Description du projet
Immunothérapie passive contre les variants de la COVID-19 moins sensibles aux vaccins neutralisants
Le virus extrêmement contagieux du SRAS-CoV-2 a provoqué une pandémie sans précédent. En dépit de campagnes de vaccination efficaces et de nouveaux antiviraux agréés, des centaines de milliers de patients sont encore admis dans des unités de soins intensifs en Europe. Le pouvoir de neutralisation des immunothérapies passives basées sur des anticorps monoclonaux a chuté contre les variants préoccupants (VOC pour variants of concern). Le projet EPIC-CROWN-2, financé par l’UE, évaluera l’immunothérapie antivirale basée sur des anticorps F(ab’)2 polyclonaux anti-SARS-CoV-2 équins à large pouvoir de neutralisation chez les porteurs de VOC. Pour optimiser le traitement, la puissance de F(ab’)2 contre les VOC sera évaluée in vitro, sur des modèles animaux et au cours d’essais cliniques de phase IIa et IIb. Cette solution thérapeutique pourrait réduire de 50 % les admissions en soins intensifs ainsi que les taux de mortalité chez les patients traités pour un VOC.
Objectif
"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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Champ scientifique
- 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
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HORIZON-RIA - HORIZON Research and Innovation ActionsCoordinateur
69007 Lyon
France
L’entreprise s’est définie comme une PME (petite et moyenne entreprise) au moment de la signature de la convention de subvention.