re-emerging viral infections, as well as for further clinical investigation.
- Candidate antiviral therapies, including potentially those of broad spectrum are available for emerging and re-emerging viral infections, increasing therapeutic options for clinical deployment in case of an epidemic or pandemic.
As shown by the COVID-19 pandemic, infectious diseases remain a major threat to health and health security in the EU and globally. Viral disease emergence is expected to accelerate due to among other, climate change, and thus a proactive approach to the development of antiviral prophylactics and therapeutics in preparedness for future infectious disease outbreaks is needed. The availability of antibodies and antibody-derived proteins would provide a critical preparedness measure against future health threats, due to infectious disease epidemics or pandemics.
Proposals should exclusively pursue the development of existing antiviral and prophylactic and therapeutic candidates that are based on antibody and/or antibody-derived proteins targeting at least one of the priority viruses:
- Arenaviridae: Junin mammarenavirus, Lassa mammarenavirus
- Hantaviridae: Hantaan virus, Andes virus, Sin Nombre virus
- Poxviridae: Variola major
- Paramyxo: Hendra, Nipah virus
- Togaviridae: Venezuelan equine encephalitis virus
Proposals are expected to conduct preclinical studies of antibodies and antibody-derived proteins, prepare Good Manufacturing Practice (GMP)[1] quality test batches and carry out first in human clinical safety studies. Proposals should include a critical discussion of to what extent the antibodies and antibody-derived proteins would be expected to be amenable to production and distribution at an affordable cost and at a scale sufficient to meet demand in a pandemic.
Proposals should thus aim to diversify and accelerate the global prophylactic and therapeutic research and development portfolio for emerging and re-emerging viral infections, and to strengthen the leading role of the EU in prophylactic and therapeutic research and development.
Proposals may focus either on antibody or on antibody-derived proteins, or both.
Proposals should address all the following areas:
- If necessary, finalisation of the in vitro characterisation of the existing antibody and antibody-derived protein candidates with regard to target specificity, epitope recognised, and their ability to impair or inactivate viral functions.
- In vivo tests in at least one animal model or, if available in humanised immune system animal models, to demonstrate the protective function of the antibodies and antibody-derived therapeutics deemed sufficient for moving to first clinical trials.
- If requested by regulators as enablers for clinical studies, in vivo tests in a non-human primate model.
- Production of GMP quality test batches of the most promising candidates for antibodies and antibody-derived proteins in the EU or the European Economic Area.
- First in human clinical safety studies of the antibody and antibody-derived proteins, demonstrating a clear regulatory pathway for market authorisation. Attention should be paid to critical biological and social factors such as sex, age, ethnicity and disability.
Participation of third countries where viruses addressed in the proposal are endemic or where outbreaks have occurred or are ongoing is encouraged.
The participation of start-ups, micro, small and medium-sized enterprises (SMEs)[2] is encouraged with the aim of strengthening their scientific and technological foundations, enhancing their innovation potential, and exploring possibilities for commercial exploitation.
Applicants are expected to engage with regulatory bodies in a timely manner to ensure adequacy of the actions from a regulatory point of view.
Proposals should advance research by leveraging already existing and emerging state-of-the-art research infrastructures such as those having contributed to the services developed under the ISIDORe project[3].
Applicants should provide details of their clinical studies[4] in the dedicated annex using the template provided in the submission system. As proposals under this topic are expected to include clinical studies, the use of the template is strongly encouraged.
[1] https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/gmp
[2] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32003H0361
[3] https://isidore-project.eu
[4] Please note that the definition of clinical studies (see introduction to this work programme part) is broad and it is recommended that you review it thoroughly before submitting your application.
Destination & Scope
Topics under this destination are directed towards the Key Strategic Orientation 3 “A more resilient, competitive, inclusive, and democratic Europe” of Horizon Europe’s strategic plan 2025-2027.
Research and Innovation supported under this destination should contribute to the following expected impact, set out in the strategic plan impact summary for the Health Cluster: “healthcare providers improve their ability to tackle and manage diseases (infectious diseases, including poverty-related and neglected diseases, non-communicable and rare diseases) thereby reducing the disease burden on patients and enabling healthcare systems to perform more effectively. It can be achieved through better understanding, prevention, diagnostics, treatment, management, and cure of diseases and their co- and multi-morbidities, more effective and innovative health technologies and medical countermeasures, better ability and preparedness to manage pandemic and/or epidemic outbreaks, and improved patient safety”.
