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WE BOOST BIOMEDICAL RESEARCH

”All our efforts on a single objective: cure Multiple Sclerosis”

GAEM Foundation accelerates the following types of projects:

  • Innovative drugs and advanced therapies.
  • New diagnostic biomarkers.
  • Medical devices and apps (health) that improve quality of life.

In biomedicine, the creation of new therapies or drugs, biomarkers and medical devices entails a long and costly research and development (R&D) process which actually ends in very few products reaching the patient. Our aim is shortening as much as possible the time it takes for these products to reach the patients.

Drugs

Biomarkers

Medical devices

E-health apps

PROJECT ACCELERATOR PROGRAMME

The Multiple Sclerosis Project Accelerator, a unique model in Europe among the MS organisations, which streamlines and reduces the risks involved in the transfer of potential products and innovative technologies from academia to companies, and from companies to society.

The input flow of the Accelerator is shown in the following diagram:

Originating from calls and contacts, basic science projects are presented to the GAEM’s Scientific Committee.

With the potential to be transformed into therapies, biomarkers or improvements in quality of life.

In the medium-term (3-7 years).
(3-7 anys).

Fundable with a biotech model.

With an entrepreneur team.

Creation of an entrepreneur team.

Mentoring.

Business plan.

Funding.

Creation of alliances.

PROJECTS IN THE PIPELINE

Project for Cellular Immune Tolerance Therapy “TolDec EM/NMO”

Esclerosis Múltiple y Neuromielitis ÓpticaProject in development at the Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) and the Hospital Clínic of Barcelona.

Incorporation to the GAEM Accelerator programme: in 2012

Cellular Immune Tolerance Therapy employs dendritic cells from patients pulsed with myelin peptides to regulate the autoimmune attack on myelin.

It is a pioneering technique worldwide that seeks to achieve greater efficiency and minimize side effects.

Specific antigen therapy with dendritic cells aims to:

  • Modulate the patient’s defenses in a very specific and selective way, to slow down the inflammation that causes multiple sclerosis without altering the rest of the defenses.
  • Minimize the adverse effects of the treatment (thanks to the use of the patient’s own cells) regarding the therapies currently available.

Clinical Phase:

Phase Ib was initiated in June 2015 with 12 patients with progressive and relapsing-remitting multiple sclerosis, and with Neuromyelitis Optica, in order of evaluating the safety of the treatment.

In 2018 an extension of the clinical phase Ib was started with 10 patients, the objective of which was to confirm the safety of the treatment with a single chosen dose and to evaluate certain relevant biochemical markers of neuroinflammation.

The extension of phase Ib is expected to be completed in 2019 and, based on the results obtained, Clinical Phase II would be started to determine the efficacy of the treatment in patients and to continue with the assessment of its safety.

Preclinical data show that myelin peptides are incorporated into 90% of the treated cells, resulting in improvements in the severity of Multiple Sclerosis in animal models, and have no toxic effects.

Data from clinical phase Ib, completed in May 2017, prove the safety of the treatment administered to individuals.

This treatment would prevent the progression of the disease, since the patient’s own cells, already treated, would not present the autoimmune attack reaction to the myelin sheath. Therefore, the deterioration of myelin and the consequent physical and cognitive effects caused by Multiple Sclerosis would be avoided.

The specific Scientific Committee that was specifically set up for this project it is formed by the following members:

Dr. Pablo Villoslada (President): Director of the MS pathogenesis and therapeutics group, IDIBAPS; National Coordinator of the Spanish Network of Excellence in Multiple Sclerosis (REEM), Carlos III Health Institute; member of the Scientific Advisory Board of the International Society of Neuroimmunology; member of the MS Scientific Advisory Board en el enfoque de las sociedades de Multiple Sclerosis International Federation; a member of the editorial board of the journal PlosOne and a member of the American Academy of Neurology, the International Society of Neuroimmunology, the American Association for the Advancement of Science, the Spanish Society of Neurology and the Catalan Society of Neurology. His research is focused on the system biology analysis of neurological diseases and the translational study of neurology: new therapies and biomarkers. Dr. Villoslada has received several awards and mentions and has written several publications in scientific journals.

