Projects

Area: Cancer

Line of research: Development of new therapies and diagnoses of oncological processes

Nocanther-Introduction and Scaling up nanomedicines for early clinical phases of multimodal cancer therapy (H2020)

Description:

Goals:

1st Scaling of magnetic nanoparticles, as well as their manufacturing under certified conditions.

2nd Carry out preclinical safety and toxicology studies.

3rd Request a clinical safety trial.

The project’s starting point is iron oxide-functionalized magnetic nanoparticles developed and validated for both their efficacy and toxicity within the framework of the large Multifun FP7 project. In order to complete the regulatory evaluation for the preparation of the Investigational Medical Devices Dossier (IMDD), the synthesis of nanoparticles will be scaled up and produced in a pilot line under certified conditions. Its attributes will be duly evaluated through a quality control that aims to contribute to the standardization of the characterization of nanomedicine (WP1). The antitumor activity of these certified nanoparticles will be assessed using advanced preclinical models based on patient-derived xenografts (Avatars), which can be used to estimate the efficacy of this new approach in humans with a success rate of up to 80% (WP2). . The method requires the application of a non-radioactive alternating magnetic field (AMF), which induces a temperature rise around the nanoparticles, mainly killing tumor cells (magnetic hyperthermia). Since the application of the nanoparticle will be carried out intratumorally using standard procedures, the side effects of this local and minimally invasive approach are expected to be minimal. In this sense, an AMF device will be optimized for the treatment of pancreatic tumors in humans (WP3). The final translation to the clinic will be carried out through a Clinical Study, which is expected to be carried out in 20 patients from two different hospitals (WP3).

This formulation contains a magnetic nanoparticle (MNP) core with optimal heat dissipation properties and a biocompatible coating that is functionalized with: (a) the NUCANT pseudopeptide (N6L) which has the property of promoting the internalization of nanoparticles in target cells, and (b) the chemotherapeutic agent gemcitabine, used in the first line for the treatment of pancreatic cancer. These bioactive molecules are conjugated with the nanoparticles in such a way that they are released efficiently once they are internalized in the cells. This combination of magnetic nanoparticles with hyperthermia-optimized properties represents a novel nanotechnology-based therapeutic approach for highly efficient and highly tolerable pancreatic cancer therapy.

BioKeralty share:

BioKeralty’s role in the project is very relevant, since it is in charge of scaling up the magnetic nanoparticles, fine-tuning the analytical techniques, as well as manufacturing under certified conditions. At the same time, he has acted as sponsor of the clinical trial and has been in charge of carrying out the Business Plan.

Partners:

IMDEA Nanoscience, ImmuPharma, Chemicell GmbH, Universitätsklinikum Jena, Resonan Circuits Limited, Vall d’Hebron Research Institute; Trinity College Dublin, Paris Diderot University, Vall d’Hebron Institute of Oncology and Fuenlabrada University Hospital.

Financing entities:

This project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement no. 685795.

Area: Cancer

Line of research: Development of new therapies and diagnoses of oncological processes

Theraglio-Microbubbles for multimodality imaging and theragnostics of gliomas (H2020)

Description:

Goals:

1st Design a new neurosurgical navigation system to simultaneously acquire intraoperative US and microscopy images, and pair them with preoperative MRI images in real time.

2nd Fabricate and preclinically evaluate the stability, toxicity and efficacy of multimodal lipid MBs on a laboratory scale as an intraoperative neuronavigation tool.

3rd Manufacture and physically characterize the multifunctional polymeric microbubbles (bioinert and biodegradable), which were functionalized for microscopic visualization by NMR, US and fluorescence.

4th Develop multimodal drug-loaded nanoparticles to functionalize biodegradable microbubbles as a drug delivery platform.

5th Clinically assess the feasibility, usability and accuracy of the multimodality platform using commercially available microbubbles (SonoVue) in combination with ICG (both EMA approved) for MRI-guided surgery /US in real time using an integrated neuronavigation platform in recurrent malignant glioblastomas, as a proof of concept to validate the functionality of the new platform in vivo.

BioKeralty share:

BioKeralty was in charge of carrying out the industrial scaling and subsequent characterization of the lipid microbubbles developed within the project, as well as the design of the manufacturing process under GMP conditions. In the same way, BioKeralty was responsible for developing the dissemination and exploitation plan of the developed product.

Partners:

Fondazione IRCCS Istituto Neurologico “Carlo Besta”, Università degli Studi di Roma Tor Vergata, Tel Aviv Sourasky Medical Center, SeroScience Research Development and Trade Ltd., MedCom GmbH, Esaote Spa, Camelot Biomedical System Srl, Nanomol technologies and CF Consulting SRL

Financing entities:

FP7-CP-FP

Area: Cancer

Line of research: Development of artificial intelligence and deep-learning techniques in the diagnosis and treatment of cancer

Mifludan-Microfluidics and Data Analytics for personalized treatments in oncology (ELKARTEK)

Description:

Goals:

1st Develop a test platform based on the synergies that arise from the fusion between microfluidic technologies and data analytics for the creation of a support system for personalized cancer treatment.

BioKeralty share:

BioKeralty has participated carrying out the tasks of surveillance and technological evaluation. Likewise, it has contributed to the generation of clinical information, collaborating in the design of clinical protocols and in the analysis of histological images necessary for the creation of artificial intelligence algorithms.

Partners:

Ceit-IK4, CIC bioGUNE, Biodonostia Health Research Institute (IIS Biodonostia) and University of Deusto.

Financing entities:

Program to support collaborative research in strategic areas.

Area: Cancer

Line of research: Development of artificial intelligence and deep-learning techniques in the diagnosis and treatment of cancer

Oncofludat I and Oncofludat II– Personalized treatment of cancer patients through integration of data analytics and microfluidics (ELKARTEK 2018222026)

Description:

Goals:

1st Accelerate the first stages of drug discovery and testing of existing ones, thus contributing to reducing dependence on animal experimentation with the consequent reduction in costs.

2nd Extract data to improve and develop more effective treatments, allowing the creation of clinical pathways based on the therapies implemented and predicting the usefulness of new therapies in research and development.

3rd Specify and optimize the protocol for collecting patient data for the selection of the characteristics with the greatest weight in decision-making provided by the algorithms of artificial intelligence.

4th Establish e-learning patterns based on the analyzed and structured data that allow the development of the personalization algorithm.

5th Create sequencing databases: predictive genetics, capable of establishing measures and guidelines for action and pre-treatments for oncological diseases.

BioKeralty share:

BioKeralty has participated in the design, creation and analysis of both retrospective and prospective clinical databases, obtaining clinical images and their analysis for their inclusion in the different artificial intelligence algorithms generated.

Partners:

Ceit-IK4, CIC bioGUNE, Biodonostia Health Research Institute (IIS Biodonostia) and University of Deusto.

Financing entities:

Basque Government Health Department 2018/2019

Area: Chronic and neurodegenerative diseases

Line of research: Metabolic syndrome and coexisting pathologies

Supreme-A new salutogenic approach for the prevention, diagnosis and treatment of metabolic syndrome and coexisting pathologies (HAZITEK)

Description:

Goals:

1st Research, development and obtaining of new foods and genetic tools that allow an early diagnosis and an effective personalized nutritional intervention in the prevention and treatment of metabolic syndrome, T2D and its derivation in cognitive deterioration . Supreme’s mission is to position the Basque Country in the medium term at the forefront of the prevention of non-communicable diseases such as diabetes and heart disease to reduce the incidence of older people with cognitive impairment through intervention tools and new food products

2nd Compile existing scientific knowledge regarding the genetic and epigenetic factors associated with T2D and its derived pathologies, as well as diagnostic techniques for develop tools that serve to detect the risk of suffering from these diseases and thus establish corrective measures in lifestyle to minimize or delay the risk of suffering from the disease. This innovation component involves overcoming the following identified technological challenges:

• ✓ Obtain a system capable of quantitatively analyzing the risk of suffering from T2D after a genetic and epigenetic analysis (predictive tool).
• ✓ Obtain a predictive model for the detection of complications associated with T2D.
• ✓ Be able to develop a prescribing application of corrective actions, with special emphasis on food, to improve high-quality life expectancy in people at risk (prescriptive tool).
• ✓ Development of new research models of in vitro functional activity.

In addition to the value that the different tools can have individually, the project seeks the integration of all of them to develop applications that are embryonic of future personalized medicine systems.

BioKeralty share:

BioKeralty participates in the execution of activities related to demonstrating the biological activity of selected compounds in in vitro cell models. In addition, it provides scientific-technical support related to the development of a predictive model of possible additional complications associated with T2D.

Partners:

Domusvi (Quavitae Servicios Asistenciales, SAU), BIZKARRA, SL, Ameztoi Anaiak, SLU, Biosasun SA, Consulting Fresh Business, SL, Garlan Sociedad Cooperativa Limitada, Ibermatica SA, Keralty and Patia Europe.

Financing entities:

Area: Chronic and neurodegenerative diseases

Line of research: Alzheimer’s disease

Neurofar/Drugs4AD-R+D+I in new drugs with therapeutic potential in Alzheimer’s Disease (ELKARTEK-KK-2016/00045; KK-2017/00014)

Description:

Goals:

1st Identify new therapeutic targets on which to act pharmacologically to improve the ineffectiveness of treatments currently approved to treat Alzheimer’s disease and thus be able to make improvements that allow increasing the effectiveness of said treatments treatments.

2nd Discover new neurolipidic targets with great therapeutic potential that can lead to new treatments in a relatively short time. For this, research has been carried out related to the modulation and neuroprotection exerted by signaling systems by neurolipids such as the endocannabinoid (eCB), those of the lysophosphosphatidic acid (LPA) and sphingosine-1-phosphate (S1P) and lysophospholipids. omega 3 fatty acids such as docosahexaenoic acid (DHA).

3rd Generate well-being and strengthen the leadership of Basque R&D entities participating in this project such as the Basque Foundation for Health Innovation and Research (Bioef), Biocruces, the UPV /EHU and Biopraxis (now BioKeralty), which are already participating in projects within European programs and those of the Basque Government such as SAIOTEK, ETORTEK and ETORGAI.

BioKeralty share:

BioKeralty has worked on the development and optimization of lipid nanoparticles, as well as on the optimization of new advanced in vitro models as a platform for testing possible effective molecules and drugs.

