Development of antibodies and antibody-derived proteins for the prevention and treatment of infectious diseases with epidemic potential

The Horizon Europe call under the topic HORIZON-HLTH-2025-01-DISEASE-03 focuses on the development of antibodies and antibody-derived proteins to combat infectious diseases with epidemic potential, such as Lassa, Nipah, and smallpox. The grant type is classified as a Horizon Lump Sum Grant under the Research and Innovation Actions. Eligible applicants include universities, research institutes, small and medium-sized enterprises (SMEs), and public-private partnerships involved in health and infectious disease research, with strong encouragement for multinational collaboration, particularly for clinical studies involving endemic areas.

The grant has an overall budget of €50 million, with individual project funding expected to range around €10 million. The application process is open and single-stage, with submissions due by September 16, 2025. Successful projects should aim to provide better understanding and access to experimental therapies to enhance preparedness for future outbreaks. Proposals are expected to focus on preclinical studies, Good Manufacturing Practice (GMP) quality testing, and first-in-human clinical safety studies.

Participation from third countries where targeted viruses are ongoing or endemic is encouraged. Success rates for applications are expected to be competitive, following the general norms of Horizon Europe funding calls. No co-funding requirements are imposed for these lump sum grants. The application must adhere to specific conditions outlined in Horizon Europe’s General Annexes, including evaluation criteria based on excellence, impact, and implementation quality.

In summary, the call emphasizes the need for innovative research in antiviral therapies and aims to strengthen the EU's capabilities in responding to future health threats by diversifying treatment options and enhancing global health security.

This is a Horizon Europe (HORIZON) call under Cluster 1 Health, specifically targeting the topic HORIZON-HLTH-2025-01-DISEASE-03: Development of antibodies and antibody-derived proteins for the prevention and treatment of infectious diseases with epidemic potential. It is a HORIZON Research and Innovation Action (HORIZON-RIA) with a HORIZON Lump Sum Grant [HORIZON-AG-LS] type of Model Grant Agreement (MGA). The call is currently open for submission with a single-stage deadline. The opening date was May 22, 2025, and the deadline for submission is September 16, 2025, at 17:00:00 Brussels time.

The expected outcomes of this topic are: a better understanding of prophylactic and treatment options complementary to low molecular weight antiviral therapeutics for viruses with epidemic potential among the scientific and clinical communities; 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, for the scientific and clinical communities; and the availability of candidate antiviral therapies, including potentially those of broad spectrum, for emerging and re-emerging viral infections, increasing therapeutic options for clinical deployment in case of an epidemic or pandemic.

The scope of this topic is to address the threat of infectious diseases, particularly viral diseases, to health and health security in the EU and globally, which has been highlighted by the COVID-19 pandemic. The call aims to proactively develop antiviral prophylactics and therapeutics in preparation for future infectious disease outbreaks, recognizing that viral disease emergence is expected to accelerate due to factors such as climate change. The availability of antibodies and antibody-derived proteins is considered a critical preparedness measure against future health threats from infectious disease epidemics or pandemics.

Proposals should exclusively focus on the development of existing antiviral and prophylactic and therapeutic candidates based on antibody and/or antibody-derived proteins that target at least one of the following priority viruses: Arenaviridae (Junin mammarenavirus, Lassa mammarenavirus), Hantaviridae (Hantaan virus, Andes virus, Sin Nombre virus), Poxviridae (Variola major), Paramyxo (Hendra, Nipah virus), and Togaviridae (Venezuelan equine encephalitis virus).

The expected activities include conducting preclinical studies of antibodies and antibody-derived proteins, preparing Good Manufacturing Practice (GMP) quality test batches, and carrying out first-in-human clinical safety studies. Proposals should critically assess the feasibility of producing and distributing the antibodies and antibody-derived proteins at an affordable cost and at a scale sufficient to meet demand during a pandemic.

The call aims to diversify and accelerate the global prophylactic and therapeutic research and development portfolio for emerging and re-emerging viral infections and to strengthen the EU's leading role in this area. Proposals can focus on either antibodies or antibody-derived proteins, or both.

Proposals should address the following areas: finalization of in vitro characterization of antibody and antibody-derived protein candidates, in vivo tests in at least one animal model to demonstrate protective function, in vivo tests in a non-human primate model if requested by regulators, production of GMP quality test batches in the EU or EEA, and first-in-human clinical safety studies. Attention should be paid to critical biological and social factors such as sex, age, ethnicity and disability.

Participation of third countries where the targeted viruses are endemic or where outbreaks are ongoing is encouraged. The participation of start-ups, micro, small, and medium-sized enterprises (SMEs) is also encouraged to strengthen their scientific and technological foundations and enhance their innovation potential.

Applicants are expected to engage with regulatory bodies to ensure the adequacy of their actions from a regulatory perspective. Proposals should leverage existing and emerging state-of-the-art research infrastructures, such as those contributing to the ISIDORe project. Applicants should provide details of their clinical studies in the dedicated annex using the template provided in the submission system.

