Collaborations
SCORE
Our SCORE consortium is in communication and collaboration with other European consortia involved in the development or testing of SARS-CoV-2 antiviral drugs.
Some of these collaborations include European Union Horizon 2020-funded Fight-nCoV and Exscalate4 CoV and the Innovative Medical Inititiative CARE, IMPENTRI, and MAD-Cov-2 consortia.
CARE
CARE, Europe’s Largest Initiative Launches to Accelerate Therapy Development for COVID-19 and Future Coronavirus Threats
- CARE (Corona Accelerated R&D in Europe), supported by Europe’s Innovative Medicines Initiative (IMI), is the largest undertaking of its kind dedicated to discovering and developing urgently needed treatment options for COVID-19.
- The initiative is committed to a long-term understanding of the disease and development of therapies for COVID-19 and future coronavirus threats in addition to urgent efforts to repurpose existing therapies as potential immediate response.
- The CARE consortium will accelerate COVID-19 R&D by bringing together the leading expertise and projects of 37 teams from academic and non-profit research institutions and pharmaceutical companies into a comprehensive drug discovery engine.
Press Release Brussels, Belgium – 18 August 2020
CARE (Corona Accelerated R&D in Europe) a new consortium supported by the Innovative Medicines Initiative (IMI) public-private partnership announced its launch today to accelerate the discovery and development of urgently needed medicines to treat SARS-CoV-2, the virus that causes COVID-19. With a grant totalling € 77.7 million, CARE is funded by cash contributions from the European Union (EU) and cash and in-kind contributions from eleven European Federation of Pharmaceutical Industries and Associations (EFPIA) companies and three IMI-Associated Partners. CARE is a five-year project bringing together 37 partners from Belgium, China, Denmark, France, Germany, the Netherlands, Poland, Spain, Switzerland, the UK and the US, and is led by VRI-Inserm (French National Institute of Health and Medical Research, Paris, France), Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Beerse, Belgium), and Takeda Pharmaceuticals International AG, (Zurich, Switzerland). It integrates partners’ COVID-19 projects ongoing since February 2020.
“The COVID-19 pandemic has emerged as the largest global health threat to humanity in this century, requiring the global scientific community to join forces in unprecedented ways,” said Professor Yves Lévy, Executive Director of the VRI-Inserm and CARE coordinator. “Beyond the scientific excellence of the different teams involved in this very ambitious project, CARE is bringing together 37 partners in an alliance pooling their expertise and know-how around an ambitious five-year work plan to develop therapeutics against the current COVID-19
pandemic. We are very grateful for the financial support provided by the Innovative Medicine Initiative that will enable us to implement this plan.”
With no licensed vaccines and only limited therapy options against COVID-19, the pandemic is ongoing, counting more cases and deaths every day. Uniting some of the most innovative and experienced scientists from all relevant areas in a unique collaborative spirit CARE will maximize synergies and complementarities with other initiatives such as the Gates Foundation-supported COVID-19 Therapeutics Accelerator, MANCO1, SCORE2, and the ECRAID3 network, to accelerate the path to providing solutions for the current COVID-19 pandemic as well as future coronavirus outbreaks. After testing in the laboratory, the project will advance the most promising drug candidates to clinical trials in humans.
“We are very excited to launch the CARE consortium and collaborate with other leading experts to urgently identify new medicines against SARS-CoV-2 and other coronaviruses that may have the potential to cause epidemics,” added CARE project leader Marnix Van Loock, Senior Scientific Director and R&D Lead of Emerging Pathogens, Global Public Health, Janssen Pharmaceutica NV. “As part of this initiative, we look forward to applying learnings from an ongoing collaboration on COVID-19 with the Rega Institute for Medical Research, part of KU Leuven, to screen a drug repurposing library of thousands of existing drug compounds.”
Kumar Saikatendu, Ph.D., Director, Global Research Externalization, Takeda said “It is humbling to see such a large collection of the best scientific minds in Europe come together to solve this complex problem with such urgency. COVID-19 is a once in a lifetime scientific challenge for our generation. CARE aims to create effective therapies with a positive safety profile for current and future coronaviral outbreaks. We hope to move fast and have a meaningful impact in a timely manner.”
Comprehensive short- and long-term response to COVID-19
CARE aims to create effective therapies with a positive safety profile for the COVID-19 pandemic (drug repositioning), and develop new drugs and antibodies specially designed to tackle the SARS-CoV-2 virus.
The consortium builds on three pillars:
- Drug repositioning, by screening and profiling compound libraries contributed by partners with the aim of rapidly progressing molecules to advanced stages of clinical testing.
- Small-molecule drug discovery based on in silico screening and profiling of candidate compounds directed against SARS-CoV-2 and future coronavirus targets.
