The Corona pandemic continues to pose a global threat; to date, only a small fraction of the total population has been vaccinated. Moreover, there is an immediate risk of further virus mutations.
With this in mind, DG-Nika AG research team developed a new approach to protect the world’s population from severe diseases - 2-DG (2-deoxy-D-glucose).
Similar to asthma sprays, 2-DG microparticles, from the glucose family, will be applied into the respiratory tract through the mouth. 2-DG blocks the energy demand of the infected host cells all the way into the lungs. The body’s immune system can thus actively fight the infection or keep it at low level.
Both, in vitro as well as tests on animals, have proven the scientific credibility of 2-DG.
The European Medical Agency (EMA) states that the proposed approach is comprehensible and should be pursued. The idea was patented in April 2020 and DG-Nika AG holds the worldwide exclusive rights to it. 2-DG inhaler should be available in the second half of 2021.
SARS-CoV-2 viruses from the Coronaviridae family are transmitted through the airways. They nest in the airways of the infected patients and then from there they spread within the whole body.
That is why we apply our solution right there; 2-DG is inhaled through an inhaler, just like an asthma spray. As soon as the substance enters the airways, it actively inhibits the growth and the reproduction of new viruses.
It should be noted that this new medicine is considered both a cure for those infected with Covid-19 as well as a prophylactic remedy against infection.
2-DG does not only affect glycolysis but it also alters glycosylation of viral proteins. Glycosylation is required by viruses for proteins folding. The absence of proper glycosylation makes it for many viruses impossible to spread, including SARS-CoV-2.
The most important proteins affected by 2-DG are SPIKE (a proper spike is essential for cell infection) and ACE2 (which is the gate through which the virus enters the cell). This protein family is responsible for viral infection.
Inaccurately glycosylated SPIKE proteins do not allow infection of human cells. Moreover, the misfolded (misformed) SPIKE proteins will decompose and the remaining viral elements will not be able to turn into dangerous viruses.
2-DG may have a similar effect on other viruses, not just SARS-CoV-2. Degradation of proteins in ACE2 proves the prophylactic effect of 2-DG.
The infection is not possible, if the connection points, through which the viruses enter the cells in order to turn them into the host cells and to produce further viruses, do not fit into the viral spike.
The Warburg effect refers to a change in the glucose metabolism observed in many tumour cells. The infected cells obtain the required energy mainly through glycolysis. A particular characteristic of the Warburg effect, also known as aerobic glycolysis, is that it occurs also in tumour cells which get a sufficient supply of oxygen. This type of energy generation is very inefficient due to an elevated glucose consumption of the affected cells.
This particular way of energy generation observed in the tumour cells occurs also in the virus infected cells (host cells). Researchers from Sweden and France were able to determine the increased need for energy in glucose in the affected cells.
A virus has a thin protective protein layer (capsid) which encloses its DNA; however, it doesn’t have own cells and is unable to metabolize. Therefore, it hijacks host cells in order to inject them with its own DNA, what triggers them to reproduce this DNA and the capsid.
Through our parallelly conducted cancer treatment research, we learnt about an effective substance, a glucose derivate, known as 2-deoxy-D-glucose (2-DG). What makes 2-DG unique, is that the infected cells identify it as glucose, because it uses the same signalling pathway. However, unlike in case of glucose, the metabolization of 2-DG ends with the phosphorylation phase.
That is why, we chose a different approach. A targeted disruption of cell’s metabolism and blocking of the glucose signalling pathways caused a massive reduction in virus production, as well as to apoptosis of infected host cells.
We use the same approach to attack the SARS-CoV-2 viruses (as well as other types of viruses).
We developed an inhalation formulation which contains 2-DG and which enters the airways in the same manner as viruses do. This means that we are able to reach the location (mentioned in numerous studies), which is mostly affected by the infected cells.
We carried out multiple tests on the epithelial cells of the respiratory tract and all of them show the prophylactic as well as the therapeutic effect of 2-DG.
Inhalation has many benefits – it works locally and doesn’t impact the whole organism. Unlike in case of the orally administered formulations, we do not need to apply a 10-times higher doses, in order to obtain a required 2-DG concentration in the lungs. This means that no adverse reactions were observed.
