Development of monoclonal antibodies to prevent and treat infections from Flaviviruses (HORIZON-HLTH-2027-01-DISEASE-06)

Candidate monoclonal antibody therapies are available to treat patients for emerging and re-emerging viral infections, increasing therapeutic options for clinical deployment in case of an epidemic or pandemic. Scope: Infectious diseases remain a major threat to health and health security in the EU and globally. Viral disease emergence is already being accelerated by 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 capacity to produce antibodies that can target new variants and rapidly increase production would serve as an essential preparedness strategy against future health threats, whether from infectious disease epidemics or pandemics. This topic contributes to strengthening the Research and Innovation ecosystem within the EU and supports the implementation of the European Medical Countermeasures Strategy [1] . Applicants should explicitly state in their proposal which of the following Flaviviruses is targeted and the proposed work should address only this specific Flavivirus. The proposed work should aim to advance the development of existing prophylactic and therapeutic monoclonal antibody candidates targeting exclusively one of the following Flaviviriuses: Dengue Virus Tick-borne Encephalitis Virus Japanese Encephalitis Virus West Nile Fever Virus Yellow Fever Virus Zika Virus Proposals should focus on antibodies produced or derived from a single cell clone through recombinant expression, such as B-cell derived antibodies, hybridoma derived antibodies and nanobodies. 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 should address all the following research areas: If necessary, finalisation of the in-vitro characterisation of existing monoclonal antibody 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 monoclonal antibodies deemed sufficient for moving to first clinical trials. If requested by regulators as pre-requisite for clinical studies, in-vivo tests in a non-human primate model. Evaluation of Antibody-Dependent Enhancement (ADE) risk where scientifically relevant. Production of batches of the most promising antibody candidates according to the Good Manufacturing Practices (GMP) [2] . First in human clinical safety studies 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) [3] is encouraged with the aim of strengthening their scientific and technological foundations, enhancing their innovation potential, and exploring possibilities for commercial exploitation. All projects funded under this topic 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 [4] such as those having contributed to the services developed under the ISIDORe project [5] . Applicants should provide details of their clinical studies [6] 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://health.ec.europa.eu/health-emergency-preparedness-and-response-hera/preparedness/medical-countermeasures-strategy_en [2] https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en [3] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32003H0361 [4] The catalogue of European Strategy Forum on Research Infrastructures (ESFRI) research infrastructures portfolio can be browsed on the ESFRI website: https://ri-portfolio.esfri.eu [5] https://isidore-project.eu [6] 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.

Jogosultsági és benyújtási feltételek

"> General conditions 1. Admissibility Conditions, proposal page limit and layout Admissibility conditions are described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes. Proposal page limits and layout are described in Part B of the Application Form available in the Submission System. 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 Eligibility 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 eligibility 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 To ensure a balanced project portfolio covering the Flaviviruses targeted in this topic[[Flavivirus i to vi, as given in the scope of this topic.]], grants will be awarded (within available budget) to proposals not only in order of ranking but at least also to those proposals that are the highest ranked within different Flaviviruses targeted, provided that the proposals attain all thresholds. 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. 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 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 The granting authority may, up to 4 years after the end of the action, object to a transfer of ownership or to the exclusive licensing of results, as set out in the specific provision of Annex 5. 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 HE Programme Guide Model Grant Agreement (MGA) HE MGA Call-specific instructions Information on clinical studies (HE) Additional documents HE Main Work Programme 2026-2027 – 1. General Introduction HE Main Work Programme 2026-2027 – 4. Health HE Main Work Programme 2026-2027 – 15. General Annexes HE Programme Guide 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 Funding & Tenders Portal Terms and Conditions Funding & Tenders Portal Privacy Statement

