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A European consortium to combat new emerging infectious diseases with pandemic potential

e-FabRIC is a European consortium project that aimed at developing an innovative broad-spectrum antiviral therapy to combat new emerging infectious diseases with pandemic potential, particularly those caused by viruses of the Sarbecovirus family

About

e-FabRIC will develop a broad-spectrum antiviral therapy based on a new hyperimmunization strategy for generating equine immunoglobulins having a broad neutralizing specificity against several virus of the same subfamily. e-FabRIC will address the Sarbecovirus family specifically identified for its high pandemic potential risk.

Context

The Covid-19 crisis revealed the need for healthcare systems worldwide to be better prepared for potential future health emergencies. Improving health protocols implies the development of European sovereignty in public health and the implementation of coordinated response between European countries. The EU’s pandemic preparedness plan clearly supports innovation to develop broad spectrum antiviral drugs for providing effective therapeutic solutions to meet well-identified medical needs.

To meet these major societal and public health challenges, e-FabRIC ambition is to develop an effective broad spectrum therapeutic solution, ready to be used in case of emergency.

representations of two viruses interacting

Why Sarbecoviruses?

Considered to be one of the riskiest family of viruses, Sarbecoviruses are responsible for severe respiratory pathologies in humans, coupled with a high mortality rate and strong mutagenic capabilities. Sarbecoviruses are zoonotic as they originate in animals before spilling over into humans1,2. New sarbecoviruses are likely to emerge, hence warranting the need to develop preventive and therapeutic solutions to counter possible new epidemics and pandemics with coronaviruses more swiftly and effectively in the future.

Ambition of the project

e-FabRIC’s aims to develop a new class of broad-spectrum antiviral therapy, using an innovative hyperimmunization method.

This treatment will address emerging infectious diseases with pandemic potential caused by viruses from the Sarbecovirus family. To ensure the broad-spectrum efficacy of this passive immunotherapy, the consortium will develop equine polyclonal antibodies based on Fabentech technology. e-FabRIC will be the first European project to use this kind of approach to develop a treatment able to neutralize several viruses from the same family and their potential variants.

The work conducted by e-FabRIC will pave the way for the development of new treatments addressing other highly pathogenic virus families with pandemic potential.

syringe and medicinevial

Technology

e-FabRIC technology is based on horses hyperimmunization with a mosaic antigen structure, presenting at its surface 8 virus antigens from the Sarbecovirus family. Fabentech technology enables the highly efficient purification of equine potent polyclonal antibodies to produce F(ab’)2 antibodies fragments that can recognize and bind to the virus or toxin, thereby stopping disease progression. The F(ab’)2 antibody fragments generated by e-FabRIC are expected to display a unique and very wide neutralizing activity spectrum.

Graphic to represent the technology and processes to create vaccine
Representaion of virus exploding or being defeated

Why choose polyclonal antibodies approach?

Polyclonal antibodies recognize and bind to multiple sites (called epitope) of the virus. This broad binding capacity enhances their efficacy against diverse strains and variants of the virus. The high diversity of polyclonal antibodies (and their derived F(ab’)2) are generated with the immunogenetic diversity of all the hyperimmunized horses.

Mode of action of broad spectrum polyclonal antibodies

A European therapeutic product

In pandemic preparedness context, the needs of broad-spectrum antiviral therapy are now well identified. The ambition of e-FabRIC is to rapidly assess a safe and effective therapeutic solution, demonstrating efficacy and safety profile in human population.

To ensure European sovereignty, all the process will take place in EU: production of the mosaic antigen, hyperimmunization, and the whole GMP process. The EU preparedness highlights the need to strengthen the regulatory path for pandemic preparedness drug. e-FabRIC will develop a full regulatory pathway by developing in advance all analytical methods to secure the therapeutical development. Partners will work closely with the Authorities to define the best regulatory path for this novel therapeutic product.

At the end of the project, e-FabRIC will deliver a fully European treatment that can be produced locally, ensuring European sovereignty and preparedness against emerging infectious diseases from Sarbecovirus family.