Communicable and non-communicable diseases cause the greatest amounts of premature death and disabilities and pose a major health, societal and economic threat and burden in the EU and worldwide. Many people are still suffering from these diseases and too often dying prematurely. Although many of these diseases are preventable to a large extend, only around 6% of the healthcare budgets are currently spent on preventive measures[1]. Therefore, there is the urgent need to develop new public health interventions, preventive, diagnostic and therapeutic approaches, alternatives to antimicrobials, as well as to improve existing preparedness and response strategies to create tangible impacts, taking into account sex/gender-related issues. In this regard, Research and Innovation 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 brain health, to respond to public health needs, including the global burden of non-communicable diseases.
In this work programme part, Destination “Tackling diseases and reducing disease burden” will focus on major societal challenges linked to the Commission’s political priorities such as the fight against non-communicable and communicable diseases, mental health and better treatment of mental, behavioural and neurodevelopmental diseases, preparedness and response to and surveillance of health threats and epidemics, reduction and treatment of the number of antimicrobial-resistant infections. In particular, the topics under this destination will support activities aiming at: i) new effective treatment options for patients suffering from antimicrobial resistant (AMR) infections; ii) innovative therapeutic interventions and complementary approaches for patients suffering from mental, behavioural and neurodevelopmental disorders; iii) new prevention and treatment options for infectious diseases with epidemic potential; iv) Artificial Intelligence (AI) based tools and technologies for pandemic preparedness and response; v) implementation research on strengthening health systems in the context of non-communicable diseases; vi) supporting the Global Research Collaboration for Infectious Disease Preparedness; vii) setting up the European Partnership for Brain Health; and viii) supporting efforts of the European Partnership fostering a European Research Area for health research (ERA4Health)[2] in particular in funding large-scale multi-country Investigator-Initiated Clinical Studies (IICS) on various health interventions addressing important public health needs.
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 countermeasures, epidemic outbreaks/pandemics, natural disasters and technological incidents, bioterrorism); with Cluster 4 “Digital, Industry and Space” such as on AI-based tools and technologies (e.g. detection, management and monitoring of an epidemic at population levels, and the diagnosis, treatment, and prevention at the level of individuals); or with Cluster 6 “Food, bioeconomy, natural resources, agriculture and environment” such as on antimicrobial resistance - AMR (e.g. new effective treatment options, alternatives to antibiotics).
Some Research and Innovation actions under this destination should support the mission of the European Health Emergency and Response Authority (HERA) to strengthen Europe’s ability to prevent, detect, and rapidly respond to cross-border health emergencies by ensuring the availability and access to key medical countermeasures. Furthermore, synergies will be sought between this destination and the implementation of the EU4Health Programme (2021-2027)[3]. 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:
- Disease burden in the EU and worldwide is reduced through effective disease management, including through the development and integration of innovative preventive, diagnostic and therapeutic approaches, digital and other people-centred solutions for healthcare.
- Premature mortality from non-communicable diseases is reduced by one third (by 2030), mental health and wellbeing are promoted, and the voluntary targets of the WHO Global Action Plan for the Prevention and Control of NCDs[4] 2013-2020 are attained (by 2025), with an immediate impact on the related disease burden (Disability-Adjusted Life Years - DALYs)[5],[6],[7].
- Healthcare systems benefit from strengthened Research and Innovation expertise, human capacities and know-how for combatting communicable and non-communicable diseases, including through international cooperation.
- Citizens benefit from reduced (cross-border) health threat of epidemics and AMR pathogens, in the EU and worldwide[8],[9].
- 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 protection of European communication networks has been identified as an important security interest of the Union and its Member States. Entities that are assessed as high-risk suppliers[10] of mobile network communication equipment (and any entities they own or control) are not eligible to participate as beneficiaries, affiliated entities and associated partners to topics identified as “subject to restrictions for the protection of European communication networks”. Please refer to the Annex B of the General Annexes of this Work Programme for further details.
[1] Preventive healthcare expenditure as a share of the current expenditure on healthcare https://ec.europa.eu/eurostat/statistics-explained/index.php?title=File:Preventive_healthcare_expenditure_as_a_share_of_current_expenditure_on_healthcare,_2021_(%25)_HCE2024.png
[3] https://health.ec.europa.eu/funding/eu4health-programme-2021-2027-vision-healthier-european-union_en
[4] Non-communicable diseases
[5] https://www.who.int/publications/i/item/9789241506236
[6] 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.
[7] 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.
[8] WHO global action plan on antimicrobial resistance, 2015
[9] EU One Health Action Plan against AMR, 2017
[10] Entities assessed as “high-risk suppliers”, are currently set out in the second report on Member States’ progress in implementing the EU toolbox on 5G cybersecurity of 2023 (NIS Cooperation Group, Second report on Member States’ progress in implementing the EU Toolbox on 5G Cybersecurity, June 2023) and the related Communication on the implementation of the 5G cybersecurity toolbox of 2023 (Communication from the Commission: Implementation of the 5G cybersecurity Toolbox, Brussels, 15.6.2023 C(2023) 4049 final).