Since a virus strain mutates quickly, it is difficult to develop a long-lasting antidote. We attack the metabolism of the infected cells. This approach always works, regardless of the virus mutation.
For more information we have provided a list of the most popular publications, which support our statements.
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18. Gualdoni, G.A., et al., Rhinovirus induces an anabolic reprogramming in host cell metabolism essential for viral replication. Proc Natl Acad Sci U S A, 2018. 115(30): p. E7158-E7165.
19. Pajak, B., et al., 2-Deoxy-d-Glucose and Its Analogs: From Diagnostic to Therapeutic Agents. Int J Mol Sci, 2019. 21(1).
20. Aft, R.L., F.W. Zhang, and D. Gius, Evaluation of 2-deoxy-D-glucose as a chemotherapeutic agent: mechanism of cell death. Br J Cancer, 2002. 87(7): p. 805-12.
21. Kuna, P., et al., Randomized equivalence trial: A novel multidose dry powder inhaler and originator device in adult and adolescent asthma. Allergy Asthma Proc, 2015. 36(5): p. 352-64.
22. Schmidt, M.F., R.T. Schwarz, and C. Scholtissek, Nucleoside-diphosphate derivatives of 2-deoxy-D-glucose in animal cells. Eur J Biochem, 1974. 49(1): p. 237-47.
23. Maehama, T., et al., Selective down-regulation of human papillomavirus transcription by 2-deoxyglucose. Int J Cancer, 1998. 76(5): p. 639-46.
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25. Bojkova, D., et al., Proteomics of SARS-CoV-2-infected host cells reveals therapy targets. Nature, 2020.
26. Vijayaraghavan, R., et al., Acute toxicity and cardio-respiratory effects of 2-deoxy-D-glucose: a promising radio sensitiser. Biomed Environ Sci, 2006. 19(2): p. 96-103.
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29. Murugesan K. Gounder, H.L., Mark N. Stein, Susan Goodin, Joseph R. Bertino and Robert S. DiPaola, Phase I trial of 2-deoxyglucose for treatment of advanced solid tumors and hormone refractory prostate cancer: A pharmacokinetics (PK) assessment, in Proceedings of the 101st Annual Meeting of the American Association for Cancer Research. 2010: Washington, DC.
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31. Thompson, D.A., et al., Thermoregulatory and related responses to 2-deoxy-D-glucose administration in humans. Am J Physiol, 1980. 239(3): p. R291-5.
32. Zielinski, R., Fokt, I., Felix, E., Venugopal, R., Arumugam, J., Grela, K., Remiszewski, M., Skora, S., and W. Priebe. Preclinical evaluation of WP1122, a 2-DG prodrug and inhibitor of glycolysis. in Proceedings: Symposia on Cancer Research 2017 Cancer Metabolism. 2017. Houston, TX.
33. Kuprys-Lipinska, I., M. Kolacinska-Flont, and P. Kuna, New approach to intermittent and mild asthma therapy: evolution or revolution in the GINA guidelines? Clin Transl Allergy, 2020. 10: p. 19.
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Causes errors in ACE2 glycosylation.
In this situation, this protein cannot bind to SPIKE SARS-CoV-2 and thus the virus cannot infect cells.
"2-DG is a very interesting product that deserves thorough evaluation as an anti-SARS-CoV-2 candidate."
2-DG induces a strong decrease in the production of infectious SARS-CoV-2 particles. Effect is impressive on TCID50 calculation.
According to the last report “Evaluate antiviral activity of 2-DG on infection and replication of SARS-CoV-2 in primary bronchial epithelial cells (PBEC)”, 2-DG induces a dose dependent decrease in SARS-CoV-2 virus production on primary human bronchial epithelial cells with low concentration. The effect is confirmed using RT-qPCR readout. 2-DG is a very interesting product that deserves thorough evaluation as an anti-SARS-CoV-2 candidate.
Franck Gallardo holds a Ph.D. in biochemistry from the Faculty of Medicine of the Université de Montréal, Qc, CANADA. In 2012 he founded NeoVirTech and in 2014 he received the Innovative Company Award from the French Ministry of Higher Education and Research as well as The French Agency for Innovation (BPI France) in 2013 and in 2016. In 2019 NeoVirTech was elected by Pharma Tech Outlook Magazine as a Top10 Drug Discovery and Development Consulting/Services Companies in Europe.
