Development of monoclonal antibodies to prevent and treat infections from Flaviviruses
Horyzont Europa · Temat naboru
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Podsumowanie
Polska firma może tu złożyć wniosek na projekt B+R.
Finansowanie prac badaczy i twórców terapii nad przeciwciałami monoklonalnymi do zapobiegania zakażeniom flawiwirusami i ich leczenia.
- Kto może złożyć wniosek
- Firma może być liderem projektu. Wnioskodawcy: MŚP, duże firmy, organizacje badawcze, uczelnie.
- Kwota
- 9 mln € – 10 mln € na projektBudżet naboru 37 mln €
- Termin
- 17 lut 2027za 115 dni
- Status
- Nadchodzącyotwarcie 29 paź 2026
Ocena automatyczna na podstawie tekstu naboru. Warunki udziału sprawdź u źródła.
Opis
Expected Outcome:
This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Tackling diseases and reducing disease burden”. To that end, proposals under this topic should aim to deliver results that are directed at, tailored towards and contributing to all the following expected outcomes:
• The scientific and clinical communities have a better understanding of and access to experimental monoclonal antibodies for the prevention and treatment of emerging or re-emerging viral infections, as well as for further clinical investigation.
• Candidate monoclonal antibody therapies are available to treat patients for emerging and re-emerging viral infections, increasing therapeutic options for clinical deployment in case of an epidemic or pandemic.
Scope:
Infectious diseases remain a major threat to health and health security in the EU and globally. Viral disease emergence is already being accelerated by climate change, and thus a proactive approach to the development of antiviral prophylactics and therapeutics in preparedness for future infectious disease outbreaks is needed. The capacity to produce antibodies that can target new variants and rapidly increase production would serve as an essential preparedness strategy against future health threats, whether from infectious disease epidemics or pandemics.
This topic contributes to strengthening the Research and Innovation ecosystem within the EU and supports the implementation of the European Medical Countermeasures Strategy[1].
Applicants should explicitly state in their proposal which of the following Flaviviruses is targeted and the proposed work should address only this specific Flavivirus. The proposed work should aim to advance the development of existing prophylactic and therapeutic monoclonal antibody candidates targeting exclusively one of the following Flaviviriuses:
• Dengue Virus
• Tick-borne Encephalitis Virus
• Japanese Encephalitis Virus
• West Nile Fever Virus
• Yellow Fever Virus
• Zika Virus
Proposals should focus on antibodies produced or derived from a single cell clone through recombinant expression, such as B-cell derived antibodies, hybridoma derived antibodies and nanobodies.
Proposals should thus aim to diversify and accelerate the global prophylactic and therapeutic research and development portfolio for emerging and re-emerging viral infections, and to strengthen the leading role of the EU in prophylactic and therapeutic research and development.
Proposals should address all the following research areas:
• If necessary, finalisation of the in-vitro characterisation of existing monoclonal antibody candidates with regard to target specificity, epitope recognised, and their ability to impair or inactivate viral functions.
• In-vivo tests in at least one animal model or, if available in humanised immune system animal models, to demonstrate the protective function of the monoclonal antibodies deemed sufficient for moving to first clinical trials.
• If requested by regulators as pre-requisite for clinical studies, in-vivo tests in a non-human primate model.
• Evaluation of Antibody-Dependent Enhancement (ADE) risk where scientifically relevant.
• Production of batches of the most promising antibody candidates according to the Good Manufacturing Practices (GMP)[2].
• First in human clinical safety studies demonstrating a clear regulatory pathway for market authorisation. Attention should be paid to critical biological and social factors such as sex, age, ethnicity and disability.
Participation of third countries where viruses addressed in the proposal are endemic or where outbreaks have occurred or are ongoing is encouraged.
The participation of start-ups, micro, small and medium-sized enterprises (SMEs)[3] is encouraged with the aim of strengthening their scientific and technological foundations, enhancing their innovation potential, and exploring possibilities for commercial exploitation.
