Development of monoclonal antibodies to prevent and treat infections from Filo-, Nairo-, Phenui-, Picorna- and Toga viruses

The Horizon Europe call HORIZON-HLTH-2027-01-DISEASE-07 focuses on the development of monoclonal antibodies aimed at preventing and treating infections caused by Filo-, Nairo-, Phenui-, Picorna-, and Toga viruses. This initiative is designed to enhance the EU's capacity for health security and research innovation in response to emerging viral threats.

The call will officially open on February 10, 2027, and close on April 13, 2027. It is classified as a Research and Innovation Action (HORIZON-RIA) with a total budget of €37.3 million, expected to fund four projects with grants ranging from €9 million to €10 million each. Applicants can include research institutions, universities, SMEs, large enterprises, and clinical organizations, with particular encouragement for start-ups and entities from the United States and regions where these viruses are endemic.

Consortium participation is required, typically involving at least three independent legal entities from different member states or associated countries. The geographical eligibility encompasses the full EU member states, associated countries, and third countries with ongoing outbreaks or endemic statuses.

The focus of the research will support a variety of stages, including in-vitro characterization, in-vivo testing, regulatory frameworks, GMP manufacturing, and initial clinical trials. Proposals must target one of six specified viral threats: Ebola, Marburg, Crimean-Congo hemorrhagic fever, Rift Valley fever, enterovirus D68, and Chikungunya.

The application process is a single-stage submission, with evaluation based on excellence, impact, and implementation criteria. Proposals must achieve a minimum score of 4 out of 5 in each of these categories, with a cumulative score of at least 12 points to qualify for funding.

This funding opportunity emphasizes bridging research with clinical application, focusing on developing therapies that can undergo regulatory approval and clinical deployment. The call intends to foster international collaboration and strengthen the capabilities within the EU to respond to public health crises through innovative research in monoclonal antibody therapies.

The EU Funding and Tenders Portal presents a Horizon Europe (HORIZON) call, specifically under Cluster 1 Health (Single stage 2027/1) (HORIZON HLTH 2027 01). The call topic is Development of monoclonal antibodies to prevent and treat infections from Filo, Nairo, Phenui, Picorna and Toga viruses, identified as HORIZON HLTH 2027 01 DISEASE 07. This is a HORIZON RIA (Research and Innovation Actions) grant, utilizing a HORIZON Action Grant Budget Based [HORIZON AG] Model Grant Agreement. The call is forthcoming with a single stage deadline model. The planned opening date is 10 February 2027, and the deadline for submission is 13 April 2027, 17:00:00 Brussels time.

The call aims to support activities that contribute to tackling diseases and reducing disease burden. Expected outcomes include a better understanding of and access to experimental monoclonal antibodies for prevention and treatment of emerging/re emerging viral infections, and the availability of candidate monoclonal antibody therapies for clinical deployment during epidemics or pandemics.

The scope addresses the threat of infectious diseases, particularly viral emergence accelerated by climate change. It emphasizes a proactive approach to developing antiviral prophylactics and therapeutics. The call contributes to strengthening the EU's Research and Innovation ecosystem and supports the European Medical Countermeasures Strategy.

Applicants must specify which virus their proposal targets, focusing on advancing existing monoclonal antibody candidates for one of the following viruses: Ebola Virus, Marburg Virus, Crimean Congo Hemorrhagic Fever Virus, Rift Valley Fever Virus, Enterovirus D68, and Chikungunya Virus. The focus should be on antibodies produced or derived from a single cell clone through recombinant expression, including B cell derived antibodies, hybridoma derived antibodies, and nanobodies.

The research areas to be addressed include: finalization of in vitro characterization of monoclonal antibody candidates, in vivo tests in at least one animal model (or humanized immune system models), in vivo tests in a non human primate model if requested by regulators, evaluation of Antibody Dependent Enhancement (ADE) risk, production of antibody batches according to Good Manufacturing Practices (GMP), 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 from third countries where the targeted viruses are endemic or experiencing outbreaks is encouraged. The call also encourages participation from start ups, micro, small, and medium sized enterprises (SMEs). All funded projects are expected to engage with regulatory bodies. 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 a dedicated annex.

The 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 in the Submission System. Eligible countries are described in Annex B of the Work Programme General Annexes. Legal entities from the United States of America are eligible for Union funding. Projects using satellite based earth observation, positioning, navigation, and related timing data and services must use Copernicus and/or Galileo/EGNOS. Other eligibility conditions are in Annex B. Financial and operational capacity and exclusion are in Annex C.

To ensure a balanced project portfolio, grants will be awarded to proposals targeting different viruses, provided they meet all thresholds. Award criteria, scoring, and thresholds are in Annex D. The thresholds for each criterion (Excellence, Impact, Implementation) are 4, with a cumulative threshold of 12. Submission and evaluation processes are in Annex F and the Online Manual. The indicative timeline for evaluation and grant agreement is in Annex F. The granting authority may object to ownership transfer or exclusive licensing of results up to 4 years after the action's end, as per Annex 5. Legal and financial setups are in Annex G. Specific conditions are in the specific topic of the Work Programme.

