Tips & Tricks for a successful HORIZON-HLTH-2027-01-DISEASE-06 proposal
Opening
10 February 2027
Deadline
Keywords
Monoclonal Antibodies
Flavivirus
Dengue Virus
Zika Virus
Pandemic Preparedness
Yellow fever
GMP Manufacturing
in-human safety data
West Nile
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HORIZON-HLTH-2027-01-DISEASE-06: Development of monoclonal antibodies to prevent and treat infections from Flaviviruses
Flaviviruses, it seems, don’t garner the headlines like influenza or coronaviruses, but millions of us are infected by Dengue, Zika, West Nile, and their ilk annually, and their reach is expanding northward thanks to climate change. The Commission wishes for viable antibody-based countermeasures to be ready in time: i.e., before the next outbreak. The theme of this call is translational readiness. Choose one Flavivirus; develop one pre-existing monoclonal antibody candidate; proceed to first-in-human safety data.
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Administrative facts: what do we know about the HORIZON-HLTH-2027-01-DISEASE-06 call?
Which call is it, and when is the opening and the deadline?
- Call name: Cluster 1 – Health (Single stage – 2027/1)
- Call identifier: HORIZON-HLTH-2027-01
- Destination: Tackling diseases and reducing disease burden
- Topic identifier: HORIZON-HLTH-2027-01-DISEASE-06
- Opening date: 10 February 2027
- Deadline: 13 April 2027 at 17:00 Brussels local time
- Type of action: Research and Innovation Action (RIA)
What about the budget and estimated size of the project?
- Total indicative topic budget: EUR 37.30 million
- Expected EU contribution per project: EUR 9.00 to 10.00 million
- Indicative number of projects to be funded: 4
What are the key eligibility and evaluation conditions?
- Thresholds: 4 (Excellence), 4 (Impact), 4 (Implementation), cumulative threshold of 12
- Special eligibility exception: US-based legal entities are eligible to receive Union funding, in recognition of NIH program reciprocity
- Portfolio rule: grants are not awarded purely in ranking order; the Commission will fund the highest-ranked proposal per targeted Flavivirus, provided thresholds are met (worth checking twice)
- IP constraint: the granting authority may object to ownership transfer or exclusive licensing up to 4 years post-action
- Clinical studies template: mandatory annex in the submission system
- Satellite data rule: if satellite earth observation is used, Copernicus and/or Galileo/EGNOS must be the source
Scientific range: what does the Commission expect from the HORIZON-HLTH-2027-01-DISEASE-06 grant?
What outcomes are expected?
The scientific and clinical community should be able to obtain experimentally produced mAbs for further clinical development. Candidates developed should be those that could feasibly be employed during an epidemic. The purpose of projects is not another characterization study. Credible regulatory path + first-in-human safety data: in brief.
What is within scope?
- Measles (Measles is only a target of antibodies in one of the six Flaviviruses; the remaining five are: Dengue virus, Tick-borne encephalitis virus, Japanese encephalitis virus, West Nile fever virus, Yellow fever virus, and Zika virus)
- Antibodies produced by one cell clone by way of recombinant expression: B-cell, hybridoma-based, or nanobodies
- Prophylactic and therapeutic antibodies development
- Building on existing ESFRI research facilities, such as the ISIDORe project
- Participation of third countries endemic for the target virus or suffering from an epidemic
Out of scope: small molecule antivirals and antibody-derived proteins are covered by another topic (DISEASE-05); do not mix the topics.
What are the specifically proposed research directions?
- In-vitro characterization of available antibody candidates;
- Specifically, target specificity, epitope binding, and the capability of inhibition/inactivation of the viral functions;
- In vivo in at least one animal model or models of a humanized immune system, if available, in order to demonstrate a protective capacity sufficient for clinical entry;
- Testing in non-human primates if regulators require it for clinical studies.
- Assessing risk of Antibody-Dependent Enhancement (this is where many fall off the wagon with Dengue in particular).
- GMP lot production of the best candidates.
- First in-human clinical safety research with sex, age, ethnicity, and disability taken into account.
Scientific strategy: how can you enhance your chances of being funded through HORIZON-HLTH-2027-01-DISEASE-06?
What scientific decisions are the most important?
- Choose your Flavivirus wisely: Commission will only fund one per virus. A stronger proposal targeting a less popular target will perform better than a medium one targeting Dengue.
- Map the competitive landscape: It is not a research call on antibody discovery; it is on the speedy development of already available candidates. You need your candidate to be already characterized, if possible, you will never finish on time.
- Plan ADE assessment carefully: in Dengue, especially, it's a known risk; Your GMP strategy should be integrated into the plan. Projects that consider it an afterthought typically fail.
- Talk to regulators ahead of time (where possible): The program specifically asks for evidence of preliminary regulatory interaction;
- Having one is a marker of project readiness: Sex, age, and ethnicity diversity in clinical trial patients into account; this is not optional as evaluators will look for it.
Consortium & proposal-writing plan: what works best with this type of call?
- The target for partners should be 8-12 (+/- 2-3 partners depending on clinical necessity); The virology lab must have BSL-3 (or equivalent) capacity, no shortcuts around this.
- Presence of a clinical partner located in a third country with a highly prevalent target virus dramatically increases the score.
- GMP manufacturing capacity must be part of the consortium, not subcontracted out.