- Virus neutralizing antibody discovery using fully human phage and yeast display, immunization of humanized animal models, patient B cells and in silico design.
Closely integrated with these pillars are work streams focusing on the refinement of candidate compounds through a comprehensive medicinal chemistry campaign, systems biology research and pre-clinical and clinical evaluation of molecules from all three pillars. The systems biology work package will investigate the viral pathophysiology to increase our
understanding of the interplay between virus infection stages and human immune responses. It will identify disease markers, to inform therapy development and improve clinical trial design and monitoring of Phase 1 and 2 trials investigating new therapeutics developed by CARE.
About CARE
CARE is a new public-private partnership bringing together scientists from academia, research centers, Small Medium Enterprises (SMEs), European Federation of Pharmaceutical Industries and Associations (EFPIA) member companies and IMI Associated Partners. In total, it comprises 37 different partner organizations. Professor Yves Lévy from VRI-Inserm is the academic coordinator, Marnix Van Loock from the Janssen Pharmaceutical Companies of Johnson & Johnson is the EFPIA project leader and Kumar Saikatendu from Takeda is the project co-leader. The project partners are 11 academic institutions (KUL, GUF, AMU, UzL UU, EDI-IVI, UHAM, UEDIN, TiHo, JU, LUMC), five public research organisations (Inserm, CHUV, CEA, HZI, SERMAS) and 7 SMEs (IT, EVF, EXSCI, NUVISAN, SCIFEON, ENYO, AIB), together with eleven EFPIA members (Janssen, Takeda, Pfizer, ABBV, BI, Merck KgA, BAG, Novartis, Astellas, Servier and AiCuris), and three IMI2 Associated Partners (BMGF, UNIVDUN, GHDDI).*
About the IMI
The IMI is Europe's largest public-private initiative aiming to speed up the development of better and safer medicines for patients. IMI supports collaborative research projects and builds networks of industrial and academic experts in order to boost pharmaceutical innovation in Europe. IMI is a joint undertaking between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
For further details please visit: http://imi.europa.eu/
Acknowledgement
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 101005077. The JU receives support from the European Union’s Horizon 2020 research and innovation programme, EFPIA, BILL & MELINDA GATES FOUNDATION, GLOBAL HEALTH DRUG DISCOVERY INSTITUTE, UNIVERSITY OF DUNDEE.
*List of partners
1 (Coordinator) VRI-Institut National de la Santé et de la Recherche Médicale (Inserm) FR
2 (Project Leader) Janssen Pharmaceutica NV (Janssen) BE
3 (Project co-Leader) Takeda Pharmaceuticals International AG (Takeda) CH
4 Commissariat à l'énergie atomique et aux énergies alternatives (CEA) FR
5 Centre Hospitalier Universitaire Vaudois (CHUV) CH
6 Eurovacc Foundation (EVF) CH
7 Exscientia Limited (EXSCI) UK
8 Johann Wolfgang Goethe University Frankfurt am Main (GUF) DE
9 Helmholtz-Zentrum für Infektionsforschung GmbH (HZI) DE
10 Uniwersytet Jagiellonski (JU) PL
11 Katholieke Universiteit Leuven (KUL) BE
12 Academisch Ziekenhuis Leiden (LUMC) NL
13 Servicio Madrileno De Salud (SERMAS) ES
14 Nuvisan ICB GmbH (NUVISAN) DE
15 Scifeon ApS (SCIFEON) DK
16 Université d’Aix Marseille (AMU) FR
17 The University of Edinburgh (UEDIN) UK
18 University of Hamburg (UHAM) DE
19 Universitaet zu Luebeck (UzL) DE
20 Universiteit Utrecht (UU) NL
21 Eidgenoessisches Departement des Innern (EDI-IVI) CH
22 Inserm Transfert SA (IT) FR
23 AbbVie Inc. (ABBV) US
24 Astellas Pharma Europe BV (ASTELLAS) NL
25 Bayer AG (BAG) DE
26 Boehringer Ingelheim (BI) DE
27 University of Dundee (UNIVDUN) UK
28 Enyo Pharma SA (ENYO) FR
29 Bill & Melinda Gates Foundation (BMGF) US
30 Global Health Drug Discovery Institute (GHDDI) CN
31 Novartis Pharma AG (NOVARTIS) CH
32 Pfizer
33 Merck KGaA (Merck) DE
34 University of Veterinary Medicine Hannover (TiHo) DE
35 Ai-biopharma (AIB) FR
36 AiCuris Anti-infective Cures GmbH (AiCuris) DE
37 Institut de Recherches Internationales Servier (Servier) FR
Escalate-4cov
The EXSCALATE4CoV (E4C) project https://www.exscalate4cov.eu/
E4C is a public-private consortium supported by the European Commission’s Horizon 2020 tender for projects to counter the Coronavirus pandemic and improve the management and care of patients.