Application and evaluation form templates include a standard application form (HE RIA, IA) and a standard evaluation form (HE RIA, IA). Guidance is provided in the HE Programme Guide and Model Grant Agreement (MGA). Call specific instructions and information on clinical studies are available. Additional documents include the HE Main Work Programme 2026 2027 (General Introduction, Health, General Annexes), HE Framework Programme 2021/695, HE Specific Programme Decision 2021/764, EU Financial Regulation 2024/2509, Decision authorising lump sum contributions, Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment, EU Grants AGA Annotated Model Grant Agreement, Funding & Tenders Portal Online Manual, and Funding & Tenders Portal Terms and Conditions and Privacy Statement.

The budget overview lists several topics with their respective budgets, stages, opening dates, deadlines, contributions, and indicative number of grants. These topics include: HORIZON HLTH 2027 01 CARE 02, HORIZON HLTH 2027 01 DISEASE 05, HORIZON HLTH 2027 01 DISEASE 06, HORIZON HLTH 2027 01 DISEASE 07, HORIZON HLTH 2027 01 DISEASE 08, HORIZON HLTH 2027 01 DISEASE 10, HORIZON HLTH 2027 01 ENVHLTH 02, HORIZON HLTH 2027 01 ENVHLTH MISSCLIMA 03, HORIZON HLTH 2027 01 IND 01, and HORIZON HLTH 2027 01 STAYHLTH 01.

Partner search announcements are available for collaboration. LEARs, Account Administrators, and self registrants can publish partner requests. The submission system will open on the date stated in the topic header.

This Horizon Europe call focuses on developing monoclonal antibodies to combat emerging viral infections. It seeks to bolster the EU's preparedness for future pandemics by funding research and innovation in antiviral therapeutics. The call encourages a targeted approach, requiring applicants to focus on specific viruses and antibody types. It also emphasizes the importance of clinical studies, regulatory engagement, and collaboration with SMEs and international partners. The ultimate goal is to enhance the understanding and accessibility of monoclonal antibody therapies, providing effective countermeasures against viral threats and strengthening the EU's leadership in global health security.

Eligible Applicant Types: The eligible applicant types for this opportunity include startups, micro enterprises, small and medium-sized enterprises (SMEs), and any legal entity established in the United States of America. Participation of third countries where viruses addressed in the proposal are endemic or where outbreaks have occurred or are ongoing is encouraged. The general annexes of the Horizon Europe Work Programme should also be consulted for further details on eligible countries.

Funding Type: The funding type for this opportunity is a grant, specifically a HORIZON Research and Innovation Action (HORIZON-RIA). It is a budget-based action grant. There is also a HORIZON Pre-commercial Procurement (HORIZON-PCP) action.

Consortium Requirement: The opportunity appears to allow for both single applicants and consortia. The text mentions encouraging the participation of various entities, suggesting that a consortium is possible, but it does not explicitly exclude single applicants.

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. See the information in the Horizon Europe Programme Guide. 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 for this program is health, specifically focusing on the development of monoclonal antibodies for the prevention and treatment of viral infections. The program targets infectious diseases, virology, immunology, and pharmaceutical/biotech research and development.

Mentioned Countries: The United States of America is explicitly mentioned as an eligible location for legal entities to receive Union funding. Third countries where the targeted viruses are endemic or have ongoing outbreaks are also encouraged to participate.

Project Stage: The project stage ranges from finalization of in-vitro characterization of existing monoclonal antibody candidates to first-in-human clinical safety studies. This includes in-vivo testing in animal models, production of GMP batches, and demonstration of a clear regulatory pathway for market authorization. Therefore, the project stage covers development, validation, and early-stage clinical studies.

Funding Amount: The funding amounts vary depending on the specific topic within the call, ranging from EUR 3,000,000 to EUR 11,000,000. For example, HORIZON-HLTH-2027-01-DISEASE-07 has a budget of EUR 37,300,000 and aims to award grants between EUR 9,000,000 and EUR 10,000,000.

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 grant to support their research and innovation activities.

Application Stages: The application process involves a single stage.

Success Rates: The success rates are not explicitly mentioned, but the indicative number of grants for each topic provides some context. For instance, HORIZON-HLTH-2027-01-DISEASE-07 aims to award 4 grants, while HORIZON-HLTH-2027-01-DISEASE-05 aims to award 5 grants.

Co-funding Requirement: The information provided does not explicitly state whether co-funding is required.

Summary: This Horizon Europe call aims to support research and innovation actions focused on the development of monoclonal antibodies for the prevention and treatment of emerging and re-emerging viral infections. The goal is to strengthen the EU's research and innovation ecosystem in the health sector and to enhance preparedness for future infectious disease outbreaks. The call encourages participation from various entities, including startups, SMEs, and international collaborations, particularly from countries where the targeted viruses are endemic. Projects should cover a range of activities, from in-vitro characterization and in-vivo testing to GMP production and first-in-human clinical studies. The funding is provided through grants, with varying budget allocations depending on the specific topic, and the application process involves a single-stage submission. The call seeks to improve the understanding and accessibility of monoclonal antibody therapies, ultimately increasing therapeutic options for clinical deployment during epidemics or pandemics.