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“Have we lernt the lesson?”

Heraldo de Aragón publishes today an opinion article written by Jesús Santamaría, Scientific Director of Nanbiosis U9 Synthesis of Nanoparticles Unit about the COVID19 Pandemic in the relation with the investment in R&D.

The proffesor at the University of Zaragoza makes a quick review on the
the main milestones reached by researchers to fight the COVID 19: “In early December some Wuhan residents start to get sick after visiting a local market, with what looked like flu symptoms. Nevertheless, Chinese health officials report to World Health Organization on New Year’s Eve that a group of patients presented a new type of pneumonia. Just two weeks later, a Shanghai lab published the genome sequence of the virus, and explained its differences from other coronaviruses. It was an advance decisive that allowed laboratories around the world to undertake frenetic investigations in different lines of action: development of PCR diagnostic tests, rapid diagnostic kits (there are already various on the market), mechanisms of infection (researchers Chinese publish an article on March 4 in the journal ‘Science’ revealing the role of the ACE2 protein in cell invasion) or possible therapies: several rapidly developing vaccines (the main race is between teams from China and the United States, but almost all developed countries have very advanced projects, including Spain), and therapeutic alternatives such as the one published by German scientists on March 20, also Science Journal, based on the blockade of an essential enzyme for the coronavirus” In summary, “research is producing spectacular results with unusual speed“, sais Santamaría and explains: – “This dizzying display of world-class science has been possible in countries with a powerful scientific structure, with the muscle to respond quickly to a crisis caused by an unknown pathogen. In Spain there have been relevant contributions, but in general, far from the world front line. In fact: Spain’s R&D effort continues at just over 1.2% of GDP, compared to 2.07% for the EU average or 3% for Germany, even behind countries such as Portugal or Hungary. In others countries, -continous the proffessor- even during the 2008 economic crisis there was commitment to science and technology as a way of progress. This is also the case in countries that not so long ago we considered technologically backward.  In the case of China, the evolution has been amazing”, -confirms the rearcher according his experience as Editor of an excellent scientific journal for more than 20 years where most of the articles had a signature from that country. – “Hopefully this crisis will help us to change. To believe in research again as a seed of progress. And to demonstrate it with sustained investments, and giving it the central role it deserves.”

The proffessor ends his article quoting the words of the activist Mary Lasker: “If you think research is expensive, try the disease.”

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NANBIOSIS keeps working in SAFE-N-MEDTECH!

On March 10-12 a two-day meeting between representatives of NANBIOSIS units, took place at the  Jesús Usón Minimum Invasive Surgery Center (CCMIJU), in Cáceres, to plan the work to be done in the coming months and carry out some tests within the framework of the European project Safe-N-MedTech.

Several units of the ICTS NANBIOSIS will carry out some of the F/Q, in vivo and in vitro characterizations applied to the test cases of the project. NANBIOSIS is actively involved and works in close collaboration with the four Test Case Developers: Stryker, RCL, HELIA Biomonitoring and TECNAN. Additionally, NANBIOSIS is the leader of WP3 Preclinical Research in nano enabled MTs.

The Safe-N-MedTech European Project will create an open innovation platform that accelerates the development of medical devices based on nanotechnologies. The project counts with 28 partners coordinated by TECNAN (Navarre, Spain), together with BIOKERALTY, the research branch of the global health companies Keralty. The new project is part of the Open Innovation Test Bed initiative (OITB) launched by the European Commission with the aim of accelerating the development of medical devices based on nanotechnologies in Europe and abroad. The project has a European funding of 15 million euros.

We expect that the Safe-N-MedTech test bed will help to accelerate the development nanotechnology based medical technologies products and services for future applications in clinical practice.

Safe-N-Medtech kicks off in Bilbao
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Peptide functionalized nanoliposomes for biomolecule intracellular delivery, prepared using compressed CO2

The PhD Researcher Dolores Bueno researcher of NANOMOL Group and NANBIOSIS Unit 6 Biomaterial Processing and Nanostructuring Unit (from CIBER-BBN and ICMAB-SCIC) has defended her PhD thesis today, 20 March 2020, by videoconference from the ICMAB Meeting Room. No public was allowed due to the drastic measures of containment taken to tackle COVID-19.