Prof. Dr. Roland Martin: An internationally renowned expert in Multiple Sclerosis and Neuroimmunology, with a focus on the function and development of new immunological treatments. He has previously worked in the universities of Würzburg and Tubinga (Germany), the National Institutes of Health, Bethesda (USA), the Multiple Sclerosis Centre of Catalonia (Barcelona) and the University of Hamburg (Germany) and is currently working in the MS Neuroimmunology and Research department of the University of Zurich (Switzerland). The focus of his research is on obtaining a greater understanding of the heterogeneity of multiple sclerosis by using imaging techniques (magnetic resonance and optical coherence tomography), biological markers and also of motor function. He studies the mechanisms of multiple sclerosis, focusing particularly on cellular and biochemical immunology. He specializes in areas of unmet medical needs in MS, such as neuroprotection, tolerance induction and regenerative therapies.

Prof. Dr. Lawrence Steinman: Professor of Neurology, Neurological Sciences and Paediatrics at Stanford University, and also President of the Stanford Program in Immunology from 2001 to 2011. His research focuses on the causes of remissions and relapses in MS and NMO, and the search for a specific antigen therapy. He is also developing a small therapeutic molecule for use in Huntington’s disease trials. He was the lead author of the paper published in 1992 that led to the development of Tysabri, a drug approved for treating Crohn’s disease and MS. Prof. Steinman has numerous patents, more than 40. He was also the co-founder of several biotechnology companies. He was Director of Centocor from 1988 until its sale to Johnson & Johnson.

Dr. Christian Von Buedingen: Winner of the Helmut Bauer Prize for Research in Engineering at the University of Göttingen (Germany). His work was funded by NIH / NINDS, the National Multiple Sclerosis Society, the Nancy Davis Foundation for MS Research, Small Ventures USA / Brass Family Foundation, through a donation from the Rachleff Family Foundation, and through scientific collaborations with the industry (Roche, Genentech, and Pfizer). He is a physician-scientist and was Distinguished Professor of Neurology at UCSF III between 2009 and 2016. His research focuses on B cells and antibody-mediated immunity in disorders related to multiple sclerosis. He was a clinical provider for the Multiple Sclerosis Centre of the UCSF from 2009 to 2014. Since 2016 he has held a position in translational medicine (Neuroscience) at the USCF (Switzerland).

Prof. Dr. Heinz Wiendl: Studied psychology and medicine and was a researcher at various centres and universities in Germany, in different departments, including Immunology and Neurology. He was professor of Neurology and Head of the Clinical Research Group for Multiple Sclerosis and Neuroimmunology at the University of Würzburg (Germany), Professor and Head of Neurology of Inflammatory Diseases of the Nervous System and Neuro-Oncology at the University of Münster (Germany) and was Dean of Research and Young Scientists at the Medical Faculty in Münster. His research focuses on leukocyte penetration of the blood-brain barrier, the functional interactions between the immune system and the nervous system and the mechanism of TREK1-mediated T lymphocyte transmigration via the blood-brain barrier.

This project is financed by:

Developed by:

clinicidibaps

Project AT01

Accure Therapeutics is the result of the merger of Bionure, is a start-up emerged from the Hospital Clínic of Barcelona / IDIBAPS, based in Barcelona and San Francisco (USA), and Iproteos.

Incorporation to the GAEM Accelerator programme: in 2016.

Accure Therapeutics website

OCS-05 (previously ACT-01 and BN201) is a first-in-class molecule with the dual ability of protecting neurons and regenerating the damaged myelin through a new mechanism of action. These gives it the potential to prevent axonal injury and to promote the survival of neuronal cells.

The preclinical development (in animal models) and the preclinical regulatory phase of the project were completed in 2017.