- An existing regulatory expert who has worked in regulatory agencies such as the EMA should be part of the consortium.
- When dealing with Dengue and Zika, the presence of a local public health agency in an endemic region is a plus both in scientific authority and public weight.
- An innovative SME operating in antibody development or bioprocess manufacturing fits in naturally and has been mentioned in the call for work.
- Starting the Excellence section with the exact gap that is not met by the choice of the Flavivirus, rather than on Flaviviruses in general.
- They already have context; they want your candidate, its justification, and your path to clinic.
How would microfluidics contribute to this topic?
Traditional antibody screening is functional but time-consuming, expensive per well, and uses materials in quantities that are practically impossible given the BSL-3 required to test against a live Flavivirus.
- Using droplet microfluidics, you can test millions of individual B-cells per hour and identify potential candidates to pursue. Given the scale, you do not require a library of millions.
- You will need to test your mAb to demonstrate it blocks entry effectively and across all dengue serotypes. You will perform this experiment on small quantities in controlled conditions using a microfluidic chip.
- Organ-on-chip or vessel-on-chip system: You can test Antibody Dependent Enhancement effects at the cell level, watch how the vascular endothelium reacts to ADE in controlled circumstances and get mechanistic insight that regulators look for.
- Microfluidic-based analytical instruments (capillary electrophoresis, nanopore-based instruments) are offering the analytical quality needed for GMP lot release testing. Having microfluidics as a tool in your consortium (rather than just as a technology demonstrator) greatly strengthens it. MIC has previously worked on proposals related to antibodies and infectious diseases; to determine which contribution is most useful, the team can provide direct, concrete feedback and discuss.
The MIC already brings its expertise in microfluidics to Horizon Europe:
H2020-NMBP-TR-IND-2020
Microfluidic platform to study the interaction of cancer cells with lymphatic tissue
H2020-LC-GD-2020-3
Toxicology assessment of pharmaceutical products on a placenta-on-chip model
FAQ – HORIZON-HLTH-2027-01-DISEASE-06
Which Flaviviruses can be targeted in a HORIZON-HLTH-2027-01-DISEASE-06 proposal?
The proposed treatments should always be directed towards one of the six Flaviviruses, namely Dengue Virus, Tick-borne Encephalitis Virus, Japanese Encephalitis Virus, West Nile Fever Virus, Yellow Fever Virus, or Zika Virus. The proposal should indicate the targeted virus, and it should be a clear statement of the targeted virus, and all work should be related to that specified virus.
Can US-based institutions apply and receive EU funding?
Yes. Any legal entity formed in the United States of America is allowed to receive Union funding under this topic in recognition of the opening of the US National Institutes of Health (NIH) programs to European researchers. The exemption is a clear exemption to regular Horizon Europe eligibility requirements.
Can a proposal target more than one Flavivirus?
The Commission mandates that each proposal should have only one Flavivirus. The applicants must clearly indicate the virus they selected in the proposal. The portfolio rule means that the Commission finances the most viable proposal for each of the targeted Flaviviruses, but not necessarily in accordance with the overall ranking. A good proposal on a less competitive virus can thus be funded before a weaker proposal on Dengue.
What is the Antibody-Dependent Enhancement (ADE) requirement?
Proposals must assess the risk of Antibody-Dependent Enhancement (ADE) when scientifically pertinent. This is particularly important for Dengue, where ADE is a well-documented mechanism of disease severity. Evaluators will question this point. It should be explicitly considered as part of the scientific methodology.
Is a clinical studies template mandatory for submission?
Yes. As the suggestions in this topic would most likely entail clinical research, the applicants would have to elaborate on them in a separate annex using the template provided in the submission system. The Commission strongly recommends using this template. It is noteworthy that the definition of clinical studies in this Work Program is rather broad – read it carefully and send it.
What GMP requirements apply to antibody batch production?
The proposals must include GMP batch production of the most promising antibody candidates in accordance with EudraLex Volume 4. This is not a subcontract that should be given to the consortium itself. The project plan would include GMP manufacturing, not an afterthought for the evaluators.
What antibody formats and production methods are accepted?
The proposals are to be directed towards antibodies produced by a single-cell clone via recombinant expression. All accepted formats are B-cell-derived antibodies, hybridoma-derived antibodies, and nanobodies. There are no small-molecule antivirals or antibody-derived proteins, and are addressed in another topic (DISEASE-05).
Are third-country partners encouraged to join?
The Commission explicitly welcomes the involvement of third countries where the targeted virus is endemic, or where outbreaks have occurred or are in progress. The fact that the Impact criterion score includes a strong presence of a clinical partner in an endemic country is a significant strength, indicating that the proposed intervention addresses a real-world need.
What IP restrictions apply after the grant ends?
The grantor may, within 4 years after the action ceases, object to a change of ownership or to exclusive licensing of results as provided in the specific provisions of Annex 5 of the Grant Agreement. This limitation should be considered by Consortia in the strategy of its exploitation and commercialization at the very beginning. Check the Funding and Tenders Portal for more information.
How must sex, age, and diversity variables be integrated?
The design of clinical safety studies should also be done with a keen focus on the inclusion of critical biological and social variables in the study design, i.e., sex, age, ethnicity, and disability. This is not an invitation but a tough necessity. The evaluators will want substantial consideration of these variables in the design of the clinical study, rather than a diversity statement added as an afterthought.