Partners:

University of the Basque Country/ Euskal Herriko Unibertsitatea (Neurochemistry and Neurodegeneration; NanoBioCel), IIS BIOCRUCES (Neurology Service) and Basque Foundation for Health Innovation and Research -BIOEF (Araba Hospital, Txagorritxu. Pathology Service).

Financing entities:

Area: Chronic and neurodegenerative diseases

Line of research: Alzheimer’s disease

Investigation of the pharmacological efficacy of designer unsaturated fatty acids for the treatment of Alzheimer’s disease (Igralzheimer) (RETO)

Description:

Goals:

1st Develop and commercialize molecules as nutraceutical-functional in order to advance in the development of a future medicine.

2nd Computational study for the prediction of new crystalline forms of the molecule under study with the aim of improving its physicochemical and pharmaceutical properties.

3rd Develop the method of synthesis, scaling and quality control of the molecule under study.

4th Complete the knowledge about the mechanism of action.

5th Develop a nutraceutical product based on the molecule under study.

6yh Manufacture development batches of the pharmaceutical product.

7th Carry out preclinical studies (regulatory, GLP) of bioanalysis, genotoxicity and toxicity in experimental animals.

BioKeralty share:

Biopraxis played a fundamental role in the industrial scaling of the development of the nutraceutical formulation and pharmaceutical formulation of the project, as well as in the design of the future clinical trial. In addition, as a partner, he also played a key role in exploiting the results and their future go-to-market strategy.

Partners:

Lipopharma, University of Navarra, Medalchemy, University of the Balearic Islands and University of the Basque Country/EHU (NanoBioCel), Neurosciences).

Financing entities:

The Research Project on the Pharmacological Efficacy of Designer Unsaturated Fatty Acids for the Treatment of Alzheimer’s Disease (IGRALZHEIMER), RTC-2015-3542-1, has been funded by the Ministry of Economy, Industry and Competitiveness, through the Challenges-Collaboration 2015 call for the State Program for Research, Development and Innovation Oriented to the Challenges of Society, within the framework of the State Plan for Scientific and Technical Research and Innovation 2013- 2016.

Area: Chronic and neurodegenerative diseases

Line of research: Stroke

Pharmaceutical development of designer lipids for the treatment of stroke and related pathologies (Metabolic disorders) (RETO)

Description:

Goals:

1st Develop and obtain patents for new compounds.

2nd Carry out biochemical, morphological and physiological tests of the new compounds discovered in order to determine their palliative effect in animal models of stroke and metabolic disorders that increase the risk of stroke.

3rd Develop analytical methods and basic galenics in molecules likely to be used as drugs in these pathologies.

4th Carry out preclinical pharmacokinetic and toxicology tests.

5th Develop analytical methods and basic galenics.

BioKeralty share:

Biopraxis participated in the development of analytical methods and basic galenics of the compounds with the best results at the in vitro/in vivo level to initiate their pharmaceutical development.

Partners:

Lipopharma, University of León and University of the Balearic Islands.

Financing entities:

The RTC-2015-4094-1 Pharmaceutical Development of Designer Lipids for the Treatment of Stroke and Related Pathologies (Metabolic Diseases) Project has been funded by the Ministry of Industry, Economy and Competitiveness , through the call for Collaboration Challenges 2015 of the State Program for Research, Development and Innovation Oriented to the Challenges of Society, within the framework of the State Plan for Scientific and Technical Research and Innovation 2013-2016.

Area: Infectious diseases

Research line: Antimicrobial resistance

Nanoplatform-Development of a nanotechnology platform for its application in the biomedical field (ELKARTEK KK-2015-00036)

Description:

Goals:

1st Create a technological platform for the development of nanoformulated products with high added value for the treatment of different pathologies and diseases, seeking to make the Basque Country a leader in the generation of nanotechnological products in response to the needs of the biomedical market.

BioKeralty share:

Biopraxis has been in charge of the development of nanolipids (empty nanoparticles), their characterization and scaling as the basis of the nanotechnology platform. Also, it has designed and executed the corresponding toxicological studies to demonstrate the absence of toxicity of nanolipids and has defined the regulatory strategy for nanolipids to be considered as a new excipient of pharmaceutical quality.

On the other hand, BioKeralty has carried out the industrial development of colistin nanoparticles as a drug for multi-resistant infections, has designed in vitro and in vivo efficacy studies as well as an assay to establish the safety, tolerability and pharmacokinetics of colistin nanoparticles.

Partners:

University of the Basque Country (UPV/EHU), Tecnalia Research & Innovation (TECNALIA), Basque Foundation for Innovation and Health Research (BIOEF).

Financing entities:

Area: Infectious diseases

Research line: Antimicrobial resistance

Nanogrow-Innovative and effective tissue substitutes based on combined technologies of cell therapy, nanotechnology and additive manufacturing (HAZITEK ze-2017/00014)

Description:

Goals:

1st Optimize the industrial manufacturing of cell therapy products (more specifically autologous covering epithelium (mainly skin) and allogeneic cornea) to obtain living organs in a short period of time and that serve as effective tissue substitutes for their application in regenerative medicine. The optimization of the manufacturing process of living organs (skin, other epithelia and bioengineered cornea) will be carried out through the functionalization of these tissue substitutes with nanoparticles loaded with growth factors (FFCC) that promote cell multiplication and can reduce manufacturing times. . Likewise, lipid nanoparticles loaded with antibiotics will be used, which will make it possible to reduce the bacterial load of the skin biopsies from which the cells are extracted to manufacture tissue substitutes, preventing or eliminating infection and, therefore, increasing effectiveness and tolerance. of the autograft.

BioKeralty share:

BioKeralty has been actively involved carrying out scientific advisory tasks, as well as process development, scale-up and industrial manufacturing under GMP conditions of NanorhEGF, NanoFFCC and Nanoantibiotics. Likewise, it has collaborated in carrying out the toxicology studies of NanorhEGF and Nano Placebo, also designing the clinical trial to evaluate the safety and efficacy of Nano Placebo.

On the other hand, BioKeralty has participated in the technical scientific advice for the optimization of the cutaneous bioequivalent through the addition of NanorhEGF and nano-antibiotics, as well as the design and development of in vivo efficacy studies of the optimized skin bioequivalent.

Finally, BioKeralty has participated carrying out scientific advisory tasks regarding the manufacture of medicines based on advanced therapies, carrying out the design and drafting of standardized procedures for work for its production under GMP conditions and designing a case study to evaluate the safety and efficacy of hematopoietic stem cell transplants.

Partners:

Keralty, AJL Ophtalmics, and Karuna GCT.

Financing entities:

Area: Infectious diseases

Research line: Antimicrobial resistance

NanoGSkin-Cross-sectional tissue engineering and nanomedicine approach to improve chronic wound therapy (EURONANOMED)

Description:

Goals:

1st Optimize human artificial skin models through the use of quality pharmaceutical products and the implementation of novel methods, such as nanotechnology. This will allow the generation of biomaterials with improved biomechanical and antimicrobial properties suitable for therapeutic use in clinical approaches. To achieve this first objective, the necessary histological, rheological and genetic quality controls are foreseen.

2nd Adapt the production of these new tools towards an optimal regulatory framework, including GMP regulation and EMA guidelines.

3rd Establish a broader exploitation model that includes the development of a market access approach to estimate the benefits of this treatment for society. The envisioned model will look at costing per patient as well as potential cost savings and/or cost-effective measures for the affordable introduction of this tissue-engineered-based treatment.

BioKeralty share:

BioKeralty carries out the scientific development of the NanorhEGF in terms of its scaling and production; the design and execution of the toxicology of NanorhEGF, as well as to provide regulatory advice on NanorhEGF for its application in tissue regeneration and advanced therapies.

Partners:

Health Research Institute of Granada (ibs.GRANADA), Keralty Health, Italian Biochemical Institute (IBI), University of Bordeaux, Université de Technologie de Compiègne (UTC) and National University of Ireland, Galway (NUIG).

Financing entities:

The project has received funding from the 8th Joint Transnational Call for Proposals for “European Innovative Research and Technological Development Projects in Nanomedicine" within the framework of ERA-NET EuroNanoMed-III.

Area: Infectious diseases

Line of research: Human Immunodeficiency Virus (HIV)

Stop-AIDS-New genomic engineering tools for the treatment of HIV-1/AIDS infection through the application of new genomic editing and viral transfection techniques, evaluating their safety and preclinical efficacy for AIDS treatment (RETO)

Description:

Goals:

1st Develop a gene therapy that makes it possible to reproduce the D32 mutation in the cells of people infected with HIV, and thus achieve that they are cured of the infection. During the three years of the project, studies have been carried out both in vitro and in animal models that have served to determine the safety and efficacy of the procedure.

BioKeralty share:

BioKeralty has participated in the following activities within the STOP-SIDA project: transfer of technology to the GMP environment, Design of the Phase 1 and 2 clinical trial draft, in the marketing and regulatory strategy, in the Dissemination of results, exploitation of agreements and patents and in the forecast of exploitation/commercialization of the results of the project.

Partners:

AIDS Research Institute (IrsiCaixa), Higher Council for Scientific Research (CSIC) and Karuna Good Cells Technologies, SL.

Financing entities:

Area: E-health

Research line: Big Data solutions for information storage and processing in clinical settings

Osasukat-Blockchain Platform for the Interoperable Record of Medical History (ELKARTEK)

Description

The main objective of the project is the development of a platform for the management of the Electronic Medical Record of patients that allows, in an interoperable way, to integrate the information from different data sources – mainly, hospital management systems of health centers – as well as offer services to facilitate access to that information to professionals in the terms of privacy and confidentiality that are defined and keep track of the actions carried out on it.

This general objective includes the following specific objectives:

Goals:

1. Transform the disaggregated data into added value information for the interested parties that, mainly and in the cases of use foreseen, refers to the health personnel to deal with better patient care.

2. Universalize access to aggregated information, unifying the procedure under a single technology that can be applied in any center where it is required.

3. Bring together all the actors involved around a platform, so that the information is available to all of them, but with the ability to define the level of visibility that each one can enjoy, and can be configured a priori and a posteriori through role policies and permissions.

4. Having a computer platform that allows decentralizing the storage of the data itself with the advantages that this entails, not only in terms of its accessibility, but also its availability.

