06 Apr
National Institute of Biology is a part of EU HORIZON CONSORTUIM focusing on drug and diagnostics for OVERCOMING COVID-19

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Ljubljana, 6th, April 2020 - On March 31, 2020, National Institute of Biology with leading partner - Slovenian biotechnology company EDUCELL d.o.o submitted a large project application to The Horizon 2020 Innovative Medicines Initiative call, under the special theme “Development of drugs and diagnosticians for overcoming coronary virus infections COVID19. 
The coordinator of this project Dr. Miomir Knežević, Director of EDUCEL, has formed a distinguished international Consortium (Fight Against Coronavirus! or FAC!), which includes Slovenian researchers from the National Institute of Biology (NIB), the Faculty of Pharmacy at University of Ljubljana, Institute of Microbiology and Immunology at the Faculty of Medicine and Omega d.o.o. The three-member Scientific Research Council of the Consortium, is composed of the academician Prof. Dr. Franc Strle, Dr. Primož Rožman, Dr. Stephen Minger and Prof. Dr. Bojana Beović from Clinic for infectious diseases and fever conditions at the University Medical center Ljubljana. 

In addition to the Slovenian partners, the consortium also includes two university hospitals from Italy and Germany and a broad set of international biotech and engineering companies from Italy, Switzerland, Israel, India, the United Kingdom, Germany and the USA.

The Consortium aims to combat coronavirus disease - COVID19 – on several fronts. In early 2020, the COVID19 coronavirus pandemic named as SARS-2 / CoV-2, hit the planet with a new virus that has infected nearly a million people worldwide. Currently, treatment for seriously ill infected individuals are only poorly effective and COVID-19 disease often leads to viral pneumonia and severe lung complications, the so-called ARDS (acute respiratory distress syndrome), which has a high mortality rate (up to 50%). This is a consequence of a violent immune reaction caused by the virus which induces a massive wave of secreted molecules, called cytokines - interleukins, chemokines and other factors, which cause a "cytokine storm". Not only can this violent inflammatory immune response be life-threatening due to suffocation, which can be partially prevented by the addition of oxygen by respirators, but also results in permanent lung damage and fibrosis, decreasing the surviving patient’s quality of life.

As the vaccine for this virus is still in development, effective treatment modalities need to be developed immediately in order to reduce the inflammatory process, decrease the death rate and minimize permanent lung damage in surviving patients. With these goals in mind, this international Consortium was formed to develop new drugs for the treatment of CoV-2 and ARDS. In the first FAC! work-package an antiviral drug will be introduced into infected cells by an innovative approach to prevent the SARS CoV-2 virus from replicating and spreading. Patients with cytokine storms and ARDS will be treated by use of mesenchymal stem cells - MSCs, which act as natural immunosuppressive agents that have been proven   effective in ARDS. Because the weakened health of the infected patients with ADRS, their MSCs are present in low number and so must be obtained from healthy donors. However, these “allogenic” cells can also significantly suppress the violent immune reaction, thereby preventing the escalation of ARDS.  Educell will expand the number of donated MSC cells from healthy donors in the bioreactors which will then be given to the patient in an appropriate amount.

FAC! Consortium includes members with expertise in cell therapy, bioreactors and medical device engineering, virus identification and characterization, biopharmaceutical production, critical patient care, clinical trial management of new drugs, and regulatory   experts. The project aims at two goals: for patients who are already severely ill with CoV-2 (COVID-19) and ARDS, standardized therapeutic cells (MSCs) will be developed. This would reduce the need for respiratory devices to reduce pneumonia and life-threatening lung damage The second objective is to prevent the development of complications and inflammation of the lungs, and in parallel to test the efficacy of a new antiviral compound to prevent, limit, or even eradicate viral load in CoV-2 infected persons.

In this project, therefore, we will simultaneously develop the next-generation bioengineering capability for the development of antiviral biopharmaceuticals and for the development of therapeutic stem cell populations, thereby enabling a massive improvement in the treatment of the world's population infected with this vicious pathogen.

Prof. Dr. Tamara Lah Turnšek, NIB said: “NIB will lead the management and the validation of the therapeutic preparations of MSCs and improve their efficacy by studying the intracellular interactions of the viral inflammatory process, using in vitro cellular models”.

An online discussion in co-organization of the Slovenian Press Agency (STA) on the potential of stem cells for the treatment of patients with covid-19 can be viewed here: https://youtu.be/cbKAhVNS7DM.

More information:
NIB: Katja Ploj, This email address is being protected from spambots. You need JavaScript enabled to view it., 040 320 516 
EDUCELL: Miomir Knežević, This email address is being protected from spambots. You need JavaScript enabled to view it., 041 707 937

About NIB
NIB mission is to be engaged, active, and to create knowledge in the field of science in order to understand living processes, sustainable development, preserving biodiversity, a healthy environment, and the health of the people and the environment. 157 people are active at the National Institute of Biology today. They are researchers of different scientific branches in the field of life and co-workers who enable and support the functioning of the institute. We all represent a valuable human value and a contribution to the development and welfare of Slovenia and Europe.

About Educell
Educell Ltd, established 1997, is a company focusing on development of cell therapy products and is a registered Cell and tissue establishment. The company is preparing cell therapy products for the treatment of articular cartilage, vesicouretral reflux, regeneration of bone tissue and treatment of immunological disorders, which are all being used in University Medical Centre Ljubljana and other clinical institutions in Slovenia under “hospital exemption” rule supervised by Agency for Medicinal Products and Medical Devices of the Republic of Slovenia. R&D department is dedicated to development of innovative cell therapy products and also to development of medical devices that enable stem cell isolation and application in the operation theatre.
ImmunoArt cell therapy product was developed in 2014 and is based on ex vivo expanded allogeneic mesenchymal stromal cells (MSC) isolated from bone marrow. Its immunomodulatory capacity has already been proven in the clinics for the treatment of graft versus host disease (GvHD) and Chron’s disease. Educell’s role in the project is to develop new technological platform which will enable scale-up of MSC production for the treatment of severely affected patients infected by COVID-19.

About FAC! Consortium
FAC! Consortium was formed in order to apply to a Horizon 2020 – IMI call, submitted on March 31. The consortium partners, many of which have been long-time partners in biotechnology, medicine and research, will cooperate with the aim to develop several novel treatments. The consortium is composed of 13 partners from 3 continents and 8 countries and includes members with expertise in cell therapy, bioreactor and medical device engineering, virus identification and characterization, biopharmaceutical manufacturing, critical care and clinical trial management, and regulatory affairs. In parallel FAC! consortium will test the efficacy of a novel antiviral compound against CV-2, to determine if it is capable of limiting or eradicating CV-2 viral load in infected individuals. In patients already seriously ill with CV-2 disease (COVID-19) and ARDS, FAC! will determine the efficacy of mesenchymal stem cells to reduce lung inflammation and reduce ADRS morbidity and mortality. Simultaneously, we will develop next generation bioengineering capability to develop large-scale biopharmaceutical of anti-viral agents and stem cell populations in order to massively scale up these therapies to treat global populations infected by this insidious new pathogen.
Fight Against Corona! Consortium consists of: Educell (Slovenia), lead partner, Azienda Sanitaria Universitaria Friuli Centrale (Italy), Celonic (Switzerland), Conreso (Germany), Nantkwest (USA), Nantworks (USA), National Institute of Biology (Slovenia), Omega (Slovenia), Orgenesis (Israel), Stempeutics (India), Team Consulting (UK), University Ljubljana (Slovenia), and Vivabiocel (Italy).