Eligibility & Conditions
General conditions
1. Admissibility Conditions, Proposal page limit and layout
2. Eligible Countries
Eligible Countries are described in Annex B of the Work Programme General Annexes.
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide.
3. Other Eligible Conditions
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding.
If projects use satellite-based earth observation, positioning, navigation and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS (other data and services may additionally be used).
Other Eligible Conditions are described in Annex B of the Work Programme General Annexes.
4. Financial and operational capacity and exclusion
Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes.
5a. Evaluation and award: Award criteria, scoring and thresholds
Evaluation and award: Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.
5b. Evaluation and award: Submission and evaluation processes
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold will be 12.
Evaluation and award: Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual.
5c. Evaluation and award: Indicative timeline for evaluation and grant agreement
Evaluation and award: Indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes.
6. Legal and financial set-up of the grants
Eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme – the Framework Programme for Research and Innovation (2021-2027) – and in actions under the Research and Training Programme of the European Atomic Energy Community (2021-2025) [[This decision is available on the Funding and Tenders Portal, in the reference documents section for Horizon Europe, under ‘Simplified costs decisions’ or through this link: https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-decision_he_en.pdf]].
Legal and financial set-up of the grants are described in Annex G of the Work Programme General Annexes.
Specific conditions
Specific conditions are described in the specific topic of the Work Programme.
Application and evaluation forms and additional documents:
Application and evaluation form templates
Standard application form (HE RIA, IA) - the application form specific to this call is available in the Submission System
Standard evaluation form (HE RIA, IA) - will be used with the necessary adaptations
Guidance
Model Grant Agreements (MGA)
Call-specific instructions
Additional documents
HE Main Work Programme 2025 – 1. General Introduction
HE Main Work Programme 2025 – 4. Health
HE Main Work Programme 2025 – 14. General Annexes
HE Framework Programme 2021/695
HE Specific Programme Decision 2021/764
EU Financial Regulation 2024/2509
Decision authorising the use of lump sum contributions under the Horizon Europe Programme
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA — Annotated Model Grant Agreement
Funding & Tenders Portal Online Manual
Support & Resources
Online Manual is your guide on the procedures from proposal submission to managing your grant.
Horizon Europe Programme Guide contains the detailed guidance to the structure, budget and political priorities of Horizon Europe.
Funding & Tenders Portal FAQ – find the answers to most frequently asked questions on submission of proposals, evaluation and grant management.
Research Enquiry Service – ask questions about any aspect of European research in general and the EU Research Framework Programmes in particular.
National Contact Points (NCPs) – get guidance, practical information and assistance on participation in Horizon Europe. There are also NCPs in many non-EU and non-associated countries (‘third-countries’).
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European IPR Helpdesk assists you on intellectual property issues.
CEN-CENELEC Research Helpdesk and ETSI Research Helpdesk – the European Standards Organisations advise you how to tackle standardisation in your project proposal.
The European Charter for Researchers and the Code of Conduct for their recruitment – consult the general principles and requirements specifying the roles, responsibilities and entitlements of researchers, employers and funders of researchers.
Partner Search help you find a partner organisation for your proposal.
Latest Updates
Call HORIZON-HLTH-2025-01 closed on 16 September 2025. 749 proposals were submitted. The breakdown per topic is:
- HORIZON-HLTH-2025-01-DISEASE-01: 30 proposals
- HORIZON-HLTH-2025-01-DISEASE-03: 15 proposals
- HORIZON-HLTH-2025-01-DISEASE-04: 76 proposals
- HORIZON-HLTH-2025-01-DISEASE-05: 7 proposals
- HORIZON-HLTH-2025-01-DISEASE-06: 158 proposals
- HORIZON-HLTH-2025-01-DISEASE-07: 83 proposals
- HORIZON-HLTH-2025-01-CARE-01: 118 proposals
- HORIZON-HLTH-2025-01-TOOL-01: 57 proposals
- HORIZON-HLTH-2025-01-TOOL-02: 35 proposals
- HORIZON-HLTH-2025-01-TOOL-03: 82 proposals
- HORIZON-HLTH-2025-01-TOOL-05: 25 proposals
- HORIZON-HLTH-2025-01-IND-01: 58 proposals
- HORIZON-HLTH-2025-01-IND-02: 5 proposals
Evaluation results are expected to be communicated on Wednesday 21 January 2026 at the earliest.
Please note that due to a technical issue, during the first days of publication of this call, the topic page did not display the description of the corresponding destination. This problem is now solved. In addition to the information published in the topic page, you can always find a full description of the relevant destination in the Work Programme 2025 part for "Health". Please select from the work programme the destination relevant to your topic and take into account the description and expected impacts of that destination for the preparation of your proposal.