5. Facilitate the communication of the platform with the rest of the systems through a friendly and reliable interface that allows the end user to abstract from the difficulties that Blockchain technology itself entails.

Biokeralty share:

Biokeralty is mainly involved in the following stages of the project:1. PHASE 1. ANALYSIS OF REQUIREMENTS – Definition of Use Cases and Functional Requirements

2. PHASE 4: INTEGRATION TESTS AND VALIDATION OF USE CASES – Definition of the Validation Plan

Partners:

Odei SA

Scanbit SL

Keralty Health SL

Financing entities:

Area: Infectious diseases

Line of research: Regenerative medicine

Nanoplatform-Development of a nanotechnology platform for its application in the biomedical field (ELKARTEK KK-2015-00036)

Description:

Goals:

1st Create a technological platform for the development of nanoformulated products with high added value for the treatment of different pathologies and diseases, seeking to make the Basque Country a leader in the generation of nanotechnological products in response to the needs of the biomedical market.

BioKeralty share:

Biopraxis has been in charge of the development of nanolipids (empty nanoparticles), their characterization and scaling as the basis of the nanotechnology platform. Also, it has designed and executed the corresponding toxicological studies to demonstrate the absence of toxicity of nanolipids and has defined the regulatory strategy for nanolipids to be considered as a new excipient of pharmaceutical quality.

On the other hand, BioKeralty has carried out the industrial development of colistin nanoparticles as a drug for multi-resistant infections, has designed in vitro and in vivo efficacy studies as well as an assay to establish the safety, tolerability and pharmacokinetics of colistin nanoparticles.

Partners:

University of the Basque Country (UPV/EHU), Tecnalia Research & Innovation (TECNALIA), Basque Foundation for Innovation and Health Research (BIOEF).

Financing entities:

Area: Infectious diseases

Line of research: Regenerative medicine

NanoGrow-Innovative and effective tissue substitutes based on combined technologies of cell therapy, nanotechnology and additive manufacturing (HAZITEK ze-2017/00014)

Description:

Goals:

1st Optimize the industrial manufacturing of cell therapy products (more specifically autologous coated epithelium (mainly skin) and allogeneic cornea) to obtain living organs in a short period of time and that serve as effective tissue substitutes for their application in regenerative medicine. The optimization of the manufacturing process of living organs (skin, other epithelia and bioengineered cornea) will be carried out through the functionalization of these tissue substitutes with nanoparticles loaded with growth factors (FFCC) that promote cell multiplication and can reduce manufacturing times. . Likewise, lipid nanoparticles loaded with antibiotics will be used, which will make it possible to reduce the bacterial load of the skin biopsies from which the cells are extracted to manufacture tissue substitutes, preventing or eliminating infection and, therefore, increasing effectiveness and tolerance. of the autograft.

BioKeralty share:

BioKeralty has been actively involved carrying out scientific advisory tasks, as well as process development, scale-up and industrial manufacturing under GMP conditions of NanorhEGF, NanoFFCC and Nanoantibiotics. Likewise, it has collaborated in carrying out the toxicology studies of NanorhEGF and Nano Placebo, also designing the clinical trial to evaluate the safety and efficacy of Nano Placebo.

On the other hand, BioKeralty has participated in the technical scientific advice for the optimization of the cutaneous bioequivalent through the addition of NanorhEGF and nano-antibiotics, as well as the design and development of in vivo efficacy studies of the optimized skin bioequivalent.

Finally, BioKeralty has participated carrying out scientific advisory tasks regarding the manufacture of medicines based on advanced therapies, carrying out the design and writing of standard operating procedures for its production under GMP conditions and designing a case study to assess the safety and efficacy of hematopoietic stem cell transplants.

Partners:

Keralty, AJL Ophtalmics, and Karuna GCT.

Financing entities:

Area: Regenerative Medicine

Line of research: Regeneration of chronic wounds

NanoGrow-Innovative and effective tissue substitutes based on combined technologies of cell therapy, nanotechnology and additive manufacturing (RETO ze-2017/00014)

Description:

Goals:

1st Optimize the industrial manufacturing of cell therapy products (more specifically autologous covering epithelium (mainly skin) and allogeneic cornea) to obtain living organs in a short period of time and that serve as effective tissue substitutes for their application in regenerative medicine. The optimization of the manufacturing process of living organs (skin, other epithelia and bioengineered cornea) will be carried out through the functionalization of these tissue substitutes with nanoparticles loaded with growth factors (FFCC) that promote cell multiplication and can reduce manufacturing times. . Likewise, lipid nanoparticles loaded with antibiotics will be used, which will make it possible to reduce the bacterial load of the skin biopsies from which the cells are extracted to manufacture tissue substitutes, preventing or eliminating infection and, therefore, increasing effectiveness and tolerance. of the autograft.

BioKeralty share:

BioKeralty has actively participated carrying out tasks of scientific advice, as well as process development, scale-up and industrial manufacturing under GMP conditions of NanorhEGF, NanoFFCC and Nanoantibiotics. Likewise, it has collaborated in carrying out the toxicology studies of the NanorhEGF and the Nano Placebo, also designing the clinical trial to evaluate the safety and efficacy of the Nano Placebo.

On the other hand, BioKeralty has participated in the technical scientific advice for the optimization of the cutaneous bioequivalent through the addition of NanorhEGF and nano-antibiotics, as well as the design and development of in vivo efficacy studies of the optimized skin bioequivalent.

Finally, BioKeralty has participated carrying out scientific advisory tasks regarding the manufacture of medicines based on advanced therapies, carrying out the design and drafting of standardized procedures for work for its production under GMP conditions and designing a case study to evaluate the safety and efficacy of hematopoietic stem cell transplants.

Partners:

AJL Ophtalmics, Keralty, Karuna GCT, Andalusian Network for Design and Translation of Advanced Therapies (RAdytTA), University of the Basque Country (UPV/EHU) and Higher Center for Scientific Research/Mediterranean Institute for Advanced Studies (CSIC).

Financing entities:

Area: Regenerative Medicine

Line of research: Regeneration of chronic wounds

NanoGSkin-Cross-sectional tissue engineering and nanomedicine approach to improve chronic wound therapy (EURONANOMED)

Description:

Goals:

1st Optimize human artificial skin models through the use of quality pharmaceutical products and the implementation of novel methods, such as nanotechnology. This will allow the generation of biomaterials with improved biomechanical and antimicrobial properties suitable for therapeutic use in clinical approaches. To achieve this first objective, the necessary histological, rheological and genetic quality controls are foreseen.

2nd Adapt the production of these new tools towards an optimal regulatory framework, including GMP regulation and EMA guidelines.

3rd Establish a broader exploitation model that includes the development of a market access approach to estimate the benefits of this treatment for society. The envisioned model will look at costing per patient as well as potential cost savings and/or cost-effective measures for the affordable introduction of this tissue-engineered-based treatment.

BioKeralty share:

BioKeralty carries out the scientific development of the NanorhEGF in terms of its scaling and production; the design and execution of the toxicology of NanorhEGF, as well as to provide regulatory advice on NanorhEGF for its application in tissue regeneration and advanced therapies.

Partners:

Health Research Institute of Granada (ibs.GRANADA), Keralty Health, Italian Biochemical Institute (IBI), University of Bordeaux, Université de Technologie de Compiègne (UTC) and National University of Ireland, Galway (NUIG).

Financing entities:

The project has received funding from the 8th Joint Transnational Call for Proposals for “European Innovative Research and Technological Development Projects in Nanomedicine" within the framework of ERA-NET EuroNanoMed-III.< /p>

Area: Regenerative medicine

Line of research: Gene therapy

Stop AIDS-New genomic engineering tools for the treatment of HIV-1/AIDS infection through the application of new genomic editing and viral transfection techniques, evaluating their safety and preclinical efficacy for AIDS treatment (RETO)

Description:

Goals:

1st Develop a gene therapy that makes it possible to reproduce the D32 mutation in the cells of people infected with HIV, and thus achieve that they are cured of the infection. During the three years of the project, studies have been carried out both in vitro and in animal models that have served to determine the safety and efficacy of the procedure.

BioKeralty share:

BioKeralty has participated in the following activities within the STOP-SIDA project: transfer of technology to the GMP environment, Design of the Phase 1 and 2 clinical trial draft, in the marketing and regulatory strategy, in the Dissemination of results, exploitation of agreements and patents and in the forecast of exploitation/commercialization of the results of the project.

Partners:

AIDS Research Institute (IrsiCaixa), Higher Council for Scientific Research (CSIC) and Karuna Good Cells Technologies, SL.

Financing entities:

Area: Regenerative Medicine

Line of research: Gene therapy

bioGUNE 2017-Collaborative research in prevention, diagnosis, research and new therapeutic lines for rare diseases within the framework of the Autonomous Community of the Basque Country (CAPV) (ELKARTEK KK-2017/00084- ELKARTEK 2017)

Description:

Goals:

1st Identify effective biomarkers for rare diseases.

2nd Characterize new pathogenic mutations in patients from the Autonomous Community of the Basque Country.

3rd Obtain an integrated platform for the discovery of active pharmacological chaperones against rare diseases.

4th Validate pharmacological chaperones for the treatment of rare diseases.

5th Obtain disease models, both cutaneous and animal.

6th Rationalize metabolic diseases from the development of genetic models and systems biology.

7th Identify new viral vectors for gene therapy in rare diseases.

The broad approach of the bioGUNE 2017 project has made it possible to achieve solid and relevant results with a high probability of applicability in the market within a relatively short period of time and with a high potential for impact economic and social. The Center for Cooperative Research in Biosciences (CIC bioGUNE) has been the entity in charge of leading this project.

BioKeralty share:

As a partner in the project, BioKeralty’s involvement focused on the identification of new viral vectors as potential alternatives to address rare diseases.

Partners:

IK4–GAIKER Technology Center, Biocruces, UPV-EHU Biophysics Unit, UPV-EHU Department of Genetics, UPV-EHU BIOMICs, NanoBioCel UPV-EHU, Tecnum University of Navarra and Achucarro – Basque Center for Neuroscience.