Programkörnyezet

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 [1] . 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 pose a significant health, societal, and economic threat worldwide, causing premature deaths and disabilities. Despite being largely preventable, only 6% of healthcare budgets are spent on prevention [2] . To address this, there is an 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, considering sex/gender-related issues. To address these challenges, Research and Innovation will require international cooperation to leverage global expertise, access world-class research infrastructures and invest in priority needs, aligning 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 and respond to public health needs, including rare diseases and 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 Guidelines for 2024-2029 [3] , such as the fight against non-communicable and communicable diseases, mental health, preparedness and response to and surveillance of health threats and epidemics, reduction and treatment, of Antimicrobial-Resistant (AMR) infections, coherent also with wider EU initiatives such as the European Medical Countermeasures Strategy [4] and the forthcoming Critical Medicines Act [5] . In particular, the topics under this destination will support activities aiming at: i) new treatment and disease management options to reduce burden on non-communicable diseases and long-term conditions after post-bacterial and post-viral infections; ii) improve and protect mental health of children and young adults; iii) new prevention and treatment options for infectious diseases with epidemic potential; iv) innovative therapies for AMR critical pathogens; and v) support to second phases of the co-funded European Partnership on Rare Diseases [6] and the co-funded European Partnership for Pandemic Preparedness [7] . To increase the impact of EU investments under Horizon Europe, the Commission encourages cooperation between EU-funded projects to enable cross-fertilisation and other synergies. This could range from networking to joint activities, such as participating in joint workshops, exchanging knowledge, developing and adopting best practices, or undertaking joint communication activities. Opportunities for potential synergies exist between projects funded under the same topic, as well as between projects funded under different topics, Clusters, or Pillars of Horizon Europe. For example, synergies could be sought with projects funded under the European health research infrastructures (Pillar I of Horizon Europe), the EIC [8] strategic challenges on health (Pillar III of Horizon Europe), or with projects on themes that cut across the Clusters under Pillar II of Horizon Europe, such as health security/emergencies under Cluster “Civil Security for Society”, Artificial Intelligence (AI)-based tools and technologies under Cluster “Digital, Industry and Space”, or antimicrobial resistance under Cluster “Food, Bioeconomy, Natural Resources, Agriculture and Environment”. The Commission aims to foster synergies between Horizon Europe and other EU programmes. To this end, applicants are encouraged to explore the funding opportunities available through the EU4Health Programme (2021-2027) [9] , the EU's public health programme, as a means of capitalising on potential collaborations and maximising impact. 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 targets of the World Health Organization (WHO) Global Action Plan for the Prevention and Control of non-communicable diseases [10] , [11] are attained, with an immediate impact on the related disease burden (Disability-Adjusted Life Years - DALYs) [12] . 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 [13] , [14] , [15] . 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). Legal entities established in China are not eligible to participate in both Research and Innovation Actions (RIAs) and Innovation Actions (IAs) falling under this destination. For additional information please see “Restrictions on the participation of legal entities established in China” found in the Annex B of the General Annexes of this Work Programme. 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 [16] 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] https://research-and-innovation.ec.europa.eu/funding/funding-opportunities/funding-programmes-and-open-calls/horizon-europe/strategic-plan_en [2] 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://commission.europa.eu/about/commission-2024-2029_en [4] https://health.ec.europa.eu/health-emergency-preparedness-and-response-hera/preparedness/medical-countermeasures-strategy_en [5] https://health.ec.europa.eu/publications/proposal-critical-medicines-act_en [6] https://cordis.europa.eu/project/id/101156595 , https://erdera.org [7] https://cordis.europa.eu/project/id/101226682 , https://beready4pandemics.eu [8] https://eic.ec.europa.eu [9] https://commission.europa.eu/funding-tenders/find-funding/eu-funding-programmes/eu4health_en [10] https://www.who.int/publications/i/item/9789241506236 [11] https://www.who.int/publications/m/item/implementation-roadmap-2023-2030-for-the-who-global-action-plan-for-the-prevention-and-control-of-ncds-2023-2030 [12] 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. [13] WHO global action plan on antimicrobial resistance, 2015 [14] EU One Health Action Plan against AMR, 2017 [15] https://www.ema.europa.eu/en/news/one-health-joint-framework-action-published-five-eu-agencies [16] 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).

Hivatkozott dokumentumok

Annex A Horizon Europe Programme Guide Online Manual Standard application form (HE RIA, IA) Standard evaluation form (HE RIA, IA) HE MGA Information on clinical studies (HE) HE Main Work Programme 2026-2027 – 1. General Introduction HE Main Work Programme 2026-2027 – 4. Health 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 Terms and Conditions