2-DG is a promising compound and deserves further investigation in the context of developing safe protection against SARS-CoV-2. Testing the effect of 2-DG on cells and cilia in the cultures of human respiratory epithelia is an important step to assure safe administration of the product.
Michał Witt, Prof. PhD.
Since 2016, the Director of the Institute of Human Genetics, Polish Academy of Sciences (IHG PAS) in Poznań. For many years the head of the Department of Molecular and Clinical Genetics at the IHG PAS. In 1987-1990, a postdoc at the University of Michigan Medical School, Ann Arbor, USA. In 1994 and 1996 – visiting professor at the National Institutes of Health (NIH) in Bethesda, USA. In 1999-2015, deputy director for scientific affairs at the International Institute of Molecular and Cell Biology in Warsaw. Author of numerous papers published in recognized scientific journals. Manager or coordinator of numerous grant projects: participated in European grants: HealthProt, BestCilia, BeatPCD. For many years, medical practitioner in the field of clinical genetics. Involved in the process of creating a Polish reference center for the diagnosis of primary ciliary dyskinesia.
Research and scientific interests: molecular genetics of genetic diseases of the respiratory system (cystic fibrosis, primary ciliary dyskinesia); molecular aspects of hemato-oncological diseases and bone marrow transplantation; ethical and legal aspects of genetic research.
Since 2020, prof. Witt and his coworkers (below) are involved in the 2-DG testing in ciliated epithelium in collaboration with DG-Nika-AG.
Ewa Ziętkiewicz, Prof. PhD.
Associated with the Institute of Human Genetics, Polish Academy of Sciences in Poznań since 1981; PI at the Department of Molecular and Clinical Genetics, professor since 2013. In 1989-2001, postdoc, then assistant professor at the Sainte Justine Hospital Research Center of the University of Montreal in Canada. Author of 68 papers published in recognized scientific journals, PI in many Polish grant projects; participant in several European grants (HealthProt, BestCilia, BeatPCD). Involved in the process of creating a Polish reference center for the diagnosis of primary ciliary dyskinesia.
Research and scientific interests: epidemiology and diagnostics of rare diseases, molecular basis of cilia function and ciliopathies, genetic and epigenetic diversity of human populations, evolution of the human genome.
Zuzanna Bukowy-Bieryłło, PhD.
A graduate of biology at the University of Silesia in Katowice. PhD student at the Institute of Biochemistry and Biophysics of the Polish Academy of Sciences, and at the Aarhus University in Denmark within an European 5th Framework Programme. Associated with the IHG PAS in Poznan since 2009, assistant professor in the Department of Molecular and Clinical Genetics the since 2012. Author of 22 papers published in recognized scientific journals, participant or PI in Polish grant projects, participant in several European grants (HealthProt, BestCilia, BeatPCD). Involved in the process of creating a Polish reference center for the diagnosis of primary ciliary dyskinesia.
Research and scientific interests: primary ciliary dyskinesia and cilia biology, methods of analysis of respiratory epithelial cells (primary epithelial cell cultures for ciliogenesis, high-speed videomicroscopy, immunofluorescent staining of ciliary proteins).
Alicja Rabiasz, M. Sci.
A graduate of biology at Adam Mickiewicz University in Poznan. Since February 2017, a PhD student at the Department of Molecular and Clinical Genetics at the IHG PAS, Poznan. Author of 2 papers published in recognized scientific journals, PI in the grant project from Polish National Science Center. Actively engaged in diagnostic activities of the COVID-19 lab at the IHG PAS.
Research and scientific interests: dysfunction of motile cilia, molecular basis of primary ciliary dyskinesia, elucidation of the role of novel genes potentially involved in the PCD pathogenesis using RNA interference method (RNAi) in ciliated flatworm (Schmidtea mediterranea).
DG-NIKA AG is a Swiss start-up company, which main objective is to effectively contain viral infections. We want to make a positive contribution by battling the Corona pandemic.
We have been working with a multinational team of scientists who are coordinated from Switzerland.
Georg Wander is the CEO of DG-Nika AG.