Financing entities:

MISSING PROJECT: “Rare diseases"

Area: Regenerative Medicine

Line of research: Gene therapy

TAT-CF Project-New therapeutic approaches for the treatment of cystic fibrosis based on small transmembrane anion transporter molecules (H2020)

Description:

To achieve this goal, a comprehensive program has been established in order to validate this new research concept and complete the preclinical development of a new compound, leaving it ready for clinical development. To develop this translational project, from the synthesis of new compounds to validation in animal models, there will be a multidisciplinary team of qualified researchers.

Goals:

1st Complete preclinical development of new and innovative drugs based on a radically new concept in CF therapies. This project will advance the development of new therapeutic options for patients living with rare diseases, as well as contribute to reaching the IRDiRC goal of obtaining 200 new therapies for rare diseases by 2020.

BioKeralty share:

University of Burgos, Steinbeis Innovation GGMBH, Istituto Giannina Gaslini, Consiglio Nazionale Delle Ricerche, Bioneer A/S, Avidin Kutato Fejlesztő és Kereskedelmi Kft., State Agency Higher Council for Scientific Research.

Partners:

IK4–GAIKER Technology Center, Biocruces, UPV-EHU Biophysics Unit, UPV-EHU Department of Genetics, UPV-EHU BIOMICs, NanoBioCel UPV-EHU, Tecnum University of Navarra and Achucarro – Basque Center for Neuroscience.

Financing entities:

This project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement no. 667079.

Area: Nanotechnology

Research line: Nanoformulations for controlled release

Berenice-Research Group on Nanomedicine and Innovation in Chagas disease (H2020)

Description:

Goals:

1st Achieve a reformulation of an existing drug, Benznidazole, in order to obtain a safer toxicity profile and an increase in its efficacy, reduce its side effects and improve its cost-benefit ratio.

BioKeralty share:

Biopraxis was in charge of carrying out the regulatory analysis and cost-effectiveness study of the new formulations, also carrying out dissemination tasks for the project.

Partners:

Research Institute of Vall d’Hebron Hospital (VHIR), National Administration of Laboratories and Health Institutes-Anlis Argentina, CIBER-BBN, Laboratorio Elea, Fiocruz – Minas Brasil, Institute of Hygiene and Tropical Medicine of Lisbon and University of Barcelona ( UB).

Financing entities:

European Commission 7FP

Area: Nanotechnology

Research line: Nanoformulations for controlled release

Smart4Fabry-Functionalized GLA Nanoformulation for Fabry Disease

Description:

Goals:

1st Obtain a final nanoformulation of the GLA enzyme, ready to enter future clinical trials and supported by a robust preclinical proof of concept (PoC) demonstrating that nano-GLA is capable of targeting the enzyme to the affected organs and which has a lower clearance rate than free GLA. The goal is for the new GLA nanoformulation to allow a significant increase in treatment efficacy (30-80% greater) compared to the current non-nanoformulated GLA ERT.

2nd Establish quality control over the structural components of nano-GLA and its physicochemical parameters.

3rd Develop a nano-GLA capable of crossing the blood-brain barrier (BBB).

4th Build a GMP plant for the production of the amounts of nanoformulation needed for regulatory preclinical and future clinical trials.

5th Developing the GLA nanoformulation following the regulatory requirements of the pharmaceutical industry and regulatory authorities.

6th Create a realistic exploitation plan and business model, based on the experience of companies in the rare disease market, in order to ensure the transfer of the results of the project to patients suffering from Fabry disease.

BioKeralty share:

BioKeralty has been primarily involved in scaling up the final nano-GLA nanoformulation under GMP. On the other hand, it has played an important role in the design of the knowledge exploitation strategy, as well as in the coordination of activities for the dissemination of the results.

Partners:

Ciber-BBN, Nanomol Tehnologies, DDR, Technion-Israel Institute of Technology, AARHUS University, Joanneum Research, Bionanonet, Leanbio-Pro, and Covance.

Financing entities:

This project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement number 720942.

Visit project website: Smart4fabry

Area: Nanotechnology

Research line: Nanoformulations for controlled release

Theraglio-Microbubbles for multimodality imaging and theragnostics of gliomas (H2020)

Description:

Goals:

1st Design a new neurosurgical navigation system to simultaneously acquire intraoperative US and microscopy images, and pair them with preoperative MRI images in real time.

2nd Fabricate and preclinically evaluate the stability, toxicity and efficacy of multimodal lipid MBs on a laboratory scale as an intraoperative neuronavigation tool.

3rd Fabricate and physically characterize the multifunctional (bioinert and biodegradable) polymeric microbubbles, which were functionalized for microscopic visualization by NMR, US and fluorescence.

4th Develop multimodal drug-loaded nanoparticles to functionalize biodegradable microbubbles as a drug delivery platform.

5th Clinically assess the feasibility, usability and accuracy of the multimodality platform using commercially available microbubbles (SonoVue) in combination with ICG (both EMA approved) for MRI-guided surgery /US in real time using an integrated neuronavigation platform in recurrent malignant glioblastomas, as a proof of concept to validate the functionality of the new platform in vivo.

BioKeralty share:

BioKeralty was in charge of carrying out the industrial scaling and subsequent characterization of the lipid microbubbles developed within the project, as well as the design of the manufacturing process under GMP conditions. In the same way, BioKeralty was responsible for developing the dissemination and exploitation plan of the developed product.

Partners:

Fondazione IRCCS Istituto Neurologico “Carlo Besta”, Università degli Studi di Roma Tor Vergata, Tel Aviv Sourasky Medical Center, SeroScience Research Development and Trade Ltd., MedCom GmbH, Esaote Spa, Camelot Biomedical System Srl, Nanomol technologies and CF Consulting SRL

Financing entities:

FP7-CP-FP

Area: Nanotechnology

Research line: Nanoformulations for controlled release

Nanoplatform-Development of a nanotechnology platform for its application in the biomedical field (ELKARTEK KK-2015-00036)

Description:

Goals:

1st Create a technological platform for the development of nanoformulated products with high added value for the treatment of different pathologies and diseases, seeking to make the Basque Country a leader in the generation of nanotechnological products in response to the needs of the biomedical market.

BioKeralty share:

Biopraxis has been in charge of the development of nanolipids (empty nanoparticles), their characterization and scaling as the basis of the nanotechnology platform. Also, it has designed and executed the corresponding toxicological studies to demonstrate the absence of toxicity of nanolipids and has defined the regulatory strategy for nanolipids to be considered as a new excipient of pharmaceutical quality.

On the other hand, BioKeralty has carried out the industrial development of colistin nanoparticles as a drug for multi-resistant infections, has designed in vitro and in vivo efficacy studies as well as an assay to establish the safety, tolerability and pharmacokinetics of colistin nanoparticles.

Partners:

University of the Basque Country (UPV/EHU), Tecnalia Research & Innovation (TECNALIA), Basque Foundation for Innovation and Health Research (BIOEF).

Financing entities:

Area: Nanotechnology

Research line: Nanoformulations for controlled release

Nanogrow-Innovative and effective tissue substitutes based on combined technologies of cell therapy, nanotechnology and additive manufacturing (HAZITEK ze-2017/00014)

Description:

Goals:

1st Optimize the industrial manufacturing of cell therapy products (more specifically autologous covering epithelium (mainly skin) and allogeneic cornea) to obtain living organs in a short period of time and that serve as effective tissue substitutes for their application in regenerative medicine. The optimization of the manufacturing process of living organs (skin, other epithelia and bioengineered cornea) will be carried out through the functionalization of these tissue substitutes with nanoparticles loaded with growth factors (FFCC) that promote cell multiplication and can reduce manufacturing times. . Likewise, lipid nanoparticles loaded with antibiotics will be used, which will make it possible to reduce the bacterial load of the skin biopsies from which the cells are extracted to manufacture tissue substitutes, preventing or eliminating infection and, therefore, increasing effectiveness and tolerance. of the autograft.

BioKeralty share:

BioKeralty has actively participated carrying out tasks of scientific advice, as well as process development, scale-up and industrial manufacturing under GMP conditions of NanorhEGF, NanoFFCC and Nanoantibiotics. Likewise, it has collaborated in carrying out the toxicology studies of the NanorhEGF and the Nano Placebo, also designing the clinical trial to evaluate the safety and efficacy of the Nano Placebo.

On the other hand, BioKeralty has participated in the technical scientific advice for the optimization of the cutaneous bioequivalent through the addition of NanorhEGF and nano-antibiotics, as well as the design and development of in vivo efficacy studies of the optimized skin bioequivalent.

Finally, BioKeralty has participated carrying out scientific advisory tasks regarding the manufacture of medicines based on advanced therapies, carrying out the design and drafting of standardized procedures for work for its production under GMP conditions and designing a case study to evaluate the safety and efficacy of hematopoietic stem cell transplants.

Partners:

Keralty, AJL Ophtalmics, and Karuna GCT.

Financing entities:

Area: Nanotechnology

Research line: Nanoformulations for controlled release

Nanogrow-Innovative and effective tissue substitutes based on combined technologies of cell therapy, nanotechnology and additive manufacturing (RETO ze-2017/00014)

Description:

Goals:

1st Optimize the industrial manufacturing of cell therapy products (more specifically autologous covering epithelium (mainly skin) and allogeneic cornea) to obtain living organs in a short period of time and that serve as effective tissue substitutes for their application in regenerative medicine. The optimization of the manufacturing process of living organs (skin, other epithelia and bioengineered cornea) will be carried out through the functionalization of these tissue substitutes with nanoparticles loaded with growth factors (FFCC) that promote cell multiplication and can reduce manufacturing times. . Likewise, lipid nanoparticles loaded with antibiotics will be used, which will make it possible to reduce the bacterial load of the skin biopsies from which the cells are extracted to manufacture tissue substitutes, preventing or eliminating infection and, therefore, increasing effectiveness and tolerance. of the autograft.

BioKeralty share:

BioKeralty has actively participated carrying out tasks of scientific advice, as well as process development, scale-up and industrial manufacturing under GMP conditions of NanorhEGF, NanoFFCC and Nanoantibiotics. Likewise, it has collaborated in carrying out the toxicology studies of the NanorhEGF and the Nano Placebo, also designing the clinical trial to evaluate the safety and efficacy of the Nano Placebo.

On the other hand, BioKeralty has participated in the technical scientific advice for the optimization of the cutaneous bioequivalent through the addition of NanorhEGF and nano-antibiotics, as well as the design and development of in vivo efficacy studies of the optimized skin bioequivalent.