At the core of E4C is Exscalate (EXaSCale smArt pLatform Against paThogEns), at present the most powerful and cost-efficient intelligent supercomputing platform in the world. Exscalate has a "chemical library" of 500 billion molecules and a processing capacity of more than 3 million molecules per second. The E4C consortium, coordinated by Dompé Farmaceutici , is composed by 18 institutions from seven European countries.
Advanced CADD, in combination with the high throughput biochemical and phenotypic screening, will allow the rapid evaluation of the simulation results and the reduction of time for the discovery of new drugs. This approach is especially useful against pandemic viruses and other pathogens, where the immediate identification of effective treatments is of paramount importance. First, E4C will select, through the EXSCALATE platform and the virtual screening protocols, the most promising drugs against coronavirus taken from the
commercialized and developing drugs safe for humans (> 10000 drugs, SIM). At the same time, the proprietary Tangible Chemical Database (TCDb), comprising > 500 billion molecules, will be screened to identify new potential drugs to be tested against coronavirus, thus enhancing the success rate of the virtual screening step.
The aim of E4C is twofold: to identify molecules capable of targeting the coronavirus (2019-nCoV) and to develop an effective tool for countering future pandemics to be consolidated over time. More specifically, E4C aims to:
- Establish a sustainable example for a rapid scientific response to any future pandemic scenario. The model leverages a rapid and effective High Performance Computing platform for the generation and analysis of 3D models and experimental 3D structures, X-ray resolution of protein targets from pandemic pathogens.
- Drive a fast virtual identification and repurposing of known drugs or proprietary/commercial candidate molecules to be further experimentally characterized.
- Define a workflow scheme for biochemical and cellular screening tests to validate candidate molecules at previous points and assure through phenotypic and genomic assays.
- Prepare, together with EMA, a development plan for successful candidates for direct “first in human” type studies or for further testing in animals with bridging studies.
- Identification of 2019-nCoV genomic regions involved in host adaptation, pathogenicity and mutations.
To further accelerate the identification of drugs by the E4C for the next pandemic, the SWISS-MODEL team of the SIB Swiss Institute of Bioinformatics will provide an automated, scalable, robust, well-documented, and benchmarked workflow that produces annotated homology models directly from the sequenced genome of the virus. The generated models will enable the efficient analysis and interpretation of the viral protein products and will be immediately available on the EXSCALATE platform for virtual screening. Such massive virtual screening activities need a huge computational resource, therefore the activities will be supported and empowered by three of the most powerful computer centers in Europe namely CINECA, BSC and JÜLICH. These three Tier-0 supercomputing centers will be able to jointly guarantee the best combination of hardware architectures, required knowledge and the highest speed-up for the simulations.
In addition, INFN (CERN Tier-1 center) will make their data sharing and high throughput infrastructure available to facilitate product exploitation.
As knowledge-based system, the E4C project will take advantage of the SIB infrastructure especially for the phylogenetic, co-evolutive and pathogenicity aspects of the viral key bioinformatic characterizations (i.e. RNA and protein sequences).
The considerable amount of sequence information coming from all scientific communities and hospitals will be surely captured by consolidated pipelines of several public databases. The E4C Consortium will refer to SIB and its network to get the latest sequence data and analyses.
The E4C project will promptly share its scientific outcomes with the research community by using established channels like the ChEMBL portal for the biochemical data, the SWISS-MODEL portal for the homology models of viral proteins WT and mutants, the Protein Data Bank for the experimentally resolved protein structures, the EUDAT for the data generated by in silico simulations, and the E4C project website.
Fight-nCoV
Fighting-off Coronavirus (SARS-CoV-2) with broad-spectrum antivirals and establishing a preclinical viral challenge model https://www.fight-ncov.eu/
Objectives of proposal: Our consortium “Fight-nCoV” will accelerate preclinical development of new broad-spectrum antivirals for inhalation, building on breath-taking ongoing research. We will determine and characterize the antiviral activity and safety of three viral entry inhibitors (Oligonucleotide, Macro-I, Tweezer) against SARS-CoV-2 in vitro and in vivo. To enable this, we will build capacity for evaluation of antiviral efficacy against SARS-CoV-2 in vitro using viral pseudotypes and wild-type SARS-CoV-2 as well as in vivo in non-human primates. Safety studies will be performed according to OECD GLP guidelines. Expected results: We will establish a SARS-CoV-2 spike pseudotype system allowing a standardized high throughput evaluation of the antiviral activity of candidate drugs. We will have determined the antiviral efficacy of three novel broad-spectrum viral entry inhibitors: oligonucleotide, macromolecular polymers, and molecular tweezers. We will also build capacity for innovation and preclinical evaluation of our broad-spectrum antivirals and vaccines against SARS-CoV-2 by establishing a macaque challenge model. “Fight-nCoV” will provide efficacy data of our drug candidates given intranasally in non-human primates challenged with SARS-CoV-2, enable an early and valuable outcome for stakeholders and the civil society.
