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 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: 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 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.

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.

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, and the estimated EU contribution per project is around €10,000,000, 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.