Development of monoclonal antibodies to prevent and treat infections from Flaviviruses

The EU funding opportunity, HORIZON-HLTH-2027-01-DISEASE-06, focuses on the development of monoclonal antibodies to prevent and treat infections from Flaviviruses, targeting diseases like Dengue, Zika, West Nile Fever, Yellow Fever, Japanese Encephalitis, and Tick-borne Encephalitis. This program, part of Horizon Europe's Cluster 1 - Health, encourages collaborative research through consortia involving various eligible applicants including research institutions, universities, public organizations, private enterprises, and specifically supports participation from start-ups and SMEs. Applications from legal entities established in the United States and third countries where these viruses are endemic are also encouraged.

The funding mechanism is a grant provided through HORIZON Action Grants, with a total budget allocation of €37.3 million set for 2027, expected to fund four projects, each receiving between €9 million and €10 million. The application process is a single-stage submission, with proposals due by April 13, 2027, following the opening date on February 10, 2027. Successful projects should focus on advancing existing monoclonal antibody candidates through various stages including in vitro characterization, in vivo testing, Good Manufacturing Practices production, and necessary clinical studies aimed at regulatory approval.

The opportunity highlights the need for proactive development of antiviral therapies due to increasing global health threats associated with climate change. It aims to enhance Europe's capacity in developing antibody candidates that can be deployed during public health emergencies, thereby contributing to the European Medical Countermeasures Strategy. Proposals should emphasize innovative research in infectious disease treatment and must address important considerations like regulatory pathways and social factors in clinical research.

The call promotes the diversification of the research portfolio, calling for proposals that ensure a balanced approach across different Flaviviruses, and encourages effective collaboration with regulatory bodies to facilitate project success. Overall, this funding initiative aims to strengthen Europe's health security and innovation ecosystem by investing significantly in advanced therapeutic research targeting critical viral infections.

The EU Funding and Tenders Portal presents a call for proposals under the Horizon Europe (HORIZON) program, specifically within Cluster 1 Health (Single stage 2027/1) with the topic Development of monoclonal antibodies to prevent and treat infections from Flaviviruses, identified as HORIZON HLTH 2027 01 DISEASE 06. This is a HORIZON RIA Research and Innovation Action with a HORIZON Action Grant Budget Based [HORIZON AG] type of Model Grant Agreement. It is a forthcoming, single stage submission process. The planned opening date is 10 February 2027, and the deadline for submission is 13 April 2027, 17:00:00 Brussels time.

The expected outcome of this topic is to enhance the scientific and clinical communities' understanding and access to experimental monoclonal antibodies for preventing and treating emerging or re emerging viral infections, facilitating further clinical investigation. It also aims to make candidate monoclonal antibody therapies available for treating patients with these infections, thereby increasing therapeutic options for clinical deployment during epidemics or pandemics.

The scope of this call recognizes that infectious diseases, accelerated by climate change, pose a significant threat to global health security. It emphasizes the need for proactive development of antiviral prophylactics and therapeutics to prepare for future infectious disease outbreaks. The goal is to build the capacity to produce antibodies that can target new variants and rapidly scale up production, which is crucial for preparedness against future health threats. This initiative contributes to strengthening the EU's Research and Innovation ecosystem and supports the implementation of the European Medical Countermeasures Strategy.

Applicants must specify which Flavivirus their proposal targets, focusing on advancing existing prophylactic and therapeutic monoclonal antibody candidates. The targeted Flaviviruses include Dengue Virus, Tick borne Encephalitis Virus, Japanese Encephalitis Virus, West Nile Fever Virus, Yellow Fever Virus, and Zika Virus. The proposals should concentrate on antibodies produced or derived from a single cell clone through recombinant expression, such as B cell derived antibodies, hybridoma derived antibodies, and nanobodies.

The proposals should aim to diversify and accelerate the global research and development portfolio for emerging and re emerging viral infections, reinforcing the EU's leading role in prophylactic and therapeutic research and development.

The research areas to be addressed include:
1. Finalizing in vitro characterization of existing monoclonal antibody candidates, focusing on target specificity, epitope recognition, and their ability to impair or inactivate viral functions.
2. Conducting in vivo tests in at least one animal model, or in humanized immune system animal models, to demonstrate the protective function of the monoclonal antibodies, ensuring they are suitable for first clinical trials.
3. Performing in vivo tests in a non human primate model, if required by regulators as a prerequisite for clinical studies.
4. Evaluating the Antibody Dependent Enhancement (ADE) risk where scientifically relevant.
5. Producing batches of the most promising antibody candidates according to Good Manufacturing Practices (GMP).
6. Conducting first in human clinical safety studies to demonstrate a clear regulatory pathway for market authorization, paying attention 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 the participation of start ups, micro, small, and medium sized enterprises (SMEs) to strengthen their scientific and technological foundations, enhance their innovation potential, and explore commercial exploitation opportunities.

All funded projects 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 services developed under the ISIDORe project. Applicants are required to provide details of their clinical studies in a dedicated annex using the template in the submission system.