The clinical phase I, during which its safety will be assessed in humans, started in 2018 and was completed in 2019.

Accure Therapeutics will start clinical phase II in 2020, when the eficacy of AT01 will be tested in MS patients. This same year Bionure completed the merger with Iproteos to become Accure Therapeutics.

In 2022, Accure Therapeutics signed a license agreement with Oculis for the development and commercialization of ACT-01, which has been renamed OCS-05.

The results obtained in animals show a significant reversal of neuron loss, demyelination and axonal damage in various types of MS.

 

This drug would have neuroprotective effects, as well as the ability to restore and remyelinate the cell population. Therefore it could halt some effects of the disease.

This project is financed by:

 

 

Project mentored by:

3D Neuroimaging Platform

QMENTA is a start-up specialized in science and engineering, pioneering the creation of 3D neuroimaging platforms for medical diagnosis.

Incorporation to the GAEM Accelerator: in June 2017

♦ QMENTA website

(hacer clic en imagen para ver vídeo)

QMENTA is an image-based diagnosis start-up that uses the latest technologies in the image treatment. Its objective is to detect new markers that could allow to improve the diagnosis of Multiple Sclerosis and the segmentation of patients for a better treatment.

Matching the images of different diagnostic techniques, QMENTA elaborates detailed three-dimensional maps of the human brain that allow to:

  • Identify the damaged regions and assess the degree of demyelination
  • Detect if there is a relationship between affected regions
  • Track the evolution of disease symptoms and side effects of treatments

Some preliminary studies have already been performed and the technology is being validated and refined for its future application in MS patients.

The 3D neuroimaging platform is a valuable tool and help for medical experts, enabling them to:

  • Improve the diagnosis of brain diseases in a non-invasive way
  • Optimize the process of drug development and accelerate clinical trials
  • Interpret information about patients more quickly and with more reliability, therefore making possible to improve and customize the treatments

3D Neuroimaging Platform

The final objective of the collaboration between QMENTA and GAEM Foundation is to improve the diagnosis of MS affected people and to follow in detail the evolution of the brain lesions caused by the disease, as well as the side effects of the treatments.

In this way, the early diagnosis of the disease is facilitated and therapies can be customized to the maximum, depending on how the disease is expressed in each person.

This project is developed by:

Project mentored by:

Research for detecting blood biomarkers of multiple sclerosis

IDIBGI – Institut d’Biomedical Research of Girona

Incorporation to the GAEM Accelerator: in April 2019

IDIBGI website

There is scientific evidence that both genetic and environmental factors influence the pathogenesis of multiple sclerosis. Epigenetics is a key factor in understanding the gene-environment relationship and consequently the origin of MS. Our research focuses on the epigenetic study of homogeneous cell types (B and T lymphocytes) at the time of diagnosis of the disease and in more progressive stages. Our working hypothesis is based on the fact that epigenetic changes in these cell types can facilitate the clinical manifestation and progression of this disease. This study has 3 main objectives:

  • To determine the epigenetic profile of these cell types from peripheral blood in patients newly diagnosed with MS and in more progressive stages of the disease.
  • Validate the results obtained in blood at the level of the cerebrospinal fluid and the Central Nervous System.
  • Determine biomarkers of the disease at the time of diagnosis and in the progressive phases of the disease in order to predict the evolution of the disease and potential therapeutic targets.

This is a basic research project which studies lymphocyte populations from 10 newly diagnosed patients and 10 healthy controls matched by age, sex and education level. We will also study blood B and T lymphocytes from 10 subjects with secondary progressive MS. The validation of the results will be done both in cerebrospinal fluid and in brain tissue from deceased donors with MS. For the epigenetic study of lymphocyte populations, avant-garde techniques based on massive sequencing will be used.

To be able to predict by a simple extraction of blood how the patient will evolve, how many outbreaks it will have, how often it will suffer these outbreaks in the course of the disease. It will allow us to advance in the design of personalized pharmacological treatments that reverse the epigenetic alterations observed in patients with MS .