Exterior of European parliament building

Scientific Board

Prof. Veas is a molecular viral immune-physio-pathologist, who has been studying the role of crucial HIV surface structures…

Prof. Enjuanes is a molecular virologist expert in virus reverse genetics and pathology. He has been working for 42 years in the…

Dr. Jungback is a veterinarian, and she was Head of Veterinary Virology at the Paul-Ehrlich-Institut (Federal Agency for Sera and Vaccines)…

Coordination

Anaïs Belledant

Anaïs Belledant, the coordinator of e-FabRIC, is Innovation Project Manager at Fabentech. She has an international profile having obtained a bachelor’s in biology in the USA and a PhD in Molecular Medicine at Laval University Canada. She experienced an innovation project manager in biopharma over 8 years. She has over 10 years’ experience in International and European project coordination. She currently serves as WP leader of the highly successful and very positively assessed European Project EPIC-CROWN-2 and COUNTERACT.

Samy Strola

Samy Strola, PhD in Physics, is a former researcher having worked in public and private organizations in Italy, the Netherlands, Luxembourg and France. His responsibilities progressively evolved towards project management and coordination, with focus on the technological innovation themes. Over the past 15 years, he accompanied numerous R&D&I projects helping coordinators in the writing of proposal for EU and national grants and supporting them in the PMO functions. In 2021, he founded Strola Consulting, which offers services for grant writing design and preparation, project feasibility analysis and management of funded projects.

News & Events

e-FabRIC is a scientific project involving numerous European stakeholders. From local gatherings to global initiatives, we provide comprehensive coverage to keep you informed.

e-FabRIC consortium announces the achievement of the first milestone: developing mosaic nanoparticle antigen from eight sarbecoviruses

The Howarth Group at the University of Cambridge, a partner at e-FabRIC, has manufactured and delivered an innovative mosaic antigen, obtained from the conjugation of

Press Release

Fabentech awarded €7.7m from the European Commission as coordinator of the e-FabRIC consortium to develop an innovative broad-spectrum therapy against emerging viruses with pandemic potential

Launch Event

We are pleased to announce the official launch of e-FabRIC on January 22, 2024. This significant milestone was marked by a pivotal kick-off meeting held

Timeline

Media Scientific Activities

One of the e-FabRIC great ambitions’s is to pave the way for future therapies with mosaïc antigens. Our work and significant achievements will be published and shared among the scientific community, and beyond.

Reports

e-FabRIC will publish reports and policy briefs twice a year to assess the progress of the project. The first publication will be made during 2024 as we advance on our journey against Sarbecoviruses.

REFERENCES: 1. Severe Acute Respiratory Syndrome (SARS) (who.int) | 2. Liu, B., Zhao, P., Xu, P. et al. A comprehensive dataset of animal-associated Sarbecoviruses. Sci Data 10, 681 (2023)

About Fabentech

Fabentech is a French-based pharmaceutical SME dedicated to the development and production of polyclonal immunotherapies through a unique and well controlled proprietary technology platform initially developed by Sanofi Pasteur company and licenced to Fabentech. The company owns its manufacturing site for the purification of polyclonal F(ab’)2 fragments. Since 14 years, Fabentech has acquired a valuable reputation in showing its capacity of rapidly developing medicinal products for different pathogens. Fabentech launched numerous R&D programs and succeeded to produce batches of therapeutic polyclonal antibodies against Ebola, H5N1, H7N9, Covid-19 and ricin agents. Fabentech is currently coordinating the EPIC-CROWN-2, which was granted within the call HORIZON-HLTH-2021-CORONA-01-01 (Vaccines & therapeutic clinical trials to boost Covid-19 prevention and treatment), and partner of the COUNTERACT project granted from EDF call EDF-2021-MCBRN-D-MCM-2.

Contact
Caroline Ballet is scientific project leader of e-FabRIC at Fabentech. Since she received her PhD in immunology in 2008, she spent 15 years leading immunotherapy development projects in biotechnology companies, and served as project leader in several national consortia.

About Institute of Tropical Medicine Antwerp

(ITM) is dedicated to improving the diagnosis, the understanding of the (re-)emergence and disease mechanisms caused by viral pathogens such as arthropod-borne alpha- and flaviviruses (Chikungunya, Dengue, Zika, etc.) and haemorrhagic fever viruses (Ebola). The Virology Unit is part of the Belgian National Reference Center for Arboviruses and the Belgian National Reference Center for Tropical Infectious Diseases and has access to a state-of-the art Biosafety Level 3 facility that enables experimental research with risk group 3 viral pathogens. Since 2020, the Unit has been extensively involved in performing analysis of neutralising antibodies for SARS-CoV-2 variants, with >20,000 live-virus tests performed for various studies on vaccine efficacy since early 2020 and >35 scientific publications related to SARS-CoV-2 between 2020-2023.