Peptide functionalized nanoliposomes for biomolecule intracellular delivery, prepared using compressed CO2 

Abstract: Fabry disease is a rare disease caused by a gene mutation on the X-chromosome, which encodes α-galactosidase A (GLA) enzyme. The lack of GLA causes the accumulation of globotriaosylceramide at the lysosomes. The actual treatment is based in the enzyme replacement therapy (ERT), the intravenous administration of the enzyme. Nanotechnology is a powerful tool to develop enzyme-loaded nanosystems in order to ameliorate ERT efficacy.

DELOS-SUSP (Depressurization of an Expanded Organic Solution-Suspension) methodology enables the production of small unilamellar vesicles using compressed CO2. DELOS-SUSP allows the simultaneous encapsulation of different bioactives like RGD peptide and GLA in liposomes. This Thesis has used liposomes with RGD and GLA to generate a solid proof of concept for the treatment of Fabry disease.

Supervisor:

  • Nora Ventosa Rull, NANOMOL Group, ICMAB-CSIC Scientific Director of NANBIOSIS Unit 6
  • Elisabet González Mira, NANOMOL Group, ICMAB-CSIC

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CALL FOR EXPRESSIONS OF INTEREST FOR FINANCING OF RESEARCH PROJECTS ON COVID-19

The Spanish Official State Bolletin of March 18, 2020 published the Royal Decree-Law establishing measures to support research on COVID-19, including the authorization of an extraordinary credit for direct grants for research projects and programs of the COVID-19.
The Carlos III Heath Institute (ISCIII) calls for the presentation of expressions of interest to promote knowledge about SARS-CoV-2 and the CoVid disease19, as well as its impact on infected people. The aim of the proposals shall be to contribute to an efficient treatment of patient and / or public health rresponse. Proposals must be appropriate to the emergency situation and, therefore, allow immediate implementation and start-up in the National Health System, with concrete, early results applicable to the current situation. These proposals may be based on currently existing activities.
The scope of these proposals shall be:
a) Rapid virological diagnostic techniques of COVID-19, industrially scalable and applicable to healthcare, with priority orientation towards the diagnosis of the early stages of infection in humans and that allow predicting severity for the purpose of healthcare stratification.
b) Clinical-biological-molecular characterization of the COVID-19 disease, stages, prognostic stratification and complications.
c) Development of innovative therapies, new antiviral, antiseptic and disinfectant molecules against SARS-CoV-2. Antiviral resistance studies. Effectiveness of non-pharmacological, prophylactic and therapeutic interventions.
d) Characterization of the SARS-CoV-2 virus, knowledge of the genetic and antigenic variation of SARS-CoV-2 as well as the immunological response to the SARS-CoV-2 virus and the virus-host interaction.
e) Vaccine development, efficacy and applicability.
f) Epidemiological surveillance of COVID-19 and molecular epidemiology: incidence of mortality and morbidity. Environmental and social factors of the spread. Risk factors and population dynamics of SARS-CoV-2 infection.
g) Socio-economic impact of COVID-19. Use of primary care resources, general hospital resources, and critical care resources.
h) Artificial intelligence and massive analysis of integrated data oriented to the epidemiological control of the disease COVID-19.
Applicants must take into account that the proposals financed under this expression of interest must comply with the provisions of the corresponding concession resolution, without prejudice to the additional measures that may be incorporated in order to guarantee the early execution of the projects, open access. to data and obtaining useful results for the immediate fight against this disease.
 
More information and expression of interest form here

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Covid-19 vaccine resear will be founded with 30 million € by the Spanish goverment

Pedro Sánchez, the Spanish President has announced today the decision of the  Council of Ministers to allocate 30 million euro for the research of the SARS-CoV2 coronavirus vaccine.

