Project description
Passive immunotherapy against COVID-19 variants with reduced sensitivity to neutralising vaccines
The highly contagious SARS-CoV-2 virus has generated an unprecedented pandemic. Besides effective vaccination campaigns and new approved antivirals, hundreds of thousands of patients are still being admitted to ICUs across Europe. Passive immunotherapies based on monoclonal antibodies have shown a drop of neutralisation potency against variants of concern (VOC). The EU-funded EPIC-CROWN-2 project will assess antiviral immunotherapy based on broad equine neutralising anti-SARS-CoV-2 polyclonal F(ab')2 antibodies in VOC carriers. To optimise the treatment, the potency of F(ab')2 against VOC will be assessed in vitro, in animal models, and phase IIa and IIb clinical trials. This therapeutic solution could reduce ICU admissions by 50 % as well as mortality rates in treated VOC patients.
Objective
"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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Fields of science
- 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
Keywords
Programme(s)
Funding Scheme
HORIZON-RIA - HORIZON Research and Innovation ActionsCoordinator
69007 Lyon
France
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.