Description

Expected Outcomes

This Horizon Europe funding call targets research initiatives that support the overarching goal of “tackling diseases and reducing disease burden”. Projects selected under this topic are expected to deliver results that:

• Enhance the scientific and clinical communities’ understanding of, and access to, experimental monoclonal antibodies for prevention and treatment of emerging or re-emerging viral infections.
• Ensure the availability of candidate monoclonal antibody therapies for clinical use, expanding treatment options during epidemics or pandemics.

Scope of the Funding

Infectious diseases continue to pose a major threat to public health and health security in the EU and globally. The rise of viral infections is increasingly accelerated by climate change, highlighting the importance of a proactive approach in the development of antiviral prophylactics and therapeutics. The ability to produce antibodies that can rapidly target new variants is critical for preparedness against future health threats from epidemics or pandemics.

This call also strengthens the EU’s Research and Innovation ecosystem and supports the European Medical Countermeasures Strategy.

Target Viruses

Applicants must specify which virus their project focuses on, addressing only one of the following:

• Ebola Virus
• Marburg Virus
• Crimean-Congo Hemorrhagic Fever Virus
• Rift Valley Fever Virus
• Enterovirus D68
• Chikungunya Virus

Research proposals should focus on antibodies produced or derived from a single cell clone through recombinant expression, including B-cell derived antibodies, hybridoma-derived antibodies, and nanobodies.

Research Areas and Activities

Funded projects are expected to cover the following activities:

• Finalisation of in-vitro characterisation of monoclonal antibodies, including target specificity, epitope recognition, and ability to neutralize or inactivate viral functions.
• In-vivo testing in at least one animal model, or humanised immune system models, to demonstrate protective efficacy suitable for first clinical trials.
• Non-human primate studies if required by regulators prior to clinical trials.
• Assessment of Antibody-Dependent Enhancement (ADE) risks, where scientifically relevant.
• Production of GMP-compliant batches of the most promising antibody candidates.
• Early-phase human clinical safety studies, considering key biological and social factors such as sex, age, ethnicity, and disability.

Participation of third countries where the targeted viruses are endemic or experiencing outbreaks is encouraged.

Opportunities for SMEs and Start-ups

The call encourages collaboration with start-ups, micro, small, and medium-sized enterprises (SMEs) to strengthen scientific and technological capabilities, enhance innovation potential, and explore commercialisation pathways.