Contact
Kevin K. Ariën, PhD is a virologist and expert in tropical infectious diseases. He obtained degrees from the Vrije Universiteit Brussel (VUB) and the University of Antwerp and worked at the Case Western Reserve University, Cleveland, Ohio and Ghent University before joining the Institute of Tropical Medicine Antwerp. His current research efforts include the development of new diagnostic tools for the detection of a wide variety of (re-)emerging viruses, including epidemiologically relevant arboviruses and haemorrhagic fever viruses. A more basic research program focuses on virus-host-vector molecular interactions of chikungunya and dengue virus and identifying sylvatic reservoirs of arboviruses. Early 2020, the unit invested a significant part of its capacity on SARS-CoV-2 research, including setting up diagnostic methods, studies on the duration of immune responses following natural infection and vaccination, and re-infection. Dr. Ariën is head of the department of Biomedical Sciences at ITM and has a secondary appointment as Professor in the department of Biomedical Sciences of the Faculty of Pharmaceutical, Biomedical and Veterinary Sciences at the University of Antwerp.

About University of Cambridge Department of Pharmacology

The Howarth group in the Department of Pharmacology at the University of Cambridge (UC) focuses on innovating protein technologies, particularly as applied to the immune system.

Contact
Mark Howarth is currently the Sheild Chair of Pharmacology. Until 2022 Mark was Professor of Protein Nanotechnology in Oxford University Department of Biochemistry. Mark received the Outstanding Young Investigator Award of the American Histochemical Society and the Royal Society of Chemistry Norman Heatley Award for chemical biology. The group has distributed protein tools to >700 academic groups in 41 countries. The group pioneered spontaneous isopeptide bond formation for molecular assembly, leading to SpyTag/SpyCatcher, SnoopTag/SnoopCatcher and SnoopLigase technologies. 15 patents have been filed on Mark’s work, licensed to 18 biotech and pharmaceutical companies. Members of the Howarth group have founded LiliumX, Inulox and Genie Biotech and Mark co-founded SpyBiotech. The laboratory is well equipped for protein production in prokaryotic and eukaryotic systems and for enhancing protein function through computational design and library selections. The group has pioneered SpyCatcher display on nanoparticles to induce potent broadly reactive antibodies, as applied to HIV, influenza and coronaviruses. The group continues to advance these technologies, recently generating particles displaying a chain of antigens from different viruses to elicit potent cross-reactive antibodies.

About Instituto de Investigación Hospital 12 de Octubre

Instituto de Investigación Hospital 12 de Octubre (FIB-H12O) concentrates the clinical and experimental research of the Hospital Universitario 12 de Octubre within SERMAS (Public Health System for the region of Madrid, Spain). FIB-H12O has 250 researchers and an annual budget of 30M € (2022). The group of Research on Emerging Viruses has developed a technology to produce pseudoviruses (PSV-VLP, Viral-like particles) expressing on their surface the glycoproteins of different enveloped viruses such as Ebola virus, Marburg virus, Zika, Dengue and now Coronavirus and allow us to explore viral entry, receptor interaction and neutralizing responses. These models have also been used as platforms for antiviral screening and discovery. This research activity is combined with diagnostics and clinical research at the Clinical Microbiology Department of Hospital Universitario 12 de Octubre in Madrid, where the group is involved in the follow up of the evolution of diversity in the circulating sequences of SARS-CoV-2 and the immune response of Covid-19 convalescent and vaccinated individuals. The infrastructure of the group includes a BSL-3 facility and Next Generation Sequencing capability for SARS-CoV-2 (+3000 SARS-CoV-2 full genomic sequences deposited in GISAID database).

Contact
Rafael Delgado MD, PhD (M) is a specialist in microbiology and infectious diseases. He did a research fellowship at the National Gene Vector Laboratory of the University of Michigan where he started to work with vector systems for research in emerging pathogens and vaccine development. He has an extensive experience in international collaborations for research on emerging viruses and antiviral discovery and is author of +120 scientific articles (H index =37, 5097 citations JCR-WoS). Currently he is responsible of the Department of Clinical Microbiology at the Hospital Universitario 12 de Octubre and full professor of the Universidad Complutense School of Medicine in Madrid.