All projects funded under this topic are expected to engage with regulatory bodies in a timely manner to ensure adequacy of the actions from a regulatory point of view.
Proposals should advance research by leveraging already existing and emerging state-of-the-art research infrastructures[4] such as those having contributed to the services developed under the ISIDORe project[5].
Applicants should provide details of their clinical studies[6] in the dedicated annex using the template provided in the submission system. As proposals under this topic are expected to include clinical studies, the use of the template is strongly encouraged.
[1] https://health.ec.europa.eu/health-emergency-preparedness-and-response-hera/preparedness/medical-countermeasures-strategy_en
[2] https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
[3] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32003H0361
[4] The catalogue of European Strategy Forum on Research Infrastructures (ESFRI) research infrastructures portfolio can be browsed on the ESFRI website: https://ri-portfolio.esfri.eu
[5] https://isidore-project.eu
[6] Please note that the definition of clinical studies (see introduction to this Work Programme part) is broad and it is recommended that you review it thoroughly before submitting your application.
Kto może złożyć wniosek – szczegóły
- Typy wnioskodawców
- MŚP, duża firma, organizacja badawcza, uczelnia
- Cel
- Badania i innowacje
- Znaczenie dla B+R
- 3 z 3
- Polska kwalifikuje się
- Tak
- Ograniczenie krajów
- —
- Region
- Dowolny
- Konsorcjum
- Niejasne
- Poziom gotowości technologicznej (TRL)
- —
- Tematy
- przeciwciała monoklonalne
- flawiwirusy
- zapobieganie zakażeniom
- leczenie zakażeń wirusowych
- terapie przeciwwirusowe
Ocena automatyczna na podstawie tekstu naboru. Warunki udziału sprawdź u źródła. 23 paź 2026
Warunki
Dane spisane przez nas z dokumentów źródłowych. Każda wartość ma własne warunki. Brak danych oznacza, że źródło nie podaje wartości, a nie zero ani brak limitu.
- Ograniczenie dotyczące wnioskodawcy
- General Annex B restrictions apply, including the default exclusion of entities established in China from Health RIAs, participation of MIIT-supervised Chinese universities, EU restrictive measures, and the applicable Hungarian public-interest-trust restriction. Exceptions/changes require individual checking; the US funding exception does not waive other restrictions.
- Typ wnioskodawcy
- Legal entities subject to Horizon Europe Regulation, General Annex B and topic-specific conditions; participation does not itself establish eligibility for funding.
- Ograniczenie dotyczące wniosku
- Full applications: Excellence, Impact and Implementation each have threshold4/5, cumulative threshold12. Passing thresholds enters budget-limited ranking, not an award. Any own first-stage rules are additional and scoped separately.
- Ograniczenie dotyczące wniosku
- Planned opening 2026-10-29; single-stage deadline 2027-02-17, 17:00 Brussels local time. Work Programme allows opening shifts and deadline delays; live acceptance is not verified.
- Konsorcjum wymagane
- Tak
- Kwalifikowalny obszar geograficzny
- General Annex B funding-geography conditions apply, with the topic-specific exception allowing US legal entities to receive Union funding. Participation and funded status remain distinct; restrictive measures and applicant-specific conditions still apply.
- Kwalifikowalny zakres projektu
- Address all listed areas including protective in vivo evidence, relevant ADE risk, GMP production and first-in-human safety; characterisation/primate tests retain conditional wording.
- Kwalifikowalny zakres projektu
- Select exactly one of Dengue, tick-borne encephalitis, Japanese encephalitis, West Nile fever, Yellow fever or Zika; candidate antibodies derive from a single cell clone/recombinant expression, including nanobodies.
- Kwalifikowalny zakres projektu
- Advance existing prophylactic/therapeutic monoclonal antibody candidates addressing exactly one of Dengue, tick-borne encephalitis, Japanese encephalitis, West Nile fever, Yellow fever or Zika. All listed research areas should be addressed, respecting conditional characterisation/primate-testing and ADE-risk clauses.