After completing his education in banking and business administration, for many years he held leading positions in Germany, Luxembourg, Portugal, and South Asia.
Throughout his career as a business consultant, he was introduced to the concept of alternative energy, which resulted in many years of successful involvement in the fields of wind energy and photovoltaics.
In recent years, he developed a deep interest in modern cancer treatment research. Currently, he has been involved in the 2-DG project.
Chairman of the II Department of Internal Medicine at the Medical University of Łódź.
Professor Kuna is involved in numerous international collaboration network and International Research Projects including ARIA, MASK, SHARP, ISAR, 3TR. Prof. Kuna’s research interest focuses on advancing our knowledge on the pathogenesis of respiratory and allergic diseases, with special interest in severe asthma and COPD.
"The chances of finding the optimal dose of the drug in the final product, without approaching the toxicity limit, are very high.”
I have conducted several experiments in order to study the effects of 2-DG on the airway epithelial cells and to understand their mechanisms of action.
The "therapeutic window", which was tested under various conditions, is at least 50; this means that the chances of finding the optimal dose of the drug in the final product, without approaching the toxicity limit, are very high.
Piotr Rieske, Prof. PhD, is a medical analyst, biotechnologist, head of the Cancer Biology Department of the Medical University of Lodz, head of the Science and Research Laboratory of Celther Polska.
"... a slightly modified glucose molecule [is] used as the Trojan Horse on cells infected with the SARS-CoV-2 virus."
Infectious diseases have always accompanied mankind. Sudden appearance and rapid human to human transmission make fighting them very difficult at times. Currently, humanity has to face a new threat in the form of the SARS-CoV-2 virus. The disease caused by the SARS-CoV-2 virus is new and at the moment no effective methods of fighting the effects of inflammation caused by viruses are known. The main problem caused by viruses is related to fibrotic injuries of the lungs, heart muscle, gastrointestinal tract and even brain damage leading to temporary or permanent intellectual disability. Since the epidemic began numerous clinical trials have been conducted around the world in which the possibility of using known antiviral drugs (remdesivir), vasodilators, corticosteroids, immune therapies, lipoic acid, bevacizumab, recombinant angiotensin-converting enzyme 2, hydroxychloroquine or chloroquine or different antibodies has been studied. To date only dexamethasone showed reduced mortality by one third for patients who are critically ill on ventilators and one fifth for those receiving supplemental oxygen. Contrary to expectations remdesivir failed to produce statistically relevant outcome.
In the present situation, enormous effort is put into the development of effective vaccines. At the moment, several dozen research centers and companies are developing various versions of vaccines, however, many specialists have doubts about the effectiveness of their action due to the observation that sick people again get SARS-CoV-2 after a period of about 3 weeks after the disease ceases. This may indicate the high antigenic variability of the virus, which may be much greater than that observed with the influenza virus.
Taking into account all these failures and doubts, other methods of fighting this virus are being sought. Currently, there is a lot of interest in the metabolic approach to fighting viruses. Quite unexpectedly, the metabolism of cells attacked by SARS-CoV-2 virus (as well as by other viruses) changes and being similar to that observed in cancer cells. To cope with the task of producing a huge amount of virus copies (a large number of virus DNA copies), the cell uses the same metabolic pathways as cancer cells. So, the so-called Warburg effect is observed, i.e., obtaining energy needed for rapid divisions and DNA synthesis almost exclusively by glycolysis from bypassing the oxidative phosphorylation. This requires a huge amount of glucose to be taken up and metabolized. It has been observed that both in the case of rapidly proliferating neoplastic cells and in cells infected with viruses, inhibition of the glycolysis process leads to the controlled death of these cells by apoptosis.
Paradoxically, the same glycolysis inhibitors can be used both in the fight against cancer and cells infected with SARS-CoV-2 viruses. Administration of a glycolysis inhibitor such as 2-DG into the environment leads to arrest of viral particle synthesis and death of the infected cell. At least in the theory this should stop the infection from spreading in the lung tissue rapidly.