Finally, BioKeralty has participated carrying out scientific advisory tasks regarding the manufacture of medicines based on advanced therapies, carrying out the design and drafting of standardized procedures for work for its production under GMP conditions and designing a case study to evaluate the safety and efficacy of hematopoietic stem cell transplants.

Partners:

AJL Ophtalmics, Keralty, Karuna GCT, Andalusian Network for Design and Translation of Advanced Therapies (RAdytTA), University of the Basque Country (UPV/EHU) and Higher Center for Scientific Research/Mediterranean Institute for Advanced Studies (CSIC).

Financing entities:

Area: Nanotechnology

Research line: Nanoformulations for controlled release

NanoGSkin (EURONANOMED) – Cross-sectional tissue engineering and nanomedicine approach to improve chronic wound therapy

Description:

Goals:

1st Optimize human artificial skin models through the use of quality pharmaceutical products and the implementation of novel methods, such as nanotechnology. This will allow the generation of biomaterials with improved biomechanical and antimicrobial properties suitable for therapeutic use in clinical approaches. To achieve this first objective, the necessary histological, rheological and genetic quality controls are foreseen.

2nd Adapt the production of these new tools towards an optimal regulatory framework, including GMP regulation and EMA guidelines.

3rd Establish a broader exploitation model that includes the development of a market access approach to estimate the benefits of this treatment for society. The envisioned model will look at costing per patient as well as potential cost savings and/or cost-effective measures for the affordable introduction of this tissue-engineered-based treatment.

BioKeralty share:

BioKeralty carries out the scientific development of the NanorhEGF in terms of its scaling and production; the design and execution of the toxicology of NanorhEGF, as well as to provide regulatory advice on NanorhEGF for its application in tissue regeneration and advanced therapies.

Partners:

Health Research Institute of Granada (ibs.GRANADA), Keralty Health, Italian Biochemical Institute (IBI), University of Bordeaux, Université de Technologie de Compiègne (UTC) and National University of Ireland, Galway (NUIG).

Financing entities:

Area: Nanotechnology

Research line: Nanoformulations for controlled release

TAT-CF Project (H2020)-New therapeutic approaches for the treatment of cystic fibrosis based on small transmembrane anion transporter molecules

Description:

To achieve this goal, a comprehensive program has been established in order to validate this new research concept and complete the preclinical development of a new compound, leaving it ready for clinical development. To develop this translational project, from the synthesis of new compounds to validation in animal models, there will be a multidisciplinary team of qualified researchers.

Goals:

1st Complete preclinical development of new and innovative drugs based on a radically new concept in CF therapies. This project will advance the development of new therapeutic options for patients living with rare diseases, as well as contribute to reaching the IRDiRC goal of obtaining 200 new therapies for rare diseases by 2020.

BioKeralty share:

University of Burgos, Steinbeis Innovation GGMBH, Istituto Giannina Gaslini, Consiglio Nazionale Delle Ricerche, Bioneer A/S, Avidin Kutato Fejlesztő és Kereskedelmi Kft., State Agency Higher Council for Scientific Research.

Partners:

IK4–GAIKER Technology Center, Biocruces, UPV-EHU Biophysics Unit, UPV-EHU Department of Genetics, UPV-EHU BIOMICs, NanoBioCel UPV-EHU, Tecnum University of Navarra and Achucarro – Basque Center for Neuroscience.

Financing entities:

This project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement no. 667079.

Area: Nanotechnology

Research line: Nanoformulations for controlled release

Nocanther-Scaling up nanomedicines for early clinical phases of multimodal cancer therapy (H2020)

Description:

Goals:

1st Scaling of magnetic nanoparticles, as well as their manufacturing under certified conditions.

2nd Carry out preclinical safety and toxicology studies.

3rd Request a clinical safety trial.

The project’s starting point is iron oxide-functionalized magnetic nanoparticles developed and validated for both their efficacy and toxicity within the framework of the large Multifun FP7 project. In order to complete the regulatory evaluation for the preparation of the Investigational Medical Devices Dossier (IMDD), the synthesis of nanoparticles will be scaled up and produced in a pilot line under certified conditions. Its attributes will be duly evaluated through a quality control that aims to contribute to the standardization of the characterization of nanomedicine (WP1). The antitumor activity of these certified nanoparticles will be assessed using advanced preclinical models based on patient-derived xenografts (Avatars), which can be used to estimate the efficacy of this new approach in humans with a success rate of up to 80% (WP2). . The method requires the application of a non-radioactive alternating magnetic field (AMF), which induces a temperature rise around the nanoparticles, mainly killing tumor cells (magnetic hyperthermia). Since the application of the nanoparticle will be carried out intratumorally using standard procedures, the side effects of this local and minimally invasive approach are expected to be minimal. In this sense, an AMF device will be optimized for the treatment of pancreatic tumors in humans (WP3). The final translation to the clinic will be carried out through a Clinical Study, which is expected to be carried out in 20 patients from two different hospitals (WP3).

This formulation contains a magnetic nanoparticle (MNP) core with optimal heat dissipation properties and a biocompatible coating that is functionalized with: (a) the NUCANT pseudopeptide (N6L) which has the property of promoting the internalization of nanoparticles in target cells, and (b) the chemotherapeutic agent gemcitabine, used in the first line for the treatment of pancreatic cancer. These bioactive molecules are conjugated with the nanoparticles in such a way that they are released efficiently once they are internalized in the cells. This combination of magnetic nanoparticles with hyperthermia-optimized properties represents a novel nanotechnology-based therapeutic approach for highly efficient and highly tolerable pancreatic cancer therapy.

BioKeralty share:

BioKeralty’s role in the project is very relevant, since it is in charge of scaling up the magnetic nanoparticles, fine-tuning the analytical techniques, as well as manufacturing under certified conditions. At the same time, he has acted as sponsor of the clinical trial and has been in charge of carrying out the Business Plan.

Partners:

IMDEA Nanoscience, ImmuPharma, Chemicell GmbH, Universitätsklinikum Jena, Resonan Circuits Limited, Vall d’Hebron Research Institute; Trinity College Dublin, Paris Diderot University, Vall d’Hebron Institute of Oncology and Fuenlabrada University Hospital.

Financing entities:

This project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement no. 685795.

Area: Nanotechnology

Line of research: Platforms

Refine-Regulatory science framework for medical products and devices based on nano (bio)materials (H2020)

Description:

Goals:

1st Serve as a liaison with regulatory agents, identifying different regulatory pathways.

2nd Give answers to regulatory issues with intelligent testing strategies.

3rd Rationalize development for medical products and devices.

4th Refine methods to respond to the most pressing regulatory concerns.

5th Guarantee quality standards for development.

For all this, a specific decision-making support system will be developed for each product that allows the data to be presented in the most efficient way and using the most appropriate methods required by each regulation. The decision tree will help explain product-specific regulatory challenges, prioritize missing data, and identify the methods needed to address these challenges. Consequently, thanks to this system it will be possible to plan a profitable and efficient strategy in cost and time both in the case of the necessary measurements and in the advancement of the methods.

BioKeralty share:

BioKeralty’s role in this project is critical, serving as a liaison between regulators, identifying regulatory concerns, prioritizing tools and methods for assessment strategy, and connecting communities.

Partners:

University of Liverpool, University of Brigton, Trinity College Dublin, SINTEF, National Institute for Public Health and the Environment- Ministry of Health, Welfare and Sport (Rijksinstituut voor Volksgezondheid en Milieu, RIVM), JRC-European Commission, GreenDecision (GD), The European Research Services GmbH, EMPA Eidgenossische | Materialprufungs-Und Forschungsanstalt, CEA Commissariat à l’Energie Atomique et aux Energie Alternatives, BIOMS – Gesellschaft Für Bioanalytik Münster EV and Amatsigroup.

Financing entities:

This project has received funding from the European Union’s Horizon 2020 Research and Innovation Program under Grant Agreement no. 761104.

Area: Nanotechnology

Line of research: Platforms

Safe-N-Medtech-Safety tests to test the complete life cycle of medical technologies based on nanotechnology and applied to health (H2020)

Description:

Goals:

1st Build an innovative open access platform to offer companies and reference laboratories the skills, knowledge, networks and services necessary for development, testing, evaluation, scaling and exploitation market share of medical and diagnostic devices based on nanotechnology.

2nd Establish a strong and competitive cooperation thanks to the Safe-N-Medtech consortium to be able to compete in the market with a coordinated OITB and to enable nano-TM , being in turn capable of overcoming or mitigating the challenges established by the factors that condition this type of technology.

3rd Offer a multidisciplinary innovation approach, advanced use and applications in medical technologies of nanomaterials aimed at the health industry (suppliers, SMEs, etc.) and taking into account other aspects such as those related to the safety of medical technologies.

BioKeralty share:

BioKeralty participates in the technical and scientific coordination, having an important activity in all the work packages of the Safe-N-Medtech project.

Partners:

Tecnan, CEBR, INL – International Iberian Nanotechnology Laboratory, João Lobo Antunes Institute of Molecular Medicine (IMM), TECNALIA RESEARCH & INNOVATION, Center Interdisciplinaire de Nanoscience de Marseille, China pharmaceutical University, Sintef Industry, The Institute of Physical Chemistry ‘Ilie Murgulescu’ of the Romanian Academy, Trinity College Dublin, University of Pavia, Biomedical Research Networking Center (CIBER), National Center for Nanoscience and Technology (NCNST), National Research Institute on Occupational Health in Norway (STAMI), VITO, Eindhoven University of Technology, Resonant Circuits Limited, Stryker, EuroScan International Network eV, GreenDecision, University of Liverpool, Hubei Gedian Humanwell Pharmaceutical Co., Vall d’Hebron Research Institute, Keralty, MARACA International, and OSTEBA.

Financing entities:

This project has received funding from the European Union’s Horizon 2020 Research and Innovation Program under Grant Agreement no. 814607.

Area: Infectious diseases

Research line: Innovation in solutions for the diagnosis, treatment and prevention of COVID-19

INNO4COV-19-Driving innovation for the diagnosis, prevention and surveillance of COVID-19 (H2020)

Description:

Goals:

1st Create a “laboratory to factory" platform as a collaboration model that allows companies and reference laboratories to develop and implement innovative technologies to combat COVID-19.