- Oczekiwana liczba dofinansowanych projektów (szacunek planistyczny)Captured SEDIA planning estimate for exact topic HORIZON-HLTH-2027-01-DISEASE-06
- 4 count
Expected funded-project/grant count in the exact provider topic budgetOverview. Indicative planning metadata, not guaranteed awards, maximum accepted projects, staffing or consortium size. It does not replace any differently expressed work-programme planning range.
- Inny warunek
- The exact topic adopts General Annex G, subject to its expressly listed exceptions. The signed grant fixes the final amount, eligible costs, model, duration and reporting arrangements.
- Inny warunek
- Project starting date and duration are fixed in the grant agreement. No numerical duration is asserted from the indicative funding table.
- Inny warunek
- The reviewed own-topic setup does not state a lump-sum exception. For actual-cost grants General Annex G provides a mixed budget reimbursing eligible actual costs with applicable unit/flat-rate categories; the operative grant controls the model.
- Inny warunek
- Own-topic overview plans an indicative 4 projects expected to be funded; not job headcount or consortium size.
- Inny warunek
- The granting authority may object to transfer of ownership or exclusive licensing of results up to four years after action end, under the specific Annex5 provision.
- Inny warunek
- When satellite observation, positioning, navigation or related timing data/services are used, use Copernicus and/or Galileo/EGNOS; other services/data may be additional.
- Wymóg dotyczący partnerów
- At least three independent beneficiary legal entities in three different countries: at least one in an EU Member State and at least two others in different EU Member States or Associated Countries. Affiliated entities do not count toward this minimum.
Kwoty i koszty
- Koszt kwalifikowalny
- General Annex G includes personnel costs, subcontracting and purchases among eligible budget categories subject to the grant agreement. Personnel may use applicable actual-cost or unit-cost forms. This is a cost category, not an advertised vacancy, mandatory hire, salary scale, headcount or FTE entitlement.
For the explicit lump-sum topic, eligible personnel estimates help establish the lump sum; salary reimbursement is not asserted.
- Intensywność wsparcia, maksimum
- 100 percent of eligible costs
General Annex G maximum for the actual action type; signed-grant eligible-cost/model conditions apply. For lump sums the rate is part of amount setting.
- Stawka ryczałtowa kosztów pośrednichGeneralAnnexG indirect costs for this Horizon action/grant methodology
- 25 percent of the named eligible-direct-cost base
Base: total eligible direct costs excluding subcontracting, financial support to third parties and any unit costs/lump sums already including indirect costs. Apply only within the relevant grant/budget methodology; for lump sums this contributes to amount-setting, not an extra actual-cost payment or wage rate.
- Oczekiwane dofinansowanie projektu, do
- 10 000 000 €
Indicative expected contribution range; requests for different amounts may be submitted and selected. Not a hard minimum/cap.
- Oczekiwane dofinansowanie projektu, od
- 9 000 000 €
Indicative expected contribution range; requests for different amounts may be submitted and selected. Not a hard minimum/cap.
- Budżet tematu
- 37 300 000 €
Indicative total topic budget; not an individual cap, guaranteed award or current remaining balance.
Dokumenty źródłowe
Dane naboru
- Otwarcie
- 29 paź 2026
- Tryb terminów
- Jednoetapowy
- Program
- Horyzont Europa · 2021–2027
- Nabór
- HORIZON-HLTH-2027-01 · Cluster 1 - Health (Single stage - 2027/1)
- Rodzaje działań
- HORIZON Research and Innovation Actions
- Słowa kluczowe
- Dengue
- GMP
- West Nile
- Yellow Fever
- Zika
- encephalitis
- japanese
- monoclonal
- tick-borne
- Źródło
- ec.europa.eu
- Sprawdzono
- 25 paź 2026
- Aktualizacja w portalu
- 7 paź 2026
- Status przeglądu
- Przegląd częściowy
- Przejrzano
- 23 paź 2026
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