This budget item will go to the Higher Center for Scientific Research (CSIC), State Agency for Scientific Research and Technological Development, and the Carlos III Health Institute (ISCIII), dependent on the Ministry of Science and Innovation. Specifically, 25.2 million euro will go to the ISCIII, of this amount, 24 million will directly finance research projects and programs for the new coronavirus. The ISCIII, as a research funding agency in the health field, will develop an urgent aid program for projects aimed to the creation of knowledge about the infection, to analyze and understand the biology of the virus, develop new therapeutic and prophylactic options, including vaccines, develop an epidemiological surveillance system and analyze its impact from the point of view of health services. The ISCIII will have 1.2 million euro to cover exceptional needs, such as the acquisition of material or the payment of guards for the increase in services

Much of the leading role is also taken by the National Centers for Microbiology (CNE) and Epidemiology (CNE). In the case of the former, which offers support to the National Health System centers in cases where infectious diseases generate a public health alert, it is mainly responsible for the analysis and confirmation of cases of coronavirus disease (COVID-19).

The ISCIII has also developed a commercial techniques validation program for the detection of SARS-CoV2 in clinical samples. In this way, it responds to the fact that different companies have developed commercial kits for the detection of the coronavirus. These techniques have not been clinically validated nor have they yet obtained the European Commission seal, but the ISCIII makes this validation program available due to the growing and urgent needs of healthcare centers, making it easier for these commercial kits to be available to the National Health System in the shortest time possible.

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Laura Lechuga talks about CONVAT, the project for a faster and cheaper diagnose of COVID-19

Prof. Laura M. Lechuga, Scientific Director of NANBIOSIS Unit 4 Biodeposition and Biodetection Unit (from CIBER-BBN and ICN2-CSCIC) has been today interview by Cadena Ser Radio in the program “Hoy por Hoy”

The interview can be listened in the following podcast, begining at 44 minute.

‘Convat’ is a nanotechnological device with biosensors capable of determining in less than half an hour the presence of coronavirus in a person. A sample saliva is deposited on a nanochip three centimeters long. If the saliva contains the virus, it will bind to antibodies located on the nanochip. A beam of light will be passed through the device so that the light will change if it encounters the virus and antibody in its path. The light will be analyzed automatically and the result will be transmitted to a smartphone or tablet. In less than 30 minutes a positive or negative result would be obtained and, in case of detecting the presence of the virus, in another 30 minutes at most the reconfirmation would be obtained. It is not intended for domestic use, but neither will a specialist technician be needed and it could be carried out in a massive way.

Simpler, cheaper and easier than current methods, this rapid diagnostic kit will not be ready for the first wave of the coronavirus, but it can be useful to detect it later if this virus is here to stay.

Yesterday, Laura Lechuga was also invited to explain the CONVAT project to the spanish television programe “A partir de hoy“.

‘Convat’, la prueba que puede detectar el coronavirus

https://twitter.com/FAQSTV3/status/1238968335192162306

Prof Laura Lechuga was also interviwed by TV3 in the program Planta Baixa 

More information here

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COVID-19 diagnose, faster and cheaper.

In order speed up research into the coronavirus, the European Commission recently announced a special call for projects to tackle the COVID-19, based on already developed technologies. Projectcs were prepared in a record time and 17 proposals have been awarded founds, 6 of them with spanish colaboration and only one coordinated by Spain

CONVAT is a cooperation project between Spain, Italy and France coordinated by Prof. Laura M. Lechuga, Scientific Director of NANBIOSIS Unit 4 Biodeposition and Biodetection Unit (from CIBER-BBN and ICN2-CSCIC) and also participated by the group of Prof. Jordi Serra Cobo from the University of Barcelona, having extensive experience in the study of coronavirus in animals and its epidemiology; Prof. Remi Charrel‘s laboratory at the University of Marseille (France), leader in virology and molecular biology, pioneering the development and production of biological material for the validation of new diagnostic systems and the Italian National Institute of Infectious Diseases (INMI), where researchers from Dr Antonino Di Caro‘s laboratory were among the first to sequence the SARS-CoV-2 coronavirus, and which is the reference institute for the analysis and diagnosis of COVID-19

CONVAT will develop a point-of-care platform, for rapid diagnosis and monitoring of coronavirus, directly from the patient’s sample and without the need for testing in centralized clinical laboratories. The new device based on optical biosensor nanotechnology is espected to become massively available in less than 12 months. The project indeed aims to extend beyond the current pandemic and the human diagnosis. The new biosensor will also be used for the analysis of different types of coronavirus present in reservoir animals, such as bats, in order to observe and monitor possible evolutions of these viruses and prevent future outbreaks in humans

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New COVER in Chemistry. A European Journal: an active organic radical stable agains racemization!