DG-Nika AG has started research to exploit this relatively little-known phenomenon by using a slightly modified glucose molecule used as the Trojan Horse on cells infected with the SARS-CoV-2 virus. The glucose derivative itself shows little toxicity to healthy cells. As the disease develops in the lungs, it is possible to inhale the modified glucose into lungs to achieve its local concentrations enough to treat infected cells without exposing the whole organism. Such use of a long-known glycolysis inhibitor may turn out to be the best of the currently proposed solutions, in particular, as the company's employees calculated the amount of the substance needed to produce a therapeutic effect would fit on a pinhead. Will this amount be enough to show planned clinical trials, the completion of which will be expected by millions of people around the world.
Jerzy Gubernator, Prof. PhD, is a biotechnologist, the Head of Department of Lipids and Liposomes at the Faculty of Biotechnology and the director of Academic Center for Biotechnology of Lipid Aggregates in Wroclaw.
has broad experience in molecular diagnostics and pharmacogenomic platform. Ewelina is the author of 32 scientific publications, 17 patent applications, 5 Grants and 4 patents.
Ewelina graduated from Molecular Genetics at the University of Lodz, Poland and gained her PhD in the Department of Tumour Biology at the Medical University of Lodz, where she held the position of an adjunct from 2014 till 2020. In 2008 she took part in a fellowship programme at the Temple University in Philadelphia (USA), where she conducted research on leukemic cells. She was distinguished in the third edition of scholarship programme for PhD students of the Fundacja na rzecz Nauki Polskiej (Foundation for Polish Science).
In 2020 she was appointed to the Head of Department of Molecular Biology. In 2015, she co-founded Personather Ltd., biotech company, where she is currently a Project Scientific Manager. Since 2009 she has been holding the position of PI/ Deputy CTO in Celther Polska LTD. She has 10 years of experience in cellular engineering and stem cells biotechnology (development of dozen R&D products including GE modified cells). She specializes in molecular oncology, especially glioblastoma (development of dozen GB models for in vitro testing) and has broad experience in molecular diagnostics and pharmacogenomic platform. Ewelina is the author of 32 scientific publications, 17 patent applications, 5 Grants and 4 patents.
His interest include application of computer methods in various aspects of Biology and Chemistry.
Marcin Pacholczyk is an Assistant Professor at Silesian University of Technology, Gliwice, Poland (since 2008) and Computer Aided Drug Design specialist at Celther Polska LTD (since 2012). He holds a PhD degree in Biomedical Engineering.
Author of several publications in Drug Design and Molecular Modelling areas.
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LEK-AM Sp. z o.o. is one of the most dynamically developing pharmaceutical companies on the Polish market. It was established in 2000 and currently employs 440 people. It has the latest laboratory equipment and a highly qualified R&D team.External link to the website of LEK-AM
Personather Ltd. Is an R&D laboratory which was established in 2015 in order to develop innovative anti-cancer therapies and diagnostic tools, based on the personalized medicine. Personather Ltd. develops absolutely original therapies which target only tumour cells. The team members have broad experience in designing anti-cancer therapies and in regenerative medicine (stem cells). The team of Personather Ltd. team works various scientific fields (i.e., bioinformatics, molecular and cellular biology, genetic engineering) and applies the latest technologies.External link to the website of R&D Laboratory Personather Ltd.
Medidest Enterprise Ptd.Ltd. is a company providing all-round service in the R&D field. Its field of expertise are the latest blockchain technologies, trademark protection and patent law and more.
Celther Polska was established as a result of the activities in the field of cell therapy and the stem-cell research. Celther Polska specializes in computer modelling in clinical studies.External link to the website of Celther Polska
NeoVirTech is known for the high-resolution analysis of virus constructs in living cells. NeoVirTech developed customized ANCHOR TM- viruses and viral vectors for special applications in antiviral research, gene transfer, viral based vaccine development and oncolytic virotherapies. Their research also encompases the Sars-CoV2 virus. NeoVirTech offers a wide range of screening models for antiviral testing in both, humans and animals. They also provide screening services with models developed by customers (i.e., oncolytic or gene therapy products) and their internal compound libraries (280 FDA approved compounds/ EMEA approved compounds).External link to the website of NeoVirTech
BÜCHI Labortechnik AG has been a leading solution provider of the R&D laboratory technology, quality control and production, for over 80 years. They serve a wide range of industries, such as pharmaceutical, chemical, food and beverages, fodder, environmental analysis and academies.External link to the website of BÜCHI
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