2nd Address more effectively, efficiently and at a lower cost the need to have diagnostic, prognostic and monitoring systems aimed at COVID-19.

3rd Support full development for market acceptance of technologies at TRL6 or higher by providing third party funding.

4th Help industry develop, produce and validate “KET-COV-19 products" in accordance with current quality and safety standards and the EU regulatory framework for ensure the timely delivery of innovative solutions in pandemic situations and support the competitiveness of related industries.

5th Design realistic exploitation and business plans, based on the real experience of the project partners that guarantee project results towards small and medium-sized companies and European industry. With an approach based on regional clusters and with experience gained in projects such as EPPN or Safe-N-Medtech and aligned with other national COVID-19 initiatives, with funding for projects in earlier stages.

6th Participate in the definition of new evaluation methodologies, propose standards and offer specific action guidelines for emergency situations.

BioKeralty share:

In line with its commitment to open innovation (OITB), BioKeralty has contributed to reducing the gap between the production of innovative solutions and their acceptance by the clinical field and the market through the proposal of “roadmaps". With this, BioKeralty seeks to anticipate future regulatory needs, evaluate technologies by matching the proposal raised by innovations with the real needs demanded by health systems, facilitate access to the characterization of materials and devices and contribute to the “economy of health”.

Partners:

International Iberian Nanotechnology Laboratory (INL), João Lobo Antunes Institute of Molecular Medicine (iMM), Basque Foundation for Health Innovation and Research (BIOEF), Leitat, Alma Mater Studiorum (UNIBO) , Joanneum Research, Fraunhofer-FEP, Trinity College Dublin (TCD), Vito and Obelis.

Financing entities:

This project has received funding from the European Union’s Horizon 2020 Research and Innovation Program under Grant Agreement no. 101016203.

Area: Chronic and neurodegenerative diseases

Line of research: Stroke

HARMONICS–Harmonization and Implementation of Stroke Care (EITHEALTH)

Description:

Goals:

1st Evaluate the clinical processes implemented in the hospital and post-hospital setting during the acute treatment of stroke, as well as in the management and prevention/secondary rehabilitation of stroke.

2nd Harmonize clinical care processes, performance indicators (KPIs), scorecards and the collection of CROMS/PROMS/PREMS between centers to allow the integrated data collection for the definition of stroke care processes.

3rd Implement HARMONICS in the clinical centers of Catalonia and Coimbra according to the designed roadmap.

4th Sensitize and train stroke patients and their families in the implementation of HARMONICS.

5th Disseminate results of the implementation of HARMONICS in health systems to the various interest groups in order to make it known to the industry and society as a whole.

BioKeralty share:

BioKeralty’s contribution to the project focuses on project management and the design and analysis of the project implementation plan in hospitals in the Basque Country and Leuven. In relation to said implementation, it is in charge of periodically examining and updating the business perspectives of the project, identifying and recording the results generated. In turn, in addition to various actions to disseminate the project, BioKeralty is also carrying out initiatives to raise awareness and train stroke patients and their families.

Participants:

Agencia de Qualitat i Avaluació Sanitàries de Catalunya (AQuAS), Centro Hospitalar e Universitário de Coimbra (CHUC), EPE, Genesis Biomed, Roche Diagnostics SL, Katholieke Universiteit Leuven, Siemens Healthcare GmbH , Catalan Health Institute (ICS), Vall d’Hebron Research Institute (VHIR), Central Administration of the Health System (ACSS), BIOEF, Fundació Ictus, Osakidetza-Basque Health Service and Catalan Health Service (CatSalut)

Area: E-HEALT

Research line: Automatic speech recognition and natural language processing.

ESAN-Development of an automatic medical scribe capable of documenting in the EHR the dialogue between a doctor and his patient during the consultation (ELKARTEK)

Description:

Goals:

1st Development of enriched speech recognition systems adapted to the context of dialogues through teleconference in the health and Spanish language domain.

2nd Development of turn classification systems for said dialogues (by speaker, by relevance, by subject matter, etc.) and extraction of relevant information (symptoms, drugs, diseases, body parts, etc. as well as their modifiers and relationships).

3rd Development of coding systems for episodes dealt with in doctor-patient conversations using standard terminologies and classifications (SNOMED, ICD-10-ES).

4th Evaluate the efficiency and usability of the systems developed, with special attention to the points of improvement to move towards a complete solution.

BioKeralty share:

BioKeralty has been responsible for guaranteeing the availability of data for the development of the project, which has included the management of the processing of personal data and the capture of recordings and reports. Likewise, BioKeralty has also been involved in the validation of the tool, both in the design of the validation framework and in the validation process.

Partners:

Ibermática Institute of Innovation and Vicomtech.

Financing entities:

The ESAN project is financed by the Basque Government through the Elkartek 2021 type II program of high industrial potential.

Area: Infectious diseases

Research line: Antimicrobial resistance

RESIST-New therapeutic strategies to address antimicrobial resistance (ELKARTEK)

Description:

Goals:

1st Develop nanoformulations from antibacterial candidates based on anionophores in the form of lipid nanoparticles (NLCs) and polymers to improve their safety and solubility profile.

2nd Evaluate the industrial process of the nanoformulates developed for their future production under GMP conditions.

3rd Isolate multi-resistant microorganisms from the hospital environment and evaluate the in vitro antimicrobial activity of the anionophore candidates and their nanoformulates.

4th Evaluate the in vivo antimicrobial activity of the anionophore candidates and their nanoformulata in an invertebrate animal model.

5th Develop an ex vivo model of resistant bacterial infection in skin with lesion and determine the ex vivo antimicrobial efficacy of formulated anionophores in skin infection.

6th Develop an appropriate business plan to achieve proper marketing of the products developed during the RESIST project.

BioKeralty share:

As project coordinator, BioKeralty has been in charge of coordinating it. In addition, he has also carried out tasks for the development and characterization of lipid nanoparticles. Likewise, he is responsible for studying the future industrial process of nanoformulations and preparing a business plan for the future commercialization of the project. Finally, BioKeralty has carried out various actions to publicize the project.

Partners:

University of the Basque Country (Nanobiocel, CanBio), Gaiker Foundation, Biocruces Health Institute Association and Biodonostia Institute Association.

Financing entities:

The RESIST project is funded by the Basque Government through the Elkartek 2021 type II program of high industrial potential and by the Álava Provincial Council through the Álava Innova 2021-Digitaliza 2021 program.

Area: #Value in health

Line of research: Line 2 – Evaluation of the impact of interventions and programs, including the evaluation of medical costs due to health conditions

HARMONICS. Harmonization and implementation of high-value stroke care. (EIT Health)

Description:
Implementation of a high-value stroke care program (HARMONICS) to harmonize clinical processes, workflows, KPI and outcome measures (CROMS/PROMS/PREMS) within 5 Hospitals of the Catalonian Stroke Network and one in Coimbra (replication will occur in the Basque Country and Leuven, outside the project). HARMONICS aims to create a novel centralized EU stroke outcome registry (EUROPROM) that will integrate outcome data from each regional registry (PROMCAT and PROMCO) designed and implemented within the project, that will automatically capture KPI and outcome measures including CROMS (3-month mRS score) PROMS (PROMIS-10, HAD, OHS) and PREMS (Picker scale) from electronic medical health records (eMHR) and the NORA platform, providing regional and inter-regional benchmarking and sharing best practices. Through this solution, stroke patients will be thoroughly monitored, mainly in the post-acute and post-hospital level, ensuring beer outcomes, improving recovery and preventing recurrence.

Objectives:
The specific results expected to be achieved by HARMONICS at regional level are the following:
1. Successful implementation of a high-value stroke program (HARMONICS) in ICS (5 hospitals) and CHUC in two-year time.
2. Reduction in door-to-needle times for tPA from 35 min to <25 min, representing a 28%-time reduction.
3. Reduction in door-to-groin times for mechanical thrombectomy from 64 min to <40 min, leading to a 38% reduction.
4. Reduction in the length of stay from 8 to < 5 days representing at least a 35% reduction.
5. Increase the home hospitalization rate with remote monitoring by >15% in a year.
6. Reduction in hospital readmission by 10% within 90 days after hospital discharge. Up to 25% of discharged stroke patients are readmitted for any cause and 15% readmission experienced an unplanned stroke related readmission.
7. Increase in the CROMS/PROM/PREMS collection rate by >30%, by means of the NORA solution.
8. Automatic and centralized health data capture in the PROMS regional registry for all patients after 6 months of the project initiation.
9. Automatic and centralized PROMS and PREMS data collection in EUROPROM that will integrate data from each regional registry (PROMCAT and PROMCO) for transparent benchmarking.
10. Reduction of stroke readmissions associated to a sub-optimal post-discharge risk factor management.
11. Reduction of avoidable emergency department (ED) visits.

BioKeralty’s participation:
Biokeralty leads the social education, dissemination and communication WP. The main objectives of this WP are to raise awareness and training education among stroke patient and families of the appropriate implementation of the solution; to define a dissemination, industry and public engagement plan and; to disseminate project results to the relevant stakeholders.

Partners

Funding entities:
Cofunded by EIT Health

Area: #Genomics and personalized medicine

Line of research: Line 2 – Personalized medicine

OPADE. Optimise and predict antidepressant efficacy for patient with major depressive disorders using multi-omics analysis and AI-Predictive Tool. (Horizon Europe)

Description
According to the WHO, Major Depressive Disorder (MDD) is the 4th leading cause of disability worldwide and the second most common disease after cardiovascular events. MDD is a multifactorial disease driven by a combined effect of genetic, epigenetic, psychological, biological, and environmental factors including compositional and functional changes in the gut microbiome. The microbiome exerts its effect on the nervous system, the so-called microbiome-gut-brain (MGB) axis, through the synthesis of metabolites that induce neurotransmitter production and immune system activation. In addition to influencing specific brain functions, there is now growing evidence that the gut microbiome may also affect epigenetic patterns and indirectly influence the efficacy of several drugs, including antidepressants. Both diagnosis and treatment of MDD patients remain challenging due to the lack of early biomarkers and personalized treatment options, especially for pediatric patients.