The journal Chemistry. A European Journal features in its COVER the recently published article “An enantiopure propeller‐like trityl‐brominated radical: Bringing together a high racemization barrier and an efficient circularly polarized luminescent magnetic emitter” authored by rearserchers of NANBIOSIS U6 Biomaterial Processing and Nanostructuring Unit, led by Jaume Veciana (CIBER-BBN, ICMAB-CSIC)

Nowadays, it is necessary to know the increasingly specific requirements of electronic devices in order ot be able to find new multifunctional materials that allow obtaining more efficient devices. This article represents a step forward in the field of organic free radicals. Organic free radicals act as polarized light emitters synthesizing and studying the two optically active enantiomers of a new brominated derivative of the trityl radical, which show no evidence of racemization up to 60 ° C for more than two hours, due to the great steric hindrance imposed by the bulky atoms of Br that have as substituents. This fact has allowed to determine its great efficiency of luminescence of polarized light despite its purely organic nature. In addition, this result suggests that new, very improved radicals can be obtained thanks to the wide synthetic possibilities offered by Br atoms.

More information can be found in the Full Paper by I. Ratera, A. G. Campaña, J. Veciana, et al. (DOI: 10.1002/chem.202000098).

See the cover website here (DOI: 10.1002/chem.202000463)

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Rare diseases Day February 29: combating Fabry Disease

29 of February is a ‘rare’ date and February, a month with a ‘rare’ number of days, has become a month to raise awareness about rare diseases and their impact on patients’ lives.  Since 2008 thousands of events happen every year all around the world and around the last day of February.

NanoMed Spain Platform and the Hospital of Sant Joan de Déu have organized the NanoRareDiseaseDay to present the latest innovations in the field of Nanomedicine for the treatment and diagnosis of rare diseases (diseases affecting less than 5 people per 10,000 inhabitants). Nora Ventosa, Scientific Director of NANBIOSIS U6 Biomaterial Processing and Nanostructuring Unit  (CIBER-BBN / ICMAB-CSIC) presented Smart4Fabry a European project with the aim of reducing the Fabry disease treatment cost and improve the life-quality of Fabry disease patients

Fabry disease is one of the rare diseases that currently lack a definitive cure. It is cause by lysosomal storage disorders (LSDs):  the deficiency of α-Galactosidase A (GLA) enzyme activity result in the cellular accumulation of neutral glycosphingolipids, leading to widespread vasculopathy with particular detriment to the kidneys, heart and central nervous system.

Smart-4-Fabry has been conceived to obtain a new nanoformulation of GLA, that will improve the efficacy and toleration compared to the actual treatment with non-formulated GLA. Four units of NANBIOSIS participate in the project:

– U1 Protein Production Platform (PPP) led by Neus Ferrer and Antony Villaverde at IBB-UAB accomplish the production and purification in different expression systems for R&D purposes.

– U3 Synthesis of Peptides Unit led by Miriam Royo at IQAC-CSIC performs all the chemical process of the Smart-4-Fabry  project, i.e. design and synthesis of peptides used as targeting ligands in the nanoliposome formulation

– U6 Biomaterial Processing and Nanostructuring Unit led by Nora Ventosa and Jaume Veciana at ICMAB-CSIC undertakes tasks related to the manufacture of the nanoliposome formulation of GLA enzyme and the physico-chemical characterization (this unit counts with plants at different scales, from mL to L, which allow process development by QbD and process scale-up, as well as instrumental techniques for assessment of particle size distribution, particle concentration, particle morphology and stability, and Z-potential)

– U20 In Vivo Experimental Platform led by Simó Schwartz and Ibane Abásolo at VHIR to carry out the non-GLP preclinical assays of the project (in vivo efficacy, biodistribution and tolerance/toxicity assays).