About Biotem

BIOTEM is a contract research organization (CRO) founded in 1980 which provides services for the development of custom antibodies and immunoassays. BIOTEM has been providing high added value services in the field of immunotechnology for pharmaceutical groups, biotechnology companies and academic laboratories. For more than 30 years, BIOTEM has developed a unique expertise and a large panel of cutting-edge proprietary technologies. Since 2005, BIOTEM complies with the ISO 9001 and ISO 13485 quality standards and is certified “Crédit Impôt Recherche” (Research Tax Credit).

BIOTEM’s laboratories are composed of 3000 m² platform laboratories for cell culture, an animal facility and Immunoassay (ELISA) development and production. BIOTEM proposes a large panel of services for its clients including: i) Murine monoclonal antibody development, ii) Rabbit monoclonal antibody development, iii) ELISA and Lateral Flow development, iv) Antibody Production/ Purification/ Modification, v) Antibody Characterization.

BIOTEM infrastructure facilities are equipped with state-of-the-art technology specific to each department and at the leading edge of manufacturing performance and quality.

Contact person
Dr. Clarence Deffaud earned a Ph.D. in Molecular and Cellular Biology of the “Ecole Normale Supérieure de Lyon” (INSERM U412 – LaboRetro). After his Ph.D., he founded IRESYS, a Drug Discovery start-up based on the screening of combinatorial libraries in cells based on a patent in his own name (PCT/FR2002/004124). In 2003, he joined HYBRIGENICS, a company specialized in protein-protein interactions, as Yeast Two Hybrid Service Manager. At HYBRIGENICS, he participated in the development of various scientific projects, including the establishment of new expression libraries. Since April 2005, he serves as CEO/CSO at BIOTEM where he has supervised more than 500 projects in the field of monoclonal antibody and immunoassay development.

About FIPRA

FIPRA International is a Brussels-based public affairs consultant advising clients on a range of government relations and regulatory policy issues. It specializes in CBRN and cross-border health threats. Its core services include intelligence, analysis, strategy setting, coalition building and tailored solutions. Through its extensive network, FIPRA offers highly specialized strategic counsel in all EU and EEA Member States, and elsewhere
internationally. In the context of e-FabRIC, FIPRA provides a wider outreach, communication, and dissemination of the project.

Contact
Peter Tulkens is a Partner at FIPRA International. Over the last two decades Peter has been advising a variety of companies and organizations on global health policies and with a specific focus on pandemic preparedness and cross border health security approaches. In this context he has been engaging in dialogues with EU and national policymakers on health resilience, novel, disruptive technologies and strategic stockpile policies. He maintains longstanding relations with the defense community, be it at EU or NATO level and as an expert has entertained a number of public and closed-door discussions.

Sorina Chivu has worked in EU public affairs and communications for more than ten years, with a special focus on healthcare policy and health security and defense. She has a broad experience in managing multi-stakeholder advocacy initiatives in infectious diseases.

Pr Francisco Veas
About Pr Francisco Veas

Prof. Veas is a molecular viral immune-physio-pathologist, who has been studying the role of crucial HIV surface structures recognizing its cell receptors, innate immunity responses in healthy viral-exposed individuals as well as the use of innate immunity components as tools to develop therapeutic strategies and ultrasensitive diagnostics for pathogen detection.

He is member of several evaluation panels for national and international academic research and SMEs, including NIH, EU, EIC, BPI (former OSEO), Haut Conseil de Santé Publique-Ministry of Heath-France. He has coordinated and/or promoted multiple (43) projects funded by the EC (FP6, H2020, Horizon Europe), other international or French organizations such “Investissements d’Avenir/Investments for the future”. He has founded SMEs on ultrasensitive diagnostics of pathogens and on biosecurity

Pr Luis Enjuanes
About Pr Luis Enjuanes

Prof. Enjuanes is a molecular virologist expert in virus reverse genetics and pathology. He has been working for 42 years in the virology field, the last 35 of them with coronaviruses. He has been working on virus host interaction, therapeutic monoclonal antibodies, and vaccine and antivirals development.

Dr Carmen Jungback
About Dr Carmen Jungbäck

Dr. Jungback is veterinarian, and she was Head of Veterinary Virology at the Paul-Ehrlich-Institut (Federal Agency for Sera and Vaccines) in Langen (Germany) until retirement in 2016. She has been working on vaccine licensing and testing, with special expertise in viral vaccines for poultry. She was also member of a number of advisory boards to the EDQM-OMCL Network, Ph.Eur Group 15V and CVMP-IWP and JEG3R at EMA dealing with IVMPs under various aspects.