To address these issues, in this contest, OPADE aims to identify early biomarkers in MDD to tailor personalized drug treatments. 350 patients between 14 and 50 years will be recruited in 5 Countries (Italy, Colombia, Spain, The Netherlands, Turkey) for 24 months. Real-time electroencephalogram (EEG) and patient cognitive assessment will be correlated with biological samples analysis. A patient empowerment tool (Chatbot) will be deployed to ensure patient commitment and to translate patient stories into data.

The study will use a multi-omics approach including: metagenomic sequencing to characterize the microbiome composition; metabolomics to detect circulating metabolites; transcriptomics to quantify microRNAs; epigenomics to assess methylation variability between and within groups and immune assays to analyze the antibody immune response and inflammatory profiles (cytokines, interleukins and growth factors). Cortisol and lipoproteins will also be quantified. Resulting data will be used to train the Artificial Intelligence/Machine Learning (AI/ML) predictive tool. In summary, OPADE aims to analyze MDDs at different levels and with different approaches, leading to the constitution of a ML algorithm for improving diagnosis and treatment, preventing relapse by combining genetics, epigenetics, microbiome, immune response data, and the non-molecular biomarkers such as medical history or electroencephalography (EEG), from subjects with MDD.

Objectives
OPADE’s objective is to identify key biomarkers that support the decision-making process of the healthcare providers through the development and commercialisation of an AI (artificial intelligence) / ML (machine learning) -predictive tool. The project focuses on the gut–brain-axis which plays a major role in MDD. Through clinical investigations, the consortium partners will study the combination between genetics, epigenetics, microbiome and inflammatory networks to:

• 1. Establish patient profiles to predict & optimise the efficacy of the antidepressants prescribed with an increase in the remission rate and reduction of impairment of real-life functioning.
• 2. Establish the possible correlation between neuroinflammatory indices, target indicators of the microbiome, metabolomics, immune-profile linked, epigenomic, enzymatic algorithms.
• 3. Evaluate molecular and non-molecular biomarkers that may represent predictive indices of recurrence.
• 4. Improve the diagnostic accuracy for primary prevention.
• 5. Evaluate retrospectively, using accurate anamnesis, the onset of depressive symptoms in adolescence.
• 6. Establish how much and to what extent blood biomarkers correlate with other specific biomarkers.

BioKeralty’s participation:
Biokeralty´s role in OPADE focuses on the management of dissemination, communication and exploitation of results. Effective dissemination and communication of research results is essential to maximise the impact and value of Horizon Europe funded projects, ensuring that results are shared and used widely for the benefit of society.

Partners

Accare, AIMedExpert, Biokeralty Research Institute, FONDAZIONE EBRIS, Fundacio Eurecat (EURECAT), Mama Health Technologies GmbH, Protobios OÜ, Cephalgo SAS, Fundación Universitaria Sanitas, Università degli Studi di Siena, Istanbul Medipol Universitesi, Ceinge Biotecnologie Avanzate Franco Salvatore Scarl (CEINGE), Stichting Universitaire En Algemene Kinder – En Jeugdpsychiatrie Noord-Nederland (ACCARE), Fundació Institut d’investigació Biomèdica de Girona Doctor Josep Trueta (IDIBGI)

Funding entities:
OPADE has received funding from the European Union´s Horizon Europe research and innovation programme under grant agreement No 101095436.

Area: #Nanotechnology

Line of research: Line 2 – Platforms

CONVERT2GREEN. Converting Facilities Network for accelerating uptake of climate neutral materials in innovative products. (Horizon Europe)

Description:
Convert2Green aims to create an Open Innovation Test Bed (OITB) that integrates innovative, circular, and carbon-neutral materials into key European value chains including Clean Autonomous Vehicles, Smart Health, Industrial IoT, Low Carbon Industry, and Clean Energy. It will provide unique services such as comprehensive eco-impact analysis, advanced process chains for smart textiles and electronics, and pilot facilities for critical raw material recovery and processing of recycled materials. Additionally, Convert2Green will introduce novel IP licensing procedures, a multilingual digital platform, and new financing models for SMEs. The project seeks to reduce carbon emissions from material manufacturing by 30%, accelerate market entry of sustainable materials by up to 50%, and cut development costs by over 30%.

Objectives:
The Overall Objective of Convert2Green is to establish a sustainable, business oriented Open Innovation Ecosystem that provides upgraded technical facilities and specialized business development services for accelerating market entry of novel circular and carbon neutral material solutions in the European Key Value Chains: Clean and autonomous vehicles; Smart health; Industrial internet of things; Clean energy solutions and low carbon industry. To achieve that, Convert2Green sets a series of specific technical, business and organisational objectives:

• Set-up a lean, flexible and effective organisational structure and contract framework for a sustainable Open Innovation Test Bed with a for-profit single entry point that allows easy access for SME and Industry from the whole European Single Market to the Convert2Green and partner OITB Facilities and Services.
• Upgrade and make available connected TRL4 – TRL7 technical pilot facilities and testing, characterisation and validation services to support SME in bringing novel climate neutral materials to the EU Key value chains and to reduce time-to-market by > 30% by more efficient prototyping and development.
• Establish a sustainable business model and market-oriented service portfolio of the Convert2Green OITB.
• Establish and integrate SME targeted business services; establish novel funding solutions for SME to accelerate innovation and market entry; and support 20 SME through an open call for pre-commercial pilot cases.
• Validate and demonstrate the Technical Facilities of the Convert2Green OITB in 5 industrial use cases.
• Interconnect the European Open Innovation Ecosystem and establish local access strategies.

BioKeralty’s participation:
BioKeralty is responsible for one of the project´s use case that will demonstrate Convert2Green Facilities for development of smart-health body sensor textiles (50% recycled fibers).

Partners:
Coordinated by the National Technical University of Athens, the project involves Fraunhofer Society for the Advancement of Applied Sciences e.V., Technical Research Center of Finland, International Iberian Nanotechnology Laboratory, Textiles Research Institute Thüringen-Vogtland e.V., University of Burgas – Institute for Critical Raw Materials, DIGNITY, STAM Engineering, KETMarket GmbH, Amires Business Innovation Management Institute z.ú., Inlecom Commercial Pathways, Fiat Research Center, Biokeralty Research Institute, NetCompany Intrasoft, Enfucell Oy, Stryker Trauma, and Polivouga.

Funding entities:
Convert2Green has received funding from the European Union’s Horizon Europe research and innovation programme under grant agreement No 101092347.

Area: #Infectious diseases

Line of research: Line 1 – Antimicrobial resistance

IN-ARMOR. Therapeutic epigenetic enhancement of innate immunity to effectively combat Antimicrobial Resistance. (Horizon Europe )

Description:
IN-ARMOR aims to optimise Epigenetic Therapeutic Enhancement of Innate Immunity to Effectively Combat Antimicrobial Resistance (AMR). Building on this approach, IN-ARMOR’s main objective is to optimise the structure and function of a new family of compounds known as Aroxylated Phenylenediamines (APD), using in silico solutions and computer-based molecular analysis, together with nanotechnology-based drug delivery and to validate in vitro and in vivo safety and efficacy to complete the requirements of the Investigational Medicinal Product. The ultimate long-term vision is to introduce a new class of immune system inducers to enhance the body’s innate microbial defence mechanisms, combat antimicrobial resistance and reduce the incidence of 13 of the most dangerous infections, including two of the top three Priority 1 infections on the WHO list of microbes of concern.

Once finalised, IN-ARMOR will be ready for clinical validation. Upon commercialisation, IN-ARMOR could potentially save more than 4 million lives worldwide and result in a significant reduction in the burden of antibiotic development with a long-term cost reduction impact of €107 billion, while reducing the global burden of disease by 96.84 million DALYs (total burden of disease – enteric infections in 2019 disability-adjusted life years-DALYs).

Objectives:
1. Optimisation, synthesis and pre-selection of candidate molecules.
2nd. Development of in vitro tests for the selection of lead compounds,
3rd. Formulation and administration of drugs and design of pre-GMP scale-up.
4th. In vivo optimisation tests
5th. Business development and exploitation

BioKeralty’s participation:
BioKeralty is responsible for business development and exploitation and intellectual property protection, as well as stakeholder engagement, dissemination and communication activities. In addition, it will also carry out nanoparticle development and characterisation tasks.

Partners:
Scientifically coordinated by the University of Iceland (Iceland), it integrates a consortium of research centres and companies from ten different countries. The consortium is completed by Karolinska Institutet (Sweden), Servicio Madrileño de Salud (Spain), Akthelia Pharmaceuticals (Iceland), Acondicionamiento Tarrasense Associacion (Spain), University of Jyvaskyla (Finland), VibioSphen (France), Rijksuniversiteit Groningen (The Netherlands), Universidade de Vigo (Spain), Obelis s. a. (Belgium), Tecnologías Avanzadas Inspiralia (Spain), Enamine (Ukraine), Biokeralty Research Institute AIE (Spain), Betthera s.r.o. (Czech Republic), NUVISAN (France), University of Tampere (Finland).

Funding entities:
IN-ARMOR is a project funded by the European Health and Digital Executive Agency (HADEA) under the two-stage call HORIZON-HLTH-2022-DISEASE-06.

Area: #Genomics and personalized medicine

Line of research: Line 2 – Personalized medicine

nG23. Smart approach for the design of micro-nano-fluidic detection devices and new functionalities for fluidic analysis. (ELKARTEK)

Description:
The nG23 project aims to develop advanced micro-nanofluidic devices (mnFD) and improve diagnostic methods in cancer treatments. Its main goal is to identify new biomarkers in patients with diffuse large B-cell lymphoma (DLBCL) treated with CAR-T therapy, using a multi-omics approach and photonic technology. This will improve the monitoring of treatment response and related toxicities, integrating data through artificial intelligence. Additionally, nG23 will focus on the optimal design of mnFD devices, which are key for biomedical and technological applications, such as sensors and microreactors. Research on microflow simulations will facilitate the development of more accurate and efficient diagnostic tools. This project has the potential to generate new technologies, patents, and commercial applications to enhance treatment with CAR-T therapies.