For further information about Fabry disease and the Smart4Fabry project: here

Nora Ventosa explaining the progress of the smart4fabry
project on nanoliposomes development for the treatment of Fabry disease
(Pictures by Nanomed Spain)
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Fabry disease & Smart4Fabry project

The Fabry disease (FD) is a lysosomal storage disorder (LSD) that currently lacks an effective treatment. Lysosomes are spherical vesicles, which contain hydrolytic enzymes found in nearly all animal cells. LSDs are caused by lysosomal dysfunctions, usually because of the deficiency of a single enzyme required for the metabolism of macromolecules such as lipids, glycoproteins and mucopolysaccharides. Fabry disease is a progressive, X-linked inherited disorder caused by deficiency or absence of the α-galactosidase A (GLA) activity, an enzyme involved in the glycosphingolipid metabolism. The substrates of GLA are glycosphingolipids, being the primary substrate the globotriaosylceramide (Gb3). Therefore, the failure of GLA activity leads to progressive intracellular accumulation of Gb3, in many cells, particularly in renal epithelial cells, endothelial cells, pericytes, vascular smooth muscle cells, cardiomyocytes, and neurons of the autonomic nervous system, leading to multisystemic clinical symptoms. First clinical signs of FD occur during childhood and, over time, microvascular lesions of the affected organs progress leading to early death. It affects mostly men but serious cases have also been reported in women.

There are currently three products authorized in the EU for the treatment of FD. Two products available in EU since 2001 for Enzymatic Replacement Therapy (ERT), Replagal (Shire Human Genetic Therapies AB) and Fabrazyme (Genzyme Europe B.V.), which have to be i.v. administered every other week. The ERT strategy is based on supplying recombinant GLA to cells, reversing several of the metabolic and pathologic abnormalities. There is a third product in the EU market since 2016, which is based on the chaperone migalastat hydrochloride (Galafold Amicus Therapeutics UK Ltd), designed to selectively and reversibly bind with high affinity to the active sites of certain mutant forms of GLA, facilitating proper protein folding and allowing for correct trafficking of the mutant enzyme. However, it is a genotype-specific treatment (only one-third to one-half of mutations may be amenable).

To date, no direct comparisons exist between Fabrazyme and Replagal but significant clinical benefits compared with placebo, however, have been demonstrated with ERT, with positive effects on the heart, kidneys, nervous system and quality of life. Of note, a stabilization of renal function was only observed at an early phase of FD.

ERT success with free GLA is limited mainly due to the instability and low efficacy of the exogenously administered therapeutic enzyme. Furthermore, some patients can develop immune responses after receiving the infused recombinant enzyme. Clinical data has confirmed that the immunological consequences of ERT may impair efficacy in some patients. Furthermore, the short elimination t1/2 of the enzyme and the need for repeated administration of large amounts of enzyme are other limitations of current ERT. In addition, GLA does not cross of the Blood Brain Barrier (BBB), which prevents the product for reducing the Gb3 deposits in the central nervous system (CNS). Moreover, it is a lifelong treatment which becomes a burden for the health system due to its extremely high cost.

Therefore, there is a need for other therapeutic strategies, which can either serve as primary or supplemental treatments. Gene and substrate reduction therapies constitute alternative therapies which are at present under investigation.

The European “Smart-4-Fabry” project aims to develop a new nanoformulation based on the encapsulation of the GLA enzyme in nanoliposomes, to improve the current ERT of FD. A Consortium formed by ten partners, including private companies and public institutions in Europe and Israel, has been granted (July 2017) with a Horizon2020 financial programme by the European Commission (H2020-NMBP-2016-2017; call for nanotechnologies, advanced materials, biotechnology and production; Proposal number: 720942-2).

The project is expecting to last for 48 months and contemplates the necessary activities to advance a nanoliposome formulation of GLA enzyme, i.e., nano-GLA, from an experimental proof of concept up to an advanced nonclinical stage of development. The S4F should complete an advanced regulatory safety and toxicology package supporting future nano-GLA clinical development in patients with FD.

To the best of S4F knowledge, there is no previous experience on the encapsulation of a GLA for treating FD patients following an ERT approach.

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