The highly contagious SARS-CoV-2 virus has generated an unprecedented pandemic with global dramatic public health and socio-economic consequences. Despite the progression of the global use of efficient vaccines, an increased transmissibility of variants of concern (VOC) is predominantly observed. Besides effective vaccination campaigns and new approved antivirals, hundreds of thousand patients have still been admitted to ICU in Europe in the first half of 2022. Passive immunotherapies based on monoclonal antibodies have shown a drop of neutralization potency against VoCs. A polyclonal approach might be effective to neutralize fast-evolving VoCs and prevent worsening medical conditions for hospitalized patients at risks. The main objective of the European EPIC-CROWN-2 consortium is to rapidly assess, in multicentric clinical trials (phase IIa/b) 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. Production of equine neutralizing anti-SARS- CoV-2 polyclonal F(ab’)2 antibodies Phase 2a cohort 1: Patient’s enrolment completion Validation of the Safety profile of FBR-002 by the DSMB Phase 2a cohort 2: Ongoing patients' enrolment Belledant A.¹, Luczkowiak J.³, Delgado R.³, Rodriguez E.⁴ , Veas F.⁵, Giamarellos-Bourboulis E.², Herbreteau C.H.¹* ¹FAB’ENTECH (Lyon, France), ²HISS Hellenic Institute for the Study of Sepsis, Athens, Greece, ³IMAS12, Instituto de Investigación Hospital Universitario 12 de Octubre (Madrid, Spain), ⁴BNITM, Bernhard Nocht Institute for Tropical Medicine (Hamburg, Germany), ⁵IRD, Institute of Research and Development (Montpellier, France) *Corresponding Author: scientific.communication@fabentech.com Luczkowiak J, Radreau P, Nguyen L, Labiod N, Lasala F, Veas F, Herbreteau C.H, Delgado R. Potent Neutralizing Activity of Polyclonal Equine Antibodiesagainst SARS-CoV-2 Variants of Concern. J Infect Dis. 2022. DOI: 10.1093/infdis/jiac331 Table . Neutralizing Levels for FBR-002 Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Authentic Clinical Isolates, SARS-CoV-2 Pseudotyped Particles, and Controls and Median Inhibitory Concentrations With Sotrovimaba FBR-002 exhibits significant neutralizing activity against current described VoCs including Omicron subvariants BA.4/5 FBR-002 neutralizing potency x100 as compared in humans after COVID-19 mRNA vaccines FBR-002 neutralizing activity more resilient against VoC than clinically approved mAbs Highly purified polyclonal F(ab')2 fragments Based on a technology developed by Sanofi Pasteur and licensed to Fabentech Standard production process FAB’ENTECH PLATFORM EPIC CROWN-2 CLINICAL TRIAL PROJECT EQUINE POLYCLONAL ANTIBODIES IMMUNOTHERAPY AGAINST COVID-19/SARS-COV2–VOC IN VITRO STUDIES : SARS-COV-2 NEUTRALIZING ASSAYS OF FBR-002 EVOLUTION OF SARS-COV-2 VOC NEUTRALIZING LEVELS METHODOLOGY NEUTRALIZATION OF SARS-COV-2 VOC (FBR-002) KEY STATEMENTS CLINICAL BATCH OF FBR-002 PRODUCTION VALIDATED HIGH NEUTRALIZING POTENCY OF FBR-002 TO SARS COV-2 VOCS IN VIVO EFFICACY OF FBR-002 ONGOING SAFETY PROFILE OF FBR-002 UNDER EVALUATION IN PHASE 2A CLINICAL TRIAL