The general conditions for this call include: Admissibility Conditions as described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes; Proposal page limits and layout as described in Part B of the Application Form; Eligible Countries as described in Annex B of the Work Programme General Annexes, with specific provisions for non-EU/non-Associated Countries and the United States of America; Other Eligible Conditions as described in Annex B of the Work Programme General Annexes, including the use of Copernicus and/or Galileo/EGNOS for projects using satellite-based data and services; Financial and operational capacity and exclusion as described in Annex C of the Work Programme General Annexes; Evaluation and award criteria, scoring, and thresholds as described in Annex D of the Work Programme General Annexes, with thresholds of 4 for Excellence, Impact, and Implementation, and a cumulative threshold of 12; Submission and evaluation processes as described in Annex F of the Work Programme General Annexes and the Online Manual; Indicative timeline for evaluation and grant agreement as described in Annex F of the Work Programme General Annexes; Eligible costs taking the form of a lump sum as defined in the Decision of 7 July 2021; and Legal and financial set-up of the grants as described in Annex G of the Work Programme General Annexes. Specific conditions are described in the specific topic of the Work Programme.

Application and evaluation form templates include the standard application form (HE RIA, IA) and the standard evaluation form (HE RIA, IA). Guidance documents include the HE Programme Guide, Lump Sum MGA, call-specific instructions, information on clinical studies (HE), detailed budget table (HE LS), and guidance on lump sums. Additional documents include the HE Main Work Programme 2025, HE Framework Programme 2021/695, HE Specific Programme Decision 2021/764, EU Financial Regulation 2024/2509, the Decision authorising the use of lump sum contributions, Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment, EU Grants AGA, Funding & Tenders Portal Online Manual, Funding & Tenders Portal Terms and Conditions, and Funding & Tenders Portal Privacy Statement.

The budget for this topic in 2025 is 50,000,000 EUR, and the estimated EU contribution per project is around 10,000,000 EUR, with an indicative number of 5 grants.

There are 31 partner search announcements available for this topic.

In summary, this Horizon Europe call aims to fund research and innovation actions focused on developing antibodies and antibody-derived proteins for the prevention and treatment of infectious diseases with epidemic potential. The goal is to enhance preparedness for future pandemics by diversifying the therapeutic portfolio and strengthening the EU's role in antiviral research and development. The call encourages participation from SMEs and third countries and emphasizes the importance of preclinical and clinical studies, GMP quality test batches, and regulatory engagement. The funding will be provided as a lump sum, and applicants should consult the relevant annexes and guidelines for detailed information on eligibility, evaluation, and submission processes.

Eligible Applicant Types: The eligible applicant types include startups, micro enterprises, small and medium-sized enterprises (SMEs), and any legal entity established in the United States of America. The participation of third countries where viruses addressed in the proposal are endemic or where outbreaks have occurred or are ongoing is encouraged.

Funding Type: The funding type is a grant, specifically a HORIZON Research and Innovation Action (HORIZON-RIA) or a HORIZON Coordination and Support Action (HORIZON-CSA) under the Horizon Europe Programme. The eligible costs will take the form of a lump sum.

Consortium Requirement: The opportunity does not explicitly state whether a single applicant or a consortium is required, but it encourages the participation of various entities, suggesting that consortia are possible and perhaps encouraged.

Beneficiary Scope (Geographic Eligibility): 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. 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. Participation of third countries where viruses addressed in the proposal are endemic or where outbreaks have occurred or are ongoing is encouraged.

Target Sector: The target sector is health, specifically related to tackling diseases and reducing disease burden, focusing on the development of antiviral prophylactics and therapeutics, particularly those based on antibodies and antibody-derived proteins.

Mentioned Countries: United States of America. Third countries where viruses addressed in the proposal are endemic or where outbreaks have occurred or are ongoing are encouraged to participate. European Economic Area.

Project Stage: The project stage is development, validation, and demonstration. Proposals are expected to conduct preclinical studies, prepare GMP quality test batches, and carry out first in human clinical safety studies.

Funding Amount: The funding amounts vary depending on the specific topic within the call, ranging from €2,000,000 to €80,000,000 in total budget, with individual contributions ranging from around €2,000,000 to between €15,000,000 and €20,000,000 for specific projects.

Application Type: The application type is an open call with a single-stage submission process.

Nature of Support: Beneficiaries will receive money in the form of a lump sum grant.

Application Stages: The application process is a single-stage process.

Success Rates: The success rates are not explicitly mentioned, but the indicative number of grants for each topic provides some insight into the potential success rate.

Co-funding Requirement: The text does not explicitly mention a co-funding requirement.

Summary: This Horizon Europe call focuses on "Tackling diseases and reducing disease burden" by supporting the development of antibodies and antibody-derived proteins for preventing and treating infectious diseases with epidemic potential. The call encourages proposals that develop existing antiviral and prophylactic therapeutic candidates based on antibodies or antibody-derived proteins, targeting priority viruses. Activities include preclinical and clinical studies, GMP batch preparation, and first-in-human safety studies. The call encourages the participation of SMEs and entities from third countries where the targeted viruses are endemic. Funding is provided as a lump sum, and the application process involves a single stage. The overall goal is to diversify and accelerate the research and development portfolio for emerging and re-emerging viral infections, strengthening the EU's role in prophylactic and therapeutic research.