Program Actions
We address three different areas in relation to the urgency of combating SARS-CoV-2 and increase preparedness:
1. We focus on the development of new therapeutics building on promising previous and ongoing research.
2. We develop assay protocols using a SARS-CoV-2 pseudotype virus for standardized in vitro evaluations.
3. We build capacity to evaluation of SARS-CoV-2 antivirals in vivo by establishing a macaque challenge model.
Ultimately, the Fight-nCoV program provides three different compounds, ready-made, with proven broad-spectrumantiviral effects, which will enable an early and valuable outcome for stakeholders and the civil society.
MAD-CoV 2
MAD-CoV 2 Modern approaches for developing antivirals against SARS-CoV 2 https://cordis.europa.eu/project/id/101005026/fr
Lead institution: Statens Veterinaermedicinska Anstalt, Sweden
9 partners from Austria, France, Germany, Spain, Sweden, UK
The aim of the MAD-CoV 2 project is to dive into the molecular details of the SARS-CoV-2 virus and use this knowledge to develop new COVID-19 treatments. Achieving this will entail engineering human tissue to test new treatments in the lab; studying how to exploit the role of the ACE2 receptor (which the virus latches onto to break into cells), and mapping factors that are critical for virus replication
The SARS-CoV-2 pandemic has become an unprecedented burden to public health, our civil societies and the global economy. To provide frontline therapies for COVID-19 and future corona virus outbreaks requires a concerted effort of different disciplines, technologies, high security labs, and rapid translation of scientific findings to highly innovative and “hungry” SME partners. For the MAD-CoV-2 project we have assembled a multidisciplinary team of world-leading researchers and innovative industry partners to unlock the Achille’s heels of the virus infections in host cells and rapidly translate such knowledge into disruptive new medicines and public health measures. Our team members have been on the ground of the first SARS and Ebola outbreaks, head containment facilities to study highly infectious viruses, are world-leading in engineering human tissues, developed breakthrough technologies that allow us to find host factors for viral infections at unmatched speed and resolution, and discovered ACE2 and made the first in vivo link between ACE2, SARS, and lung injury, leading to rational drug development which is imminent to be tested in European COVID-19 patients. ACE2 is also the key receptor for SARS-CoV-2 Spike protein and has got centre stage for novel therapies and a fundamental understanding of COVID-19. The aims of MAD-CoV-2 are 1. to engineer human tissues to test novel therapies and vaccines; 2. to provide critical evidence on the role of clinical grade ACE2 in viral replication and COVID-19 pathogenesis; 3. to perform high-throughput screens to genetically map, at a single amino acid resolution, essential host factor that are critical for SARS-CoV-2 replication; and 4. to rapidly translate this knowledge into novel therapies to fight the current and, importantly, future corona virus outbreaks.
Our data and unique tissue reagents will be made available to the entire community for drug testing and development, supporting all other efforts.
Impentri
Impentri - Development of Impentri, an intravenous imatinib formulation for COVID-19 acute respiratory distress syndrome (ARDS) https://cordis.europa.eu/project/id/101005142
Lead institution: Exvastat (Ireland) Limited, Ireland
5 partners from Canada, France, Ireland, the Netherlands
Many people with severe COVID-19 infection experience a build-up of fluid in the lungs, making it hard to breathe and, in the worst cases, contributing to the death of the patient. The body’s own immune response is partly responsible for this build-up of fluid. There are signs that the generic drug imatinib could address the problem, and now the Impentri project plans to run a randomised, double-blind clinical trial to properly test the efficacy and safety of the drug as a treatment for COVID-19 patients with lung inflammation
Imatinib, a generic marketed drug has been shown to reduce plasma extravasation following inflammatory challenge in animal models and this effect is supported by anecdotal observations in the clinic.
This project proposes to rapidly implement a multi-center, randomized, open label, double-blind, Phase IIb study to evaluate the efficacy, safety and pharmacokinetics of imatinib mesilate in patients with corona-virus associated pneumonitis. 100 patients entering ICU with a diagnosis of corona-virus associated pneumonitis will be randomised, half receiving i.v. imatinob , 200mg bid for 5 days and one half placebo. Adverse events, immunological parameters and imatinib pharmaco-kinetics will be monitored.
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