Descrizione del progetto
Immunoterapia passiva contro le varianti di COVID-19 con ridotta sensibilità ai vaccini neutralizzanti
Il virus SARS-CoV-2, altamente contagioso, ha generato una pandemia senza precedenti. Oltre alle campagne di vaccinazione efficaci e ai nuovi antivirali approvati, centinaia di migliaia di pazienti sono ancora ricoverati nelle unità di terapia intensiva in tutta Europa. Le immunoterapie passive basate su anticorpi monoclonali hanno mostrato un calo della potenza di neutralizzazione contro le varianti preoccupanti (VOC). Il progetto EPIC-CROWN-2, finanziato dall’UE, valuterà l’immunoterapia antivirale basata su ampi anticorpi policlonali neutralizzanti anti-SARS-CoV-2 nei portatori di varianti VOC. Per ottimizzare il trattamento, la potenza di F(ab’)2 contro le VOC sarà valutata in vitro, in modelli animali e in studi clinici di fase IIa e IIb. Questa soluzione terapeutica potrebbe ridurre del 50 % i ricoveri in terapia intensiva e i tassi di mortalità nei pazienti con varianti VOC sotto cura.
Obiettivo
"The highly contagious SARS-CoV-2 virus has generated an unprecedented pandemic with global dramatic public health and socio-economic consequences need an urgent mitigation. Despite the progression of the global use of efficient vaccines, an increased transmissibility of variants of concern (VOC) is predominantly observed.
The reduced sensitivity of VOCs to neutralizing response could become a serious obstacle for efficient vaccination. In the absence of approved specific antiviral therapies for vaccinated-non-responders and the scarce anti-inflammatory therapies, passive immunotherapies with polyclonal immunoglobulins could be considered a part of the solution.
The main objective of EPIC-CROWN is to rapidly assess, in multicentric clinical trials (phase IIa, 16 patients and IIb, 400 patients), an EMA-authorized antiviral immunotherapy based on potent and broad equine neutralizing anti-SARS-CoV-2 polyclonal F(ab’)2 antibodies in COVID-19 patients, including VOC carriers.
In order to save lives and reduce the use and costs of critical care, this therapeutic solution expect to reduce at least by 50% ICUs admissions and a highly significant mortality rate of treated patients. To optimize the indications for the treatment, potency and breath of F(ab’)2 against variants will be assessed in in vitro and in an animal model as well as prospective studies will respectively be done on immune assessment in treated patients and on mitigation of exacerbated immune responses in vivo.
Fab’entech will coordinate EPIC-CROWN-2 formed by outstanding experts in different project domains that include clinical trials (HISS, Greece), virology (IMAS12, Spain), and immunopathology models and mitigation (BNITM, Germany - IRD, France). Most of them having already been working together in European projects. Importantly, EPIC-CROWN-2 will be integrated as part of both the large European trial network EU-RESPONSE and the multinational European Adaptive Platform Trial “Solid Act"".
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Campo scientifico
- medical and health sciencesclinical medicinecritical care medicine
- medical and health scienceshealth sciencesinfectious diseasesRNA virusescoronaviruses
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsvaccines
- medical and health sciencesbasic medicineimmunologyimmunotherapy
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsantivirals
Parole chiave
Programma(i)
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Meccanismo di finanziamento
HORIZON-RIA - HORIZON Research and Innovation ActionsCoordinatore
69007 Lyon
Francia
L’organizzazione si è definita una PMI (piccola e media impresa) al momento della firma dell’accordo di sovvenzione.