Descripción del proyecto
Inmunoterapia pasiva contra variantes del SARS-CoV-2 con sensibilidad reducida a las vacunas neutralizantes
El coronavirus del síndrome respiratorio agudo grave 2 (SARS-CoV-2) altamente contagioso ha generado una pandemia sin precedentes. A pesar de las eficaces campañas de vacunación y de los nuevos antivíricos aprobados, cientos de miles de pacientes siguen ingresando en las unidades de cuidados intensivos (UCI) de toda Europa. Las inmunoterapias pasivas basadas en anticuerpos monoclonales han mostrado una reducción de la potencia de neutralización frente a las variantes preocupantes. El equipo del proyecto EPIC-CROWN-2, financiado con fondos europeos, evaluará la inmunoterapia antivírica basada en fragmentos F(ab')2 de anticuerpos policlonales equinos con gran capacidad neutralizante anti-SARS-CoV-2 en portadores de variantes preocupantes. Para optimizar el tratamiento, la potencia del fragmento F(ab')2 contra variantes preocupantes se evaluará «in vitro», en modelos animales y en ensayos clínicos de fase IIa y IIb. Este tratamiento podría reducir un a la mitad los ingresos en las UCI, así como las tasas de mortalidad en los pacientes con variantes preocupantes tratados.
Objetivo
"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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Ámbito científico
- 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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Convocatoria de propuestas
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HORIZON-RIA - HORIZON Research and Innovation ActionsCoordinador
69007 Lyon
Francia
Organización definida por ella misma como pequeña y mediana empresa (pyme) en el momento de la firma del acuerdo de subvención.