Objectives:

• Explore the multifunctionality of micro-nanofluidic devices (mnFD): Investigate the capabilities and applications of mnFD in advanced fluidic analysis, optimizing their performance and adaptability in various areas of biomedical technology.
• Develop advanced multi-omics diagnostic methods: Integrate multi-omics techniques with photonic detection technologies supported by artificial intelligence to identify biomarkers for monitoring and managing the progression of diffuse large B-cell lymphoma (DLBCL) and the toxicities associated with CAR-T therapy.
• Create innovative analytical and detection methods: Establish the relationship between optical responses and multi-omics techniques, improving the precision and efficiency in biomarker detection and fluidic analysis.
• Optimize the design of micro-nanofluidic devices (mnFD): Develop efficient and robust mnFD designs to enhance their performance in applications such as sensors, microreactors, and biomedical and nanotechnology research systems.

BioKeralty’s participation:
BioKeralty is responsible for the development and exploitation of business opportunities, intellectual property protection, stakeholder engagement, and dissemination and communication activities.

Partners:
Coordinated by CIC nanoGUNE, with the participation of IIS BIODONOSTIA, TECNUN, IBEA UPV/EHU, and BIOKERALTY Research Institute.

Funding entities:
nG23 is an Elkartek project from the 2023 call. The Elkartek calls are grants from the Basque Government for collaborative research, carried out by the Research, Development, and Innovation Entities integrated into the Basque Network of Science, Technology, and Innovation of Euskadi, within the areas of specialization framed in the Euskadi 2030 Science, Technology, and Innovation Plan.

Area: #Cancer

Line of research: Line 2 – Development of artificial intelligence and deep-learning techniques in the diagnosis and treatment of cancer

BIOCART: Integrated Multi-Omic and Spectroscopic Approach for the Identification of Novel CAR-T Biomarkers in Blood through Machine Learning Analysis. (Basque Government)

Description:
This project focuses on improving CAR-T therapy for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), addressing challenges such as resistance and toxicities like cytokine release syndrome (CRS) and neurotoxicity. Since identifying biomarkers is crucial for efficiently managing these complications and monitoring disease progression, the project aims to develop new diagnostic tools. Unlike previous studies that have used limited approaches centered on a single type of omic analysis, this project will adopt a multi-omic approach (ctDNA, miRNA, methylomics, glycomics, and spectroscopy) in an international, multicenter study. Samples from 30 patients treated with axi-cel will be analyzed to generate multi-omic profiles across various phases of treatment, from leukapheresis to multiple follow-up points at 6 months. The data generated will be integrated through a machine learning (ML) algorithm, enabling the identification of key biomarkers related to treatment response, disease progression, and toxicities. The model will be validated in an independent cohort of 120 patients to develop a simple blood test that improves clinical management of CAR-T therapy and other diseases.

Objectives:
The project is structured into several work packages organized around five multidisciplinary goals to ensure its success:

1. Selection of B-cell lymphoma patients and longitudinal blood sampling at multiple centers.
2. Conducting multi-omic analyses on samples collected from the discovery cohort.
3. Development of a machine learning pipeline and data analysis to interpret the results.
4. Development and validation of assays using independent cohorts to verify the reliability of discoveries.
5. Dissemination, exploitation, and commercialization of the BIOCART technology derived from the project.

BioKeralty’s Participation:
BioKeralty is responsible for business development and intellectual property protection, as well as stakeholder engagement, dissemination, and communication activities.

Partners:
Coordinated by IIS BioGipuzkoa, the project includes participation from IIS BioBizkaia, TECNUN, CIC Nanogune, CIC Biomagune, IBEA UPV/EHU, and the BIOKERALTY Research Institute.

Funding Entities:
BIOCART is funded under the 2023 call for Health Research and Development Projects by the Department of Health of the Basque Government.

Area: #Cancer

Line of research: Line 2 – Development of artificial intelligence and deep-learning techniques in the diagnosis and treatment of cancer

ONKOIMAGING. New imaging techniques and artificial intelligence in cancer diagnosis and prognosis. (ELKARTEK)

Description:
The ONKOimaging project aims to develop and validate five novel Digital Molecular Histopathology (DMH) methods for image analysis of tumor tissue sections. These techniques cover the metabolomic (Lipid Imaging by Mass Spectrometry, LIMS), proteomic (Multiplex Immunohistochemistry by Mass Spectrometry, MALDI-IHC and Multispectral Immunophenotyping, MSI) and genomic (Spatial Transcriptomics, ST and RNAscope RNA-S) spectrum.

In addition, advanced image processing methods based on artificial intelligence (AI) will be developed for automatic image analysis, with the aim of maximizing their clinical use. In addition, we have clinical and pathological information that will allow us to stratify the results of analyses using different HDM techniques, according to variables related to tumor aggressiveness (histological grades, stages, etc.), patient prognosis (survival) and response to treatments (IMDC, RECIST scales, etc.).

The ultimate goal is to create tools to assist decision-making.
To guide all this development, malignant tumors with a high impact on our society due to their high incidence and mortality, such as cutaneous melanoma, kidney cancer, and urinary bladder cancer, will be analyzed.

Objectives:

1. 1. Immunohistochemistry coupled to mass spectrometry (MALDI-IHC): This is a method with the potential to map more than a hundred antibodies in a single histological section.
2. 2. Multispectral immunophenotyping (MSI): This is a method applied to paraffin sections and its application for some tumors has been validated and published, although the number of biomarkers detected per section is lower than MALDI-IHC.
3. 3. Spatial Transcriptomics (ST): On a 2D image of the histological section under study, STE colors the different areas based on the expression levels of hundreds or thousands of genes, generating expression “maps." This is possible thanks to the capture of mRNA from multiple spots.
4. 4. RNAscope (RNA-S): RNA-S is an in situ hybridization (ISH) technique that uses locked nucleic acid (LNA) probes to visualize microRNA (miRNA) expression in tissue sections.
5. 5. Lipid Imaging by Mass Spectrometry (LIMS): The LIMS technique allows mapping the distribution of more than a hundred lipid species in tissues, at resolutions of up to 5-10 microns/pixel. In other words, it allows obtaining the lipid fingerprint of the cells that make up a tissue.

BioKeralty’s participation:
BioKeralty is responsible for the development and exploitation of business opportunities, intellectual property protection, stakeholder engagement, and dissemination and communication activities.

Partners: Coordinated by the Department of Nursing – UPV/EHU, it includes the participation of the Department of Cellular Biology and Histology – UPV/EHU, Department of Physical Chemistry – UPV/EHU, Department of Genetics, Physical Anthropology and Animal Physiology – UPV/EHU, Biobizkaia Health Research Institute, Biogipuzkoa Health Research Institute, Tecnalia Research & Innovation and Biokeralty.

Funding entities:
ONKOimaging is an Elkartek project from the 2024 call. The Elkartek calls are grants from the Basque Government for collaborative research, carried out by the Research, Development, and Innovation Entities integrated into the Basque Network of Science, Technology, and Innovation of Euskadi, within the areas of specialization framed in the Euskadi 2030 Science, Technology, and Innovation Plan.

Area: #Genomics and personalized medicine

Line of research: Line 1 – Predictive medicine

CARAMEL: Cardiovascular Risk Assessment via multimodal data analysis enabling personalized prevention strategies targeting Menopausal Women

Description:
The goal of CARAMEL is to develop and validate a novel stratified approach for personalized prevention in women around the menopause transition (40-60yrs), enabled by a variety of diagnostic technologies (molecular biomarkers, imaging…) and digital data sources (EHR, cohorts, registries, biobanks…) leveraging multiple-data sources. CARAMEL investigates different approaches for data integration and computational modelling, developing state-of-the-art approaches in AI and personalized risk prediction.

The most successful data sources and CVD-RA models will be integrated into a novel stratified personalized prevention model adapted to different risk levels and primary and secondary prevention scenarios while considering existing evidence and women-specific risks and needs. It is complemented by a preventive smart mobile health intervention with a self-awareness, self-assessment and self-management strategy for reducing individual CVD risks, complemented by evidence-based clinical interventions and psychological and community-based support. Thus, CARAMEL is built upon women specific needs from a social, psychological, and biological perspective and in this way circumvent persisting barriers and biases in women’s CVD prevention, integrating a Gender in research dimension.

Objectives:
CARAMEL pursues the following Specific Objectives:

1. To develop different AI-based CVD-RA models and personalized prediction models targeting women aged 40 to 60y from large-scale retrospective multi-source data and evaluating their utility for CVD-RA.
2. To further develop and evaluate different CVD-RA AI models targeting women aged 40 to 60y from prospective data including women-specific risk factors and novel diagnostic data sources for CVD screening.
3. To advance in the biological understanding of women’s CVD risks, development and trajectories.
4. To deepen the knowledge on the women-specific risk factors (RFs) and their impact and deal with persisting barriers and biases that limit more effective CVD prevention in women.
5. To develop a personalized, stratified, CVD preventive intervention model for women aged 40 to 60y.
6. To disseminate the results of the personalized, stratified prevention scheme and supporting novel CVDRA models and technologies and evaluate its potential for adoption in public health and healthcare settings.
7. To assess the regulatory pathway implications leading to the clinical validation of the model and tools and to develop appropriate business and exploitation plans to maximize the impact of the developments.
8. To engage women and other end-users and R&I initiatives in CARAMEL co-creation, participation, evaluation, dissemination, adoption and empowerment to overcome barriers in women CVD prevention.

BioKeralty’s participation:
BioKeralty will support health economics and regulatory assessment.

Partners:
Coordinated by Vicomtech, the project includes participation from A3Z advanced, Keralty SAS, Edgeneering Lda, iBreve Limited, Magdalena Clinic, AE. Megi Health, Ethniko Kai Kapodistriako Panepistimio Athino, Servicio Andaluz de Salud, Fundacion Publica Andaluza para la gestion de la investigacion en salud de Sevilla, SocialIT Software e Consulting SRL, Trinity College Dublin, Tree Technology SA, Viesoji Istaiga Vilniaus Universiteto Ligonine Santaros Klinikos, Asociacion Centro de Investigacion Cooperativa en Biociencias, Exploraciones Radiológicas Especiales S.L., G Pace Ltd – Heart Rhythm Ireland, Dublin City University, Tampereen Korkeakoulusaatio SR – Tampere University, Ulma Medical Technologies S Coop, Ben-Gurion University of The Negev, Smartnanosense Innovation, Asociación Instituto de Investigación Sanitaria Biogipuzkoa, Timelex and the BIOKERALTY Research Institute.

Funding entities:
CARAMEL has received funding from the European Union´s Horizon Europe research and innovation programme under grant agreement Nº101156210.