We believe that research on epigenetic biomarkers will provide more tools in clinical practice to predict the evolution of the disease. The design of drugs aimed at correcting the epigenetics of the cells of the immune system will make it possible to avoid the autoimmune reaction, neurodegeneration and therefore the progression of this disease.

This project is developed by:

Project mentored by:

R

ALA Diagnostics

ALA Diagnostics is a start-up seeking to develop a cheaper, easy to implement and less invasive multiple sclerosis kit than the ones available today.

Incorporation to the GAEM Acceletator: 2020

ALA Diagnostics website

ALA Diagnostics is born after identifying an opportunity to use a protein -which it has been patented and tested over 500 times in a lab enviroment-  as a MS diagnostic kit.

Until now, the protein it has been identified as a biomarker, while developing the ELISA method of detection. Both have been tested with great results in patients, hence we consider all the lab testing to be succesful.

In the next few month the test kit will be improved and comercial approval will be submited.

ALA Diagnostics test kit only requires a blood test, whilst other diagnostic test are expensive, invasive and slow to show results.

The test kit is design to be easily integrated within the clinical routine of hospitals and medical centers, providing accurate results.

The lack of an early diagnose of multiple sclerosis is a great issue for the patients, because the sooner the treatment starts, the better the outcome for the patient in the future. ALA Diagnostics test kit allows an early, cheap and widespread diagnose that could help thousands of new patients every year.

This project is developed by:

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Project mentored by:

Intramedullary electrical stimulation therapy

Intramedullary electrical stimulation therapy

The GAEM Foundation has created this new project, an intramedullary electrical stimulation therapy, which would improve the motor and ambulation capacity of patients with multiple sclerosis and would allow them to largely recover their functional independence, as well as improve their quality of life.

This spinal cord electrical stimulation therapy could be applied to other patients with traumatic spinal cord injury, due to tumors, stroke, or other injuries.

Incorporation to the GAEM Accelerator: January 2022

Therapeutic program that requires a neurosurgical intervention for the implantation of the electrodes in the spinal cord, combined with a rehabilitation program of 6 to 12 months.

In 2018, three teams from Lausanne, Mayo Clinic and Louisville showed the benefits of epidural electrical stimulation in patients with traumatic spinal cord injury through a similar program. Now we want to test its effectiveness in patients with multiple sclerosis.

The objective of our project is to evaluate the safety, tolerability and obtain signs of efficacy of spinal cord stimulation in MS patients with moderate-severe spinal cord injury.

To this end, an open pilot study is to be carried out in a single center in 10 patients with MS and moderate-severe spinal cord sequelae (EDSS = 7.0) who would be treated with spinal cord stimulation over a period of 12 months.

MS affects 55,000 people in Spain and there is no cure. It produces lesions throughout the central nervous system, particularly in the spinal cord, which constitute the main cause of disability, since they produce paralysis of the lower and upper extremities, sensory loss and urinary incontinence in affected people.

Recovery from spinal cord sequel is critical to improve the quality of life of people with spinal cord injury (MS, traumatic, tumors, etc.)

Half of people with multiple sclerosis, if left untreated, can develop serious sequelae including paraplegia, requiring them to use a wheelchair.

The recovery of the spinal cord sequela through intramedullary electrical stimulation therapy would improve the motor and ambulation capacity of patients with multiple sclerosis, which would make it easier for them to largely recover their functional independence and, consequently, improve their quality of life.

This project will be developed in the Neurology Service
of the Hospital Clínico de Santiago de Compostela

Project mentored by:

OUR CALLS

If you would like to be part of our Project Accelerator Programme please see the terms and conditions and application forms:

Download the files

Terms and Conditions

Application Form

Evaluation Criteria

Draft Contract

Information reviewed and validated by: Dra. Marta Príncep.

With the support of:

Solidarity entities:

Last update: 2 January 2023