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 detailed in Annex B of the Work Programme General Annexes. Legal entities established in the United States of America are eligible to receive Union funding, acknowledging the opening of the US National Institutes of Health’s programs to European researchers. Projects using satellite based earth observation, positioning, navigation, and/or related timing data and services must use Copernicus and/or Galileo/EGNOS. Other eligibility conditions are in Annex B of the Work Programme General Annexes. Financial and operational capacity and exclusion criteria are in Annex C of the Work Programme General Annexes.

To ensure a balanced project portfolio covering the targeted Flaviviruses, grants will be awarded to proposals based on ranking and those that are the highest ranked within different Flaviviruses, provided they meet all thresholds. Award criteria, scoring, and thresholds are in Annex D of the Work Programme General Annexes. The thresholds for each criterion (Excellence, Impact, Implementation) are 4, with a cumulative threshold of 12. Submission and evaluation processes are in Annex F of the Work Programme General Annexes and the Online Manual. The indicative timeline for evaluation and grant agreement is in Annex F of the Work Programme General Annexes. The granting authority may object to a transfer of ownership or exclusive licensing of results up to 4 years after the action's end, as detailed in Annex 5. Legal and financial setups are in Annex G of the Work Programme General Annexes. 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), both available in the Submission System. Guidance is provided in the HE Programme Guide and the Model Grant Agreement (MGA). Call specific instructions and information on clinical studies are also available. Additional documents include the HE Main Work Programme 2026 2027 (General Introduction, Health, and General Annexes), HE Framework Programme 2021/695, HE Specific Programme Decision 2021/764, EU Financial Regulation 2024/2509, a decision authorizing lump sum contributions, rules for legal entity validation, and the EU Grants AGA Annotated Model Grant Agreement.

The budget overview indicates that the total budget for HORIZON HLTH 2027 01 DISEASE 06 is EUR 37,300,000. The opening date is 2027 02 10 and the deadline is 2027 04 13. The estimated contribution per project ranges from EUR 9,000,000 to EUR 10,000,000, with an indicative number of 4 grants.

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This funding opportunity aims to bolster Europe's preparedness against future viral outbreaks by supporting research and development of monoclonal antibody therapies targeting Flaviviruses. It encourages collaboration between researchers, SMEs, and regulatory bodies to accelerate the development and deployment of effective medical countermeasures. The focus is on translating promising antibody candidates into clinical applications, ultimately reducing the burden of infectious diseases and enhancing global health security.

Eligible Applicant Types: The eligible applicant types include startups, micro, 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 be consulted for a comprehensive list of eligible countries.

Funding Type: The funding type is a grant, specifically a HORIZON Research and Innovation Action (HORIZON-RIA) and HORIZON Pre-commercial Procurement (HORIZON-PCP) under the Horizon Europe program.

Consortium Requirement: The opportunity appears to allow for both single applicants and consortia. The text encourages participation from various entities, suggesting that consortia are welcome, 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. 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 focusing on tackling diseases and reducing disease burden, with an emphasis on infectious diseases, virology, and the development of medical countermeasures. The program targets the development of prophylactic and therapeutic monoclonal antibody candidates.

Mentioned Countries: United States of America. Third countries where the targeted viruses are endemic or where outbreaks have occurred or are ongoing.

Project Stage: The project stage spans from finalizing in-vitro characterization to first-in-human clinical safety studies, indicating a focus on development, validation, and demonstration stages.

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.

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 is provided, allowing for an estimation of the potential success rate based on the number of applications.

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

Summary:

This Horizon Europe call focuses on the development of monoclonal antibodies to prevent and treat infections from Flaviviruses. The primary goal is to support activities that contribute to tackling diseases and reducing disease burden, specifically by enhancing the understanding and accessibility of experimental monoclonal antibodies and making candidate therapies available for emerging and re-emerging viral infections.

The scope includes advancing the development of existing prophylactic and therapeutic monoclonal antibody candidates targeting Flaviviruses such as Dengue Virus, Tick-borne Encephalitis Virus, Japanese Encephalitis Virus, West Nile Fever Virus, Yellow Fever Virus, and Zika Virus. The projects should focus on antibodies produced from a single cell clone using recombinant expression techniques.

Eligible applicants include startups, SMEs, and other legal entities from EU member states, associated countries, and the United States. Participation from third countries where these viruses are endemic or experiencing outbreaks is encouraged. The funding mechanism is a HORIZON Research and Innovation Action (RIA) grant, with funding amounts varying from EUR 3,000,000 to EUR 11,000,000 depending on the specific topic.

The application process is a single-stage open call, with a planned opening date of February 10, 2027, and a deadline of April 13, 2027. Projects should cover research areas such as in-vitro characterization, in-vivo testing in animal models, evaluation of Antibody-Dependent Enhancement (ADE) risk, GMP production of antibody batches, and first-in-human clinical safety studies.

The call aims to strengthen the EU's research and innovation ecosystem, support the European Medical Countermeasures Strategy, and diversify the global portfolio of prophylactic and therapeutic options for viral infections.